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

Part of paid clinical trials in San Diego, California.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT05784129
Phase
PHASE3
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Guselkumab — DRUG
    Guselkumab will be administered subcutaneously.
  • Placebo — DRUG
    Placebo will be administered subcutaneously.

Study Details

The purpose of this study is to evaluate the effectiveness of guselkumab treatment compared with placebo (an inactive substance with no medicine) in preventing recurrence of Crohn's disease in participants after surgery.

Key Dates

Start date
Feb 21, 2023
Status verified
Apr 2025
Primary completion
Sep 29, 2023
Completion
Oct 10, 2023

Study Design

Enrollment
4 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Group 1: Guselkumab
    Participants will receive Guselkumab Dose 1 subcutaneously (SC) followed by Dose 2 SC thereafter through Week 144. Participants with disease recurrence will receive guselkumab SC treatment.
  • Placebo Comparator: Group 2: Placebo
    Participants will receive matching placebo injections subcutaneously. Participants with disease recurrence will receive guselkumab SC treatment.

Primary Outcome Measure

Percentage of Participants With Endoscopic Recurrence Prior to or at Week 48 [ Time Frame: Baseline (Day 1) up to Week 48 ]

Locations (9)

FacilityCityStateZIPSite coordinators
Medical Associates Research Group, Inc.San DiegoCalifornia92123-
Gastroenterology Group Of NaplesNaplesFlorida34102-
Gastroenterolgy Associates of Central GAMaconGeorgia31201-
Louisiana Research Center, LLCShreveportLouisiana71105-
Asheville Gastroenterology AssociatesAshevilleNorth Carolina28801-
Gastro Health OhioCincinnatiOhio45219-
Southern Star Research Institute, LLCSan AntonioTexas78229-
Texas Digestive Disease ConsultantsSouthlakeTexas76092-
Tyler Research Institute, LLCTylerTexas75701-

Find similar trials in San Diego, CA

By condition
Crohn's disease
By specialty
GastroenterologyInflammatory bowel diseaseAutoimmune disease
By research site
Medical Associates Research Group, Inc.· San Diego, CAGastroenterology Group Of Naples· Naples, FLGastroenterolgy Associates of Central GA· Macon, GALouisiana Research Center, LLC· Shreveport, LAAsheville Gastroenterology Associates· Asheville, NCGastro Health Ohio· Cincinnati, OH

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