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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
135
TQH3906 is an allosteric inhibitor targeting kinase developed by Chia Tai Tianqing Pharmaceutical Co., Ltd.
TQH3906 is an allosteric inhibitor targeting kinase developed by Chia Tai Tianqing Pharmaceutical Co., Ltd.
TQH3906 is an allosteric inhibitor targeting kinase developed by Chia Tai Tianqing Pharmaceutical Co., Ltd.
The First Affilliated Hospital of Bengbu Medical University
Bengbu, Anhui, China
NOT_YET_RECRUITINGGansu Wuwei Tumour Hospital
Wuwei, Gansu, China
NOT_YET_RECRUITINGFirst affiliated hospital of guangzhou medical university
Guangzhou, Guangdong, China
NOT_YET_RECRUITINGZhujiang Hospital, of Southern Medical University
Guangzhou, Guangdong, China
NOT_YET_RECRUITINGAdverse event rate
The occurrence of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs).
Time frame: Baseline up to week 16
Clinical remission rate: Ulcerative colitis (UC): Mayo score
UC: Mayo score ≤2 and no single item score \>1.
Time frame: Week 8
Clinical remission rate: Ulcerative colitis (UC): Crohn's disease (CD)
Crohn's disease: Average daily stool frequency ≤2.8 and average daily abdominal pain score ≤1, with neither exceeding the baseline score.
Time frame: Week 8
The change in Inflammatory Bowel Disease Questionnaire (IBDQ) score
The change in Inflammatory Bowel Disease Questionnaire (IBDQ) score relative to the baseline. Improvement ≥16points.
Time frame: Week 12
Peak concentration (Cmax)
Maximum plasma drug concentration of study drug.
Time frame: Day 1: within 1 hour pre-dose, 1, 2, 3, 4, 6, 8, 12, and 24 hours post dose; within 1 hour pre-dose on Day 15, 29, 57, Day 57: 1, 2, 3, 4, 6, 8, 12, and 24 hours post dose
Plasma concentration at steady state (Cav, SS)
The plasma concentration at which the rate of administration and rate of elimination are in equilibrium.
Time frame: Day 1: within 1 hour pre-dose, 1, 2, 3, 4, 6, 8, 12, and 24 hours post dose; within 1 hour pre-dose on Day 15, 29, 57, Day 57: 1, 2, 3, 4, 6, 8, 12, and 24 hours post dose
Clinical Response Rate: UC: A decrease of ≥2 points and ≥30% from the baseline in the Mayo score
UC: A decrease of ≥2 points and ≥30% from the baseline in the Mayo score, as well as a decrease of ≥1 point in the rectal bleeding score (RBS) from the baseline or an absolute RBS value of ≤1.
Time frame: Week 8
Clinical Response Rate: Crohn's disease: A reduction of at least 100 points in the Crohn's disease activity index
Crohn's disease: A reduction of at least 100 points in the Crohn's disease activity index from the baseline.
Time frame: Week 8
Endoscopic Remission: UC: The endoscopy subscore in the Mayo score
UC: The endoscopy subscore in the Mayo score is 0 or 1 point.
Time frame: Week 12
Endoscopic Remission: CD: The Simple endoscopic score for Crohn's disease (SES-CD) score
CD: The SES-CD score is ≤4 and has decreased by at least 2 points from the baseline, with no subscore of any individual variable being \>1.
Time frame: Week 12
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Huizhou First People's Hospital
Huizhou, Guangdong, China
NOT_YET_RECRUITINGHeilongjiang provincial hospital
Harbin, Heilongjiang, China
NOT_YET_RECRUITINGLuoyang Central Hospital (Zhengzhou University Affiliated Luoyang Central Hospital)
Luoyang, Henan, China
NOT_YET_RECRUITINGLuoyang First People's Hospital
Luoyang, Henan, China
NOT_YET_RECRUITINGNanyang Second General Hospital
Nanyang, Henan, China
NOT_YET_RECRUITINGHenan Provincial People's Hospital
Zhengzhou, Henan, China
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