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

NCT06754891 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 135

Last updated 2026-05-12

No results posted yet for this study

Summary

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.

Conditions

  • Inflammatory Bowel Diseases

Interventions

DRUG

24mg bid TQH3906 capsule

TQH3906 is an allosteric inhibitor targeting kinase developed by Chia Tai Tianqing Pharmaceutical Co., Ltd.

DRUG

32mg TQH3906 capsule

TQH3906 is an allosteric inhibitor targeting kinase developed by Chia Tai Tianqing Pharmaceutical Co., Ltd.

DRUG

TQH3906 placebo

TQH3906 is an allosteric inhibitor targeting kinase developed by Chia Tai Tianqing Pharmaceutical Co., Ltd.

Sponsors & Collaborators

  • Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-28
Primary Completion
2027-07-31
Completion
2027-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06754891 on ClinicalTrials.gov