A Study of Guselkumab in Participants With Fistulizing, Perianal Crohn's Disease

Study 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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05347095
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 3
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Janssen-Cilag Ltd.
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Janssen-Cilag Ltd. Clinical Trial
Principal Investigator Affiliation	Janssen-Cilag Ltd.
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Australia, Belgium, Canada, Czechia, Egypt, France, Germany, Greece, Hungary, Israel, Italy, Japan, Jordan, Korea, Republic of, Netherlands, Poland, Portugal, Saudi Arabia, Spain, Sweden, Taiwan, Turkey, United Kingdom, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Fistulizing Crohns Disease, Perianal Crohns Disease

Additional Details

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).

Arms & Interventions

Arms

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.

Interventions

Drug: - Guselkumab

Guselkumab will be administered subcutaneously/IV infusion.

Drug: - Placebo

Matching placebo will be administered subcutaneously/IV infusion.

Contact a Trial Team

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University of Alabama at Birmingham, Birmingham, Alabama

Status

Recruiting

Address

University of Alabama at Birmingham

Birmingham, Alabama, 35294

Site Contact

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