Ulcerative ColitisPhase 3NCT04738942
A Study of Intravenous Vedolizumab Administered Every 4 Weeks in Japanese Participants With Moderate to Severe Ulcerative Colitis or Crohn's Disease
A Phase 3 study testing Vedolizumab in people with Ulcerative Colitis and Crohn's Disease, run by Takeda at 20 sites in Japan.
Trial summary
The main aim of the study is to learn if 4-weekly vedolizumab improves symptoms of Japanese participants with moderate to severe ulcerative colitis (UC) or Crohn's disease (CD). Vedolizumab is commercially available in Japan for 8-weekly treatment but not for 4-weekly treatment. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ulcerative Colitis, Crohn's Disease
- What is being tested?
- Vedolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 20 sitesJapan
- Study dates
- 4 Jun 2021to 30 Nov 2027
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- UC cohort
- The participant has moderate to severe UC, who had previously shown clinical response in initial treatment with commercially available vedolizumab IV, then experienced secondary loss of response during maintenance therapy with commercially available vedolizumab IV Q8W.
- Previous "clinical response" is to be judged by the investigators referring to one of the following criteria.
- Reduction of >=2 points and >=25% in modified Mayo score, and a decrease of >=1 point in rectal bleeding subscore or rectal bleeding subscore of =<1, from the start of initial treatment with commercially available vedolizumab IV.
- Reduction of >=2 points and >=25% in partial Mayo score, and a decrease of >=1 point in rectal bleeding subscore or rectal bleeding subscore of =<1, from the start of initial treatment with commercially available vedolizumab IV.
- Significant improvement on endoscopy (i.e., a decrease of >=2 points in Mayo endoscopic subscore).
Show all 21Show fewer
- "Secondary loss of response" is to be judged by the investigators referring to one of the following criteria.
- Increase of >=2 points in modified Mayo score, and an increase of >=1 point in rectal bleeding subscore or rectal bleeding subscore >=2, from the start of maintenance therapy with commercially available vedolizumab IV.
- Increase of >=2 points in partial Mayo score, and an increase of >=1 point in rectal bleeding subscore or rectal bleeding subscore >=2, from the start of maintenance therapy with commercially available vedolizumab IV.
- Significant deterioration on endoscopy (i.e., an increase of >=2 points in Mayo endoscopic subscore).
- The participant has active UC as determined by a modified Mayo score of >=5 at baseline (within 10 days prior to the start of treatment phase), with a Mayo rectal bleeding subscore of >=1 at baseline (within 10 days prior to the start of treatment phase) and a Mayo endoscopic subscore of >=1 as assessed by the central reader.
- CD cohort
- The participant has moderate to severe CD, who had previously shown clinical response in initial treatment with commercially available vedolizumab IV, then experienced secondary loss of response during maintenance therapy with commercially available vedolizumab IV Q8W.
- Previous "clinical response" is to be judged by the investigators referring to one of the following criteria.
- Reduction of >=70 points in CDAI score from the start of initial treatment with commercially available vedolizumab IV.
- Reduction of >=3 points in HBI score from the start of initial treatment with commercially available vedolizumab IV.
- "Secondary loss of response" is to be judged by the investigators referring to one of the following criteria.
- Increase of >=70 points in CDAI score from the start of maintenance therapy with commercially available vedolizumab IV.
- Increase of >=3 points in HBI score from the start of maintenance therapy with commercially available vedolizumab IV.
- The participant has active CD as determined by a CDAI score of >=220 at baseline (within 10 days prior to the start of treatment phase).
- The participant has a C-reactive protein (CRP) level >3.0 mg/L during the screening phase.
Who cannot join
- The participant has had extensive colonic resection, subtotal or total colectomy.
- The participant has received any of the investigational or approved non-biologic therapies (e.g., cyclosporine, tacrolimus or tofacitinib, except for those specifically listed as permitted medications) for the treatment of underlying disease within 30 days or 5 half-lives of screening (whichever is longer).
- The participant has received any investigational or approved biologic or biosimilar agent other than vedolizumab within 60 days or 5 half-lives of screening (whichever is longer).
