The trial is taking place at:
P

Peak Gastroenterology Associates | Peak Gastro Colorado Springs

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

J

Janssen (J&J Innovative Medicine)

Status and phase

Enrolling
Phase 2

Conditions

Colitis, Ulcerative

Treatments

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

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

550 estimated 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

550 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

Trial contacts and locations

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Central trial contact

Study Contact

Data sourced from clinicaltrials.gov

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