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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

StatusRecruiting
PhasePhase 1
Started2025-01-28
View on ClinicalTrials.gov ↗

Amendment history

2026-05-07
Not Yet Recruiting→Recruiting Study Status, Study Description, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2026-12→2027-07
Start dateestimated 2025-01→confirmed 2025-01-28
Enrollment target116→135
Study sites16→30
Study arms1→3
InterventionsTQH3906 capsules (Drug)→24mg bid TQH3906 capsule (Drug), 32mg TQH3906 capsule (Drug), TQH3906 placebo (Drug)
Eligibility criteria+493 characters
[...] tion prior to screening. Active moderate to severe UC or CD. . Subjects must have failed at least one of the following dru [...] cation, and maintain a stable dose during the trial period. If oral aminosalicylate or combined hormone therapy has been discontinued recently, it must be discontinued for at least 2 weeks prior to the pre-randomization endoscopy. Subjects (including partners) are willing to voluntarily tak [...] the informed consent form. Exclusion Criteria: Pregnant or breastfeedinglactating women. Lesions confined solely to the rectal segment within 15 cm of the anus. Subjects diagnosed with i [...] [...]
Secondary endpointsdetails revised at 3 of 7 entries
2024-12-25
Original filing
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.
Trial Details
NCT Number NCT06754891
Lead Sponsor Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.
Conditions Inflammatory Bowel Diseases
Enrollment 135 participants
Start Date 2025-01-28
Primary Completion 2027-07 (estimated)
Study Completion 2027-12 (estimated)
Updated on ClinicalTrials.gov 2026-05-12