Guselkumab History and Updates

240 events · 2013 – present

Synced daily from openFDA and ClinicalTrials.gov. Last sync: September 24, 2026.

FDA Approvals

Label Revisions

335

Trial Milestones

Pivotal Publications

Source: openFDA, ClinicalTrials.gov via AACT, PubMed · Hipa.ai, 2026-09-01Download chart as PNG

This page tracks every FDA action, clinical trial milestone, and major publication for Guselkumab since 2013, drawn from openFDA, ClinicalTrials.gov, and PubMed.

All published updates (30)

2026

Results postedGuselkumab Plus Golimumab Improves Psoriatic Arthritis ACR 50 Response· Jul 23, 2026
Results postedGuselkumab Phase 3: Plaque & Scalp Psoriasis IGA 0/1 up to 74% in Skin of Color· Jun 24, 2026
Results postedGuselkumab Alters CD4+ and CD8+ T-Cell Levels in Psoriasis Study· Jun 23, 2026
Label revisionTremfya Label Updated for Pediatric Plaque Psoriasis Patients 6+ Years· Jun 4, 2026
Results postedGuselkumab Phase 3 Trial Shows Efficacy in Moderate Plaque Psoriasis· May 1, 2026
Results postedGuselkumab Phase 3 for Psoriatic Arthritis Shows Superior ACR20 Response· Feb 4, 2026
Primary completionGuselkumab Phase 3 Trial in Juvenile Psoriatic Arthritis Completes Primary Data· Jan 12, 2026

2025

Results postedGuselkumab Phase 3 for Ulcerative Colitis Shows Improved Clinical Remission· Dec 9, 2025
Results postedGuselkumab Shows Improved Psoriatic Arthritis ACR20 Response vs. Placebo· Dec 8, 2025
FDA approval (supplemental)Tremfya (Guselkumab) Receives FDA Supplemental Efficacy Approval· Sep 26, 2025
FDA approval (supplemental)Tremfya (guselkumab) Receives FDA Supplemental Approval for Efficacy· Sep 26, 2025
FDA approval (supplemental)FDA Approves Supplemental Efficacy Application for Guselkumab (Tremfya)· Sep 19, 2025
Results postedGuselkumab Phase 2 Trial in Giant Cell Arteritis Posts Remission Data· Jul 1, 2025
Primary completionGuselkumab Phase 3 Psoriasis Trial in Skin of Color Completes Primary Data· May 30, 2025
Results postedGuselkumab Phase 3 Crohn's Disease Trial Reports Safety Data· May 20, 2025
Results postedGuselkumab Improves Crohn's Disease Activity and Remission in Phase 2/3 Trial· May 7, 2025
Primary completionGuselkumab Phase 3 for Moderate Plaque Psoriasis Hits Key Efficacy Endpoints· Apr 14, 2025
Results postedGuselkumab Shows Significant Efficacy in Pediatric Plaque Psoriasis Trial· Mar 28, 2025
FDA approval (supplemental)Tremfya (Guselkumab) Receives FDA Supplemental Efficacy Approval· Mar 20, 2025
Results postedGuselkumab Achieves High Clinical Remission Rates in Crohn's Disease Trial· Feb 21, 2025
Pivotal publicationGuselkumab Efficacy and Safety for Crohn's Disease Published· Jan 1, 2025
Pivotal publicationGuselkumab QUASAR Phase 3 Data Published for Ulcerative Colitis· Jan 1, 2025

2024

Primary completionGuselkumab Phase 3 for Psoriatic Arthritis Shows Higher ACR20 Response· Dec 30, 2024
Primary completionGuselkumab Phase 3 for Psoriatic Arthritis Shows Improved ACR20 Response· Oct 28, 2024
Primary completionGuselkumab Phase 3 for Ulcerative Colitis Shows Improved Clinical Remission· Apr 2, 2024

2023

Primary completionGuselkumab Phase 3 for Pediatric Psoriasis: IGA (0/1) 65.9% vs. Placebo 16.0%· Jul 19, 2023
Primary completionGuselkumab Phase 3 for Crohn's Disease Shows Improved Remission· Jul 4, 2023

2020

Pivotal publicationGuselkumab DISCOVER-1 Psoriatic Arthritis Trial Results Published· Jan 1, 2020
Pivotal publicationGuselkumab DISCOVER-2 Phase 3 Trial Results for Psoriatic Arthritis Published· Jan 1, 2020

2019

Primary completionGuselkumab Phase 3 for Psoriatic Arthritis Shows Significant ACR20 Improvement· Feb 25, 2019

Upcoming & expected milestones

Primary completionOct 31, 2026· ClinicalTrials.gov

Phase 3 primary completion: NCT05669833

Guselkumab vs Golimumab in PsA TNF Inadequate Responder Patients

Primary completionNov 20, 2026· ClinicalTrials.gov

Phase 1 primary completion: NCT07788807

A Study to Investigate How Well an Intracolonic Formulation of Two Monoclonal Antibodies is Tolerated in Healthy Participants and the Abilit

Primary completionDec 31, 2026· ClinicalTrials.gov

Phase 4 primary completion: NCT05004727

Multi-Center PAMPA Study

Primary completionDec 31, 2026· ClinicalTrials.gov

Phase 2 primary completion: NCT06651489

Efficacy of Guselkumab in Treating Hailey Hailey Disease

Primary completionJan 1, 2027· ClinicalTrials.gov

Phase 2/Phase 3 primary completion: NCT05535738

Using a Contact Dermatitis Model With Biologic Medications to Study Skin Inflammation

Primary completionFeb 10, 2027· ClinicalTrials.gov

Phase 3 primary completion: NCT06260163

A Study of Guselkumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis

Primary completionMar 25, 2027· ClinicalTrials.gov

Phase 3 primary completion: NCT05347095

A Study of Guselkumab in Participants With Fistulizing, Perianal Crohn's Disease

Primary completionApr 1, 2027· ClinicalTrials.gov

Phase 4 primary completion: NCT04929210

A Study of Guselkumab Administered Subcutaneously in Bio-naive Participants With Active Psoriatic Arthritis Axial Disease

Primary completionJun 5, 2027· ClinicalTrials.gov

Phase 4 primary completion: NCT07141004

A Study of Guselkumab Administered Subcutaneously in Treatment of Indian Participants With Psoriatic Arthritis (PsA)

Primary completionJun 8, 2027· ClinicalTrials.gov

Phase 3 primary completion: NCT06408935

Transmural Healing and Disease-Modifying Effect of Guselkumab in Crohn's Disease Patients

Primary completionJul 10, 2027· ClinicalTrials.gov

NA primary completion: NCT07532486

A Study to Evaluate Comparative Efficacy and Safety of Guselkumab in High-dose and Extended-interval Versus Standard-dose in Chinese Partici

