A Study of Guselkumab in Participants With Moderately to Severely Active Ulcerative Colitis

Phase 2/3 Active, not recruiting NCT04033445

Condition	Ulcerative Colitis
Phase	Phase 2/3
Sponsor	Janssen Research & Development, LLC
Status	Active, not recruiting
Enrollment	1,064 participants
Interventions	Guselkumab
Start date	Sep 26, 2019
Completion date	Sep 19, 2023
Results posted	Nov 18, 2024

Summary

The purpose of this study is to evaluate the efficacy and safety of guselkumab in participants with moderately to severely active ulcerative colitis (UC).

Induction Study 1: Percentage of Participants With Clinical Response at Week I-12

At Week I-12 · Percentage of participants

IS-1: Period 1: Placebo IV at Weeks I-0, I-4 and I-8	27.6 Percentage of participants
IS-1: Period 1: Guselkumab 200 mg IV at Weeks I-0, I-4 and I-8	61.4 Percentage of participants
IS-1: Period 1: Guselkumab 400 mg IV at Weeks I-0, I-4 and I-8	60.7 Percentage of participants

p-value	< 0.001
Adjusted treatment difference	33.6 (95% CI 20.9–46.3)

Induction Study 2: Percentage of Participants With Clinical Remission at Week I-12

At Week I-12 · Percentage of participants

IS-2: Period 1: Placebo IV at Weeks I-0, I-4 and I-8	7.9 Percentage of participants
IS-2: Period 1: Guselkumab 200 mg IV at Weeks I-0, I-4 and I-8	22.6 Percentage of participants

p-value	< 0.001
Adjusted treatment difference	14.9 (95% CI 9.9–19.9)

Maintenance Study: Percentage of Participants With Clinical Remission at Week M-44

At Week M-44 · Percentage of participants

MS: Randomized: Placebo SC Every 4 Weeks (q4w)	18.9 Percentage of participants
MS: Randomized: Guselkumab 100 mg SC q8w	45.2 Percentage of participants
MS: Randomized: Guselkumab 200 mg SC q4w	50.0 Percentage of participants

p-value	< 0.001
Adjusted treatment difference	25.2 (95% CI 16.4–33.9)

Open in BENITIONS View on ClinicalTrials.gov

Other trials for this condition

GI Permeability Change in Response to Aquamin® — James Varani
A Study to Evaluate the Efficacy and Safety of PF-06480605 in Adults With Moderate to Seve — Hoffmann-La Roche
A Study of Guselkumab Therapy in Participants With Moderately to Severely Active Ulcerativ — Janssen Research & Development, LLC
A Study to Assess the Efficacy and Safety of Golimumab in Pediatric Participants With Mode — Janssen Research & Development, LLC
Efficacy and Mechanism of Fecal Microbiota Transplantation of the Bai Ethnicity in the Tre — First Affiliated Hospital of Kunming Medical University
ENhanced Recovery in CHildren Undergoing Surgery — Northwestern University

All trials

This page summarises publicly available data from ClinicalTrials.gov. It is not medical advice and not investment advice. Always consult a qualified healthcare professional.

English 한국어 日本語中文 Русский