Inflammatory Bowel DiseasesPhase 1NCT06754891
Clinical Trial of TQH3906 Capsules for the Treatment of Adult Patients With Moderately to Severely Active Ulcerative Colitis or Crohn's Disease
A Phase 1 study testing 24mg bid TQH3906 capsule and 32mg TQH3906 capsule in people with Inflammatory Bowel Diseases, run by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. at 30 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Inflammatory Bowel Diseases
- What is being tested?
- 24mg bid TQH3906 capsule and 32mg TQH3906 capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 135 participants
- Where
- 30 sitesChina
- Study dates
- 28 Jan 2025to Dec 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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:
- 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.
Trial locations and contacts
30 sites in 1 country. Contact the study team or a site near you to ask about taking part.
30 sites in 1 country
China30 sites, 30 recruiting
- Not yet recruiting
The First Affilliated Hospital of Bengbu Medical University
Bengbu, Anhui, 233000
Xiquan Ke, Doctor, 13605525659, kexq2006@sina.com
- Not yet recruiting
The first hospital of Jilin University
Changchun, Jilin, 130031
Yang Shi, Doctor, 15804301311, shiyangwhy@163.com
- Not yet recruiting
Hunan Provincial People's Hospital
Changsha, Hunan, 410000
Zhan Liu, Master, 13875868860, Liuzhan2004@126.com
- Not yet recruiting
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410000
Xuehong Wang, Doctor, 13973181426, wxh05271@126.com
- Not yet recruiting
Xiangya Hospital of Central South University
Changsha, Hunan, 410000
Xiaowei liu, Postdoctoral researcher, 13548762632, liuxw@csu.edu.cn
- Not yet recruiting
First affiliated hospital of guangzhou medical university
Guangzhou, Guangdong, 510163
Xueqing Chen, Doctor, 13808878446, chenxq@vip.163.com
- Not yet recruiting
Zhujiang Hospital, of Southern Medical University
Guangzhou, Guangdong, 510260
Xinying Wang, Doctor, 13726754880, sunwingwxy@163.com
- Not yet recruiting
Heilongjiang provincial hospital
Harbin, Heilongjiang, 150036
Xiaomei Sun, Doctor, 18686758181, 18686758181@163.com
- Not yet recruiting
The First Affiliated Hospital Of University Of South China
Hengyang, Hunan, 421000
Aijun Liao, Doctor, 15575473586, fyxhnkgcp@163.com
- Not yet recruiting
Huizhou First People's Hospital
Huizhou, Guangdong, 516003
Xuanfang Zhong, Master, 13556264698, Zhongxuanf@sina.com
- Not yet recruiting
The First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, 650032
Juan Luo, Doctor, 15877930893, 260905303@qq.com
- Not yet recruiting
Luoyang Central Hospital (Zhengzhou University Affiliated Luoyang Central Hospital)
Luoyang, Henan, 471000
Shaofeng Zhu, Master, 15137970120, drzsfly@163.com
- Not yet recruiting
Luoyang First People's Hospital
Luoyang, Henan, 471002
Hongling Liu, Bachelor, 18538882095, 1023155248@qq.com
- Recruiting
The TCM Affiliated Hospital of Southwest Medical University
Luzhou, Sichuan, 646000
Long Zhao, Doctor, 13550899628, zhaolong1982@163.com
- Not yet recruiting
Meihekou Central Hospital
Meihekou, Jilin, 135022
Zhongwei Pan, Master, 13179198955, 13179198955@163.com
- Not yet recruiting
Jiangsu Provincial People's Hospital
Nanjing, Jiangsu, 210000
Hongjie Zhang, Doctor, 13951975918, zhjjssrmyy@163.com
Jingjing MA, Doctor, 13770806156, mjjjssrmyy@163.com
- Not yet recruiting
Nanyang Second General Hospital
Nanyang, Henan, 473012
Yunhui Diao, Master, 15225635126, docnany@126.com
- Not yet recruiting
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200025
Duowu Zou, Doctor, 13901617608, zdw_clinpharmacol@163.com
- Not yet recruiting
Shengjing Hospital oh China Medical University
Shenyang, Liaoning, 110022
Lixuan Sang, Doctor, 18940253892, sanglixuan2008@163.com
- Not yet recruiting
The Second School of Clinical Medicine of Shandong First Medical University
Taishan, Shandong, 271000
Zhengwu Yang, Master, 18505387056, yzwsdta@163.com
- Not yet recruiting
Shanxi Provincial People's Hospital
Taiyuan, Shanxi, 030012
Yuxia Hao, Doctor, 13503517335, 13503517335@163.com
- Recruiting
Taizhou Municipal Hospital
Taizhou, Zhejiang, 318000
Guoxiang Wang, Master, 13957689097, Guoxiang19660422@163.com
- Not yet recruiting
Tianjin People's Hospital
Tianjin, Tianjin Municipality, 300121
Rong Zhao, Doctor, 13702156233, zhao_rong2021@163.com
- Recruiting
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, 844000
Yao Ping, Master, 18099186672, ping-yaozh@163.com
- Not yet recruiting
Union Hosiptal, Tongji Medical College, Huazhong University of Science And Technolocy
Wuhan, Hubei, 430022
Rong Lin, Doctor, 15629180035, selinalin35@hotmail.com
- Not yet recruiting
Renmin Hospital of Wuhan University
Wuhan, Hubei, 430060
Ping An, Doctor, 18627068700, anping_005@163.com
- Not yet recruiting
Gansu Wuwei Tumour Hospital
Wuwei, Gansu, 733099
Linzhi Lu, Bachelor, 13659359016, lulinzh12006@163.com
- Not yet recruiting
Henan Provincial People's Hospital
Zhengzhou, Henan, 450000
Xiuling Li, Bachelor, 13938409078, zzlixiuling@aliyun.com
- Not yet recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450000
Hongtao Wen, Doctor, 13603711902, wenhongtao68@163.com
- Not yet recruiting
The Second Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450003
Gaofeng Lu, Doctor, 15637102290, lugaofeng78@163.com
About this study
Official title: 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.