Primary completionAug 1, 2027· ClinicalTrials.gov

Primary completion: NCT05049798

A Study of Guselkumab and Interleukin-17 (IL-17) Inhibitor Therapies in Participants With Psoriatic Arthritis in Routine Clinical Practice

Primary completionAug 13, 2027· ClinicalTrials.gov

Phase 2 primary completion: NCT06563323

Guselkumab in the Treatment of Adults With Pyoderma Gangrenosum (PG)

Primary completionAug 31, 2027· ClinicalTrials.gov

Phase 4 primary completion: NCT07654751

A Study to Assess Concentration of TREMFYA in Breast Milk of Lactating Women Who Are Receiving TREMFYA Therapeutically

Primary completionSep 1, 2027· ClinicalTrials.gov

NA primary completion: NCT06586281

Elucidating Shared Mechanisms Contributing to NAFLD and PsA Disease Severity With Guselkumab Therapy

Primary completionSep 15, 2027· ClinicalTrials.gov

Phase 4 primary completion: NCT07310095

A Study to Evaluate the Efficacy of Guselkumab in Chinese Participants With Crohn's Disease (CD)

Primary completionSep 30, 2027· ClinicalTrials.gov

Primary completion: NCT07246460

Ultrasound and Proteomics for Guselkumab Response Assessment in Crohn's Disease (UPGRADE).

Primary completionSep 30, 2027· ClinicalTrials.gov

Phase 2 primary completion: NCT07138898

Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty

Primary completionOct 27, 2027· ClinicalTrials.gov

Phase 3 primary completion: NCT05923073

A Study of Guselkumab in Pediatric Participants With Moderately to Severely Active Crohn's Disease

Primary completionNov 1, 2027· ClinicalTrials.gov

Primary completion: NCT07245394

Switching to the IL-23 Inhibitor Guselkumab for People With Active IBD Who Previously Used Ustekinumab (SHIFT-IBD)

Primary completionDec 30, 2027· ClinicalTrials.gov

Phase 3 primary completion: NCT07511647

A Phase 3 Clinical Study of QL2106 Injection

Primary completionDec 31, 2027· ClinicalTrials.gov

NA primary completion: NCT05503875

Immunoclassification of Psoriasis: a Strategy for Precision Medicine

Primary completionDec 31, 2027· ClinicalTrials.gov

Primary completion: NCT07487311

A Prospective Cohort Study Evaluating the Efficacy and Safety of Guselkumab (GUS) With JAK Inhibitors in Patients With Difficult-To-Treat In

Primary completionJan 31, 2028· ClinicalTrials.gov

Phase 2 primary completion: NCT07138898

Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty

Primary completionMar 1, 2028· ClinicalTrials.gov

Phase 4 primary completion: NCT06398106

Proactive TDM Versus Standard Use of Biologics in Psoriasis

Primary completionMay 20, 2028· ClinicalTrials.gov

Primary completion: NCT07602517

Guselkumab for Overlap Inflammatory Bowel Disease and Spondyloarthritis

Primary completionMay 22, 2028· ClinicalTrials.gov

Phase 3 primary completion: NCT06260163

A Study of Guselkumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis

Primary completionMay 30, 2028· ClinicalTrials.gov

Phase 4 primary completion: NCT06916390

GUselkumAb inteRvention and DIet evaluAtioN for Pouchitis

Primary completionJun 12, 2028· ClinicalTrials.gov

Phase 3 primary completion: NCT07577843

A Study of JNJ-78934804 in Participants With Moderately to Severely Active Crohn's Disease

Primary completionJun 30, 2028· ClinicalTrials.gov

Phase 4 primary completion: NCT05858632

Immune Spatial Features of Guselkumab Cutaneous Response

Primary completionAug 11, 2028· ClinicalTrials.gov

Phase 3 primary completion: NCT07577856

A Study of JNJ-78934804 in Participants With Moderately to Severely Active Ulcerative Colitis

Primary completionNov 15, 2028· ClinicalTrials.gov

Phase 3 primary completion: NCT07499232

A Study of Guselkumab Versus Risankizumab in Participants With Moderately to Severely Active Crohn's Disease

Primary completionDec 31, 2028· ClinicalTrials.gov

Primary completion: NCT07528040

An Observational, Multicenter Study to Evaluate the Effectiveness of Guselkumab for the Treatment of Participants With Crohn's Disease After

Primary completionDec 31, 2028· ClinicalTrials.gov

Primary completion: NCT07444060

Guselkumab Vs Ustekinumab in Stricturing Crohn's Disease

Primary completionDec 31, 2028· ClinicalTrials.gov

Primary completion: NCT07726888

Efficacy and Safety of Guselkumab in Patients With Moderate-to-Severe Ulcerative Colitis

Primary completionMar 15, 2029· ClinicalTrials.gov

Phase 4 primary completion: NCT07616687

Optimal Care With Guselkumab in Crohn's Disease / OPTIM Study A Prospective Open Label Interventional, Multicenter Study

Primary completionMay 31, 2030· ClinicalTrials.gov

Primary completion: NCT02103361

Stelara and Tremfya Pregnancy Exposure Registry OTIS Autoimmune Diseases in Pregnancy Project

Primary completionJun 1, 2030· ClinicalTrials.gov

Phase 4 primary completion: NCT07352566

Utilization of a Microdevice for Psoriasis and Atopic Dermatitis

Primary completionMay 31, 2031· ClinicalTrials.gov

Primary completion: NCT07448402

Costa Rican Registry of IL-23 Inhibitors in Psoriatic Disease

Primary completionDec 12, 2031· ClinicalTrials.gov

Phase 3 primary completion: NCT06663332

A Long-term Extension (LTE) Study of Guselkumab in Pediatric Participants

Past events

2026

Trial startedOct 1, 2026· ClinicalTrials.gov

Phase 4 trial started: NCT07654751

A Study to Assess Concentration of TREMFYA in Breast Milk of Lactating Women Who Are Receiving TREMFYA Therapeutically

Primary completionSep 30, 2026· ClinicalTrials.gov

Primary completion: NCT06249555

VOICE-Early Response to Vedolizumab and IL-23 Antagonists in Participants With Crohn's Disease: A Prospective Observational Study

Trial startedSep 15, 2026· ClinicalTrials.gov

Phase 1 trial started: NCT07788807

A Study to Investigate How Well an Intracolonic Formulation of Two Monoclonal Antibodies is Tolerated in Healthy Participants and the Abilit

Primary completionSep 1, 2026· ClinicalTrials.gov

NA primary completion: NCT06586281

Elucidating Shared Mechanisms Contributing to NAFLD and PsA Disease Severity With Guselkumab Therapy

