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The Oregon Clinic | Pulmonary Critical Care & Sleep Medicine East

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A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Crohn's Disease (DUET-CD)

Janssen (J&J Innovative Medicine) logo

Janssen (J&J Innovative Medicine)

Status and phase

Enrolling
Phase 2

Conditions

Crohn's Disease

Treatments

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

Study type

Interventional

Funder types

Industry

Identifiers

NCT05242471
2021-003314-39 (EudraCT Number)
78934804CRD2001 (Other Identifier)
CR109178

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy of JNJ-78934804 at Week 48 compared to guselkumab and golimumab.

Enrollment

715 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Diagnosis of Crohn's disease (CD) for at least 3 months prior to baseline
  • Confirmed diagnosis of moderate to severe CD as assessed by Crohn's disease activity index (CDAI), stool frequency (SF), abdominal pain (AP) score and simple endoscopic score for Crohn's disease (SES-CD)
  • Demonstrated inadequate response, loss of response, or intolerance to at least one biologic approved for the treatment of Crohn's disease
  • If female and of childbearing potential, must meet the contraception and reproduction requirements

Exclusion criteria

  • Complications of CD that may be anticipated to require surgery
  • Currently has or is suspected to have an abscess. Recent cutaneous and perianal abscesses are not exclusionary if drained and adequately treated at least 3 weeks before baseline, or 8 weeks before baseline for intra-abdominal abscesses, provided that there is no anticipated need for any further surgery
  • Has had any kind of bowel resection within 24 weeks, or any other intra-abdominal or other major surgery within 12 weeks
  • Has a draining (example, functioning) stoma or ostomy
  • Currently has a malignancy or has a history of malignancy within 5 years before screening (with the exception of a nonmelanoma skin cancer or cervical carcinoma in situ that has been adequately treated with no evidence of recurrence for greater than or equal do (>=) 12 months before the first dose of study intervention)
  • 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

715 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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