NCT06897150CompletedPhase 4
Carotegrast Methyl in Ulcerative Colitis
Efficacy and Safety of Carotegrast Methyl in Active Ulcerative Colitis: A Real-World Prospective Cohort Study
Source: ClinicalTrials.gov · Last updated 2 Apr 2025
Brief summary (registry, in English)
Carotegrast methyl, an oral α4-integrin inhibitor, was recently approved in Japan for the treatment of active ulcerative colitis (UC). However, real-world data regarding its efficacy and safety remain scarce. This study aimed to assess the clinical effectiveness and safety profile of carotegrast methyl in patients with active UC.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 50 (actual)
- First submitted
- 19 Mar 2025
- Start date
- 1 Jun 2022
- Primary completion date
- 15 Mar 2025
- Lead sponsor
- Takayuki Yamamoto
- Diseases
- Ulcerative colitis
- NCT number
- NCT06897150
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 50
- From 1 Jun 2022 to the primary completion date, 15 Mar 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients currently using biologics, JAK inhibitors, thiopurines, or calcineurin inhibitors (tacrolimus or cyclosporine)
Other illness
- Patients with severe disease on endoscopy (presumed ineffective due to the drug's characteristics)
- Patients with a history of malignancy
- Patients with acute severe conditions, such as toxic megacolon, sepsis, peritonitis, or infectious colitis
Other
- Patients with severe hepatic dysfunction
- Pregnant women or those planning pregnancy
Who the study is looking for
- Patients diagnosed with UC based on endoscopic and histological findings
- Patients with clinically and endoscopically moderate UC who were eligible for outpatient treatment (however, patients in clinical remission or with mild clinical activity but endoscopically moderate UC were also considered eligible as an exception)
- Patients who exhibited an inadequate response to or intolerance of 5-ASA formulations (including topical agents) or budesonide formulations (including topical agents)
- Patients who provided informed consent for endoscopic examinations at the start of treatment and during the treatment period
- Patients who agreed to blood sampling and fecal biomarker tests
Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Yokkaichi Hazu Medical Center Coordinator of this site? Confirm its status | Yokkaichi | Japan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.