- The participant has a clinically significant active infection (e.g., pneumonia, pyelonephritis or coronavirus disease 2019 [COVID-19]) within 30 days prior to screening or during screening, or has an ongoing chronic infection.
- The participant has known or suspected intolerance or hypersensitivity to vedolizumab or closely related compounds, or any of the vedolizumab IV excipients.
- The participant has active cerebral/meningeal disease, or signs/symptoms of progressive multifocal leukoencephalopathy (PML) or any history of PML at screening.
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
Japan20 sites
Institute of Science Tokyo Hospital
Bunkyo-ku, Tokyo
Juntendo University Hospital
Bunkyo-ku, Tokyo
Fukuoka University Chikushi Hospital
Chikushino-shi, Fukuoka
Hirosaki University Hospital
Hirosaki, Aomori
Ofuna Chuo Hospital
Kamakura, Kanagawa
Tsujinaka Hospital
Kashiwa, Chiba
Kitasato University Kitasato Institute Hospital
Minato-ku, Tokyo
Kyorin University Hospital
Mitaka, Tokyo
Hyogo College of Medicine Hospital
Nishinomiya, Hyōgo
Infusion Clinic.
Osaka
Osaka Metropolitan University Hospital
Osaka
Kitasato University Hospital
Sagamihara, Kanagawa
Toho University Sakura Medical Center
Sakura, Chiba
Sapporo Kosei General Hospital
Sapporo, Hokkaido
Tohoku University Hospital
Sendai, Miyagi
Jichi Medical University Hospital
Shimotsuke, Tochigi
Keio University Hospital
Shinjuku-ku, Tokyo
Tokyo Yamate Medical Center
Shinjuku-ku, Tokyo
Ieda Hospital
Toyota, Aichi-ken
Yokohama City University Medical Center
Yokohama, Kanagawa
About this study
Official title: An Open-Label, Phase 3 Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Intravenous (IV) Vedolizumab Administered Every 4 Weeks (Q4W) in Japanese Patients With Moderate to Severe Ulcerative Colitis or Crohn's Disease Who Experienced Secondary Loss of Response During Maintenance Therapy With Vedolizumab IV Administered Every 8 Weeks (Q8W)
The main aim of the study is to learn if 4-weekly vedolizumab improves symptoms of Japanese participants with moderate to severe ulcerative colitis (UC) or Crohn's disease (CD). Vedolizumab is commercially available in Japan for 8-weekly treatment but not for 4-weekly treatment.
The study doctors will also monitor side effects from the study treatment.
Read more
This study will take place in Japan.
At the first visit, the study doctor will check if each person can take part. For those who can take part, participants will receive vedolizumab intravenously once every 4 weeks. After 3 infusions of vedolizumab (which will be 12 weeks of treatment), the study doctor will assess if symptoms of the participants have improved.
Participants who do not have improved symptoms after 12 weeks of treatment with vedolizumab will stop this treatment. Then, they will visit the study clinic 16 weeks after their last infusion of vedolizumab for a final check-up.
Participants who have improved symptoms after 12 weeks of treatment with vedolizumab will continue to receive vedolizumab every 4 weeks. Then, after their last infusion of vedolizumab, the participants will visit the study clinic 16 weeks later for a final check-up. Finally, the study clinic will make a phone call to each participant 6 months after their last infusion to check if they have any health problems.
