NCT06754891

Clinical Trial of TQH3906 Capsules for the Treatment of Adult Patients With Moderately to Severely Active Ulcerative Colitis or Crohn's Disease

A Phase Ib Clinical Trial to Evaluate the Efficacy and Safety of TQH3906 in Adults With Moderately to Severely Active Ulcerative Colitis or Crohn's Disease

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 116 (estimated)
• Sponsor: Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, single-arm Phase Ib exploratory study, divided into Cohort 1: moderate to severe active ulcerative colitis, and Cohort 2: moderate to severe active Crohn's disease. Each cohort is divided into two phases. The first phase mainly explores the safety and tolerability of three dose groups of TQH3906 (12mg, 24mg, and 32mg). Based on the findings of the first phase, the second phase of the study will be conducted to select 1-2 dose groups for preliminary efficacy confirmation in ulcerative colitis and Crohn's disease. The subjects will take TQH3906 capsules orally for 8 weeks to evaluate the safety, efficacy, and pharmacokinetic (PK) characteristics of TQH3906 capsules in subjects with moderate to severe active ulcerative colitis or Crohn's disease. The study will include a screening period of up to 4 weeks, an 8-week treatment period, and a 4-week follow-up period after treatment.

Conditions

• Inflammatory Bowel Diseases

Interventions

Type	Name	Description
DRUG	TQH3906 capsules	TQH3906 is an allosteric inhibitor targeting kinase.

Timeline

• Start date: 2025-01-01
• Primary completion: 2026-12-01
• Completion: 2027-12-01
• First posted: 2025-01-01
• Last updated: 2025-01-01

Locations

16 sites across 1 country: China