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.
Age between 18-75 years (inclusive of both 18 and 75), regardless of gender.
Diagnosed with ulcerative colitis or Crohn's disease for ≥3 months, as assessed by histological or endoscopic examination prior to screening.
Active moderate to severe UC or CD.
Subjects must have failed at least one of the following drug treatments for UC or CD or be intolerant: oral aminosalicylates, oral corticosteroids, immunosuppressants, biologics, etc.
Pregnant or lactating women.
Lesions confined solely to the rectal segment within 15 cm of the anus.
Subjects diagnosed with indeterminate colitis, radiation colitis, or ischemic colitis.
Presence of severe complications such as local stricture, intestinal obstruction, intestinal perforation, major lower gastrointestinal hemorrhage, intestinal neoplastic changes or neoplastic potential, toxic megacolon; rectal/colonic polyps, or anal diseases that the investigator assesses may impact efficacy and safety evaluation.
Parallel
24mg bid TQH3906 capsule
DrugTQH3906 is an allosteric inhibitor targeting kinase developed by Chia Tai Tianqing Pharmaceutical Co., Ltd.
32mg TQH3906 capsule
DrugTQH3906 is an allosteric inhibitor targeting kinase developed by Chia Tai Tianqing Pharmaceutical Co., Ltd.
TQH3906 placebo
DrugTQH3906 is an allosteric inhibitor targeting kinase developed by Chia Tai Tianqing Pharmaceutical Co., Ltd.
Adverse event rate
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
UC: Mayo score ≤2 and no single item score \>1.
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.
The change in Inflammatory Bowel Disease Questionnaire (IBDQ) score
The change in Inflammatory Bowel Disease Questionnaire (IBDQ) score relative to the baseline. Improvement ≥16points.
Peak concentration (Cmax)
Maximum plasma drug concentration of study drug.
Plasma concentration at steady state (Cav, SS)
The plasma concentration at which the rate of administration and rate of elimination are in equilibrium.
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.
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