Combination Therapy for Ulcerative Colitis (DUET-UC Trial)

Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Janssen Research & Development, LLC

Prior Safety Data

Trial Summary

What is the purpose of this trial?This trial is testing a new medication, JNJ-78934804, for patients with severe ulcerative colitis who haven't had success with other treatments. The medication aims to reduce inflammation by targeting the immune system.

Eligibility Criteria

This trial is for adults with moderate to severe ulcerative colitis who haven't responded well to at least one biologic or similar treatment. Participants must have been diagnosed with UC for a minimum of three months and, if female and able to have children, agree to follow specific contraception guidelines.

Inclusion Criteria

I have been diagnosed with ulcerative colitis for at least 3 months.

My ulcerative colitis is moderate to severe, according to the Mayo Score.

Exclusion Criteria

My inflammation is only in my rectum.

I have been diagnosed with a specific type of colitis or Crohn's disease.

I have severe widespread inflammation in my colon.

I have a history of or currently have a chronic infection.

Treatment Details

The study tests the effectiveness and safety of JNJ-78934804 against guselkumab and golimumab in patients whose ulcerative colitis hasn't improved with standard advanced therapies. It aims to see which treatment helps more.

6Treatment groups

Experimental Treatment

Placebo Group

Group I: Group 6: JNJ-78934804 (Low-dose)Experimental Treatment1 Intervention

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.

Group II: Group 5: JNJ-78934804 (Mid-dose)Experimental Treatment1 Intervention

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.

Group III: Group 4: JNJ-78934804 (High-dose)Experimental Treatment1 Intervention

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.

Group IV: Group 3: GolimumabExperimental Treatment1 Intervention

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.

Group V: Group 2: GuselkumabExperimental Treatment1 Intervention

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.

Group VI: Group 1: PlaceboPlacebo Group1 Intervention

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.

Golimumab is already approved in European Union, United States, Canada for the following indications:

🇪🇺 Approved in European Union as Simponi for: