GRAVITI - A Phase 3 Study to Evaluate the Efficacy and Safety of Guselkumab Subcutaneous Induction Therapy in Participants with Moderately to Severely Active Crohn’s Disease

Phase 1

Conditions: Moderately to Severely Active Crohn's Disease
MedDRA version: 20.0Level: PTClassification code 10011401Term: Crohn's diseaseSystem Organ Class: 10017947 - Gastrointestinal disorders
Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Registration Number: EUCTR2020-006165-11-DE

Lead Sponsor: Janssen-Cilag International NV

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 350

Inclusion Criteria

1- Clinically active Crohn’s disease or fistulizing Crohn’s disease of at least 3 months duration
2- Endoscopic evidence of active ileocolonic Crohn's disease
4- Current treatment with oral corticosteroids and/or immunomodulators, OR history of failure to respond to or tolerate oral corticosteroids and/or immunomodulators, OR history of corticosteroid dependence, OR has previously demonstrated lack of initial response, lost response or were intolerant to 1 or more biologic agents.

Please refer to protocol for the overall inclusion criteria
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 274
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 76

Exclusion Criteria

1-Has a draining stoma or ostomy.
2- Presence on screening endoscopy or history of adenomatous colonic polyps that were not removed.
3- Has previously received a biologic agent targeting IL-12/23 or IL-23.

Please refer to protocol for the overall exclusion criteria

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: - To evaluate the efficacy, including clinical remission and endoscopic response, of guselkumab SC induction ;Secondary Objective: - To evaluate the efficacy of guselkumab SC across a range of outcome measures<br><br>- To evaluate the safety of guselkumab SC <br>;Primary end point(s): 1- Clinical remission <br>2- Endoscopic response <br>;Timepoint(s) of evaluation of this end point: At Week 12

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1- Clinical remission <br>2- PRO-2 remission <br>3- Clinical response <br>;Timepoint(s) of evaluation of this end point: Clinical remission at Week 24 <br>PRO-2 remission and clinical response at Week 12