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

NCT06754891 | Recruiting Phase 1

• 1 other identifier: TQH3906-Ib-01
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 30

Brief 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

Outcome Measures

Primary Outcomes (3)

• Adverse event rate

  The occurrence of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs).

  Baseline up to week 16

• Clinical remission rate: Ulcerative colitis (UC): Mayo score

  UC: Mayo score ≤2 and no single item score \>1.

  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.

  Week 8

Secondary Outcomes (7)

• The change in Inflammatory Bowel Disease Questionnaire (IBDQ) score

  Week 12

• Peak concentration (Cmax)

  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)

  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

  Week 8

• Clinical Response Rate: Crohn's disease: A reduction of at least 100 points in the Crohn's disease activity index

  Week 8

Study Arms (3)

24mg bid TQH3906 capsule treatment group

EXPERIMENTAL

24mg TQH3906 capsules for 12 weeks

Drug: 24mg bid TQH3906 capsule

32mg TQH3906 capsule treatment group

EXPERIMENTAL

32mg TQH3906 capsules for 12 weeks

Drug: 32mg TQH3906 capsule

TQH3906 placebo treatment group

EXPERIMENTAL

Placebo Comparator

Drug: TQH3906 placebo

Interventions

32mg TQH3906 capsule DRUG

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

32mg TQH3906 capsule treatment group

TQH3906 placebo DRUG

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

TQH3906 placebo treatment group

24mg bid TQH3906 capsule DRUG

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

24mg bid TQH3906 capsule treatment group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• If subjects are using the following drugs for UC or CD at the time of screening, their treatment should be stabilized with oral aminosalicylates for at least 3 weeks before the first dose of the trial medication, or stabilized with oral systemic corticosteroids for at least 2 weeks before the first dose of the trial medication, 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 take appropriate and effective contraceptive measures from the time of screening until 3 months after the last administration of the study medication.
• Before the trial, understand in detail the nature, significance, potential benefits, possible inconveniences, and potential risks of the trial, understand the research procedures, and voluntarily sign the informed consent form.

You may not qualify if:

• 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.
• Subjects with current stomas, ileostomy-anal anastomoses, or fistulas, where the physician determines surgery or medical intervention may be required within 12 weeks of study entry, or where ileostomy or colostomy may be necessary.
• Subjects with extensive small bowel resection (\>100 cm) or diagnosed short bowel syndrome, or requiring total parenteral nutrition.
• Subjects with documented positive Clostridium difficile toxin (C. difficile) testing or polymerase chain reaction (PCR) testing.Polymerase Chain Reaction (PCR) test. If positive, the subject may be rescreened after appropriate treatment and retested no earlier than 7 days after treatment completion.
• Patients with confirmed cytomegalovirus-associated colitis must have undergone adequate treatment for at least 3 months prior to the screening endoscopy and must be symptom-free.
• Presence of abnormal seroviral status during the screening period:
• a Active hepatitis, or hepatitis B surface antigen (HBsAg) positive with Hepatitis B Virus (HBV) DNA positive, or hepatitis B core antibody (HBcAb) positive with HBV-DNA positive, or Hepatitis C Virus (HCV) antibody positive with HCV-RNA positive; b Screening-period HIV antibody positive, or prior history of HIV infection; c. Positive treponemal antibody during screening without positive treponemal serological test (RPR or TRUST).
• History of active tuberculosis during screening or prior to enrollment, or detection of latent tuberculosis infection during screening (defined as T-cell Spot of Tuberculosis (T-SPOT.0) positive without clinical manifestations). (Note: Patients with latent tuberculosis infection may initiate preventive treatment according to guidelines for 1 month. To continue in the study, patients must agree to complete the prophylactic treatment regimen during the study period, avoiding rifampin therapy.
• History of severe herpes zoster or herpes simplex infections, including but not limited to herpes encephalitis, disseminated herpes simplex, or generalized herpes zoster.
• History of severe bacterial, fungal, or viral infection requiring hospitalization with intravenous antibiotics or antiviral therapy within 2 months prior to first dosing.
• Receipt of live vaccine within 4 weeks prior to first dosing or planned administration of live vaccine during the study period.
• Development of clinically significant infection during the screening period, including but not limited to upper respiratory tract infection, lower respiratory tract infection, herpes simplex, or herpes zoster requiring antibiotic or antiviral treatment.

