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New treatment option for Ulcerative Colitis (UC)
Official title A Phase Ib/IIa Study of INT-210 Capsules in Participants With Active Ulcerative Colitis
ClinicalTrials.gov ID: NCT07692165
What this study is testing
What is INT-210 Capsule?
INT-210 Capsule is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for ulcerative colitis (uc).
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
- 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).
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
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
- 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...
- Active UC, defined as: a modified Mayo score (including hematochezia, stool frequency, and endoscopy findings) of 4-9, with an endoscopy subscore of...
- At pre-randomization colonoscopy, the extent of UC lesions extends beyond the rectum (active disease ≥15 cm from the anal verge on colonoscopy...
You likely can't join 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...
- 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...
- With primary sclerosing cholangitis;
See the full eligibility criteria
Who can join
- 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...
- 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...
- 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...
- 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...
What rules you out
- 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...
- 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...
- 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...
- Presence of clinically severe diseases, such as a history of cardiovascular, hepatic, endocrine, gastrointestinal, metabolic, neurological, pulmonary, or psychiatric diseases, or clinically significant diseases...
- 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...
- 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...
- Use of azathioprine or 6-mercaptopurine, cyclosporine, thalidomide, methotrexate, mycophenolate, tacrolimus/sirolimus within 4 weeks prior to randomization;
- Use of intravenous corticosteroids within 4 weeks prior to randomization, or rectal corticosteroids or rectal 5-ASA within 2 weeks prior to randomization;
- Use of interferon or TNF-α inhibitors within 8 weeks prior to randomization;
- Intravenous immunoglobulin injection or therapeutic plasma exchange within 8 weeks prior to randomization;
- Use of S1P receptor modulators within 10 weeks prior to randomization;
- Use of vedolizumab, IL-12/23 antibodies, cyclophosphamide, or chlorambucil within 12 weeks prior to randomization;
- Use of leflunomide within 12 weeks prior to randomization, unless discontinued for 4 weeks before randomization and accelerated elimination (e.g., oral cholestyramine or activated charcoal) was completed at least 2...
- Use of rituximab within 1 year prior to randomization;
- Use of any other investigational or marketed products with immunosuppressive effects within 8 weeks or 5 drug half-lives (whichever is longer) prior to randomization;
- Positive for Mycobacterium tuberculosis or judged by the investigator to have a potential M. tuberculosis infection, such as: positive T-SPOT.TB test or purified protein derivative (PPD) induration ≥5 mm (within 3...
- History of recurrent invasive fungal infections or other chronic infections; herpes zoster or cytomegalovirus infection within 8 weeks prior to signing the ICF; clinically diagnosed clostridioides difficile infection or...
- Presence of any disease that may require treatment with systemic glucocorticoid during the study (e.g., moderate to severe asthma, dermatitis atopic, rheumatoid arthritis, etc.);
- Malignant tumors within 5 years prior to screening (except for adequately treated or resected basal cell or squamous cell skin cancer); or previous neoplasm screening that did not rule out tumor lesions;
- Participants with conditions that may affect the absorption of oral drugs, such as gastrectomy or clinically significant diabetes mellitus-related gastrointestinal diseases, or specific types of obesity surgery such as...
- Participants who have undergone small intestine or colon operation and have evidence of colonic dysplasia or intestinal stenosis;
- Any of the following abnormalities in screening laboratory tests:
- Hemoglobin \<9 g/dL or white blood cells \<3.0×109/L or neutrophils \<1.5×109/L, platelets \<100×109/L
- Total bilirubin (TBIL), aspartate transaminase (AST), or alanine transaminase (ALT) ≥1.5 times the upper limit of normal (ULN)
- Blood creatinine \>1.5 times ULN
- Any other abnormal laboratory test results that the investigator considers may expose the participant to unacceptable risks by participating in this study
- Positive for hepatitis B surface antigen (HBsAg), or test results are HBsAg negative, hepatitis B core antibody (HBcAb) positive, and positive for hepatitis B virus deoxyribonucleic acid (HBV-DNA); positive for...
- Positive for intestinal pathogens (excluding colonizing microorganisms interpreted by the investigator to be non-pathogenic);
- Clinically significant electrocardiogram abnormal during the screening period, which the investigator judges may increase the participant's safety risk;
- Have received any live vaccine within 3 months prior to randomization or plan to receive any live vaccine during the clinical study;
- Participants whom the investigator considers have other factors that make them unsuitable for participation in this study.
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
- Shenyang, Liaoning, China
- Beijing, China
- Guangzhou, China
- Hangzhou, China
- Shanghai, China
- Taiyuan, China
- Weifang, China
- Wenzhou, China
- Wuhan, China
- Xi'an, China
- Xinxiang, China
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 Guangzhou, Guangdong, China; Shenyang, Liaoning, China; Beijing, China; Guangzhou, China; Hangzhou, China; Shanghai, China and 6 more location(s). Enter your location above to see the nearest site and check your eligibility.
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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.