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Phase 2 Study of CU104 in Moderate-Severe Ulcerative Colitis (UC)

Primary Purpose

Ulcerative Colitis

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
CU104
Placebo
Sponsored by
Curacle Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulcerative Colitis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    CU104

    Placebo

    Arm Description

    CU104 100 mg three capsules a day .

    Placebo three capsules a day.

    Outcomes

    Primary Outcome Measures

    Percentage of participants with clinical remission at Week 8
    Clinical remission is defined as a modified Mayo score o to 2

    Secondary Outcome Measures

    Full Information

    First Posted
    June 8, 2023
    Last Updated
    June 8, 2023
    Sponsor
    Curacle Co., Ltd.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05907330
    Brief Title
    Phase 2 Study of CU104 in Moderate-Severe Ulcerative Colitis
    Acronym
    UC
    Official Title
    A Randomized, Double-blind, Placebo-controlled, Multi-center, Phase 2 Study to Evaluate the Efficacy and Safety of CU104 in Patients With Moderate to Severe Ulcerative Colitis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 1, 2024 (Anticipated)
    Primary Completion Date
    February 28, 2026 (Anticipated)
    Study Completion Date
    March 31, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Curacle Co., Ltd.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    The study is designed to investigate efficacy and safety of CU104 in patients with moderate to severe ulcerative colitis.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Ulcerative Colitis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    45 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    CU104
    Arm Type
    Experimental
    Arm Description
    CU104 100 mg three capsules a day .
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo three capsules a day.
    Intervention Type
    Drug
    Intervention Name(s)
    CU104
    Intervention Description
    CU104 will administer the study drug once a day after a meal
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Placebo will administer the study drug once a day after a meal
    Primary Outcome Measure Information:
    Title
    Percentage of participants with clinical remission at Week 8
    Description
    Clinical remission is defined as a modified Mayo score o to 2
    Time Frame
    Week 8

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Bomi Kim
    Phone
    +82-70-4118-3886
    Email
    bomi.kim@curacle.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Phase 2 Study of CU104 in Moderate-Severe Ulcerative Colitis

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