Trial registeredAug 26, 2026· ClinicalTrials.gov

Phase 1 trial registered on ClinicalTrials.gov: NCT07788807

A Study to Investigate How Well an Intracolonic Formulation of Two Monoclonal Antibodies is Tolerated in Healthy Participants and the Abilit

Primary completionAug 4, 2026· ClinicalTrials.gov

Phase 4 primary completion: NCT04929210

A Study of Guselkumab Administered Subcutaneously in Bio-naive Participants With Active Psoriatic Arthritis Axial Disease

Trial startedAug 1, 2026· ClinicalTrials.gov

Phase 4 trial started: NCT07352566

Utilization of a Microdevice for Psoriasis and Atopic Dermatitis

Trial startedAug 1, 2026· ClinicalTrials.gov

Trial started: NCT07726888

Efficacy and Safety of Guselkumab in Patients With Moderate-to-Severe Ulcerative Colitis

Trial registeredJul 24, 2026· ClinicalTrials.gov

Trial registered on ClinicalTrials.gov: NCT07726888

Efficacy and Safety of Guselkumab in Patients With Moderate-to-Severe Ulcerative Colitis:A Real-World Prospective Cohort Study.

Results postedJul 23, 2026· ClinicalTrials.gov

Trial results posted: NCT05071664

A Study of Guselkumab and Golimumab Combination Therapy in Participants With Active Psoriatic Arthritis

Primary completionJun 30, 2026· ClinicalTrials.gov

Phase 4 primary completion: NCT05858632

Immune Spatial Features of Guselkumab Cutaneous Response

Primary completionJun 30, 2026· ClinicalTrials.gov

Primary completion: NCT06249555

VOICE-Early Response to Vedolizumab and IL-23 Antagonists in Participants With Crohn's Disease: A Prospective Observational Study

Results postedJun 24, 2026· ClinicalTrials.gov

Trial results posted: NCT05272150

Study of Guselkumab in Skin of Color Participants With Moderate-to-severe Plaque and/or Scalp Psoriasis

Results postedJun 23, 2026· ClinicalTrials.gov

Trial results posted: NCT04645355

Guselkumab Immunogenetics

Trial registeredJun 17, 2026· ClinicalTrials.gov

Phase 4 trial registered on ClinicalTrials.gov: NCT07654751

A Study to Assess Concentration of TREMFYA in Breast Milk of Lactating Women Who Are Receiving TREMFYA Therapeutically

Trial startedJun 15, 2026· ClinicalTrials.gov

Phase 3 trial started: NCT07511647

A Phase 3 Clinical Study of QL2106 Injection

Label revisionJun 4, 2026· FDA

Indication and usage updated on TREMFYA label (effective 2026-06-04)

1 INDICATIONS AND USAGE TREMFYA is an interleukin-23 antagonist indicated for the treatment of: adults and pediatric patients 6 years of age and older who also weigh at least 40 kg with moderate-to-severe plaque psoriasis and who are candid

Trial registeredJun 1, 2026· ClinicalTrials.gov

Phase 4 trial registered on ClinicalTrials.gov: NCT07616687

Optimal Care With Guselkumab in Crohn's Disease / OPTIM Study A Prospective Open Label Interventional, Multicenter Study

Trial startedJun 1, 2026· ClinicalTrials.gov

Phase 4 trial started: NCT07616687

Optimal Care With Guselkumab in Crohn's Disease / OPTIM Study A Prospective Open Label Interventional, Multicenter Study

Trial startedMay 31, 2026· ClinicalTrials.gov

Trial started: NCT07448402

Costa Rican Registry of IL-23 Inhibitors in Psoriatic Disease

Trial startedMay 29, 2026· ClinicalTrials.gov

Phase 3 trial started: NCT07577856

A Study of JNJ-78934804 in Participants With Moderately to Severely Active Ulcerative Colitis

Trial startedMay 29, 2026· ClinicalTrials.gov

Phase 3 trial started: NCT07577843

A Study of JNJ-78934804 in Participants With Moderately to Severely Active Crohn's Disease

Trial registeredMay 22, 2026· ClinicalTrials.gov

Trial registered on ClinicalTrials.gov: NCT07602517

Guselkumab for Overlap Inflammatory Bowel Disease and Spondyloarthritis

Trial registeredMay 11, 2026· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT07577856

A Study of JNJ-78934804 in Participants With Moderately to Severely Active Ulcerative Colitis

Trial registeredMay 11, 2026· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT07577843

A Study of JNJ-78934804 in Participants With Moderately to Severely Active Crohn's Disease

Results postedMay 1, 2026· ClinicalTrials.gov

Trial results posted: NCT06039189

Study of Guselkumab Versus Placebo for the Treatment of Low Body Surface Area Moderate Plaque Psoriasis

Primary completionApr 30, 2026· ClinicalTrials.gov

Phase 2 primary completion: NCT06651489

Efficacy of Guselkumab in Treating Hailey Hailey Disease

Trial startedApr 23, 2026· ClinicalTrials.gov

Phase 4 trial started: NCT06916390

GUselkumAb inteRvention and DIet evaluAtioN for Pouchitis

Trial startedApr 20, 2026· ClinicalTrials.gov

Phase 3 trial started: NCT07499232

A Study of Guselkumab Versus Risankizumab in Participants With Moderately to Severely Active Crohn's Disease

Trial registeredApr 16, 2026· ClinicalTrials.gov

NA trial registered on ClinicalTrials.gov: NCT07532486

A Study to Evaluate Comparative Efficacy and Safety of Guselkumab in High-dose and Extended-interval Versus Standard-dose in Chinese Partici

Primary completionApr 16, 2026· ClinicalTrials.gov

Primary completion: NCT07430319

Real-Life Evaluation of Guselkumab Dosing Interval Adjustments

Trial startedApr 15, 2026· ClinicalTrials.gov

Trial started: NCT07528040

An Observational, Multicenter Study to Evaluate the Effectiveness of Guselkumab for the Treatment of Participants With Crohn's Disease After

Trial registeredApr 14, 2026· ClinicalTrials.gov

Trial registered on ClinicalTrials.gov: NCT07528040

An Observational, Multicenter Study to Evaluate the Effectiveness of Guselkumab for the Treatment of Participants With Crohn's Disease After

Trial registeredApr 6, 2026· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT07511647

A Phase 3 Clinical Study of QL2106 Injection

Trial registeredMar 30, 2026· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT07499232

A Study of Guselkumab Versus Risankizumab in Participants With Moderately to Severely Active Crohn's Disease

Trial registeredMar 23, 2026· ClinicalTrials.gov

Trial registered on ClinicalTrials.gov: NCT07487311

A Prospective Cohort Study Evaluating the Efficacy and Safety of Guselkumab (GUS) With JAK Inhibitors in Patients With Difficult-To-Treat In

