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Entyvio 300 mg powder for concentrate for solution for infusion

DRUG19 trials

Sponsors

Polpharma Biologics S.A., Takeda Development Center Americas Inc., Medical University Of Gdansk, Alvotech Swiss AG, Centre Hospitalier Universitaire De Saint Etienne

Conditions

Active Chronic PouchitisActive Ulcerative Colitis (UC) or Crohn's disease (CD)Active Ulcerative Colitis or Crohn’s DiseaseChron's DiseaseCrohn's diseaseCrohn´s diseaseInflammatory bowel diseaseModerate to Severe Active Ulcerative Colitis

Phase 2

Phase 3

A randomized, double-blind, multicenter phase 3 study in patients with moderately to severely active ulcerative colitis (UC) to compare the efficacy, safety and immunogenicity of PB016 and Entyvio® for the induction and maintenance of clinical response and remission. (UCESIVE)
Active, not recruitingCTIS2022-502778-18-00
Polpharma Biologics S.A.ulcerative colitis
Start: 2023-11-17Target: 550Updated: 2026-01-19
Evaluating the efficacy and safety of hyperbaric oxygen therapy as an adjuvant treatment compared to biologic therapy alone in moderate to severe ulcerative colitis in adults
CompletedCTIS2023-507450-32-00
Medical University Of GdanskUlcerative colitis
End: 2025-07-10Target: 40Updated: 2024-12-02
A Randomized, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of Vedolizumab Intravenous as Maintenance Therapy in Pediatric Subjects with Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy
CompletedCTIS2023-509018-12-00
Takeda Development Center Americas Inc.Moderately to severely active Ulcerative Colitis (UC)
Start: 2021-12-17End: 2024-12-20Target: 85Updated: 2025-04-15
An Open Label Single-Arm Phase 3 Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Vedolizumab Intravenous in the Treatment of Pediatric Subjects with Active Chronic Pouchitis
RecruitingCTIS2023-504773-20-00
Takeda Development Center Americas Inc.Active Chronic Pouchitis
Start: 2024-08-01Target: 26Updated: 2025-11-25
A Phase 3b Extension Study to Evaluate the Long-term Safety of Vedolizumab Intravenous in Pediatric Patients With Ulcerative Colitis or Crohn's Disease
RecruitingCTIS2023-509046-36-00
Takeda Development Center Americas Inc.Active Ulcerative Colitis (UC) or Crohn's disease (CD)
Start: 2023-04-26Target: 128Updated: 2025-08-14
A Parallel-Group Treatment, Double-Blind, 2-Arm Study to Investigate the Comparative Efficacy, Safety, and Immunogenicity Between Intravenous AVT16 and Entyvio® in Male and Female Subjects Aged 18 to 80 Years Inclusive with Moderate to Severe Active Ulcerative Colitis
CompletedCTIS2023-507705-34-00
Alvotech Swiss AGModerate to Severe Active Ulcerative Colitis
Start: 2025-08-29End: 2025-10-14Target: 462Updated: 2025-02-05
A Randomized, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of Vedolizumab Intravenous as Maintenance Therapy in Pediatric Subjects with Moderately to Severely Active Crohn's Disease Who Achieved Clinical Response Following Open–Label Vedolizumab Intravenous Therapy
RecruitingCTIS2023-509045-13-00
Takeda Development Center Americas Inc.Moderately to severely active Crohn's disease (CD)
Start: 2022-02-28Target: 51Updated: 2025-08-14
IMPACT OF ANTI-TNF, VEDOLIZUMAB AND TOFACITINIB ON AORTIC STIFFNESS, CAROTID INTIMA-MEDIA THICKNESS AND CARDIOVASCULAR RISK OF PATIENTS WITH ULCERATIVE COLITIS
Not yet recruitingCTIS2024-517314-15-00
Centre Hospitalier Universitaire Amiens Picardieulcerative colitis
Target: 100Updated: 2024-09-10
An Open-label, Phase 3 Study to Evaluate the Pharmacokinetics, Safety, and Immunogenicity of Vedolizumab Subcutaneous in Pediatric Subjects With Moderately to Severely Active Ulcerative Colitis or Crohn’s Disease Who Achieved Clinical Response Following Open–label Vedolizumab Intravenous Therapy
RecruitingCTIS2023-503188-40-00
Takeda Development Center Americas Inc.Active Ulcerative Colitis or Crohn’s Disease
Start: 2025-01-06Target: 32Updated: 2025-12-04
A Randomized, Double-blind, Phase 3b Study to Evaluate the Short- and Long-term Efficacy and Safety of Dual Targeted Therapy With Intravenous Vedolizumab and Oral Upadacitinib Compared With Intravenous Vedolizumab and Oral Placebo for Induction Followed by Intravenous Vedolizumab Monotherapy for Maintenance in the Treatment of Adults With Moderately to Severely Active Crohn’s Disease
RecruitingCTIS2023-509391-42-00
Takeda Development Center Americas Inc.Chron's Disease
Start: 2025-06-02Target: 224Updated: 2025-12-04
A Phase 3b, Multicenter, Randomized, Open-Label Study of Risankizumab Compared to Vedolizumab for the Treatment of Adult Subjects With Moderate to Severe Ulcerative Colitis Who are Naïve to Targeted Therapies
RecruitingCTIS2024-518998-33-00
AbbVie Deutschland GmbH & Co. KGUlcerative Colitis
Start: 2025-07-23Target: 293Updated: 2026-01-19

Phase 4

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