BridgeMD
New treatment option for Inflammatory Bowel Diseases
Official title Clinical Trial of TQH3906 Capsules for the Treatment of Adult Patients With Moderately to Severely Active Ulcerative Colitis or Crohn's Disease
ClinicalTrials.gov ID: NCT06754891
What this study is testing
What is 24mg bid TQH3906 capsule?
24mg bid TQH3906 capsule is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for inflammatory bowel diseases.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join 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.
- people must have failed at least one of the following drug treatments for UC or CD or be intolerant: oral aminosalicylates, oral corticosteroids...
- If people are using the following drugs for UC or CD at the time of screening, their treatment should be stabilized with oral aminosalicylates for at...
You likely can't join if
- Pregnant or lactating women.
- Lesions confined solely to the rectal segment within 15 cm of the anus.
- people 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...
- people with current stomas, ileostomy-anal anastomoses, or fistulas, where the physician determines surgery or medical intervention may be required...
- people with extensive small bowel resection (\>100 cm) or diagnosed short bowel syndrome, or requiring total parenteral nutrition.
See the full eligibility criteria
Who can 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.
- people 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 people 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...
- 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.
- people (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...
What rules you out
- Pregnant or lactating women.
- Lesions confined solely to the rectal segment within 15 cm of the anus.
- people 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...
- people 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...
- people with extensive small bowel resection (\>100 cm) or diagnosed short bowel syndrome, or requiring total parenteral nutrition.
- people 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...
- 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)...
- 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...
- 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...
- 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...
- 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 \ 2 times ULN; g Other significant laboratory abnormalities...
- people 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Bengbu, Anhui, China
- Wuwei, Gansu, China
- Guangzhou, Guangdong, China
- Huizhou, Guangdong, China
- Harbin, Heilongjiang, China
- Luoyang, Henan, China
- Nanyang, Henan, China
- Zhengzhou, Henan, China
- Wuhan, Hubei, China
- Changsha, Hunan, China
- Hengyang, Hunan, China
- Nanjing, Jiangsu, China
- Changchun, Jilin, China
- Meihekou, Jilin, China
- Shenyang, Liaoning, China
- Taishan, Shandong, China
- Shanghai, Shanghai Municipality, China
- Taiyuan, Shanxi, China
- Luzhou, Sichuan, China
- Tianjin, Tianjin Municipality, China
+ 3 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bengbu, Anhui, China; Wuwei, Gansu, China; Guangzhou, Guangdong, China; Huizhou, Guangdong, China; Harbin, Heilongjiang, China; Luoyang, Henan, China and 17 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.