- Conditions
- Ulcerative Colitis, Crohn's Disease
- Being tested
- Vedolizumab
- Medical subject headings
- Colitis, Ulcerative, Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VedolizumabDrug
Vedolizumab 300 mg, IV infusion
| Study group | Role | What they receive |
|---|---|---|
| Vedolizumab 300 mg in UC cohort | Experimental | Vedolizumab 300 mg, IV infusion, for up to 12 weeks Q4W for Treatment phase, and until the date of marketing approval of vedolizumab IV Q4W or study termination for Extension phase. Receives: Drug: Vedolizumab |
| Vedolizumab 300 mg in CD cohort | Experimental | Vedolizumab 300 mg, IV infusion, for up to 12 weeks Q4W for Treatment phase, and until the date of marketing approval of vedolizumab IV Q4W or study termination for Extension phase. Receives: Drug: Vedolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
UC Cohort: Percentage of Participants With Clinical Response at Week 12 Based on Modified Mayo Score
Clinical response was defined as a reduction of greater than or equal to (>=) 2 points and >=25 percent (%) in modified mayo score, and a decrease of >=1 point in rectal bleeding sub-score or rectal bleeding sub-score of less than or equal to (<=) 1 from baseline (Week 0). Mayo score was an instrument designed to measure disease activity of UC. Modified mayo score consisted of 3 sub-scores: stool frequency, rectal bleeding, and mayo endoscopic sub-score (findings on endoscopy), each graded from 0 to 3 with higher scores indicating more severe disease. These scores were summed to give a total score range of 0 to 9. Here, a higher score indicated more severe disease.
Measured: At Week 12
CD Cohort: Percentage of Participants With Clinical Response at Week 12
Clinical response was defined as a reduction of >=70 points in Crohn's Disease Activity Index (CDAI) score from baseline (Week 0). A CDAI was a multi-item instrument that measured severity of active Crohn's Disease monitored over 7 days included participant reported symptoms, physician-assessed signs, and laboratory markers. CDAI total score was equal to sum of weighted scores for subjective items (number of liquid/soft stools, degree of abdominal pain, general well-being); and objective items (use of anti-diarrhoeal medication, abdominal mass, haematocrit, presence of extraintestinal manifestation, body weight). CDAI scores ranged approximately from 0 to 600, higher scores indicated greater disease activity.
Measured: At Week 12
Secondary outcomes (6)
UC Cohort: Percentage of Participants With Clinical Remission at Week 12 Based on Modified Mayo Score
Clinical remission was defined as a modified Mayo score of less than or equal to (<=) 2, and no individual sub-score greater than (>) 1. Mayo score was an instrument designed to measure disease activity of UC. Modified Mayo score consisted of 3 sub-scores: stool frequency, rectal bleeding, and Mayo endoscopic sub-score (findings on endoscopy), each graded from 0 to 3 with higher scores indicating more severe disease. These scores were summed to give a total score ranged of 0 to 9. Here, a higher score indicated a more severe disease.
Measured: At Week 12
UC Cohort: Percentage of Participants With Mucosal Healing at Week 12
Mucosal healing was defined as a Mayo endoscopic sub-score of <=1, in participants with baseline Mayo endoscopic sub-score of >=2. Mayo score consisted of 4 sub-scores: stool frequency, rectal bleeding, mayo endoscopic sub-score (findings on endoscopy) and physician's global assessment, each graded from 0 to 3 with higher scores indicating more severe disease. These scores were summed to give a total score ranged of 0 to 12. Here, a higher score indicated a more severe disease.
Measured: At Week 12
UC Cohort: Percentage of Participants With Corticosteroid-Free Remission Based on Partial Mayo Score
Corticosteroid-free remission was defined as participants using oral corticosteroids at baseline (Week 0) who have discontinued oral corticosteroids and were in clinical remission based on partial Mayo score at Week 52. Clinical remission based on partial Mayo score was defined as a partial Mayo score of =<2, and no individual sub-score >1. Mayo score was an instrument designed to measure disease activity of UC. Partial Mayo score consists of 3 sub-scores: stool frequency, rectal bleeding, and physician's global assessment, each graded from 0 to 3 with higher scores indicated more severe disease. These scores are summed to give a total score range of 0 to 9. Here, higher scores indicated more severe disease.
Measured: At Week 52
CD Cohort: Percentage of Participants With Clinical Remission at Week 12
Clinical remission was defined as a CDAI score of <=150. A CDAI was a multi-item instrument that measured severity of active Crohn's Disease monitored over 7 days included participant reported symptoms, physician-assessed signs, and laboratory markers. CDAI total score was equal to sum of weighted scores for subjective items (number of liquid/soft stools, degree of abdominal pain, general well-being); and objective items (use of anti-diarrhoeal medication, abdominal mass, haematocrit, presence of extraintestinal manifestation, body weight). CDAI scores ranged approximately from 0 to 600, higher scores indicating greater disease activity.
Measured: At Week 12
CD Cohort: Percentage of Participants With Enhanced Clinical Response at Week 12
Enhanced clinical response was defined as a reduction of >=100 points in CDAI score from baseline (Week 0). A CDAI was a multi-item instrument that measured severity of active Crohn's Disease monitored over 7 days included participant reported symptoms, physician-assessed signs, and laboratory markers. CDAI total score was equal to sum of weighted scores for subjective items (number of liquid/soft stools, degree of abdominal pain, general well-being); and objective items (use of anti-diarrhoeal medication, abdominal mass, haematocrit, presence of extraintestinal manifestation, body weight). CDAI scores ranged approximately from 0 to 600, higher scores indicating greater disease activity.
Measured: At Week 12
CD Cohort: Percentage of Participants With Corticosteroid-Free Remission
Corticosteroid-free remission was defined as participants using oral corticosteroids at baseline (Week 0) who have discontinued oral corticosteroids and are in clinical remission at Week 52.
Measured: At Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2021
- Study start4 Jun 2021
- Primary completion30 May 2025
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04738942
- Sponsor's protocol ID
- Vedolizumab-3039
- Other IDs
- U1111-1262-7325, jRCT2031200371
- Status last verified
- May 2026
- First submitted
- 2 Feb 2021
- Last updated
- 15 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Phase 3 Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Intravenous (IV) Vedolizumab Administered Every 4 Weeks (Q4W) in Japanese Patients With Moderate to Severe Ulcerative Colitis or Crohn's Disease Who Experienced Secondary Loss of Response During Maintenance Therapy With Vedolizumab IV Administered Every 8 Weeks (Q8W)
- ClinicalTrials.gov ID
- NCT04738942
- Acronym / sponsor ID
- Vedolizumab-3039
- Conditions
- Ulcerative Colitis, Crohn's Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 56 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 4 Jun 2021 (actual)
- Primary completion
- 30 May 2025 (actual)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 4 Feb 2021 (actual)
- Results
- Posted 15 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main aim of the study is to learn if 4-weekly vedolizumab improves symptoms of Japanese participants with moderate to severe ulcerative colitis (UC) or Crohn's disease (CD). Vedolizumab is commercially available in Japan for 8-weekly treatment but not for 4-weekly treatment.
The study doctors will also monitor side effects from the study treatment.
This study will take place in Japan.
At the first visit, the study doctor will check if each person can take part. For those who can take part, participants will receive vedolizumab intravenously once every 4 weeks. After 3 infusions of vedolizumab (which will be 12 weeks of treatment), the study doctor will assess if symptoms of the participants have improved.
Participants who do not have improved symptoms after 12 weeks of treatment with vedolizumab will stop this treatment. Then, they will visit the study clinic 16 weeks after their last infusion of vedolizumab for a final check-up.
Participants who have improved symptoms after 12 weeks of treatment with vedolizumab will continue to receive vedolizumab every 4 weeks. Then, after their last infusion of vedolizumab, the participants will visit the study clinic 16 weeks later for a final check-up. Finally, the study clinic will make a phone call to each participant 6 months after their last infusion to check if they have any health problems.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vedolizumab 300 mg in UC cohort | Experimental | Drug: VedolizumabVedolizumab 300 mg, IV infusion, for up to 12 weeks Q4W for Treatment phase, and until the date of marketing approval of vedolizumab IV Q4W or study termination for Extension phase. |
| Vedolizumab 300 mg in CD cohort | Experimental | Drug: VedolizumabVedolizumab 300 mg, IV infusion, for up to 12 weeks Q4W for Treatment phase, and until the date of marketing approval of vedolizumab IV Q4W or study termination for Extension phase. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- UC cohort
- The participant has moderate to severe UC, who had previously shown clinical response in initial treatment with commercially available vedolizumab IV, then experienced secondary loss of response during maintenance therapy with commercially available vedolizumab IV Q8W.
- Previous "clinical response" is to be judged by the investigators referring to one of the following criteria.
