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

May 7, 2026 updated by: Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.

A Phase Ib Clinical Trial to Evaluate the Efficacy and Safety of TQH3906 in Adults With Moderately to Severely Active Ulcerative Colitis or Crohn's Disease

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

135

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Xiaowei liu, Postdoctoral researcher
  • Phone Number: 13548762632
  • Email: liuxw@csu.edu.cn

Study Locations

  • China
    • Anhui
      • Bengbu, Anhui, China, 233000
        • Not yet recruiting
        • The First Affilliated Hospital of Bengbu Medical University
        • Contact:
    • Gansu
      • Wuwei, Gansu, China, 733099
        • Not yet recruiting
        • Gansu Wuwei Tumour Hospital
        • Contact:
    • Guangdong
      • Guangzhou, Guangdong, China, 510163
        • Not yet recruiting
        • First Affiliated Hospital of Guangzhou Medical University
        • Contact:
      • Guangzhou, Guangdong, China, 510260
        • Not yet recruiting
        • Zhujiang Hospital, of Southern Medical University
        • Contact:
      • Huizhou, Guangdong, China, 516003
        • Not yet recruiting
        • Huizhou First People's Hospital
        • Contact:
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150036
        • Not yet recruiting
        • Heilongjiang Provincial Hospital
        • Contact:
    • Henan
      • Luoyang, Henan, China, 471000
        • Not yet recruiting
        • Luoyang Central Hospital (Zhengzhou University Affiliated Luoyang Central Hospital)
        • Contact:
      • Luoyang, Henan, China, 471002
        • Not yet recruiting
        • Luoyang First People's Hospital
        • Contact:
      • Nanyang, Henan, China, 473012
        • Not yet recruiting
        • Nanyang Second General Hospital
        • Contact:
      • Zhengzhou, Henan, China, 450000
        • Not yet recruiting
        • The First Affiliated Hospital of Zhengzhou University
        • Contact:
      • Zhengzhou, Henan, China, 450000
        • Not yet recruiting
        • Henan Provincial People's Hospital
        • Contact:
      • Zhengzhou, Henan, China, 450003
        • Not yet recruiting
        • The Second Affiliated Hospital of Zhengzhou University
        • Contact:
    • Hubei
      • Wuhan, Hubei, China, 430060
        • Not yet recruiting
        • Renmin Hospital of Wuhan University
        • Contact:
      • Wuhan, Hubei, China, 430022
        • Not yet recruiting
        • Union Hosiptal, Tongji Medical College, Huazhong University of Science And Technolocy
        • Contact:
    • Hunan
      • Changsha, Hunan, China, 410000
        • Not yet recruiting
        • The Second Xiangya Hospital Of Central South University
        • Contact:
      • Changsha, Hunan, China, 410000
        • Not yet recruiting
        • Hunan Provincial People's Hospital
        • Contact:
      • Changsha, Hunan, China, 410000
        • Not yet recruiting
        • Xiangya Hospital of Central South University
        • Contact:
          • Xiaowei liu, Postdoctoral researcher
          • Phone Number: 13548762632
          • Email: liuxw@csu.edu.cn
      • Hengyang, Hunan, China, 421000
        • Not yet recruiting
        • The First Affiliated Hospital of University of South China
        • Contact:
    • Jiangsu
      • Nanjing, Jiangsu, China, 210000
        • Not yet recruiting
        • Jiangsu Provincial People's Hospital
        • Contact:
        • Contact:
    • Jilin
      • Changchun, Jilin, China, 130031
        • Not yet recruiting
        • The First Hospital of Jilin University
        • Contact:
      • Meihekou, Jilin, China, 135022
        • Not yet recruiting
        • Meihekou Central Hospital
        • Contact:
    • Liaoning
      • Shenyang, Liaoning, China, 110022
        • Not yet recruiting
        • Shengjing Hospital oh China Medical University
        • Contact:
    • Shandong
      • Taishan, Shandong, China, 271000
        • Not yet recruiting
        • The Second School of Clinical Medicine of Shandong First Medical University
        • Contact:
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200025
        • Not yet recruiting
        • Ruijin Hospital, Shanghai Jiaotong University School of Medicine
        • Contact:
    • Shanxi
      • Taiyuan, Shanxi, China, 030012
        • Not yet recruiting
        • Shanxi Provincial People's Hospital
        • Contact:
    • Sichuan
      • Luzhou, Sichuan, China, 646000
        • Recruiting
        • The TCM Affiliated Hospital of Southwest Medical University
        • Contact:
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300121
        • Not yet recruiting
        • Tianjin People's Hospital
        • Contact:
    • Xinjiang
      • Ürümqi, Xinjiang, China, 844000
        • Recruiting
        • The First Affiliated Hospital of Xinjiang Medical University
        • Contact:
    • Yunnan
      • Kunming, Yunnan, China, 650032
        • Not yet recruiting
        • The First Affiliated Hospital of Kunming Medical University
        • Contact:
    • Zhejiang
      • Taizhou, Zhejiang, China, 318000
        • Recruiting
        • Taizhou Municipal Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • Presence of any major disease or unstable clinical condition (e.g., renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, psychiatric, neurological, immunologic, or locally active infection/infectious disease) deemed by the investigator to make participation in this study inappropriate.
  • Suffering from angina pectoris, arrhythmia, or congestive heart failure requiring medication, or exhibiting clinically significant abnormalities on screening ECG.

