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Clinical Trials in Italy / NCT05197049
Active, not recruiting Phase 3

A Study of Guselkumab Subcutaneous Therapy in Participants With Moderately to Severely Active Crohn's Disease

NCT05197049 · tracked via the Priya Life Science Italy tracker
Sponsor
Janssen Research & Development, LLC
Phase
Phase 3
Started
2022-01-19
Last updated
2026-09-25

Condition(s) studied

Crohn Disease

Investigational drug(s) / intervention(s)

Guselkumab Dose 1 →Guselkumab Dose 2 →Guselkumab Dose 3 →Placebo

Guselkumab Dose 1: Guselkumab (Dose 1) will be administered by subcutaneous (SC) injection.

Guselkumab Dose 2: Guselkumab (Dose 2) will be administered by SC injection.

Guselkumab Dose 3: Guselkumab (Dose 3) will be administered by SC injection.

Placebo: Placebo will be administered by SC injection.

Study summary

The purpose of this study is to evaluate the efficacy and safety of guselkumab in participants with Crohn's disease.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Diagnosis of Crohn's disease (CD) of at least 3 months in duration * Have moderate to severe CD as assessed by CDAI, stool frequency, and abdominal pain score, and Simple Endoscopic Score for Crohn's disease (SES-CD). * Demonstrated intolerance or inadequate response to conventional or to biologic therapy for CD Exclusion Criteria: * Current diagnosis of ulcerative colitis or indeterminate colitis * Complications of Crohn's disease that require surgical intervention or confound efficacy assessments * Unstable doses of concomitant Crohn's disease therapy

Primary outcome measure(s)

  • Percentage of Participants Who Achieved Clinical Remission at Week 12 — At Week 12
    Clinical remission was defined as a Crohn's Disease Activity Index (CDAI) score \<150. The multi-item CDAI score assessed severity of illness by collecting information on 8 different Crohn's disease-related variables (extraintestinal manifestations, abdominal mass, weight, hematocrit, use of antidiarrheal drug(s) and/or opiates, total number of liquid or very soft stools, abdominal pain/cramps, and general well-being). The last 3 variables were scored over 7 days by the participant on a diary card. The total CDAI score ranged from 0 (improvement in disease activity) to 600 (more disease activity) and a decrease in total CDAI score over time indicates improvement in disease activity.
  • Percentage of Participants Who Achieved Endoscopic Response at Week 12 — At Week 12
    Percentage of participants who achieved endoscopic response at Week 12 were reported. Endoscopic response was defined as greater than or equal to (\>=) 50 percent (%) improvement from baseline in the Simple Endoscopic Score for Crohn's Disease (SES-CD) score. SES-CD evaluated 4 endoscopic components (presence and size of ulcer, extent of ulcerated surface, extent of affected surface, and presence and type of narrowing) across 5 ileocolonic segments (ileum, right colon, transverse colon, left colon, and rectum), each scored from 0 (best) to 3 (worst) for each segment except narrowing component for which the maximum total score (that is, stricturing) was 11 points. The total SES-CD score was the sum of all the component scores across all the segments and it ranged from 0 (best) to 56 (worst), where higher scores indicated more severe disease.

Trial sites (345)

FacilityCityRegionStatus
Digestive Health Specialists of the Southeast Dothan Alabama
Advanced Gastro P.C Chandler Arizona
Reliance Research Scottsdale Arizona
Moore Clinical Trials, LLC Little Rock Arkansas
Central Arkansas Veterans Healthcare System Little Rock Arkansas
Clinnova Research Anaheim California
Om Research LLC 1 Lancaster California
Om Research LLC Lancaster California
United Gastroenterologists Los Alamitos California
Paul Wallace MD Los Angeles California
Digestive System Healthcare Pasadena California
Northshore Gastroenterology Research, LLC San Diego California
Clinical Applications Laboratories, Inc San Diego California
Santa Maria Gastroenterology Santa Maria California
Clinical Research of California Walnut Creek California
Amel Med LLC Research Grand Junction Colorado
Western Connecticut Health Network/Danbury Hospital Danbury Connecticut
Gastroenterology Associates of SW Florida Clearwater Florida
Pioneer Research Solutions Inc. Coconut Creek Florida
Omega Research Consultants DeBary Florida
Harmony Medical Research Institute, Inc. Hialeah Florida
Central Florida Gastro Research Kissimmee Florida
Community Research Foundation, Inc. Miami Florida
Gastroenterology Group Of Naples Naples Florida
Center for Digestive Health Orlando Florida
Central Florida Internists Orlando Florida
Synergy Clinical Research St. Petersburg Florida
Atlanta Gastroenterology Specialists, PC Atlanta Georgia
Agile Clinical Research Trials, LLC Atlanta Georgia
Atlanta Center For Gastroenterology Decatur Georgia
Gastroenterolgy Associates of Central GA Macon Georgia
Gastroenterology Consultants Roswell Georgia
USF Asthma, Allergy, Immunology Clinical Research Unit Boise Idaho
Grand Teton Research Group, PLLC Idaho Falls Idaho
Lemah Creek Clinical Research Oakbrook Terrace Illinois
University of Kansas Medical Center Kansas City Kansas
BVL Clinical Research Leawood Kansas
Cotton O'Neil Digestive Health Center Topeka Kansas
Tri-State Gastroenterology Assoc Crestview Hills Kentucky
Tandem Clinical Research Marrero Louisiana

+ 305 more sites — see the full list on the official registry below.

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Other trials for the same condition

Stopping Aminosalicylate Therapy in Inactive Crohn's Disease Active, not recruiting
Integrated Clinical-Occupational Management for Workers With Chronic Noncommunicable Diseases Active, not recruiting
Changing the Future of Intestinal Failure in Intestinal Chronic Inflammation (INT-FAIL) Active, not recruiting
Treatment of Crohn's Complex Perianal Fistulas With Tissue Transplantation by Local Injection of Micro-fragmented Autologous Adipose Tissue. Active, not recruiting
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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05197049 on ClinicalTrials.gov ↗ ← All trials in Italy