A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis

Phase 2/3

Active, not recruiting

• Conditions: Moderately to Severely Active Ulcerative Colitis

• Registration Number: 2023-504718-31-00
• Lead Sponsor: Janssen - Cilag International

Brief Summary

To evaluate the efficacy and safety of guselkumab in moderately to

severely active UC.

Detailed Description

Not available

Study Timeline

• Study First Posted: 2024-07-10
• Last Update Posted: 2025-06-06

Recruitment & Eligibility

• Status: Ongoing, recruitment ended
• Sex: Not specified
• Target Recruitment: 456

Inclusion Criteria

1. Male or female, 18 years of age or older

2. Documented diagnosis of UC at least 3 months before screening

3. Moderately to severely active UC as defined by baseline modified Mayo score

4. History of inadequate response to or failure to tolerate conventional or advanced therapy as defined in the protocol

5. Screening laboratory test results within the study protocol defined parameters

Exclusion Criteria

1. Severe extensive colitis as defined in the study protocol

2. UC limited to the rectum only

3. Presence of a stoma

4. Presence or history of a fistula

5. Presence of symptomatic colonic or small bowel obstruction

6. History of extensive colonic resection

7. History of colonic mucosal dysplasia

8. Indeterminate colitis, microscopic colitis, ischemic colitis, or Crohn's disease or clinical findings suggestive of Crohn's disease.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical Response at Induction Week 12		Clinical Response at Induction Week 12

Trial Locations

Locations (64)

Unidade Local De Saude De Santo Antonio E.P.E.; 🇵🇹 Porto, Portugal

Universitaetsklinikum Ulm AöR; 🇩🇪 Ulm, Germany

Medizinische Hochschule Hannover; 🇩🇪 Hanover, Germany

Praxisgemeinschaft Jerichow; 🇩🇪 Jerichow, Germany

Studiengesellschaft BSF UG (haftungsbeschraenkt); 🇩🇪 Halle (Saale), Germany

Charite Universitaetsmedizin Berlin KöR; 🇩🇪 Berlin, Germany

Het Ziekenhuisnetwerk Antwerpen; 🇧🇪 Antwerp, Belgium

Algemeen Ziekenhuis Delta; 🇧🇪 Roeselare, Belgium

Second Multiprofile Hospital For Active Treatment Sofia EAD; 🇧🇬 Sofia, Bulgaria

Diagnostics And Consultation Center Convex Ltd.; 🇧🇬 Sofiya, Bulgaria

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Unidade Local De Saude De Santo Antonio E.P.E.

🇵🇹Porto, Portugal

Paula Lago

Site contact

00351222077500

paulalago.gastro@chporto.min-saude.pt