Ulcerative ColitisPhase 4CAR in UCNCT06897150
Carotegrast Methyl in Ulcerative Colitis
A Phase 4 study testing Carotegrast methyl in people with Ulcerative Colitis, run by Takayuki Yamamoto at 1 site in Japan.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- Carotegrast methyl
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteJapan
- Study dates
- 1 Jun 2022to 15 Mar 2025
- Phase
- Phase 4
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients with severe disease on endoscopy (presumed ineffective due to the drug's characteristics)
- Patients currently using biologics, JAK inhibitors, thiopurines, or calcineurin inhibitors (tacrolimus or cyclosporine)
- Patients with a history of malignancy
- Patients with severe hepatic dysfunction
- Pregnant women or those planning pregnancy
- Patients with acute severe conditions, such as toxic megacolon, sepsis, peritonitis, or infectious colitis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Carotegrast Methyl in Active Ulcerative Colitis: A Real-World Prospective Cohort Study
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.
- Conditions
- Ulcerative Colitis
- Being tested
- Carotegrast methyl
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carotegrast methylDrug
a dosage of 960 mg three times daily
| Study group | Role | What they receive |
|---|---|---|
| Carotegrast methyl | Experimental | Carotegrast methyl at a dosage of 960 mg three times daily Receives: Drug: Carotegrast methyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical remission
A total clinical subscores in the Mayo score of 0
Measured: Week 8
Secondary outcomes (1)
Endoscopic remission
Endoscopic subscore in the Mayo score of 0
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 posted26 Mar 2025
- Study start1 Jun 2022
- Primary completion15 Mar 2025
- Study completion15 Mar 2025
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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takayuki Yamamoto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Takayuki Yamamoto, Yokkaichi Hazu Medical Center
- Investigators
- Takayuki Yamamoto, MD, PhD, Study chair, Yokkaichi Hazu Medical CenterTakayuki Yamamoto, MD, PhD, Study director, Yokkaichi Hazu Medical CenterTakayuki Yamamoto, MD, PhD, Principal investigator, Yokkaichi Hazu Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06897150
- Sponsor's protocol ID
- Yokkaichi Hazu 2024-11
- Acronym
- CAR in UC
- Status last verified
- Mar 2025
- First submitted
- 19 Mar 2025
- Last updated
- 2 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Carotegrast Methyl in Active Ulcerative Colitis: A Real-World Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT06897150
- Acronym / sponsor ID
- CAR in UC / Yokkaichi Hazu 2024-11
- Conditions
- Ulcerative Colitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Takayuki YamamotoUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 15 Mar 2025 (actual)
- Study completion
- 15 Mar 2025 (actual)
- First posted
- 26 Mar 2025 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Carotegrast methyl | Experimental | Drug: Carotegrast methylCarotegrast methyl at a dosage of 960 mg three times daily |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- Patients with severe disease on endoscopy (presumed ineffective due to the drug's characteristics)
- Patients currently using biologics, JAK inhibitors, thiopurines, or calcineurin inhibitors (tacrolimus or cyclosporine)
- Patients with a history of malignancy
- Patients with severe hepatic dysfunction
- Pregnant women or those planning pregnancy
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 |
|---|---|---|
| Carotegrast methyla dosage of 960 mg three times daily | Drug | Carotegrast methyl |
Primary outcome
Clinical remission
Time frame: Week 8
A total clinical subscores in the Mayo score of 0
1 secondary outcome
Endoscopic remission
Time frame: Week 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2025.
- Individual participant dataSharing planned: Yes
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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.
Takayuki Yamamoto, MD, PhD study chair
Yokkaichi Hazu Medical Center
Takayuki Yamamoto, MD, PhD study director
Yokkaichi Hazu Medical Center
Takayuki Yamamoto, MD, PhD principal investigator
Yokkaichi Hazu Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Carotegrast methyl in people with Ulcerative Colitis, run by Takayuki Yamamoto at 1 site in Japan.
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 5 inclusion and 6 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: finished, as of the sponsor's last update on 2 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical remission (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 2 Apr 2025.