Phase 2 Study of CU104 in Moderate-Severe Ulcerative Colitis

NCT05907330 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: CU104-P2-01
• Study Type: interventional
• Target: 45
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

• Percentage of participants with clinical remission at Week 8

  Clinical remission is defined as a modified Mayo score o to 2

  Week 8

Study Arms (2)

CU104

EXPERIMENTAL

CU104 100 mg three capsules a day .

Drug: CU104

Placebo

PLACEBO COMPARATOR

Placebo three capsules a day.

Drug: Placebo

Interventions

CU104 DRUG

CU104 will administer the study drug once a day after a meal

CU104

Placebo DRUG

Placebo will administer the study drug once a day after a meal

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Curacle Co., Ltd.: lead

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Bomi Kim

CONTACT

+82-70-4118-3886; bomi.kim@curacle.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2023
• First Posted: June 18, 2023
• Study Start: June 1, 2024
• Primary Completion: February 28, 2026
• Study Completion: March 31, 2026
• Last Updated: June 18, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share