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NCT05481619
Study of the Effect of Vedolizumab on Intestinal Microecological Changes and Its Efficacy in the Treatment of Ulcerative Colitis
Phase 4 trial testing Vedolizumab in Ulcerative Colitis in 30 participants. Currently enrolling.
1 January 2026
Quick facts
| Lead sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University |
|---|---|
| Phase | Phase 4 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 30 |
| Start date | 1 January 2021 |
| Primary completion | 1 January 2026 |
| Estimated completion | 1 January 2026 |
| Sites | 1 location across China |
Drugs / interventions tested
- Vedolizumab (vedolizumab) — full drug profile →
Conditions studied
- Ulcerative Colitis — all drugs for Ulcerative Colitis →
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Who can join
18 and older, any sex, with Ulcerative Colitis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Inflammatory bowel disease is a group of chronic, non-specific inflammatory diseases of the intestinal tract whose etiology has not yet been fully elucidated, including ulcerative colitis and Crohn's disease. Vedolizumab, a novel biologic agent, is a recombinant humanized monoclonal antibody that specifically antagonizes intestine-selective α4β7 integrins on the surface of leukocyte subsets, thereby preventing migration of leukocyte subsets from the blood to the intestinal mucosa and reducing local inflammation in the gut. In this study the investigators propose to build on an existing cohort and analyse, by means of a multi-omics approach, the baseline gut microbial composition and abundance, intestinal and serum metabolome characteristics of UC patients and their changes during treatment, to predict the functional mechanisms by which these changing characteristics influence the therapeutic response to vindolizumab.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Cellular mechanotransduction in health and diseases: from molecular mechanism to therapeutic targets.
Di X, Gao X, Peng L, Ai J, et al · · 2023 · cited 358× · PMID 37518181 · DOI 10.1038/s41392-023-01501-9
Verify or expand the search:
- PubMed search for NCT05481619
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Trials testing the same drug.
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- NCT06227910 — A Study of Vedolizumab With and Without Upadacitinib in Adults With Crohn's Disease · Phase 3 · recruiting
- NCT06443502 — A Study to Learn About the Safety of Vedolizumab and How Well it Works in Children and Teenagers With Active Chronic Pou · Phase 3 · recruiting
- NCT06570772 — Study to Investigate Comparative Efficacy, Safety and Immunogenicity Between AVT16 and Entyvio · Phase 3 · terminated
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
- NCT07265570 — Study Evaluating ISM5411 Administered Orally to Subjects With Active Ulcerative Colitis (BETHESDA) · Phase 2 · recruiting
- NCT07223424 — Patient Preference for Subcutaneous vs. Intravenous Immune Therapy · Phase 2 · recruiting
- NCT06405087 — A Long-Term Extension Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis (UC) or Crohn's Disease (CD · Phase 3 · recruiting
- NCT07184996 — An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Activ · Phase 3 · recruiting
Other Second Affiliated Hospital, School of Medicine, Zhejiang University trials
Trials by the same sponsor.
- NCT07445152 — Research on Construction and Verification of Multimodal Medical Imaging Large Model · not yet recruiting
- NCT06775665 — A Real-World Study on Hypertrophic Cardiomyopathy in Chinese Population · not yet recruiting
- NCT07533422 — Rescue Reatment of Helicobacter Pylori Based on Fecal Antimicrobial Resistance Gene Testing · NA · not yet recruiting
- NCT07487285 — A Non-inferiority Study of Laser Combined With Ultrasonic Debridement Therapy (LCUDT) Versus Manual Combined With Ultras · NA · not yet recruiting
- NCT07505186 — Camrelizumab, Chemotherapy and Ivarmacitinib in Patients With Resectable Esophageal Squamous Cell Carcinoma · Phase 2 · 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 NCT05481619 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Second Affiliated Hospital, School of Medicine, Zhejiang University
- Last refreshed: 25 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/NCT05481619.
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