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

NCT06754891 | Not Yet Recruiting Phase 1

• 1 other identifier: TQH3906-Ib-01
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 16

Brief Summary

This is an open-label, single-arm Phase Ib exploratory study, divided into Cohort 1: moderate to severe active ulcerative colitis, and Cohort 2: moderate to severe active Crohn's disease. Each cohort is divided into two phases. The first phase mainly explores the safety and tolerability of three dose groups of TQH3906 (12mg, 24mg, and 32mg). Based on the findings of the first phase, the second phase of the study will be conducted to select 1-2 dose groups for preliminary efficacy confirmation in ulcerative colitis and Crohn's disease. The subjects will take TQH3906 capsules orally for 8 weeks to evaluate the safety, efficacy, and pharmacokinetic (PK) characteristics of TQH3906 capsules in subjects with moderate to severe active ulcerative colitis or Crohn's disease. The study will include a screening period of up to 4 weeks, an 8-week treatment period, and a 4-week follow-up period after treatment.

Conditions

Inflammatory Bowel Diseases

Outcome Measures

Primary Outcomes (3)

• Adverse event rate

  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

  UC: Mayo score ≤2 and no single item score \>1.

  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.

  Week 8

Secondary Outcomes (7)

• The change in Inflammatory Bowel Disease Questionnaire (IBDQ) score

  Week 8

• Peak concentration (Cmax)

  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)

  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

  Week 8

• Clinical Response Rate: Crohn's disease: A reduction of at least 100 points in the Crohn's disease activity index

  Week 8

Study Arms (1)

TQH3906 capsules

EXPERIMENTAL

Administration of TQH3906 capsules for 8 weeks

Drug: TQH3906 capsules

Interventions

TQH3906 capsules DRUG

TQH3906 is an allosteric inhibitor targeting kinase.

TQH3906 capsules

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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. .
• 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.
• 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.

You may not qualify if:

• Pregnant or breastfeeding women.
• Subjects diagnosed with indeterminate colitis, radiation colitis, or ischemic colitis.
• Have severe complications such as local stenosis, intestinal obstruction, intestinal perforation, lower gastrointestinal bleeding, intestinal cancer or tendency towards cancer, toxic megacolon; rectal colon polyps and anal diseases, etc., as assessed by the investigator, may affect the subject's efficacy and safety assessment.
• Subjects currently have a stoma, ileal pouch-anal anastomosis, fistula, and according to the physician's judgment, may require surgery or drug intervention within 12 weeks of entering the study, or may require ileostomy or colostomy.
• Subjects have had a large segment of the small intestine resected (\>100cm) or have been diagnosed with short bowel syndrome, or subjects require total parenteral nutrition.
• Subjects have a recorded positive test for Clostridium difficile toxin (C. difficile) in stool or positive polymerase chain reaction (PCR) test. If the result is positive, subjects may be re-screened after appropriate treatment and re-tested no earlier than 7 days after the end of treatment.
• Abnormal serum virology during the screening period: a) Active hepatitis, or positive for Hepatitis B surface antigen (HBsAg) and positive for hepatitis B virus (HBV)-DNA, or positive for Hepatitis B core antibody (HBcAb) and positive for HBV-DNA, or positive for hepatitis B virus (HCV) antibodies and positive for HCV-RNA; b) Positive for HIV antibodies during the screening period, or history of HIV infection; c) Positive for Treponema pallidum antibodies and positive for non-treponemal serologic tests (RPR or TRUST) during the screening period.
• History of active tuberculosis during the screening period or latent tuberculosis infection (defined as enzyme-linked immunospot assay (T-SPOT) positive without clinical manifestations). (Note: Patients with latent tuberculosis infection may be re-screened after starting preventive treatment for one month according to the guidelines. To continue participating in the study, patients must agree to complete the preventive treatment plan during the study period, but rifampin treatment should be avoided.)
• History of severe herpes zoster or herpes simplex infection, including but not limited to herpes encephalitis, disseminated herpes simplex, and generalized herpes zoster.
• History of severe bacterial, fungal, or viral infections within 2 months before the first dose requiring hospitalization and intravenous antibiotic or antiviral treatment.
• Received live vaccines within 4 weeks before the first dose or plan to receive live vaccines during the study period.
• Clinically significant infections during the screening period, including but not limited to upper respiratory tract infections, lower respiratory tract infections, herpes simplex, herpes zoster, requiring antibiotic or antiviral treatment.
• Subjects with any major illness or unstable clinical condition (such as kidney, liver, blood, gastrointestinal, endocrine, lung, mental, neurological, immune, or local active infection/infectious diseases), as determined by the investigator, are not suitable for participating in this study.
• Abnormal laboratory tests during the screening period: a) alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥3 times the upper limit of normal (ULN); b) Hemoglobin \<90g/L; c) White blood cell count \<3.0×109/L; d) Neutrophil count \<1.0×109/L; e) Lymphocyte count \<0.5×109/L; f) Platelet count \<100×109/L; g) Total bilirubin \>2 times ULN; h) Other significant laboratory test abnormalities that the investigator considers the subject unsuitable for participation in this study.
• Subjects with poorly controlled diabetes or diabetes with significant complications (such as retinopathy or nephropathy).

Sponsors & Collaborators

• Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.: lead

Study Sites (16)

The First Affilliated Hospital of Bengbu Medical University

Bengbu, Anhui, 233000, China

Location

Gansu Wuwei Tumour Hospital

Wuwei, Gansu, 733099, China

Location

First affiliated hospital of guangzhou medical university

Guangzhou, Guangdong, 510163, China

Location

Luoyang First People's Hospital

Luoyang, Henan, 471002, China

Location

Henan Provincial People's Hospital

Zhengzhou, Henan, 450000, China

Location

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450000, China

Location

Union Hosiptal, Tongji Medical College, Huazhong University of Science And Technolocy

Wuhan, Hubei, 430022, China

Location

Renmin Hospital of Wuhan University

Wuhan, Hubei, 430060, China

Location

Xiangya Hospital of Central South University

Changsha, Hunan, 410000, China

Location

The First Affiliated Hospital Of University Of South China

Hengyang, Hunan, 421000, China

Location

The first hospital of Jilin University

Changchun, Jilin, 130031, China

Location

Meihekou Central Hospital

Meihekou, Jilin, 135022, China

Location

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

Location

Shanxi Provincial People's Hospital

Taiyuan, Shanxi, 030012, China

Location

Tianjin People's Hospital

Tianjin, Tianjin Municipality, 300121, China

Location

The First Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, 650032, China

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Central Study Contacts

Xiaowei Liu, Postdoctoral researcher

CONTACT

13548762632; liuxw@csu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 25, 2024
• First Posted: January 1, 2025
• Study Start: January 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: January 1, 2025

Record last verified: 2024-07

Locations

CN (16)