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NCT04738942
A Study of Intravenous Vedolizumab Administered Every 4 Weeks in Japanese Participants With Moderate to Severe Ulcerative Colitis or Crohn's Disease
Phase 3 trial testing Vedolizumab in Ulcerative Colitis in 57 participants. Participants enrolled and being followed up; not accepting new ones.
30 May 2025
Quick facts
| Lead sponsor | Takeda |
|---|---|
| Phase | Phase 3 |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 57 |
| Start date | 4 June 2021 |
| Primary completion | 30 May 2025 |
| Estimated completion | 30 November 2027 |
| Sites | 20 locations across Japan |
Drugs / interventions tested
- Vedolizumab (vedolizumab) — full drug profile →
Conditions studied
- Ulcerative Colitis — all drugs for Ulcerative Colitis →
- Crohn's Disease — all drugs for Crohn's Disease →
Sponsor
Takeda — full company profile →
Who can join
Adults 18 to 80, any sex, with Ulcerative Colitis or Crohn's Disease. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04738942
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
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Related trials
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Other recruiting trials for Ulcerative Colitis
Currently open trials in the same condition.
- NCT07185009 — A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Acti · Phase 3 · recruiting
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- NCT07184996 — An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Activ · Phase 3 · recruiting
Other Takeda trials
Trials by the same sponsor.
- NCT05669729 — A Survey to Assess Participants', Caregivers', and Nurses' Use and Understanding of Educational Material on Velagluceras · not yet recruiting
- NCT07403968 — A Study of Zasocitinib (TAK-279) in Adults With Active Crohn's Disease · Phase 2 · not yet recruiting
- NCT07293364 — A Study to Learn About the C1-Inhibitor Function as Diagnosis for Hereditary Angioedema · NA · not yet recruiting
- NCT07218393 — A Study About the Diagnosis and Management of Hereditary Angioedema (HAE) in Egypt · not yet recruiting
- NCT07445087 — A Study of Takhzyro in Teenagers and Adults With Hereditary Angioedema (HAE) in South Korea · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04738942 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Takeda
- Last refreshed: 28 July 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04738942.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing