Actively Recruiting
Clinical Trial of TQH3906 Capsules for the Treatment of Adult Patients With Moderately to Severely Active Ulcerative Colitis or Crohn's Disease
Led by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. · Updated on 2026-05-12
135
Participants Needed
30
Research Sites
148 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Clinical Trial of TQH3906 Capsules for the Treatment of Adult Patients With Moderately to Severely Active Ulcerative Colitis or Crohn's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years
- Diagnosed with ulcerative colitis or Crohn's disease for at least 3 months confirmed by histological or endoscopic examination
- Active moderate to severe ulcerative colitis or Crohn's disease
- Failed or intolerant to at least one drug treatment for ulcerative colitis or Crohn's disease including oral aminosalicylates, corticosteroids, immunosuppressants, or biologics
- Stable treatment with oral aminosalicylates for at least 3 weeks or oral systemic corticosteroids for at least 2 weeks before first dose if currently using these drugs
- Discontinued oral aminosalicylates or combined hormone therapy for at least 2 weeks before pre-randomization endoscopy if recently stopped
- Willing to use effective contraception from screening until 3 months after last dose
- Able to understand the study and provide informed consent
You will not qualify if you...
- Pregnant or breastfeeding women
- Lesions limited only to the rectal segment within 15 cm of the anus
- Diagnosed with indeterminate colitis, radiation colitis, or ischemic colitis
- Severe complications such as strictures, obstruction, perforation, major gastrointestinal bleeding, neoplastic changes, toxic megacolon, polyps, or anal diseases affecting safety or efficacy
- Current stomas, ileostomy-anal anastomoses, or fistulas requiring possible surgery or intervention within 12 weeks
- Extensive small bowel resection over 100 cm or diagnosed short bowel syndrome or need for total parenteral nutrition
- Positive Clostridium difficile toxin or PCR test unless retested negative after treatment
- Confirmed cytomegalovirus colitis treated and symptom-free for at least 3 months
- Active hepatitis or positive hepatitis B or C markers with active infection
- Positive HIV antibody or history of HIV infection
- Positive treponemal antibody without confirmatory serological test
- History or latent tuberculosis infection not on prophylaxis
- History of severe herpes infections
- Severe infections requiring hospitalization or IV antibiotics within 2 months
- Received live vaccine within 4 weeks prior or planned during study
- Clinically significant infection during screening requiring treatment
- Major unstable disease or condition making participation unsafe
- Heart diseases requiring medication or abnormal ECG
- Abnormal liver, blood, or other lab tests beyond defined limits
- Poorly controlled diabetes or with major complications
- History of cancer or lymphoproliferative disorders within 5 years
- Recent use of multiple biologics or small-molecule inhibitors not targeting TYK2 or TYK2/JAK1
- Prior treatment with drugs targeting TYK2 or TYK2/JAK1
- Recent use of certain immunosuppressants or other investigational drugs
- Recent surgery or planned surgery during study
- Recent immunoglobulin or blood product use
- Use of strong CYP450 inducers
- Use of topical or intravenous corticosteroids, anti-infective or antidiarrheal medications
- Recent NSAID use excluding topical or low-dose aspirin
- Organ transplant recipients on immunosuppressives
- Allergy to TQH3906 or severe drug hypersensitivity
- History of substance abuse or positive drug screen
- Any other medical, psychiatric, or social reasons deemed unsuitable by investigator
AI-Screening
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Trial Site Locations
Total: 30 locations
1
The First Affilliated Hospital of Bengbu Medical University
Bengbu, Anhui, China, 233000
Not Yet Recruiting
2
Gansu Wuwei Tumour Hospital
Wuwei, Gansu, China, 733099
Not Yet Recruiting
3
First affiliated hospital of guangzhou medical university
Guangzhou, Guangdong, China, 510163
Not Yet Recruiting
4
Zhujiang Hospital, of Southern Medical University
Guangzhou, Guangdong, China, 510260
Not Yet Recruiting
5
Huizhou First People's Hospital
Huizhou, Guangdong, China, 516003
Not Yet Recruiting
6
Heilongjiang provincial hospital
Harbin, Heilongjiang, China, 150036
Not Yet Recruiting
7
Luoyang Central Hospital (Zhengzhou University Affiliated Luoyang Central Hospital)
Luoyang, Henan, China, 471000
Not Yet Recruiting
8
Luoyang First People's Hospital
Luoyang, Henan, China, 471002
Not Yet Recruiting
9
Nanyang Second General Hospital
Nanyang, Henan, China, 473012
Not Yet Recruiting
10
Henan Provincial People's Hospital
Zhengzhou, Henan, China, 450000
Not Yet Recruiting
11
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 450000
Not Yet Recruiting
12
The Second Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 450003
Not Yet Recruiting
13
Union Hosiptal, Tongji Medical College, Huazhong University of Science And Technolocy
Wuhan, Hubei, China, 430022
Not Yet Recruiting
14
Renmin Hospital of Wuhan University
Wuhan, Hubei, China, 430060
Not Yet Recruiting
15
Hunan Provincial People's Hospital
Changsha, Hunan, China, 410000
Not Yet Recruiting
16
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China, 410000
Not Yet Recruiting
17
Xiangya Hospital of Central South University
Changsha, Hunan, China, 410000
Not Yet Recruiting
18
The First Affiliated Hospital Of University Of South China
Hengyang, Hunan, China, 421000
Not Yet Recruiting
19
Jiangsu Provincial People's Hospital
Nanjing, Jiangsu, China, 210000
Not Yet Recruiting
20
The first hospital of Jilin University
Changchun, Jilin, China, 130031
Not Yet Recruiting
21
Meihekou Central Hospital
Meihekou, Jilin, China, 135022
Not Yet Recruiting
22
Shengjing Hospital oh China Medical University
Shenyang, Liaoning, China, 110022
Not Yet Recruiting
23
The Second School of Clinical Medicine of Shandong First Medical University
Taishan, Shandong, China, 271000
Not Yet Recruiting
24
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China, 200025
Not Yet Recruiting
25
Shanxi Provincial People's Hospital
Taiyuan, Shanxi, China, 030012
Not Yet Recruiting
26
The TCM Affiliated Hospital of Southwest Medical University
Luzhou, Sichuan, China, 646000
Actively Recruiting
27
Tianjin People's Hospital
Tianjin, Tianjin Municipality, China, 300121
Not Yet Recruiting
28
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, China, 844000
Actively Recruiting
29
The First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China, 650032
Not Yet Recruiting
30
Taizhou Municipal Hospital
Taizhou, Zhejiang, China, 318000
Actively Recruiting
Research Team
X
Xiaowei Liu, Postdoctoral researcher
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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