NCT06754891

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

Recruiting now Phase 1 Last updated 7 May 2026

What this trial tests

Phase 1 trial testing 24mg bid TQH3906 capsule in Inflammatory Bowel Diseases in 135 participants. Currently enrolling.

Timeline

28 January 2025

Primary endpoint
1 July 2027

1 December 2027

Quick facts

Lead sponsor	Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.
Phase	Phase 1
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	135
Start date	28 January 2025
Primary completion	1 July 2027
Estimated completion	1 December 2027
Sites	30 locations across China

Drugs / interventions tested

• 24mg bid TQH3906 capsule
• 32mg TQH3906 capsule
• TQH3906 placebo

Conditions studied

• Inflammatory Bowel Diseases — all drugs for Inflammatory Bowel Diseases →

Sponsor

Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. — full company profile →

Who can join

Adults 18 to 75, any sex, with Inflammatory Bowel Diseases. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Adverse event rate
  Time frame: Baseline up to week 16
  The occurrence of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs).
• Clinical remission rate: Ulcerative colitis (UC): Mayo score
  Time frame: Week 8
  UC: Mayo score ≤2 and no single item score \>1.
• Clinical remission rate: Ulcerative colitis (UC): Crohn's disease (CD)
  Time frame: Week 8
  Crohn's disease: Average daily stool frequency ≤2.8 and average daily abdominal pain score ≤1, with neither exceeding the baseline score.

Sponsor's own description

This phase will commence following dose escalation in the 24mg bid group during Phase I. Employing a 1:1:1 randomized, double-blind, placebo-controlled study design, it will evaluate the efficacy, safety, and Pharmacokinetics/Pharmacodynamics (PK/PD) characteristics of TQH3906 capsules in subjects with moderate-to-severe active ulcerative colitis. The study will include a maximum 4-week screening period, a 12-week treatment period, and a 4-week post-treatment follow-up period, enrolling a total of 105 subjects. Among these, subjects who failed conventional therapy and those who failed biologic therapy each constitute 35% of the cohort.

week treatment period, and a 4-week post-treatment follow-up period. A total of 105 subjects will be enrolled, with 50% comprising subjects who failed conventional therapy and 50% comprising subjects who failed biologic therapy.

Dose Group Design:

Group A: Placebo Group B: 32mg dose group Group C: 24mg bid dose group The specific dose will be determined based on the 48mg dose group's medication experience from Phase I and adjusted as necessary.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.