A Phase Ib/IIa Study of INT-210 Capsules in Participants With Active Ulcerative Colitis

NCT07692165 | Recruiting Phase 1

• 2 other identifiers: INT-210-II102CTR20260703
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 15

Brief Summary

A Multicenter, Randomized, Open-label Clinical Study to Evaluate the Safety and Efficacy of INT-210 Capsules in Participants with Active Ulcerative Colitis. The study aims to evaluate the safety, efficacy, pharmacokinetic (PK) characteristics, pharmacodynamic (PD) characteristics of INT-210 in participants with active ulcerative colitis (UC).

Conditions

Ulcerative Colitis (UC)

Outcome Measures

Primary Outcomes (11)

• The incidence of treatment-emergent adverse events

  Number of participants with treatment-related adverse events as assessed. The incidence of treatment-emergent adverse events will be measured using a combination of data collection methods, including tracking adverse events and assessing their onset or worsening relative to the initiation of treatment. The most recent version of the Medical Dictionary for Regulatory Activities (MedDRA) preferred terms will be used to classify adverse events, including their relationship to the treatment and maximum severity.

  From enrollment through the safety follow-up visit on Day 92

• Treatment-emergent potentially clinically- significant abnormalities in safety laboratory parameters-hematology

  From enrollment through the safety follow-up visit on Day 92

• Treatment-emergent potentially clinically significant abnormalities in safety laboratory parameters: blood chemistry

  From enrollment through the safety follow-up visit on Day 92

• Treatment-emergent potentially clinically significant abnormalities in safety laboratory parameters: serum ferritin

  From enrollment through the safety follow-up visit on Day 92

• Treatment-emergent potentially clinically significant abnormalities in safety laboratory parameters: coagulation

  From enrollment through the safety follow-up visit on Day 92

• Treatment-emergent potentially clinically significant abnormalities in safety laboratory parameters: urinalysis

  From enrollment through the safety follow-up visit on Day 92

• Treatment-emergent potentially clinically significant abnormalities in electrocardiogram values: QTcF (milliseconds)

  A standard 12-lead ECG will be used to collect ventricular rate, PR interval, QRS duration, QT interval, QTcF interval (Fridericia's correction), and ECG result description; the participant must rest for at least 5 minutes before the test. The investigator (or designated personnel) will clinically evaluate each 12-lead ECG.

  From enrollment through the safety follow-up visit on 92

• Treatment-emergent potentially clinically significant abnormalities in vital signs: heart rate (beats per minute)

  From enrollment through the safety follow-up visit on Day 92

• Treatment-emergent potentially clinically significant abnormalities in vital signs: blood pressure (mmHg)

  From enrollment through the safety follow-up visit on Day 92

• Treatment-emergent potentially clinically significant abnormalities in vital signs: respiration rate (BPM)

  From enrollment through the safety follow-up visit on Day 92

• Treatment-emergent potentially clinically significant abnormalities in vital signs: temperature (℃)

  From enrollment through the safety follow-up visit on Day 92

Secondary Outcomes (22)

• Pharmacokinetics parameter: Cmax of INT-210

  From Day 1 to Day 85

• Pharmacokinetics parameter: Cmax_ss of INT-210

  rom Day 1 to Day 85

• Pharmacokinetics parameter: Cmin_ss of INT-210

  From Day 1 to Day 85

• Pharmacokinetics parameter: Cave_ss of INT-210

  From Day 1 to Day 85

• Pharmacokinetics parameter: AUC0-inf of INT-210

  From Day1 to Day 85

Study Arms (2)

200 mg INT-210 capsule

EXPERIMENTAL

Drug: INT-210 Capsule

400 mg INT-210 capsule

EXPERIMENTAL

Drug: INT-210 Capsule

Interventions

INT-210 Capsule DRUG

All participants will receive oral treatment with INT-210 capsule 200 mg twice daily, starting from Day 1 (D1) of the treatment period (12 weeks).

200 mg INT-210 capsule

Eligibility Criteria

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

You may qualify if:

• Voluntarily participate in the study and sign the informed consent form (ICF);
• Males or females aged ≥18 and ≤75 years at the time of signing the ICF;
• Diagnosed with UC for ≥3 months at the time of signing the ICF, with the diagnosis of UC supported by clinical manifestations and colonoscopy evidence, and confirmed by a histopathology report (pre-randomization colonoscopy and histopathology examination are acceptable as supporting evidence);
• Active UC, defined as: a modified Mayo score (including hematochezia, stool frequency, and endoscopy findings) of 4-9, with an endoscopy subscore of ≥2 (confirmed by central reading) and a hematochezia subscore of ≥1 in the Mayo score;
• At pre-randomization colonoscopy, the extent of UC lesions extends beyond the rectum (active disease ≥15 cm from the anal verge on colonoscopy, confirmed by central reading);
• Participants must have had an inadequate response or intolerance to at least one of the following UC treatments (inadequate response is defined as that the participant has previously discontinued the corresponding drug due to lack of efficacy as judged by the investigator; intolerance is defined as that the participant has previously discontinued the drug due to adverse reactions as judged by the investigator): oral sulfasalazine (SASP) and/or 5- aminosalicylate (5-ASA); oral corticosteroids; azathioprine or 6- mercaptopurine; marketed anti-tumor necrosis factor-α (TNF-α) agents: infliximab or adalimumab, etc.; vedolizumab; marketed JAK inhibitors: tofacitinib, upadacitinib, etc.; marketed interleukin 12/23 (IL-12/23) inhibitors: ustekinumab, etc.; selective sphingosine-1-phosphate (S1P) receptor modulators: etrasimod, etc.; sulfasalazine (SASP) and/or 5- aminosalicylate (5-ASA); oral corticosteroids; azathioprine or 6- mercaptopurine; marketed anti-tumor necrosis factor-α (TNF-α) agents: infliximab or adalimumab, etc.; vedolizumab; marketed JAK inhibitors: tofacitinib, upadacitinib, etc.; marketed interleukin 12/23 (IL-12/23) inhibitors: ustekinumab, etc.; selective sphingosine-1-phosphate (S1P) receptor modulators: etrasimod, etc.;
• If participants are currently using the following drugs to treat UC, they must also meet the following requirements:
• Glucocorticoid therapy: oral prednisone ≤20 mg/d (or equivalent drug dose) or budesonide ≤9 mg/d or beclomethasone ≤5 mg/d, with a stable dose for at least 2 weeks before the screening colonoscopy;
• Aminosalicylate preparations: oral sulfasalazine and/or 5- aminosalicylate must be stable for at least ≥2 weeks before the screening colonoscopy and must remain stable during the study;
• Throughout the entire study period from the signing of the ICF and for 3 months after the last dose, female participants of childbearing potential and male participants who have not undergone vasectomy must comply with the specified contraception requirements.