Trial registeredMar 4, 2026· ClinicalTrials.gov

Trial registered on ClinicalTrials.gov: NCT07448402

Costa Rican Registry of IL-23 Inhibitors in Psoriatic Disease

Trial registeredMar 2, 2026· ClinicalTrials.gov

Trial registered on ClinicalTrials.gov: NCT07444060

Guselkumab Vs Ustekinumab in Stricturing Crohn's Disease

Trial startedMar 1, 2026· ClinicalTrials.gov

Trial started: NCT07444060

Guselkumab Vs Ustekinumab in Stricturing Crohn's Disease

Trial registeredFeb 24, 2026· ClinicalTrials.gov

Trial registered on ClinicalTrials.gov: NCT07430319

Real-Life Evaluation of Guselkumab Dosing Interval Adjustments

Results postedFeb 4, 2026· ClinicalTrials.gov

Trial results posted: NCT04882098

A Study of Guselkumab in Participants With Active Psoriatic Arthritis

Trial startedJan 29, 2026· ClinicalTrials.gov

Trial started: NCT07245394

Switching to the IL-23 Inhibitor Guselkumab for People With Active IBD Who Previously Used Ustekinumab (SHIFT-IBD)

Trial registeredJan 20, 2026· ClinicalTrials.gov

Phase 4 trial registered on ClinicalTrials.gov: NCT07352566

Utilization of a Microdevice for Psoriasis and Atopic Dermatitis

Primary completionJan 12, 2026· ClinicalTrials.gov

Phase 3 primary completion: NCT05083182

A Study of Ustekinumab or Guselkumab in Pediatric Participants With Active Juvenile Psoriatic Arthritis

Trial startedJan 7, 2026· ClinicalTrials.gov

Trial started: NCT07487311

A Prospective Cohort Study Evaluating the Efficacy and Safety of Guselkumab (GUS) With JAK Inhibitors in Patients With Difficult-To-Treat In

Trial startedJan 1, 2026· ClinicalTrials.gov

Phase 4 trial started: NCT07352566

Utilization of a Microdevice for Psoriasis and Atopic Dermatitis

2025

Trial registeredDec 30, 2025· ClinicalTrials.gov

Phase 4 trial registered on ClinicalTrials.gov: NCT07310095

A Study to Evaluate the Efficacy of Guselkumab in Chinese Participants With Crohn's Disease (CD)

Trial startedDec 30, 2025· ClinicalTrials.gov

Phase 4 trial started: NCT07310095

A Study to Evaluate the Efficacy of Guselkumab in Chinese Participants With Crohn's Disease (CD)

Results postedDec 9, 2025· ClinicalTrials.gov

Trial results posted: NCT05528510

A Study of Guselkumab Therapy in Participants With Moderately to Severely Active Ulcerative Colitis

Results postedDec 8, 2025· ClinicalTrials.gov

Trial results posted: NCT04936308

Guselkumab in Active Psoriatic Arthritis Participants With Inadequate Response/Intolerance to One Prior Anti-TNF Alpha Agent

Trial registeredDec 1, 2025· ClinicalTrials.gov

Trial registered on ClinicalTrials.gov: NCT07255781

Shared Pathways Between Non-Alcoholic Fatty Liver Disease and Psoriatic Disease With Guselekumab Therapy

Trial startedNov 30, 2025· ClinicalTrials.gov

Trial started: NCT07255781

Shared Pathways Between Non-Alcoholic Fatty Liver Disease and Psoriatic Disease With Guselekumab Therapy

Primary completionNov 30, 2025· ClinicalTrials.gov

Primary completion: NCT07255781

Shared Pathways Between Non-Alcoholic Fatty Liver Disease and Psoriatic Disease With Guselekumab Therapy

Primary completionNov 27, 2025· ClinicalTrials.gov

Phase 4 primary completion: NCT06974474

Potential Role of Guselkumab in Modulating PAIN Perception and Related Gene Pathways: a Proof-of-concept Study.

Trial registeredNov 24, 2025· ClinicalTrials.gov

Trial registered on ClinicalTrials.gov: NCT07245394

Switching to the IL-23 Inhibitor Guselkumab for People With Active IBD Who Previously Used Ustekinumab (SHIFT-IBD)

Trial registeredNov 24, 2025· ClinicalTrials.gov

Trial registered on ClinicalTrials.gov: NCT07246460

Ultrasound and Proteomics for Guselkumab Response Assessment in Crohn's Disease (UPGRADE).

Trial startedOct 31, 2025· ClinicalTrials.gov

Trial started: NCT07246460

Ultrasound and Proteomics for Guselkumab Response Assessment in Crohn's Disease (UPGRADE).

Trial startedOct 16, 2025· ClinicalTrials.gov

Trial started: NCT07430319

Real-Life Evaluation of Guselkumab Dosing Interval Adjustments

Trial startedSep 30, 2025· ClinicalTrials.gov

Phase 2 trial started: NCT07138898

Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty

FDA approval (supplemental)Sep 26, 2025· FDA

FDA approved supplemental application for Tremfya (guselkumab) — Efficacy (BLA 761061 S-29)

Sponsor: JANSSEN BIOTECH. Class: Efficacy.

FDA approval (supplemental)Sep 26, 2025· FDA

FDA approved supplemental application for Tremfya (guselkumab) — Efficacy (BLA 761061 S-28)

Sponsor: JANSSEN BIOTECH. Class: Efficacy.

FDA approval (supplemental)Sep 19, 2025· FDA

FDA approved supplemental application for Tremfya (guselkumab) — Efficacy (BLA 761061 S-26)

Sponsor: JANSSEN BIOTECH. Class: Efficacy.

Trial registeredAug 26, 2025· ClinicalTrials.gov

Phase 4 trial registered on ClinicalTrials.gov: NCT07141004

A Study of Guselkumab Administered Subcutaneously in Treatment of Indian Participants With Psoriatic Arthritis (PsA)

Trial registeredAug 24, 2025· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT07138898

Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty

Trial startedAug 12, 2025· ClinicalTrials.gov

Phase 4 trial started: NCT07141004

A Study of Guselkumab Administered Subcutaneously in Treatment of Indian Participants With Psoriatic Arthritis (PsA)

Results postedJul 1, 2025· ClinicalTrials.gov

Trial results posted: NCT04633447

A Study to Evaluate Guselkumab for the Treatment of Participants With New-onset or Relapsing Giant Cell Arteritis

FDA approval (supplemental)Jun 17, 2025· FDA

FDA approved supplemental application for Tremfya (guselkumab) — Labeling (BLA 761061 S-30)

Sponsor: JANSSEN BIOTECH. Class: Labeling.