Read more
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
- Being tested
- 24mg bid TQH3906 capsule, 32mg TQH3906 capsule, TQH3906 placebo
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
24mg bid TQH3906 capsuleDrug
TQH3906 is an allosteric inhibitor targeting kinase developed by Chia Tai Tianqing Pharmaceutical Co., Ltd.
32mg TQH3906 capsuleDrug
TQH3906 is an allosteric inhibitor targeting kinase developed by Chia Tai Tianqing Pharmaceutical Co., Ltd.
TQH3906 placeboDrug
TQH3906 is an allosteric inhibitor targeting kinase developed by Chia Tai Tianqing Pharmaceutical Co., Ltd.
| Study group | Role | What they receive |
|---|---|---|
| 24mg bid TQH3906 capsule treatment group | Experimental | 24mg TQH3906 capsules for 12 weeks Receives: Drug: 24mg bid TQH3906 capsule |
| 32mg TQH3906 capsule treatment group | Experimental | 32mg TQH3906 capsules for 12 weeks Receives: Drug: 32mg TQH3906 capsule |
| TQH3906 placebo treatment group | Experimental | Placebo Comparator Receives: Drug: TQH3906 placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse event rate
The occurrence of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs).
Measured: Baseline up to week 16
Clinical remission rate: Ulcerative colitis (UC): Mayo score
UC: Mayo score ≤2 and no single item score >1.
Measured: 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.
Measured: Week 8
Secondary outcomes (7)
The change in Inflammatory Bowel Disease Questionnaire (IBDQ) score
The change in Inflammatory Bowel Disease Questionnaire (IBDQ) score relative to the baseline. Improvement ≥16points.
Measured: Week 12
Peak concentration (Cmax)
Maximum plasma drug concentration of study drug.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2025
- Study start28 Jan 2025
- Primary completionJul 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- More trials run by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 135 participants (estimated)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06754891
- Sponsor's protocol ID
- TQH3906-Ib-01
- Status last verified
- May 2026
- First submitted
- 25 Dec 2024
- Last updated
- 12 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06754891
- Acronym / sponsor ID
- TQH3906-Ib-01
- Conditions
- Inflammatory Bowel Diseases
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 135 participants (estimated)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 28 Jan 2025 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 1 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 24mg bid TQH3906 capsule treatment group | Experimental | Drug: 24mg bid TQH3906 capsule24mg TQH3906 capsules for 12 weeks |
| 32mg TQH3906 capsule treatment group | Experimental | Drug: 32mg TQH3906 capsule32mg TQH3906 capsules for 12 weeks |
| TQH3906 placebo treatment group | Experimental | Drug: TQH3906 placeboPlacebo Comparator |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (35 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 24mg bid TQH3906 capsuleTQH3906 is an allosteric inhibitor targeting kinase developed by Chia Tai Tianqing Pharmaceutical Co., Ltd. | Drug | 24mg bid TQH3906 capsule treatment group |
| 32mg TQH3906 capsuleTQH3906 is an allosteric inhibitor targeting kinase developed by Chia Tai Tianqing Pharmaceutical Co., Ltd. | Drug | 32mg TQH3906 capsule treatment group |
| TQH3906 placeboTQH3906 is an allosteric inhibitor targeting kinase developed by Chia Tai Tianqing Pharmaceutical Co., Ltd. | Drug | TQH3906 placebo treatment group |
Primary outcome
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).
Clinical remission rate: Ulcerative colitis (UC): Mayo score
Time frame: Week 8
UC: Mayo score ≤2 and no single item score >1.
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.
7 secondary outcomes
The change in Inflammatory Bowel Disease Questionnaire (IBDQ) score
Time frame: Week 12
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
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
Clinical Response Rate: UC: A decrease of ≥2 points and ≥30% from the baseline in the Mayo score
Time frame: 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
Endoscopic Remission: UC: The endoscopy subscore in the Mayo score
Time frame: Week 12
Endoscopic Remission: CD: The Simple endoscopic score for Crohn's disease (SES-CD) score
Time frame: Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
30 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 24mg bid TQH3906 capsule and 32mg TQH3906 capsule in people with Inflammatory Bowel Diseases, run by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. at 30 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaowei Liu, Postdoctoral researcher (13548762632, liuxw@csu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse event rate (time frame: Baseline up to week 16). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.