  • Abnormal screening laboratory tests:

    i. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 3 times upper limit of normal (ULN); a Hemoglobin < 90 g/L; b White blood cell count < 3.0 × 10⁹/L; c Neutrophil count < 1.0 × 10⁹/L; d Lymphocyte count < 0.5 × 10⁹/L; e Platelet count < 100 × 10⁹/L; f Total bilirubin > 2 times ULN; g Other significant laboratory abnormalities deemed by the investigator to make the subject unsuitable for this study.

  • Subjects with poorly controlled diabetes or diabetes with major complications (e.g., retinopathy or nephropathy).
  • History of malignancy (including carcinoma in situ) or lymphoproliferative disorders within 5 years prior to first dosing.
  • Within 8 weeks or 5 half-lives (whichever is longer) prior to the first dose, patients must have received ≤2 classes of biologics (e.g., anti-Tumor Necrosis Factor-alpha (TNF-α) agents are considered 1 class), including but not limited to anti-TNF-α and anti-α4β7 integrin agents.
  • Patients who have received Janus Kinase (JAK) inhibitors or other small molecule inhibitors (excluding those targeting Tyrosine Kinase 2 (TYK2) or TYK2/JAK1) within 4 weeks or 5 half-lives (whichever is longer) prior to the first dose may be enrolled if the washout period is satisfied.
  • Previously received treatment with small-molecule drugs targeting the same TYK2 or TYK2/JAK1 target.
  • Received fecal microbiota transplantation, cyclosporine, tacrolimus, mycophenolate mofetil, thalidomide, immunosuppressants, or similar medications within 4 weeks prior to first dose.
  • Received any other investigational drug within 1 month or 5 half-lives (whichever is longer) prior to the first dose.
  • Underwent surgery within 4 weeks prior to the first dose, or plans to undergo surgery during the study period.
  • Received immunoglobulin or blood products within 4 weeks prior to the first dose.
  • Use of potent CYP450 inducers (e.g., rifampin, phenobarbital, carbamazepine, phenytoin) within 4 weeks prior to first dose.
  • Use of topical therapy (enemas or suppositories), intravenous corticosteroids, anti-UC or CD traditional Chinese medicine, anti-infective agents, or antidiarrheal medications.
  • Received nonsteroidal anti-inflammatory drugs (NSAIDs) within 1 week prior to first dose (excluding topical NSAIDs and low-dose aspirin for cardiovascular protection).
  • Organ transplant recipients requiring ongoing immunosuppressive therapy.
  • Known allergy to any component of TQH3906 or history of severe drug hypersensitivity.
  • History of substance abuse or positive urine drug screen.
  • Any other reasonable medical, psychiatric, or social reason deemed by the investigator to preclude participation in this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 24mg bid TQH3906 capsule treatment group
24mg TQH3906 capsules for 12 weeks
Drug: 24mg bid TQH3906 capsule
TQH3906 is an allosteric inhibitor targeting kinase developed by Chia Tai Tianqing Pharmaceutical Co., Ltd.
Experimental: 32mg TQH3906 capsule treatment group
32mg TQH3906 capsules for 12 weeks
Drug: 32mg TQH3906 capsule
TQH3906 is an allosteric inhibitor targeting kinase developed by Chia Tai Tianqing Pharmaceutical Co., Ltd.
Experimental: TQH3906 placebo treatment group
Placebo Comparator
Drug: TQH3906 placebo
TQH3906 is an allosteric inhibitor targeting kinase developed by Chia Tai Tianqing Pharmaceutical Co., Ltd.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse event rate
Time Frame: Baseline up to week 16
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
Time Frame: Week 8
UC: Mayo score ≤2 and no single item score >1.
Week 8
Clinical remission rate: Ulcerative colitis (UC): Crohn's disease (CD)
Time Frame: Week 8
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peak concentration (Cmax)
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
Maximum plasma drug concentration of study drug.
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)
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
The plasma concentration at which the rate of administration and rate of elimination are in equilibrium.
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
Time Frame: Week 8
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.
Week 8
Clinical Response Rate: Crohn's disease: A reduction of at least 100 points in the Crohn's disease activity index
Time Frame: Week 8
Crohn's disease: A reduction of at least 100 points in the Crohn's disease activity index from the baseline.
Week 8
The change in Inflammatory Bowel Disease Questionnaire (IBDQ) score
Time Frame: Week 12
The change in Inflammatory Bowel Disease Questionnaire (IBDQ) score relative to the baseline. Improvement ≥16points.
Week 12
Endoscopic Remission: UC: The endoscopy subscore in the Mayo score
Time Frame: Week 12
UC: The endoscopy subscore in the Mayo score is 0 or 1 point.
Week 12
Endoscopic Remission: CD: The Simple endoscopic score for Crohn's disease (SES-CD) score
Time Frame: Week 12
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.
Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 28, 2025

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

December 25, 2024

First Submitted That Met QC Criteria

December 25, 2024

First Posted (Actual)

January 1, 2025

Study Record Updates

Last Update Posted (Actual)

May 12, 2026

Last Update Submitted That Met QC Criteria

May 7, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TQH3906-Ib-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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