Entyvio 300 mg powder for concentrate for solution for infusion
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
A Phase 2b, Extension Study to Determine the Long-term Safety of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease Long-term Safety With Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease.
CompletedCTIS2023-507766-35-00
Start: 2018-01-09End: 2025-07-09Target: 36Updated: 2025-06-03
Assessment of the safety and effectiveness of vedolizumab induction therapy compared to standard infliximab therapy in pediatric patients with ulcerative colitis "VEDI-UC”
RecruitingCTIS2023-509775-16-00
Start: 2024-10-03Target: 66Updated: 2024-12-20
A Phase 2a, Two-Part, Open-Label and Randomized Study to Evaluate the Safety and Efficacy of OD-07656 and of Subsequent Vedolizumab Therapy in Patients with Moderately to Severely Active Ulcerative Colitis
RecruitingCTIS2024-520201-39-00
Start: 2025-08-28Target: 47Updated: 2025-06-30
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
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
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
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
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
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
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
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
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
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
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
Start: 2025-07-23Target: 293Updated: 2026-01-19
Phase 4
Comparison of Vedolizumab treatment to Adalimumab dose intensification in Crohn’s disease patients with loss of response or biomarker activity to Adalimumab on first line with therapeutic drug concentration: A randomized, multicentre, controlled VEDIAN trial.
RecruitingCTIS2023-508154-25-00
Start: 2024-05-27Target: 220Updated: 2025-07-29
An Interventional Study to Evaluate Treating to a Target of Transmural Healing in Patients with Moderately to Severely Active Crohn’s Disease (VECTORS)
RecruitingCTIS2023-509096-16-00
Start: 2024-07-31Target: 171Updated: 2025-10-10
VERDICT: In actiVE ulcerative colitis, a RanDomIzed Controlled Trial for determination of the optimal treatment target
Active, not recruitingCTIS2024-514183-21-00
Start: 2021-01-15Target: 391Updated: 2025-08-19
Evaluating the safety of shortened infusion tiMes for dIfferent oNcological immUnoThErapies; An observational prospective study (MINUTE)
Not yet recruitingCTIS2024-518878-14-01
Target: 1261Updated: 2025-12-18
Fecal microbiota transplantation in patients receiving infliximab and vedolizumab for ulcerative colitis: A randomized controlled trial
Not yet recruitingCTIS2024-520373-12-00
Target: 40Updated: 2025-01-21