NCT02743806

Extended Access Program of Vedolizumab IV in Ulcerative Colitis and Crohn's Disease

Terminated Phase 4 Results posted Last updated 18 November 2023

What this trial tests

Phase 4 trial testing Vedolizumab in Colitis, Ulcerative in 331 participants. Terminated before completion.

Timeline

1 August 2016

Primary endpoint
3 January 2023

3 January 2023

Quick facts

Lead sponsor	Takeda
Phase	Phase 4
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	331
Start date	1 August 2016
Primary completion	3 January 2023
Estimated completion	3 January 2023
Sites	78 locations across Italy, New Zealand, South Africa, Russia, Malaysia, India, Serbia, Ukraine

Drugs / interventions tested

• Vedolizumab (vedolizumab) — full drug profile →

Conditions studied

• Colitis, Ulcerative — all drugs for Colitis, Ulcerative →
• Crohn Disease — all drugs for Crohn Disease →

Sponsor

Takeda — full company profile →

Who can join

Adults 18 to 90, any sex, with Colitis, Ulcerative or Crohn Disease. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Primary · From first dose of study drug in this XAP study through 18 weeks after the last dose of study drug (up to 6.3 years)

An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a drug whether or not it is considered related to the study drug. A SAE is defined as any untoward medical occurrence that at any dose results in death, is life-threatening, requires participant hospitalization or prolongation of existing hospitalization, results in persistent or signific

AEs

Group	Value	95% CI
Vedolizumab 300 mg	61.9

SAEs

Group	Value	95% CI
Vedolizumab 300 mg	15.1

Percentage of Participants With Adverse Events of Special Interest (AESIs) Primary · From first dose of study drug in this XAP study through 18 weeks after the last dose of study drug (up to 6.3 years)

An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a drug whether or not it is considered related to the study drug. AESIs included serious infections (opportunistic infections, such as progressive multifocal leukoencephalopathy \[PML\]), malignancies, liver injury, infusion-related hypersensitivity reactions, and injection site reactions

Group	Value	95% CI
Vedolizumab 300 mg	3.9

Adverse events — posted to ClinicalTrials.gov

Time frame: From first dose of study drug in this XAP study through 18 weeks after the last dose of study drug (up to 6.3 years). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Vedolizumab 300 mg

Serious: 50/331 (15%)

Deaths: 1/331

Serious adverse events (54 terms)

Reaction	System	Vedolizumab 300 mg
Crohn's disease	Gastrointestinal disorders	—
Colitis ulcerative	Gastrointestinal disorders	—
Joint dislocation	Injury, poisoning and procedural complications	—
Myocardial infarction	Cardiac disorders	—
Osteoarthritis	Musculoskeletal and connective tissue disorders	—
Subileus	Gastrointestinal disorders	—
Abdominal abscess	Infections and infestations	—
Abdominal pain	Gastrointestinal disorders	—
Abortion spontaneous	Pregnancy, puerperium and perinatal conditions	—
Adenocarcinoma of colon	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—
Amylase increased	Investigations	—
Anaemia	Blood and lymphatic system disorders	—
Anal abscess	Infections and infestations	—
Anal fistula	Gastrointestinal disorders	—
COVID-19	Infections and infestations	—
COVID-19 pneumonia	Infections and infestations	—
Cataract	Eye disorders	—
Cerebrovascular accident	Nervous system disorders	—
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	—
Colorectal adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—
Device dislocation	Product Issues	—
Diabetes mellitus	Metabolism and nutrition disorders	—
Dizziness	Nervous system disorders	—
Fracture displacement	Injury, poisoning and procedural complications	—
Gastrointestinal viral infection	Infections and infestations	—

Other adverse events (5 terms — click to expand)

Reaction	System	Vedolizumab 300 mg
Crohn's disease	Gastrointestinal disorders	—
Nasopharyngitis	Infections and infestations	—
Hypertension	Vascular disorders	—
Colitis ulcerative	Gastrointestinal disorders	—
COVID-19	Infections and infestations	—

Most-reported serious reactions: Crohn's disease, Colitis ulcerative, Joint dislocation, Myocardial infarction, Osteoarthritis, Subileus, Abdominal abscess, Abdominal pain.

Data from ClinicalTrials.gov NCT02743806 adverse events section.

Sponsor's own description

The purpose of this study is to monitor ongoing safety in participants with ulcerative colitis (UC) and Crohn's disease (CD) and to provide access to vedolizumab for qualifying participants who, in the opinion of the investigator, continue to derive benefit from vedolizumab and for whom continued treatment with vedolizumab is desired because there is no other comparable product available or the participant may be expected to develop worsening of disease if they were to modify treatment.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Vedolizumab treatment persistence and safety in a 2-year data analysis of an extended access programme.
   Danese S, Subramaniam K, Van Zyl J, Adsul S, et al · · 2021 · cited 19× · PMID 33210333 · DOI 10.1111/apt.16160
2. Vedolizumab Efficacy, Safety, and Pharmacokinetics With Reduced Frequency of Dosing From Every 4 Weeks to Every 8 Weeks in Patients With Crohn's Disease or Ulcerative Colitis.
   Vermeire S, Lukáš M, Magro F, Adsul S, et al · · 2020 · cited 15× · PMID 32060515 · DOI 10.1093/ecco-jcc/jjaa027
3. UEG Week 2019 Oral Presentations.
   · 2019 · cited 3× · PMID 32213000 · DOI 10.1177/2050640619854670
4. Final results from the vedolizumab extended access program multinational study demonstrate long-term treatment persistence and safety.
   Danese S, Lukáš M, Volfová M, Rydzewska G, et al · · 2026 · PMID 41684725 · DOI 10.1177/17562848251406092
5. UEG Week 2023 Oral Presentations
   · 2023