Ulcerative ColitisPhase 2UCNCT05907330
Phase 2 Study of CU104 in Moderate-Severe Ulcerative Colitis
A Phase 2 study testing CU104 in people with Ulcerative Colitis, run by Curacle Co., Ltd..
Trial summary
The study is designed to investigate efficacy and safety of CU104 in patients with moderate to severe ulcerative colitis. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- CU104
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2024to 31 Mar 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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
The study is designed to investigate efficacy and safety of CU104 in patients with moderate to severe ulcerative colitis.
- Conditions
- Ulcerative Colitis
- Being tested
- CU104, Placebo
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CU104Drug
CU104 will administer the study drug once a day after a meal
PlaceboDrug
Placebo will administer the study drug once a day after a meal
| Study group | Role | What they receive |
|---|---|---|
| CU104 | Experimental | CU104 100 mg three capsules a day . Receives: Drug: CU104 |
| Placebo | Placebo comparator | Placebo three capsules a day. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants with clinical remission at Week 8
Clinical remission is defined as a modified Mayo score o to 2
Measured: Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start1 Jun 2024 (estimated)
- Primary completion28 Feb 2026 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Curacle Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05907330
- Sponsor's protocol ID
- CU104-P2-01
- Acronym
- UC
- Status last verified
- Jun 2023
- First submitted
- 8 Jun 2023
- Last updated
- 18 Jun 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05907330
- Acronym / sponsor ID
- UC / CU104-P2-01
- Conditions
- Ulcerative Colitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Curacle Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Jun 2024 (estimated)
- Primary completion
- 28 Feb 2026 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 18 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is designed to investigate efficacy and safety of CU104 in patients with moderate to severe ulcerative colitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CU104 | Experimental | Drug: CU104CU104 100 mg three capsules a day . |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo three capsules a day. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (21 listed)
- Received any of the following, prior to randomization for the treatment of UC:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CU104CU104 will administer the study drug once a day after a meal | Drug | CU104 |
| PlaceboPlacebo will administer the study drug once a day after a meal | Drug | Placebo |
Primary outcome
Percentage of participants with clinical remission at Week 8
Time frame: Week 8
Clinical remission is defined as a modified Mayo score o to 2
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CU104 in people with Ulcerative Colitis, run by Curacle Co., Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bomi Kim (+82-70-4118-3886, bomi.kim@curacle.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants with clinical remission at Week 8 (time frame: Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2023.