Trial startedJun 1, 2025· ClinicalTrials.gov

NA trial started: NCT06586281

Elucidating Shared Mechanisms Contributing to NAFLD and PsA Disease Severity With Guselkumab Therapy

Primary completionMay 30, 2025· ClinicalTrials.gov

Phase 3 primary completion: NCT05272150

Study of Guselkumab in Skin of Color Participants With Moderate-to-severe Plaque and/or Scalp Psoriasis

Primary completionMay 23, 2025· ClinicalTrials.gov

Phase 2 primary completion: NCT05242471

A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Crohn's Disease

Results postedMay 20, 2025· ClinicalTrials.gov

Trial results posted: NCT04397263

A Study of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease

Trial registeredMay 16, 2025· ClinicalTrials.gov

Phase 4 trial registered on ClinicalTrials.gov: NCT06974474

Potential Role of Guselkumab in Modulating PAIN Perception and Related Gene Pathways: a Proof-of-concept Study.

Primary completionMay 15, 2025· ClinicalTrials.gov

Phase 2 primary completion: NCT05242484

A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis

Results postedMay 7, 2025· ClinicalTrials.gov

Trial results posted: NCT03466411

A Study of the Efficacy and Safety of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease

Primary completionApr 14, 2025· ClinicalTrials.gov

Phase 3 primary completion: NCT06039189

Study of Guselkumab Versus Placebo for the Treatment of Low Body Surface Area Moderate Plaque Psoriasis

Trial registeredApr 8, 2025· ClinicalTrials.gov

Phase 4 trial registered on ClinicalTrials.gov: NCT06916390

GUselkumAb inteRvention and DIet evaluAtioN for Pouchitis

Primary completionApr 4, 2025· ClinicalTrials.gov

Phase 4 primary completion: NCT04645355

Guselkumab Immunogenetics

Results postedMar 28, 2025· ClinicalTrials.gov

Trial results posted: NCT03451851

A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneously Administered Guselkumab for the Treatment of Chronic Plaque

FDA approval (supplemental)Mar 25, 2025· FDA

FDA approved supplemental application for Tremfya (guselkumab) — Manufacturing (CMC) (BLA 761061 S-27)

Sponsor: JANSSEN BIOTECH. Class: Manufacturing (CMC).

FDA approval (supplemental)Mar 20, 2025· FDA

FDA approved supplemental application for Tremfya (guselkumab) — Efficacy (BLA 761061 S-24)

Sponsor: JANSSEN BIOTECH. Class: Efficacy.

Trial startedMar 13, 2025· ClinicalTrials.gov

Phase 2 trial started: NCT06651489

Efficacy of Guselkumab in Treating Hailey Hailey Disease

Results postedFeb 21, 2025· ClinicalTrials.gov

Trial results posted: NCT05197049

A Study of Guselkumab Subcutaneous Therapy in Participants With Moderately to Severely Active Crohn's Disease

Trial startedFeb 1, 2025· ClinicalTrials.gov

Phase 2 trial started: NCT06563323

Guselkumab in the Treatment of Adults With Pyoderma Gangrenosum (PG)

Primary completionJan 30, 2025· ClinicalTrials.gov

Phase 4 primary completion: NCT04340076

Dose Reduction of IL17 and IL23 Inhibitors in Psoriasis

Results postedJan 27, 2025· ClinicalTrials.gov

Trial results posted: NCT05125679

Effect of Guselkumab on Cardiovascular Risk Surrogate Markers in Participants With Moderate to Severe Plaque Psoriasis

Pivotal publicationJan 1, 2025· PubMed

Efficacy and safety of intravenous induction and subcutaneous maintenance therapy with guselkumab for patients with Crohn's disease (GALAXI-2 and GALAXI-3): 48- (Lancet)

GALAXI — A Study of the Efficacy and Safety of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease

Pivotal publicationJan 1, 2025· PubMed

Guselkumab in patients with moderately to severely active ulcerative colitis (QUASAR): phase 3 double-blind, randomised, placebo-controlled induction and mainte (Lancet)

QUASAR — A Study of Guselkumab in Participants With Moderately to Severely Active Ulcerative Colitis

2024

Primary completionDec 30, 2024· ClinicalTrials.gov

Phase 3 primary completion: NCT04882098

A Study of Guselkumab in Participants With Active Psoriatic Arthritis

Trial startedDec 20, 2024· ClinicalTrials.gov

Phase 4 trial started: NCT06398106

Proactive TDM Versus Standard Use of Biologics in Psoriasis

Results postedNov 18, 2024· ClinicalTrials.gov

Trial results posted: NCT04033445

A Study of Guselkumab in Participants With Moderately to Severely Active Ulcerative Colitis

Trial registeredOct 29, 2024· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT06663332

A Long-term Extension (LTE) Study of Guselkumab in Pediatric Participants

Trial startedOct 29, 2024· ClinicalTrials.gov

Phase 3 trial started: NCT06663332

A Long-term Extension (LTE) Study of Guselkumab in Pediatric Participants

Results postedOct 28, 2024· ClinicalTrials.gov

Trial results posted: NCT05784129

A Study of Guselkumab for the Treatment of Participants With Crohn's Disease After Surgical Resection

Primary completionOct 28, 2024· ClinicalTrials.gov

Phase 3 primary completion: NCT04936308

Guselkumab in Active Psoriatic Arthritis Participants With Inadequate Response/Intolerance to One Prior Anti-TNF Alpha Agent

Trial registeredOct 21, 2024· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT06651489

Efficacy of Guselkumab in Treating Hailey Hailey Disease

Results postedOct 9, 2024· ClinicalTrials.gov

Trial results posted: NCT04683029

A Study of Guselkumab in Participants With Systemic Sclerosis

Trial registeredSep 19, 2024· ClinicalTrials.gov

NA trial registered on ClinicalTrials.gov: NCT06586281

Elucidating Shared Mechanisms Contributing to NAFLD and PsA Disease Severity With Guselkumab Therapy

FDA approval (supplemental)Sep 11, 2024· FDA

FDA approved supplemental application for Tremfya (guselkumab) — Efficacy (BLA 761061 S-21)

Sponsor: JANSSEN BIOTECH. Class: Efficacy.

Trial registeredAug 20, 2024· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT06563323

Guselkumab in the Treatment of Adults With Pyoderma Gangrenosum (PG)

Trial startedJul 10, 2024· ClinicalTrials.gov

NA trial started: NCT07532486

A Study to Evaluate Comparative Efficacy and Safety of Guselkumab in High-dose and Extended-interval Versus Standard-dose in Chinese Partici

Trial startedJun 18, 2024· ClinicalTrials.gov

Phase 4 trial started: NCT06974474

Potential Role of Guselkumab in Modulating PAIN Perception and Related Gene Pathways: a Proof-of-concept Study.

