NCT07229950

A Phase 2 Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of HRS-7085 Tablets in Patients With Inflammatory Bowel Disease

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 66 (estimated)
• Sponsor: Shandong Suncadia Medicine Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is a randomized, double-blind, placebo-controlled Phase II clinical trial comprising screening period, treatment period, and follow-up period. This phase 2 study is being conducted to evaluate the efficacy, safety and pharmacokinetics of HRS-7085 in patients with moderate to severe active ulcerative colitis.

Conditions

• Adult Patients With Moderately to Severely Active Ulcerative Colitis

Interventions

Type	Name	Description
DRUG	HRS-7085	HRS-7085 Low dose po
DRUG	HRS-7085	HRS-7085 High dose po
DRUG	Placebo	Placebo po

Timeline

• Start date: 2025-10-17
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2025-11-17
• Last updated: 2026-02-06

Locations

1 site across 1 country: China