A Study of Guselkumab in Participants With Fistulizing, Perianal Crohn's Disease
Purpose
The purpose of this study to evaluate the clinical efficacy of guselkumab in fistulizing, perianal Crohn's disease and to assess the overall safety of guselkumab.
Conditions
- Fistulizing Crohns Disease
- Perianal Crohns Disease
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Must have a diagnosis of Crohn's disease with a minimum duration of at least 3 months - Has at least one active draining perianal fistula as a complication of Crohn's disease, confirmed by screening magnetic resonance imaging (MRI) results - Is naïve to biologics, or demonstrated inadequate response or intolerance to conventional therapies or approved biologic therapies for Crohn's Disease (CD)
Exclusion Criteria
- Has a very severe luminal disease activity - History of or concurrent rectovaginal fistulas, rectal and/or anal stenosis or other active complications of perianal disease - Has complications of CD, such as symptomatic strictures or stenoses, short gut syndrome, or any other manifestation that might be anticipated to require surgery or preclude fistula evaluation - Any medical contraindications preventing study participation - Has a history of ongoing, chronic or recurrent enteral or systemic infectious disease
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Group 1: Guselkumab |
Participants will receive guselkumab Dose 1 intravenous (IV) infusion followed by Dose 2 subcutaneously (SC). Participants will receive matching placebo to maintain the blind. Participants who are eligible and willing to continue guselkumab may enter the Long-Term Extension (LTE) period and continue to receive guselkumab. |
|
|
Experimental Group 2: Guselkumab |
Participants will receive guselkumab Dose 1 IV infusion followed by Dose 3 SC. Participants will receive matching placebo to maintain the blind. Participants who are eligible and willing to continue guselkumab may enter the LTE period and continue to receive guselkumab. |
|
|
Experimental Group 3: Placebo |
Participants will receive placebo IV infusion followed by placebo SC. At Week 24, placebo non-responders will continue to receive guselkumab Dose 4 followed by guselkumab Dose 2 SC. Participants will receive matching placebo to maintain the blind. Participants who are eligible and willing to continue guselkumab may enter the LTE period and continue to receive guselkumab. |
|
Recruiting Locations
Birmingham, Alabama 35294
More Details
- Status
- Recruiting
- Sponsor
- Janssen-Cilag Ltd.
Detailed Description
Crohn's disease is a chronic, progressive, and potentially life-threatening disorder which may affect any part of the gastrointestinal tract. Guselkumab is a fully human immunoglobulin G1 (IgG1) lambda monoclonal antibody (mAb) that binds to the p19 subunit of human interleukin (IL)-23 with high specificity and affinity, without blocking IL-12. The aim is to evaluate the efficacy and safety of guselkumab in the treatment of adult participants with active fistulizing, perianal Crohn's disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or biologic therapy or have medical contraindications to such therapies. This study consists of 3 phases: 6 weeks screening phase, 48 weeks treatment phase, and a 16 weeks follow-up phase. The study will have long term extension (LTE) period for participants who complete the 48-week treatment period and in the opinion of the investigator, will continue to benefit from the study intervention. Comprehensive safety data will be collected and the total duration of the study for participants will be up to 118 weeks (including the LTE period).