Results postedMay 24, 2024· ClinicalTrials.gov

Trial results posted: NCT03975153

Guselkumab in the Treatment of Pityriasis Rubra Pilaris (PRP)

Primary completionMay 22, 2024· ClinicalTrials.gov

Phase 2 primary completion: NCT04633447

A Study to Evaluate Guselkumab for the Treatment of Participants With New-onset or Relapsing Giant Cell Arteritis

Primary completionMay 14, 2024· ClinicalTrials.gov

Phase 2 primary completion: NCT05071664

A Study of Guselkumab and Golimumab Combination Therapy in Participants With Active Psoriatic Arthritis

Trial registeredMay 10, 2024· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT06408935

Transmural Healing and Disease-Modifying Effect of Guselkumab in Crohn's Disease Patients

Trial registeredMay 3, 2024· ClinicalTrials.gov

Phase 4 trial registered on ClinicalTrials.gov: NCT06398106

Proactive TDM Versus Standard Use of Biologics in Psoriasis

Trial startedApr 17, 2024· ClinicalTrials.gov

Phase 3 trial started: NCT06408935

Transmural Healing and Disease-Modifying Effect of Guselkumab in Crohn's Disease Patients

Results postedApr 16, 2024· ClinicalTrials.gov

Trial results posted: NCT04376827

A Study of Guselkumab in Participants With Active Lupus Nephritis

Primary completionApr 2, 2024· ClinicalTrials.gov

Phase 3 primary completion: NCT05528510

A Study of Guselkumab Therapy in Participants With Moderately to Severely Active Ulcerative Colitis

Primary completionMar 31, 2024· ClinicalTrials.gov

Phase 1 primary completion: NCT04736966

Guselkumab (Anti-IL 23 Monoclonal Antibody) for Alcohol Associated Liver Disease

Trial startedMar 20, 2024· ClinicalTrials.gov

Trial started: NCT06249555

VOICE-Early Response to Vedolizumab and IL-23 Antagonists in Participants With Crohn's Disease: A Prospective Observational Study

Trial startedMar 13, 2024· ClinicalTrials.gov

Phase 3 trial started: NCT05923073

A Study of Guselkumab in Pediatric Participants With Moderately to Severely Active Crohn's Disease

Primary completionFeb 29, 2024· ClinicalTrials.gov

Phase 3 primary completion: NCT04397263

A Study of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease

Trial registeredFeb 15, 2024· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT06260163

A Study of Guselkumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis

Trial registeredFeb 8, 2024· ClinicalTrials.gov

Trial registered on ClinicalTrials.gov: NCT06249555

VOICE-Early Response to Vedolizumab and IL-23 Antagonists in Participants With Crohn's Disease: A Prospective Observational Study

Trial startedJan 19, 2024· ClinicalTrials.gov

Phase 3 trial started: NCT06260163

A Study of Guselkumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis

Results postedJan 9, 2024· ClinicalTrials.gov

Trial results posted: NCT04533737

Efficacy and Safety of Brodalumab Compared With Guselkumab in the Treatment of Plaque Psoriasis After Inadequate Response to Ustekinumab

2023

Results postedDec 12, 2023· ClinicalTrials.gov

Trial results posted: NCT03662542

A Study of Efficacy and Safety of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcer

Primary completionNov 21, 2023· ClinicalTrials.gov

Primary completion: NCT04439526

A Study of Guselkumab in Naive or Bio-experienced Participants With Regional (Facial and Genital) Psoriasis

Primary completionOct 20, 2023· ClinicalTrials.gov

Phase 2/Phase 3 primary completion: NCT03466411

A Study of the Efficacy and Safety of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease

Primary completionSep 29, 2023· ClinicalTrials.gov

Phase 3 primary completion: NCT05784129

A Study of Guselkumab for the Treatment of Participants With Crohn's Disease After Surgical Resection

Primary completionSep 26, 2023· ClinicalTrials.gov

Phase 4 primary completion: NCT04914429

A Study of Guselkumab (TREMFYA) in Chinese Participants With Moderate to Severe Plaque Psoriasis

Primary completionSep 19, 2023· ClinicalTrials.gov

Phase 2/Phase 3 primary completion: NCT04033445

A Study of Guselkumab in Participants With Moderately to Severely Active Ulcerative Colitis

Trial registeredSep 15, 2023· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT06039189

Study of Guselkumab Versus Placebo for the Treatment of Low Body Surface Area Moderate Plaque Psoriasis

Trial startedAug 24, 2023· ClinicalTrials.gov

Phase 3 trial started: NCT06039189

Study of Guselkumab Versus Placebo for the Treatment of Low Body Surface Area Moderate Plaque Psoriasis

Primary completionJul 28, 2023· ClinicalTrials.gov

Phase 4 primary completion: NCT05125679

Effect of Guselkumab on Cardiovascular Risk Surrogate Markers in Participants With Moderate to Severe Plaque Psoriasis

Primary completionJul 19, 2023· ClinicalTrials.gov

Phase 3 primary completion: NCT03451851

A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneously Administered Guselkumab for the Treatment of Chronic Plaque

Trial startedJul 14, 2023· ClinicalTrials.gov

Phase 3 trial started: NCT05669833

Guselkumab vs Golimumab in PsA TNF Inadequate Responder Patients

Primary completionJul 4, 2023· ClinicalTrials.gov

Phase 3 primary completion: NCT05197049

A Study of Guselkumab Subcutaneous Therapy in Participants With Moderately to Severely Active Crohn's Disease

Trial startedJul 1, 2023· ClinicalTrials.gov

Phase 4 trial started: NCT05858632

Immune Spatial Features of Guselkumab Cutaneous Response

FDA approval (supplemental)Jun 29, 2023· FDA

FDA approved supplemental application for Tremfya (guselkumab) — Labeling (BLA 761061 S-15)

Sponsor: JANSSEN BIOTECH. Class: Labeling.

