Trial Details
RECRUITINGBasic Information
| Clinical ID | c1138 |
|---|---|
| Identifier | NCT05771155 |
| Trial Title | Efficacy, Safety and Immunogenicity of the Proposed Biosimilar Vedolizumab PB016 in Comparison With Entyvio |
| Trial URL | Visit Original Page |
Study Information
| Study Results | NO |
|---|---|
| Conditions | Ulcerative Colitis |
| Interventions | BIOLOGICAL: Intravenous (IV) infusions |
Participant Information
| Sponsor | Polpharma Biologics S.A. |
|---|---|
| City | Tbilisi |
| Country/Region | Georgia |
Enrollment Criteria
| Sex Requirement | ALL |
|---|---|
| Age Requirement | ADULT, OLDER_ADULT |
Study Design
| Study Type | INTERVENTIONAL |
|---|---|
| Phase | PHASE3 |
Time Information
| Start Date | 2023-07-24 |
|---|---|
| Primary Completion Date | 2025-09-25 |
| Completion Date | 2025-09-25 |