Print

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

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 - Has previously demonstrated lack of initial response (that is primary non-responders), responded initially but then lost response with continued therapy (that is secondary non-responders), or were intolerant to a maximum of 2 classes of biologic agents at a dose approved for the treatment of Crohn's disease (that is infliximab, adalimumab, certolizumab pegol, vedolizumab, or approved biosimilars for these agents)

Exclusion Criteria

  • Has a very severe luminal disease activity - History of concurrent rectovaginal fistulas (other types of concurrent fistula should be confirmed with the sponsor), rectal and/or anal stenosis, stoma or functioning ostomy (include all current stoma types abscess or collections which are not properly drained - 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

ArmDescriptionAssigned 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.
  • Drug: Guselkumab
    Guselkumab will be administered subcutaneously/IV infusion.
    Other names:
    • CNTO1959
  • Drug: Placebo
    Matching placebo will be administered subcutaneously/IV infusion.
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. At Week 24, guselkumab Dose 3 SC non-responders will switch to receive guselkumab dose 2 SC. Participants who are eligible and willing to continue guselkumab may enter the LTE period and continue to receive guselkumab.
  • Drug: Guselkumab
    Guselkumab will be administered subcutaneously/IV infusion.
    Other names:
    • CNTO1959
  • Drug: Placebo
    Matching placebo will be administered subcutaneously/IV infusion.
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.
  • Drug: Guselkumab
    Guselkumab will be administered subcutaneously/IV infusion.
    Other names:
    • CNTO1959
  • Drug: Placebo
    Matching placebo will be administered subcutaneously/IV infusion.

Recruiting Locations

More Details

Status
Recruiting
Sponsor
Janssen-Cilag Ltd.

Study Contact

Study Contact
844-434-4210
Participate-In-This-Study@its.jnj.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.