Sponsors & Collaborators

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

Study Sites (30)

The First Affilliated Hospital of Bengbu Medical University

Bengbu, Anhui, 233000, China

NOT YET RECRUITING

Gansu Wuwei Tumour Hospital

Wuwei, Gansu, 733099, China

NOT YET RECRUITING

First affiliated hospital of guangzhou medical university

Guangzhou, Guangdong, 510163, China

NOT YET RECRUITING

Zhujiang Hospital, of Southern Medical University

Guangzhou, Guangdong, 510260, China

NOT YET RECRUITING

Huizhou First People's Hospital

Huizhou, Guangdong, 516003, China

NOT YET RECRUITING

Heilongjiang provincial hospital

Harbin, Heilongjiang, 150036, China

NOT YET RECRUITING

Luoyang Central Hospital (Zhengzhou University Affiliated Luoyang Central Hospital)

Luoyang, Henan, 471000, China

NOT YET RECRUITING

Luoyang First People's Hospital

Luoyang, Henan, 471002, China

NOT YET RECRUITING

Nanyang Second General Hospital

Nanyang, Henan, 473012, China

NOT YET RECRUITING

Henan Provincial People's Hospital

Zhengzhou, Henan, 450000, China

NOT YET RECRUITING

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450000, China

NOT YET RECRUITING

The Second Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450003, China

NOT YET RECRUITING

Union Hosiptal, Tongji Medical College, Huazhong University of Science And Technolocy

Wuhan, Hubei, 430022, China

NOT YET RECRUITING

Renmin Hospital of Wuhan University

Wuhan, Hubei, 430060, China

NOT YET RECRUITING

Hunan Provincial People's Hospital

Changsha, Hunan, 410000, China

NOT YET RECRUITING

The Second Xiangya Hospital of Central South University

Changsha, Hunan, 410000, China

NOT YET RECRUITING

Xiangya Hospital of Central South University

Changsha, Hunan, 410000, China

NOT YET RECRUITING

The First Affiliated Hospital Of University Of South China

Hengyang, Hunan, 421000, China

NOT YET RECRUITING

Jiangsu Provincial People's Hospital

Nanjing, Jiangsu, 210000, China

NOT YET RECRUITING

The first hospital of Jilin University

Changchun, Jilin, 130031, China

NOT YET RECRUITING

Meihekou Central Hospital

Meihekou, Jilin, 135022, China

NOT YET RECRUITING

Shengjing Hospital oh China Medical University

Shenyang, Liaoning, 110022, China

NOT YET RECRUITING

The Second School of Clinical Medicine of Shandong First Medical University

Taishan, Shandong, 271000, China

NOT YET RECRUITING

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

NOT YET RECRUITING

Shanxi Provincial People's Hospital

Taiyuan, Shanxi, 030012, China

NOT YET RECRUITING

The TCM Affiliated Hospital of Southwest Medical University

Luzhou, Sichuan, 646000, China

RECRUITING

Tianjin People's Hospital

Tianjin, Tianjin Municipality, 300121, China

NOT YET RECRUITING

The First Affiliated Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, 844000, China

RECRUITING

The First Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, 650032, China

NOT YET RECRUITING

Taizhou Municipal Hospital

Taizhou, Zhejiang, 318000, China

RECRUITING

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Central Study Contacts

Xiaowei Liu, Postdoctoral researcher

CONTACT

13548762632; liuxw@csu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 25, 2024
• First Posted: January 1, 2025
• Study Start: January 28, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 12, 2026

Record last verified: 2026-05

Locations

CN (30)