A Study of JNJ-64304500 as Add-on Therapy in Participants With Active Crohn's Disease

Part of paid clinical trials in Evansville, Indiana.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT04655807
Phase
PHASE2
Status
Withdrawn

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • JNJ-64304500 — DRUG
    JNJ-64304500 will be administered as SC injection.
  • Placebo — DRUG
    Matching placebo will be administered as SC injection.
  • Adalimumab — DRUG
    Adalimumab will be administered as SOC biological therapy.
  • Ustekinumab — DRUG
    Ustekinumab will be administered as SOC biological therapy.

Study Details

The purpose of this study is to evaluate the efficacy and safety of JNJ-64304500 as add-on therapy to standard of care (SOC) biologic treatment with anti-tumor necrosis factor alpha or anti-interleukin 12/23 inhibitors in participants with active Crohn's disease in response but not remission to SOC biologic therapy.

Key Dates

Start date
Mar 3, 2021
Status verified
Apr 2025
Primary completion
May 24, 2023
Completion
Sep 4, 2023

Study Design

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

Arms

  • Experimental: Group 1- Standard of Care (SOC) Biological Therapy: Adalimumab
    Participants will receive JNJ-64304500 Dose 1 or matching placebo subcutaneous (SC) injection as induction dose (Week 0) followed by JNJ-64304500 Dose 2 or matching placebo SC injection from Week 2 through Week 10 as maintenance dose in addition to adalimumab or its biosimilar as SOC therapy.
  • Experimental: Group 2: SOC Biological Therapy: Ustekinumab
    Participants will receive JNJ-64304500 Dose 1 or matching placebo SC injection as induction dose (Week 0) followed by JNJ-64304500 Dose 2 or matching placebo SC injection from Week 2 through Week 10 as maintenance dose in addition to ustekinumab as SOC therapy.

Primary Outcome Measure

Number of Participants with Adverse Events (AEs) and Treatment Emergent Adverse Events (TEAEs) [ Time Frame: Up to Week 26 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Medisphere Medical Research Center, LlcEvansvilleIndiana47714-

Find similar trials in Evansville, IN

By condition
Crohn's disease
By specialty
GastroenterologyInflammatory bowel diseaseAutoimmune disease
By research site
Medisphere Medical Research Center, Llc· Evansville, IN

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