Trial registeredJun 28, 2023· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT05923073

A Study of Guselkumab in Pediatric Participants With Moderately to Severely Active Crohn's Disease

Primary completionMay 17, 2023· ClinicalTrials.gov

Phase 2 primary completion: NCT04683029

A Study of Guselkumab in Participants With Systemic Sclerosis

Trial registeredMay 15, 2023· ClinicalTrials.gov

Phase 4 trial registered on ClinicalTrials.gov: NCT05858632

Immune Spatial Features of Guselkumab Cutaneous Response

Results postedMay 10, 2023· ClinicalTrials.gov

Trial results posted: NCT03818035

A Study to Evaluate Further Therapeutic Strategies With Guselkumab in Participants With Moderate-to-Severe Plaque-Type Psoriasis

Trial registeredMar 24, 2023· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT05784129

A Study of Guselkumab for the Treatment of Participants With Crohn's Disease After Surgical Resection

Primary completionFeb 22, 2023· ClinicalTrials.gov

NA primary completion: NCT04394936

An Explorative Psoriasis Biomarker Study

Trial startedFeb 21, 2023· ClinicalTrials.gov

Phase 3 trial started: NCT05784129

A Study of Guselkumab for the Treatment of Participants With Crohn's Disease After Surgical Resection

Primary completionFeb 1, 2023· ClinicalTrials.gov

Phase 2 primary completion: NCT04376827

A Study of Guselkumab in Participants With Active Lupus Nephritis

Trial registeredJan 3, 2023· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT05669833

Guselkumab vs Golimumab in PsA TNF Inadequate Responder Patients

Trial startedJan 1, 2023· ClinicalTrials.gov

NA trial started: NCT05503875

Immunoclassification of Psoriasis: a Strategy for Precision Medicine

2022

Trial startedNov 15, 2022· ClinicalTrials.gov

Phase 2/Phase 3 trial started: NCT05535738

Using a Contact Dermatitis Model With Biologic Medications to Study Skin Inflammation

Trial startedSep 27, 2022· ClinicalTrials.gov

Phase 3 trial started: NCT05347095

A Study of Guselkumab in Participants With Fistulizing, Perianal Crohn's Disease

Trial startedSep 19, 2022· ClinicalTrials.gov

Phase 2 trial started: NCT05242484

A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis

Trial startedSep 13, 2022· ClinicalTrials.gov

Phase 3 trial started: NCT05528510

A Study of Guselkumab Therapy in Participants With Moderately to Severely Active Ulcerative Colitis

Trial registeredSep 10, 2022· ClinicalTrials.gov

Phase 2/Phase 3 trial registered on ClinicalTrials.gov: NCT05535738

Using a Contact Dermatitis Model With Biologic Medications to Study Skin Inflammation

Primary completionSep 8, 2022· ClinicalTrials.gov

Phase 4 primary completion: NCT04533737

Efficacy and Safety of Brodalumab Compared With Guselkumab in the Treatment of Plaque Psoriasis After Inadequate Response to Ustekinumab

Trial registeredSep 6, 2022· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT05528510

A Study of Guselkumab Therapy in Participants With Moderately to Severely Active Ulcerative Colitis

Trial startedAug 30, 2022· ClinicalTrials.gov

Phase 3 trial started: NCT05083182

A Study of Ustekinumab or Guselkumab in Pediatric Participants With Active Juvenile Psoriatic Arthritis

Trial registeredAug 17, 2022· ClinicalTrials.gov

NA trial registered on ClinicalTrials.gov: NCT05503875

Immunoclassification of Psoriasis: a Strategy for Precision Medicine

Primary completionAug 11, 2022· ClinicalTrials.gov

Phase 2 primary completion: NCT03975153

Guselkumab in the Treatment of Pityriasis Rubra Pilaris (PRP)

Trial startedJul 22, 2022· ClinicalTrials.gov

Phase 2 trial started: NCT05242471

A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Crohn's Disease

Trial startedJul 13, 2022· ClinicalTrials.gov

Phase 3 trial started: NCT05272150

Study of Guselkumab in Skin of Color Participants With Moderate-to-severe Plaque and/or Scalp Psoriasis

Primary completionJul 1, 2022· ClinicalTrials.gov

Phase 1 primary completion: NCT05083078

A Study of Guselkumab and Risankizumab in Healthy Participants and Participants With Psoriatic Arthritis

Trial registeredApr 26, 2022· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT05347095

A Study of Guselkumab in Participants With Fistulizing, Perianal Crohn's Disease

Trial registeredMar 9, 2022· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT05272150

Study of Guselkumab in Skin of Color Participants With Moderate-to-severe Plaque and/or Scalp Psoriasis

Primary completionMar 7, 2022· ClinicalTrials.gov

Phase 3 primary completion: NCT03818035

A Study to Evaluate Further Therapeutic Strategies With Guselkumab in Participants With Moderate-to-Severe Plaque-Type Psoriasis

Trial registeredFeb 16, 2022· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT05242484

A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis

Trial startedFeb 16, 2022· ClinicalTrials.gov

Phase 4 trial started: NCT05004727

Multi-Center PAMPA Study

Trial registeredFeb 16, 2022· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT05242471

A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Crohn's Disease

Trial registeredJan 19, 2022· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT05197049

A Study of Guselkumab Subcutaneous Therapy in Participants With Moderately to Severely Active Crohn's Disease

Trial startedJan 19, 2022· ClinicalTrials.gov

Phase 3 trial started: NCT05197049

A Study of Guselkumab Subcutaneous Therapy in Participants With Moderately to Severely Active Crohn's Disease

2021

Primary completionDec 30, 2021· ClinicalTrials.gov

Phase 2 primary completion: NCT04061395

Guselkumab for Hidradenitis Suppurativa, a Mode of Action Study.

Trial startedNov 23, 2021· ClinicalTrials.gov

Phase 4 trial started: NCT05125679

Effect of Guselkumab on Cardiovascular Risk Surrogate Markers in Participants With Moderate to Severe Plaque Psoriasis

Trial registeredNov 18, 2021· ClinicalTrials.gov

Phase 4 trial registered on ClinicalTrials.gov: NCT05125679

Effect of Guselkumab on Cardiovascular Risk Surrogate Markers in Participants With Moderate to Severe Plaque Psoriasis

Trial startedNov 4, 2021· ClinicalTrials.gov

Phase 1 trial started: NCT05083078

A Study of Guselkumab and Risankizumab in Healthy Participants and Participants With Psoriatic Arthritis

Trial startedOct 25, 2021· ClinicalTrials.gov

Phase 2 trial started: NCT05071664

A Study of Guselkumab and Golimumab Combination Therapy in Participants With Active Psoriatic Arthritis

Trial registeredOct 19, 2021· ClinicalTrials.gov

Phase 1 trial registered on ClinicalTrials.gov: NCT05083078

A Study of Guselkumab and Risankizumab in Healthy Participants and Participants With Psoriatic Arthritis

Trial registeredOct 19, 2021· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT05083182

A Study of Ustekinumab or Guselkumab in Pediatric Participants With Active Juvenile Psoriatic Arthritis

Trial registeredOct 8, 2021· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT05071664

A Study of Guselkumab and Golimumab Combination Therapy in Participants With Active Psoriatic Arthritis

