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Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 65 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Confirmed diagnosis of ulcerative colitis (UC) for at least 3 months prior to baseline - Moderately to severely active UC as assessed by the modified Mayo Score - Demonstrated inadequate response, loss of response, or intolerance to at least one biologic or novel oral with biologic-like activity - If female and of childbearing potential, must meet the contraception and reproduction requirements

Exclusion Criteria

  • Has severe extensive colitis as defined in the protocol - Extent of inflammatory disease limited to the rectum - Participants with current diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, or Crohn's disease (CD) - Has a history of, or ongoing, chronic or recurrent infectious disease, including but not limited to, sinopulmonary infections, bronchiectasis, recurrent renal/urinary tract infections (example, pyelonephritis, cystitis), an open, draining, or infected skin wound, or an ulcer - Currently has a malignancy or a history of malignancy within 5 years before screening (with the exception of nonmelanoma skin cancer or cervical carcinoma in situ that has been treated with no evidence of recurrence within 12 months of first dose of study intervention)

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • Drug: Placebo
    Placebo will be administered as subcutaneous injection.
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.
  • Biological: Guselkumab
    Guselkumab will be administered as subcutaneous injection.
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.
  • Biological: Golimumab
    Golimumab will be administered as subcutaneous injection.
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.
  • Biological: JNJ-78934804
    JNJ-78934804 will be administered subcutaneously as per defined regimen.
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.
  • Biological: JNJ-78934804
    JNJ-78934804 will be administered subcutaneously as per defined regimen.
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.
  • Biological: JNJ-78934804
    JNJ-78934804 will be administered subcutaneously as per defined regimen.

Recruiting Locations

MedStar Georgetown University Hospital
Washington, District of Columbia 20007

More Details

Status
Recruiting
Sponsor
Janssen Research & Development, LLC

Study Contact

Study Contact
844-434-4210
Participate-In-This-Study@its.jnj.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.