- "Secondary loss of response" is to be judged by the investigators referring to one of the following criteria.
- The participant has active UC as determined by a modified Mayo score of >=5 at baseline (within 10 days prior to the start of treatment phase), with a Mayo rectal bleeding subscore of >=1 at baseline (within 10 days prior to the start of treatment phase) and a Mayo endoscopic subscore of >=1 as assessed by the central reader.
Key exclusion criteria (6 listed)
- The participant has had extensive colonic resection, subtotal or total colectomy.
- The participant has received any of the investigational or approved non-biologic therapies (e.g., cyclosporine, tacrolimus or tofacitinib, except for those specifically listed as permitted medications) for the treatment of underlying disease within 30 days or 5 half-lives of screening (whichever is longer).
- The participant has received any investigational or approved biologic or biosimilar agent other than vedolizumab within 60 days or 5 half-lives of screening (whichever is longer).
- The participant has a clinically significant active infection (e.g., pneumonia, pyelonephritis or coronavirus disease 2019 [COVID-19]) within 30 days prior to screening or during screening, or has an ongoing chronic infection.
- The participant has known or suspected intolerance or hypersensitivity to vedolizumab or closely related compounds, or any of the vedolizumab IV excipients.
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 |
|---|---|---|
| VedolizumabVedolizumab 300 mg, IV infusion | Drug | Vedolizumab 300 mg in CD cohort, Vedolizumab 300 mg in UC cohort |
Primary outcome
UC Cohort: Percentage of Participants With Clinical Response at Week 12 Based on Modified Mayo Score
Time frame: At Week 12
Clinical response was defined as a reduction of greater than or equal to (>=) 2 points and >=25 percent (%) in modified mayo score, and a decrease of >=1 point in rectal bleeding sub-score or rectal bleeding sub-score of less than or equal to (<=) 1 from baseline (Week 0). Mayo score was an instrument designed to measure disease activity of UC. Modified mayo score consisted of 3 sub-scores: stool frequency, rectal bleeding, and mayo endoscopic sub-score (findings on endoscopy), each graded from 0 to 3 with higher scores indicating more severe disease. These scores were summed to give a total score range of 0 to 9. Here, a higher score indicated more severe disease.
CD Cohort: Percentage of Participants With Clinical Response at Week 12
Time frame: At Week 12
Clinical response was defined as a reduction of >=70 points in Crohn's Disease Activity Index (CDAI) score from baseline (Week 0). A CDAI was a multi-item instrument that measured severity of active Crohn's Disease monitored over 7 days included participant reported symptoms, physician-assessed signs, and laboratory markers. CDAI total score was equal to sum of weighted scores for subjective items (number of liquid/soft stools, degree of abdominal pain, general well-being); and objective items (use of anti-diarrhoeal medication, abdominal mass, haematocrit, presence of extraintestinal manifestation, body weight). CDAI scores ranged approximately from 0 to 600, higher scores indicated greater disease activity.
6 secondary outcomes
UC Cohort: Percentage of Participants With Clinical Remission at Week 12 Based on Modified Mayo Score
Time frame: At Week 12
UC Cohort: Percentage of Participants With Mucosal Healing at Week 12
Time frame: At Week 12
UC Cohort: Percentage of Participants With Corticosteroid-Free Remission Based on Partial Mayo Score
Time frame: At Week 52
CD Cohort: Percentage of Participants With Clinical Remission at Week 12
Time frame: At Week 12
CD Cohort: Percentage of Participants With Enhanced Clinical Response at Week 12
Time frame: At Week 12
CD Cohort: Percentage of Participants With Corticosteroid-Free Remission
Time frame: At Week 52
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain more information on the study, click here/on this linkLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
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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.
Study Director study director
Takeda
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Vedolizumab in people with Ulcerative Colitis and Crohn's Disease, run by Takeda at 20 sites 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 21 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: under way, not looking for participants, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
UC Cohort: Percentage of Participants With Clinical Response at Week 12 Based on Modified Mayo Score (time frame: At Week 12). The study lists 2 primary outcomes in all. 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 15 Jun 2026.