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Ivarmacitinib in moderate to severe active Crohn's disease
NCT03677648Phase 2
Key facts
- Status
- Completed
- Start
- May 2019
- Primary completion
- Sep 2021
- Countries
- 4
- Sponsor
- Reistone Biopharma
- Modality
- Small Molecules
- Drugs
- ivarmacitinib
- Conditions
- Crohn's disease
01
Overview
Phase 2, randomised, double-blind trial of ivarmacitinib in Crohn's disease (4 arms), sponsored by Reistone Biopharma. Primary endpoint: Percentage of subjects achieving clinical remission at 12 weeks. Started May 2019; status: completed.
02
Design
4 arms- Study design
- RandomizedDouble-blind
SHR0302 Dose A
Ivarmacitinib Dose A
SHR0302 Dose B
Ivarmacitinib Dose B
SHR0302 Dose C
Ivarmacitinib Dose C
Placebo
Placebo (switches to active at week 12)
03
Who it enrols
Adults 18-75 with moderate to severe active Crohn's Disease (CDAI 220-450) and at least 3 months diagnosis history. Excludes UC, indeterminate colitis, specific bowel complications, and treatment-naive patients.
04
Endpoints
Primary
Percentage of subjects achieving clinical remission
Secondary
Percentage of subjects achieving clinical remission (SF <= 2.5, AP <= 1)
Percentage of subjects achieving clinical remission (PRO2 < 8)
Percentage of subjects achieving clinical response (CDAI decrease >= 100)
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