New pill TQH3906 tested for tough gut diseases

NCT ID NCT06754891

Disease control Sponsor: Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests an experimental drug called TQH3906 in adults with moderate-to-severe ulcerative colitis or Crohn's disease. About 135 participants will receive either the drug or a placebo for 12 weeks to see if it safely reduces inflammation and improves symptoms. The goal is to control the disease, not cure it, and participants may need ongoing treatment.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 135 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2025

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Crohn disease inflammatory bowel disease ulcerative colitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Inflammatory bowel diseases

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

30 sites. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

Open the record ↗
A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

First affiliated hospital of guangzhou medical university
NOT_YET_RECRUITING

Guangzhou, Guangdong, 510163, China
Gansu Wuwei Tumour Hospital
NOT_YET_RECRUITING

Wuwei, Gansu, 733099, China
Heilongjiang provincial hospital
NOT_YET_RECRUITING

Harbin, Heilongjiang, 150036, China
Henan Provincial People's Hospital
NOT_YET_RECRUITING

Zhengzhou, Henan, 450000, China
Huizhou First People's Hospital
NOT_YET_RECRUITING

Huizhou, Guangdong, 516003, China
Hunan Provincial People's Hospital
NOT_YET_RECRUITING

Changsha, Hunan, 410000, China
Jiangsu Provincial People's Hospital
NOT_YET_RECRUITING

Nanjing, Jiangsu, 210000, China
Luoyang Central Hospital (Zhengzhou University Affiliated Luoyang Central Hospital)
NOT_YET_RECRUITING

Luoyang, Henan, 471000, China
Luoyang First People's Hospital
NOT_YET_RECRUITING

Luoyang, Henan, 471002, China
Meihekou Central Hospital
NOT_YET_RECRUITING

Meihekou, Jilin, 135022, China
Nanyang Second General Hospital
NOT_YET_RECRUITING

Nanyang, Henan, 473012, China
Renmin Hospital of Wuhan University
NOT_YET_RECRUITING

Wuhan, Hubei, 430060, China
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
NOT_YET_RECRUITING

Shanghai, Shanghai Municipality, 200025, China
Shanxi Provincial People's Hospital
NOT_YET_RECRUITING

Taiyuan, Shanxi, 030012, China
Shengjing Hospital oh China Medical University
NOT_YET_RECRUITING

Shenyang, Liaoning, 110022, China
Taizhou Municipal Hospital
RECRUITING

Taizhou, Zhejiang, 318000, China
The First Affiliated Hospital Of University Of South China
NOT_YET_RECRUITING

Hengyang, Hunan, 421000, China
The First Affiliated Hospital of Kunming Medical University
NOT_YET_RECRUITING

Kunming, Yunnan, 650032, China
The First Affiliated Hospital of Xinjiang Medical University
RECRUITING

Ürümqi, Xinjiang, 844000, China
The First Affiliated Hospital of Zhengzhou University
NOT_YET_RECRUITING

Zhengzhou, Henan, 450000, China
The First Affilliated Hospital of Bengbu Medical University
NOT_YET_RECRUITING

Bengbu, Anhui, 233000, China
The Second Affiliated Hospital of Zhengzhou University
NOT_YET_RECRUITING

Zhengzhou, Henan, 450003, China
The Second School of Clinical Medicine of Shandong First Medical University
NOT_YET_RECRUITING

Taishan, Shandong, 271000, China
The Second Xiangya Hospital of Central South University
NOT_YET_RECRUITING

Changsha, Hunan, 410000, China
The TCM Affiliated Hospital of Southwest Medical University
RECRUITING

Luzhou, Sichuan, 646000, China
The first hospital of Jilin University
NOT_YET_RECRUITING

Changchun, Jilin, 130031, China
Tianjin People's Hospital
NOT_YET_RECRUITING

Tianjin, Tianjin Municipality, 300121, China
Union Hosiptal, Tongji Medical College, Huazhong University of Science And Technolocy
NOT_YET_RECRUITING

Wuhan, Hubei, 430022, China
Xiangya Hospital of Central South University
NOT_YET_RECRUITING

Changsha, Hunan, 410000, China
Zhujiang Hospital, of Southern Medical University
NOT_YET_RECRUITING

Guangzhou, Guangdong, 510260, China

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