Trial intelligence / Profile preview

Guselkumab Subcutaneous Induction Therapy in Crohn's Disease

NCT05197049Phase 3

Key facts

Status: Active, not recruiting
Start: Jan 2022
Primary completion: Jul 2023
Countries: 27
Sponsor: Janssen Pharmaceutical
Modality: Monoclonal Antibodies

Drugs: guselkumab
Conditions: Crohn's disease

Overview

Phase 3, randomised, double-blind trial of guselkumab in Crohn's disease (3 arms), sponsored by Janssen Pharmaceutical. Primary endpoints: Clinical Remission at 12 weeks and Endoscopic Response at 12 weeks. Started Jan 2022; status: active, not recruiting.

Design

3 arms

Study design: RandomizedDouble-blind

Group 1: Guselkumab
Guselkumab Dose 1 SC followed by Dose 2 SC
Group 2: Guselkumab
Guselkumab Dose 1 SC followed by Dose 3 SC
Group 3: Placebo
Placebo SC

Who it enrols

Participants must have a diagnosis of moderate to severe Crohn's disease for at least 3 months, with intolerance or inadequate response to conventional or biologic therapy. Excludes patients with ulcerative colitis, indeterminate colitis, or complications requiring surgery.

Endpoints

Primary

Clinical Remission12 weeks
Endoscopic Response12 weeks

Secondary

Clinical Remission24 weeks
Patient-reported Outcome (PRO)-2 Remission12 weeks
Clinical Response12 weeks
Treatment-Emergent Adverse Events48 weeks
Treatment-Emergent Serious Adverse Events48 weeks
Treatment-Emergent Adverse Events Leading to Discontinuation of Study Drug48 weeks

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