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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
116
TQH3906 is an allosteric inhibitor targeting kinase.
The First Affilliated Hospital of Bengbu Medical University
Bengbu, Anhui, China
Gansu Wuwei Tumour Hospital
Wuwei, Gansu, China
First affiliated hospital of guangzhou medical university
Guangzhou, Guangdong, China
Luoyang First People's Hospital
Luoyang, Henan, China
Henan Provincial People's Hospital
Zhengzhou, Henan, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Union Hosiptal, Tongji Medical College, Huazhong University of Science And Technolocy
Wuhan, Hubei, China
Renmin Hospital of Wuhan University
Wuhan, Hubei, China
Xiangya Hospital of Central South University
Changsha, Hunan, China
The First Affiliated Hospital Of University Of South China
Hengyang, Hunan, China
...and 6 more locations
Adverse 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 8
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 8
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 8
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.