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Phase 2 Study of CU104 in Moderate-Severe Ulcerative Colitis

Studies

Study First Submitted Date 2023-06-08
Study First Posted Date 2023-06-18
Last Update Posted Date 2023-06-18
Start Month Year June 1, 2024
Primary Completion Month Year February 28, 2026
Verification Month Year June 2023
Verification Date 2023-06-30
Last Update Posted Date 2023-06-18

Conditions

Sequence: 51989600
Name Ulcerative Colitis
Downcase Name ulcerative colitis

Id Information

Sequence: 40017199
Id Source org_study_id
Id Value CU104-P2-01

Design Groups

Sequence: 55392742 Sequence: 55392743
Group Type Experimental Group Type Placebo Comparator
Title CU104 Title Placebo
Description CU104 100 mg three capsules a day . Description Placebo three capsules a day.

Interventions

Sequence: 52301427 Sequence: 52301428
Intervention Type Drug Intervention Type Drug
Name CU104 Name Placebo
Description CU104 will administer the study drug once a day after a meal Description Placebo will administer the study drug once a day after a meal

Design Outcomes

Sequence: 176740097
Outcome Type primary
Measure Percentage of participants with clinical remission at Week 8
Time Frame Week 8
Description Clinical remission is defined as a modified Mayo score o to 2

Browse Conditions

Sequence: 192768656 Sequence: 192768657 Sequence: 192768658 Sequence: 192768659 Sequence: 192768660 Sequence: 192768661 Sequence: 192768662 Sequence: 192768663 Sequence: 192768664 Sequence: 192768665
Mesh Term Colitis Mesh Term Colitis, Ulcerative Mesh Term Ulcer Mesh Term Gastroenteritis Mesh Term Gastrointestinal Diseases Mesh Term Digestive System Diseases Mesh Term Colonic Diseases Mesh Term Intestinal Diseases Mesh Term Pathologic Processes Mesh Term Inflammatory Bowel Diseases
Downcase Mesh Term colitis Downcase Mesh Term colitis, ulcerative Downcase Mesh Term ulcer Downcase Mesh Term gastroenteritis Downcase Mesh Term gastrointestinal diseases Downcase Mesh Term digestive system diseases Downcase Mesh Term colonic diseases Downcase Mesh Term intestinal diseases Downcase Mesh Term pathologic processes Downcase Mesh Term inflammatory bowel diseases
Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48149158
Agency Class INDUSTRY
Lead Or Collaborator lead
Name Curacle Co., Ltd.

Central Contacts

Sequence: 11968132
Contact Type primary
Name Bomi Kim
Phone +82-70-4118-3886
Email bomi.kim@curacle.com
Role Contact

Design Group Interventions

Sequence: 67905489 Sequence: 67905490
Design Group Id 55392742 Design Group Id 55392743
Intervention Id 52301427 Intervention Id 52301428

Eligibilities

Sequence: 30658686
Gender All
Minimum Age 18 Years
Maximum Age 80 Years
Healthy Volunteers No
Criteria Inclusion Criteria: Provision of signed and dated informed consent form. Stated willingness to comply with all study procedures and availability for the duration of the study. Male or female, aged 18 to 80 years. Males and female patients with clinical diagnosis of ulcerative colitis ≥3 months prior to Screening. 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. 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. 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: Corticosteroids (intravenous or rectal administration) or 5-aminosalicylic acid (rectal administration) within 3 weeks; Janus kinase (JAK) inhibitors within 2 weeks; Cyclosporine, mycophenolate, tacrolimus, methotrexate, azathioprine, or 6- mercaptopurine within 4 weeks; Anti-TNF-α biologics within 8 weeks; or Any other commercially approved biologic agent or targeted small molecule within 8 weeks or within 5 half-lives whichever is longer. Have been diagnosed with UC limited to the rectum (disease which extends < 15 cm above the anal verge). 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). 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. Presence of Crohn's disease, indeterminate colitis, ischemic colitis, fulminant colitis, ulcerative proctitis, or toxic megacolon. Previous extensive colonic resection (subtotal or total colectomy). Ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine. 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. Active viral infection with HIV, Hepatitis B, or Hepatitis C. Clinically significant, active extraintestinal infection (e.g., pneumonia, pyelonephritis). 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). 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). Has unstable angina, myocardial infarction, transient ischemic attack, cerebral infarction, coronary artery bypass surgery, or transluminal coronary angioplasty within 6 months before screening. Other clinically significant abnormal lab values per Investigator's judgement. Pregnancy or lactation. Treatment with another investigational drug or other intervention within 30 days prior to Screening.
Adult True
Child False
Older Adult True

Calculated Values

Sequence: 254269724
Registered In Calendar Year 2023
Were Results Reported False
Has Single Facility False
Minimum Age Num 18
Maximum Age Num 80
Minimum Age Unit Years
Maximum Age Unit Years
Number Of Primary Outcomes To Measure 1

Designs

Sequence: 30405515
Allocation Randomized
Intervention Model Parallel Assignment
Observational Model
Primary Purpose Treatment
Time Perspective
Masking Triple
Subject Masked True
Investigator Masked True
Outcomes Assessor Masked True

Responsible Parties

Sequence: 28772038
Responsible Party Type Sponsor