A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease

Phase 2/3

Active, not recruiting

• Conditions: Moderately to Severely Active Crohn's Disease

• Registration Number: 2023-504736-18-00
• Lead Sponsor: Janssen - Cilag International

Brief Summary

Phase 2:

- To evaluate the clinical efficacy of guselkumab in participants with Crohn's disease

- To evaluate the safety of guselkumab

Phase 3:

- To evaluate the clinical and endoscopic efficacy of guselkumab in participants with Crohn's disease

- To evaluate the safety of guselkumab

Detailed Description

Not available

Study Timeline

• Study First Posted: 2024-08-01
• Last Update Posted: 2025-05-13

Recruitment & Eligibility

• Status: Ongoing, recruitment ended
• Sex: Not specified
• Target Recruitment: 474

Inclusion Criteria

• Have Crohn's disease (CD) or fistulizing Crohn's disease of at least 3 months duration (defined as a minimum of 12 weeks), with colitis, ileitis, or ileocolitis, confirmed at any time in the past by radiography, histology, and/or endoscopy

• Have moderate to severe CD as assessed by CDAI, stool frequency (SF), and abdominal pain (AP) scores, and Simple Endoscopic Score for Crohn's Disease (SES-CD)

• Have screening laboratory test results within the protocol specified parameters

• A female participant of childbearing potential must have a negative urine pregnancy test result at screening and baseline

• Demonstrated intolerance or inadequate response to conventional or to biologic therapy for CD

Exclusion Criteria

• Current diagnosis of ulcerative colitis or indeterminate colitis

• Has complications of Crohn's disease, such as symptomatic strictures or stenoses, short gut syndrome, or any other manifestation

• Unstable doses of concomitant Crohn's disease therapy

• Receipt of Crohn's disease approved biologic agents, investigational agents, or procedures outside of permitted timeframe as specified in the protocol

• Any medical contraindications preventing study participation

Study & Design

• Study Type: Not specified
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Phase 2: Change from Baseline in the Crohn's Disease Activity Index (CDAI) Score at Week 12		Phase 2: Change from Baseline in the Crohn's Disease Activity Index (CDAI) Score at Week 12
Phase 3: Global co-primary endpoints: - clinical response at Week 12 and clinical remission at Week 48 - clinical response at Week 12 and endoscopic response at Week 48. Regional co-primary endpoints: - clinical remission at Week 12 - endoscopic response at Week 12		Phase 3: Global co-primary endpoints: - clinical response at Week 12 and clinical remission at Week 48 - clinical response at Week 12 and endoscopic response at Week 48. Regional co-primary endpoints: - clinical remission at Week 12 - endoscopic response at Week 12

Trial Locations

Locations (52)

Casa Sollievo Della Sofferenza; 🇮🇹 San Giovanni Rotondo, Italy

Medizinische Hochschule Hannover; 🇩🇪 Hanover, Germany

Charite Universitaetsmedizin Berlin KöR; 🇩🇪 Berlin, Germany

Universitaetsklinikum Augsburg; 🇩🇪 Augsburg, Germany

Universitaetsklinikum Ulm AöR; 🇩🇪 Ulm, Germany

Eugastro GmbH; 🇩🇪 Leipzig, Germany

Hepato-Gastroenterologie HK s.r.o.; 🇨🇿 Hradec Kralove, Czechia

Nemocnice Ceske Budejovice a.s.; 🇨🇿 Ceske Budejovice, Czechia

Synexus Czech s.r.o.; 🇨🇿 Prague, Czechia

NH Hospital a.s.; 🇨🇿 Horovice, Czechia

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Casa Sollievo Della Sofferenza

🇮🇹San Giovanni Rotondo, Italy

Fabrizio Bossa

Site contact

+390882410056

f.bossa@operapadrepio.it