A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis (DUET-UC)

Janssen (J&J Innovative Medicine)

Status and phase: Active, not recruiting; Phase 2

Conditions: Colitis, Ulcerative

Treatments: Biological: JNJ-78934804; Drug: Placebo; Biological: Guselkumab; Biological: Golimumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT05242484

CR109179

2021-005528-39 (EudraCT Number)

78934804UCO2001 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 577 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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577 participants in 6 patient groups, including a placebo group

Group 1: Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo

Group 2: Guselkumab

Experimental group

Description:

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.

Treatment:

Biological: Guselkumab

Group 3: Golimumab

Experimental group

Description:

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.

Treatment:

Biological: Golimumab

Group 4: JNJ-78934804 (High-dose)

Experimental group

Description:

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.

Treatment:

Biological: JNJ-78934804

Group 5: JNJ-78934804 (Mid-dose)

Experimental group

Description:

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.

Treatment:

Biological: JNJ-78934804

Group 6: JNJ-78934804 (Low-dose)

Experimental group

Description:

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.

Treatment:

Biological: JNJ-78934804