You may not qualify if:

• Pregnant or lactating women, or those planning to become pregnant during the study;
• Known allergy to any component of INT-210;
• Based on medical history and endoscopy and/or histological results, participants with suspected or confirmed Crohn's disease, unclassified colitis, acute fulminant colitis, toxic megacolon, intestinal perforation, microscopic colitis, ischemic colitis, or radiation colitis;
• Participants who have undergone surgery for UC or are planning surgery (including stoma creation, or total or partial proctectomy/colectomy, etc.);
• Evidence of unresected adenoma or dysplasia in the colon, including lowgrade or high-grade atypical hyperplasia, and unclassified atypical hyperplasia; presence of high-risk progressive adenoma, defined as:
• ① Adenoma diameter ≥10 mm; or ② Villous adenoma or mixed adenoma with villous structure exceeding 25%; or ③ Accompanied by high-grade intraepithelial neoplasia.
• With primary sclerosing cholangitis;
• History of alcohol or drug abuse or addiction within one year prior to screening;
• Have undergone other major surgery within 6 months prior to screening, or are planning surgery during the study; have a history of myocardial infarction, acute stroke or transient ischemic attack, thrombotic events such as deep vein thrombosis or pulmonary embolism, clinically significant arrhythmia or unstable angina pectoris, coronary artery bypass grafting, or severe or pulmonale or pulmonary arterial hypertension that would affect the evaluation of study results, within 6 months prior to screening;
• Presence of clinically severe diseases, such as a history of cardiovascular, hepatic, endocrine, gastrointestinal, metabolic, neurological, pulmonary, or psychiatric diseases, or clinically significant diseases, conditions, or other evidence that the investigator considers would pose a risk to participant safety or interfere with the conduct, progress, or completion of the study;
• Have received two or more classes of biological products/small molecule targeted drugs (e.g., anti-TNF-α monoclonal antibodies, anti-integrin antibodies, anti-IL12/23 monoclonal antibodies, JAK inhibitors, S1P receptor modulators) and have been assessed by the investigator as treatment failure (UC disease progression requiring salvage therapy, inability to taper glucocorticoid during the maintenance phase, or need for other effective therapies);
• Participants receiving the following drug therapies:
• Use of non-steroidal anti-inflammatory drugs (excluding stable use of
• ≤100 mg/day aspirin for prevention of cardiovascular and cerebrovascular diseases and temporary use of ≤2000 mg/day acetaminophen for no more than three days for infectious pyrexia or mild to moderate pain), intestinal probiotics (including fecal transplant), fish oil, JAK inhibitors, immunoadsorption therapy, Chinese herbal medicines, or compound preparations containing Chinese herbal medicines within 2 weeks prior to randomization;
• Use of azathioprine or 6-mercaptopurine, cyclosporine, thalidomide, methotrexate, mycophenolate, tacrolimus/sirolimus within 4 weeks prior to randomization;

Sponsors & Collaborators

• Innatus Therapeutics (Shanghai) Co., Ltd.: lead

Study Sites (15)

The Sixth Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

RECRUITING

Shengjing Hospital of China Medical University

Shenyang, Liaoning, China

RECRUITING

Beijing Chao-Yang Hospital, Capital Medical University

Beijing, China

RECRUITING

Beijing Friendship Hospital, Capital Medical University

Beijing, China

RECRUITING

Beijing Luhe Hospital, Capital Medical University

Beijing, China

RECRUITING

Guangzhou First People's Hospital

Guangzhou, China

RECRUITING

The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, China

RECRUITING

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, China

RECRUITING

XinHua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, China

RECRUITING

Shanxi Bethune Hospital

Taiyuan, China

RECRUITING

Weifang People's Hospital

Weifang, China

RECRUITING

The Second Affiliated Hospital of Wenzhou Medical University

Wenzhou, China

RECRUITING

Renmin Hospital of Wuhan University

Wuhan, China

RECRUITING

Xijing Hospital (The First Affiliated Hospital of Air Force Medical University)

Xi'an, China

RECRUITING

The First Affiliated Hospital of Henan Medical University

Xinxiang, China

RECRUITING

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Minhu Chen

  First Affiliated Hospital, Sun Yat-Sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Iris Liu

CONTACT

+86 010-82089858; irisliu@innatustherapeutics.com

Study Design

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

Study Record Dates

• First Submitted: June 23, 2026
• First Posted: July 9, 2026
• Study Start: June 11, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: July 9, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (15)