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Ustekinumab in moderately to severely active Crohn's disease in Chinese participants
NCT05029921Phase 4
Key facts
- Status
- Completed
- Start
- Dec 2021
- Primary completion
- May 2025
- Countries
- 1
- Sponsor
- Janssen Pharmaceutical
- Modality
- Monoclonal Antibodies
- Drugs
- ustekinumab
- Conditions
- Crohn's disease
01
Overview
Phase 4, open-label, single-arm trial of ustekinumab in Crohn's disease, sponsored by Janssen Pharmaceutical. Primary endpoints: Clinical Remission at Week 8 and Endoscopic Response at Week 16. Started Dec 2021; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Ustekinumab
Single-arm study with weight-based IV induction followed by SC maintenance dosing with flexible dosing intervals based on response
03
Who it enrols
Chinese participants with moderately to severely active Crohn's disease (CDAI 220-450, SES-CD ≥6) of at least 3 months duration, excluding vedolizumab nonresponders and those with complications requiring surgery
04
Endpoints
Primary
Clinical Remission at Week 8
Endoscopic Response at Week 16
Secondary
Clinical Remission at Week 52
Patient-Reported Outcome-2 Remission at Week 8
Endoscopic Remission at Week 16
Endoscopic Response at Week 52
Endoscopic Remission at Week 52
Clinical Remission at Week 3
Patient-Reported Outcome-2 Remission at Weeks 3 and 52
Clinical Response at Weeks 3, 8, and 52
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