NCT05181137

A Phase 3 Study to Investigate the Efficacy and Safety of SHR0302 With Moderately to Severely Active Ulcerative Colitis

A Phase 3 Study to Evaluate the Efficacy and Long-term Safety of SHR0302 Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 368 (estimated)
• Sponsor: Reistone Biopharma Company Limited · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, double-blind, placebo-controlled, multicenter Phase 3 study that will enroll approximately 368 subjects aged 18 to 75 years old with Moderately to Severely Active Ulcerative Colitis.

Detailed description

This study consists of a screening period followed by a placebo-controlled Part 1 phase and then a placebo-controlled Part 2 phase. An open label Part 3 phase is open to subjects who: complete the Part 2, are considered non-responders following the Part 1, or have disease worsening during Part 2.

Conditions

• Ulcerative Colitis

Interventions

Type	Name	Description
DRUG	SHR0302	Oral tablets taken once daily (QD)
DRUG	Placebo	Oral tablets taken once daily (QD)

Timeline

• Start date: 2021-11-05
• Primary completion: 2024-10-31
• Completion: 2025-03-31
• First posted: 2022-01-06
• Last updated: 2023-09-05

Locations

113 sites across 5 countries: United States, China, Georgia, Poland, Ukraine

Regulatory

• FDA-regulated drug study