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

Conditions

• Colitis, Ulcerative

Eligibility Criteria

Sex

ALL

Age

18 Years - 65 Years

Healthy Volunteers

Not accepted

Interventions

• Guselkumab — BIOLOGICAL
  Guselkumab will be administered as subcutaneous injection.
• Golimumab — BIOLOGICAL
  Golimumab will be administered as subcutaneous injection.
• JNJ-78934804 — BIOLOGICAL
  JNJ-78934804 will be administered subcutaneously as per defined regimen.
• Placebo — DRUG
  Placebo will be administered as subcutaneous injection.

Study Details

The purpose of this study is to evaluate the efficacy and safety of JNJ-78934804 as compared to guselkumab and golimumab in participants with moderately to severely active ulcerative colitis who have had an inadequate initial response, loss of response, or intolerance to one or more approved advanced therapy.

Key Dates

Start date

Sep 19, 2022

Status verified

Jun 2026

Primary completion

May 15, 2025

Completion

Mar 27, 2029

Study Design

Enrollment

577 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Placebo Comparator: Group 1: Placebo
  Participants will receive placebo subcutaneously (SC). All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension.
• Experimental: Group 2: Guselkumab
  Participants will receive guselkumab dose regimen 1 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension.
• Experimental: Group 3: Golimumab
  Participants will receive golimumab dose regimen 1 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension.
• Experimental: Group 4: JNJ-78934804 (High-dose)
  Participants will receive JNJ-78934804 dose regimen 1 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension.
• Experimental: Group 5: JNJ-78934804 (Mid-dose)
  Participants will receive JNJ-78934804 dose regimen 2 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension.
• Experimental: Group 6: JNJ-78934804 (Low-dose)
  Participants will receive JNJ-78934804 dose regimen 3 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension.

Primary Outcome Measure

Percentage of Participants with Clinical Remission at Week 48 [ Time Frame: Week 48 ]

Locations (63)

Find similar trials in Arcadia, CA

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