UC: Phase 2 Study of CU104 in Moderate-Severe Ulcerative Colitis
Study Details
Study Description
Brief Summary
The study is designed to investigate efficacy and safety of CU104 in patients with moderate to severe ulcerative colitis.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: CU104 CU104 100 mg three capsules a day . |
Drug: CU104
CU104 will administer the study drug once a day after a meal
|
| Placebo Comparator: Placebo Placebo three capsules a day. |
Drug: Placebo
Placebo will administer the study drug once a day after a meal
|
Outcome Measures
Primary Outcome Measures
- Percentage of participants with clinical remission at Week 8 [Week 8]
Clinical remission is defined as a modified Mayo score o to 2
Eligibility Criteria
Criteria
Inclusion Criteria:
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Provision of signed and dated informed consent form.
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Stated willingness to comply with all study procedures and availability for the duration of the study.
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Male or female, aged 18 to 80 years.
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Males and female patients with clinical diagnosis of ulcerative colitis ≥3 months prior to Screening.
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Active, moderate to severe ulcerative colitis, as defined by the modified Mayo score of 5 to 9, including an endoscopy sub-score of at least 2.
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For females of reproductive potential: Use of highly effective contraception for at least 1 month prior to Screening and agreement to use such method during study participation and for an additional 8 weeks after the last dose.
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For males of reproductive potential: Use of condoms or other methods to ensure effective contraception during study participation and for an additional 8 weeks after the last dose.
Exclusion Criteria:
- Received any of the following, prior to randomization for the treatment of UC:
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Corticosteroids (intravenous or rectal administration) or 5-aminosalicylic acid (rectal administration) within 3 weeks;
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Janus kinase (JAK) inhibitors within 2 weeks;
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Cyclosporine, mycophenolate, tacrolimus, methotrexate, azathioprine, or 6- mercaptopurine within 4 weeks;
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Anti-TNF-α biologics within 8 weeks; or
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Any other commercially approved biologic agent or targeted small molecule within 8 weeks or within 5 half-lives whichever is longer.
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Have been diagnosed with UC limited to the rectum (disease which extends < 15 cm above the anal verge).
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Received orally administered 5-aminosalicylic acid (ASA), sulfasalazine, or low-dose corticosteroids (prednisolone ≤20 mg/day or its equivalent) on a stable regimen (i.e., no changes in drug or dose) for <4 weeks prior to randomization. The doses must remain stable until the end of study treatment (with possible exception for tapering steroid dose after 8 weeks).
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Received any other concomitant medications for UC on a stable regimen (i.e., no changes in drug or dose) for <2 weeks or 5 half-lives, whichever is longer.
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Presence of Crohn's disease, indeterminate colitis, ischemic colitis, fulminant colitis, ulcerative proctitis, or toxic megacolon.
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Previous extensive colonic resection (subtotal or total colectomy).
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Ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine.
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Evidence of or treatment for, Clostridium difficile infection or other pathogenic bowel infection within 60 days or for another intestinal pathogen within 30 days prior to randomization.
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Active viral infection with HIV, Hepatitis B, or Hepatitis C.
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Clinically significant, active extraintestinal infection (e.g., pneumonia, pyelonephritis).
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History of cancer, including solid tumors and hematological malignancies (except basal cell and in situ squamous cell carcinomas of the skin that have been excised and resolved).
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History of any clinically significant medical condition that, in the investigator's opinion, would preclude participation in the study (e.g., End-stage renal disease (ESRD), severe liver diseases).
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Has unstable angina, myocardial infarction, transient ischemic attack, cerebral infarction, coronary artery bypass surgery, or transluminal coronary angioplasty within 6 months before screening.
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Other clinically significant abnormal lab values per Investigator's judgement.
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Pregnancy or lactation.
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Treatment with another investigational drug or other intervention within 30 days prior to Screening.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Curacle Co., Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CU104-P2-01