Trial startedSep 28, 2021· ClinicalTrials.gov

Phase 3 trial started: NCT04936308

Guselkumab in Active Psoriatic Arthritis Participants With Inadequate Response/Intolerance to One Prior Anti-TNF Alpha Agent

Trial registeredSep 20, 2021· ClinicalTrials.gov

Trial registered on ClinicalTrials.gov: NCT05049798

A Study of Guselkumab and Interleukin-17 (IL-17) Inhibitor Therapies in Participants With Psoriatic Arthritis in Routine Clinical Practice

Primary completionSep 13, 2021· ClinicalTrials.gov

Phase 1 primary completion: NCT04147338

A Study of Subcutaneously-administered Guselkumab Delivered by 3 Different Devices in Healthy Participants

Primary completionSep 13, 2021· ClinicalTrials.gov

Phase 1 primary completion: NCT03649971

A Study of Guselkumab in Participants With Familial Adenomatous Polyposis

Primary completionSep 13, 2021· ClinicalTrials.gov

Phase 1 primary completion: NCT04704843

A Study of Guselkumab in Adult Participants With Celiac Disease

Trial startedAug 30, 2021· ClinicalTrials.gov

Phase 4 trial started: NCT04929210

A Study of Guselkumab Administered Subcutaneously in Bio-naive Participants With Active Psoriatic Arthritis Axial Disease

Trial startedAug 25, 2021· ClinicalTrials.gov

Trial started: NCT05049798

A Study of Guselkumab and Interleukin-17 (IL-17) Inhibitor Therapies in Participants With Psoriatic Arthritis in Routine Clinical Practice

Trial startedAug 25, 2021· ClinicalTrials.gov

Phase 4 trial started: NCT04914429

A Study of Guselkumab (TREMFYA) in Chinese Participants With Moderate to Severe Plaque Psoriasis

Trial registeredAug 13, 2021· ClinicalTrials.gov

Phase 4 trial registered on ClinicalTrials.gov: NCT05004727

Multi-Center PAMPA Study

Primary completionJul 20, 2021· ClinicalTrials.gov

Phase 1 primary completion: NCT04617691

A Study of Intravenous Formulation of Guselkumab Using Prefilled Syringes and Final Vialed Product in Healthy Participants

Trial registeredJul 2, 2021· ClinicalTrials.gov

Trial registered on ClinicalTrials.gov: NCT04948398

Post-Trial Access for Guselkumab in Participants With Familial Adenomatous Polyposis

Trial registeredJun 23, 2021· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT04936308

Guselkumab in Active Psoriatic Arthritis Participants With Inadequate Response/Intolerance to One Prior Anti-TNF Alpha Agent

Trial registeredJun 18, 2021· ClinicalTrials.gov

Phase 4 trial registered on ClinicalTrials.gov: NCT04929210

A Study of Guselkumab Administered Subcutaneously in Bio-naive Participants With Active Psoriatic Arthritis Axial Disease

Trial startedJun 17, 2021· ClinicalTrials.gov

Phase 1 trial started: NCT04704843

A Study of Guselkumab in Adult Participants With Celiac Disease

Trial startedJun 17, 2021· ClinicalTrials.gov

Phase 3 trial started: NCT04882098

A Study of Guselkumab in Participants With Active Psoriatic Arthritis

Results postedJun 14, 2021· ClinicalTrials.gov

Trial results posted: NCT03628924

A Study to Evaluate the Efficacy, Safety, and Tolerability of Guselkumab for the Treatment of Participants With Moderate to Severe Hidradeni

Trial registeredJun 4, 2021· ClinicalTrials.gov

Phase 4 trial registered on ClinicalTrials.gov: NCT04914429

A Study of Guselkumab (TREMFYA) in Chinese Participants With Moderate to Severe Plaque Psoriasis

Trial registeredMay 11, 2021· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT04882098

A Study of Guselkumab in Participants With Active Psoriatic Arthritis

RecallMar 9, 2021· FDA

TREMFYA recall — Class III: Temperature Abuse

Tremfya (guselkumab) Injection, 100 mg/mL, one single-dose prefilled syringe per carton, Rx only, Manufactured by: Janssen Biotech, Inc., Horsham, PA 19044; NDC 57894-640-01.

Trial startedMar 3, 2021· ClinicalTrials.gov

Phase 1 trial started: NCT04736966

Guselkumab (Anti-IL 23 Monoclonal Antibody) for Alcohol Associated Liver Disease

Primary completionMar 2, 2021· ClinicalTrials.gov

Phase 3 primary completion: NCT03998683

A Study of Guselkumab for the Treatment of Palmoplantar-non-Pustular Psoriasis

Trial startedMar 1, 2021· ClinicalTrials.gov

Phase 4 trial started: NCT04645355

Guselkumab Immunogenetics

Trial startedFeb 24, 2021· ClinicalTrials.gov

Phase 2 trial started: NCT04683029

A Study of Guselkumab in Participants With Systemic Sclerosis

Trial registeredFeb 3, 2021· ClinicalTrials.gov

Phase 1 trial registered on ClinicalTrials.gov: NCT04736966

Guselkumab (Anti-IL 23 Monoclonal Antibody) for Alcohol Associated Liver Disease

Trial registeredJan 12, 2021· ClinicalTrials.gov

Phase 1 trial registered on ClinicalTrials.gov: NCT04704843

A Study of Guselkumab in Adult Participants With Celiac Disease

2020

Primary completionDec 31, 2020· ClinicalTrials.gov

Phase 1 primary completion: NCT04030533

Study of Guselkumab and Ustekinumab Following a Single Intravenous or Subcutaneous Administration in Healthy Chinese Participants

Trial registeredDec 24, 2020· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT04683029

A Study of Guselkumab in Participants With Systemic Sclerosis

Trial startedDec 17, 2020· ClinicalTrials.gov

Phase 4 trial started: NCT04533737

Efficacy and Safety of Brodalumab Compared With Guselkumab in the Treatment of Plaque Psoriasis After Inadequate Response to Ustekinumab

Trial startedDec 10, 2020· ClinicalTrials.gov

Phase 2 trial started: NCT04633447

A Study to Evaluate Guselkumab for the Treatment of Participants With New-onset or Relapsing Giant Cell Arteritis

Primary completionDec 1, 2020· ClinicalTrials.gov

Phase 2 primary completion: NCT03662542

A Study of Efficacy and Safety of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcer

Sources

FDA approvals, label revisions, and recalls come from the public openFDA APIs (Drugs@FDA, Drug Label, Drug Enforcement). Drug-safety communications come from the FDA RSS feed. Trial milestones come from ClinicalTrials.gov via the AACT pg dump. Pivotal-publication events come from PubMed, filtered to high-impact journals linked to a Phase 3 trial in our inventory.