Trial · NCT05771155
Efficacy, Safety and Immunogenicity of the Proposed Biosimilar Vedolizumab PB016 in Comparison With Entyvio®
NCT05771155, Phase 3, Unknown, Polpharma Biologics S.A.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy, Safety and Immunogenicity of the Proposed Biosimilar Vedolizumab PB016 in Comparison With Entyvio®. Trials, record NCT05771155. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05771155
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy, Safety and Immunogenicity of the Proposed Biosimilar Vedolizumab PB016 in Comparison With Entyvio®
- NCT number
- NCT05771155
- Status
- Unknown
- Phases
- Phase 3
- Enrollment
- 750 participants, estimated
- Lead sponsor
- Polpharma Biologics S.A.
- Conditions
- Ulcerative Colitis
- Interventions
- Intravenous (IV) infusions
- First posted
- 2023-03-16
- Last updated
- 2025-06-17
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | To demonstrate similarity of effect of induction treatment with IV formulations of PB016 and Entyvio® on clinical response rate at 6 weeks | Change from baseline to Week 6 | Clinical response rate, defined as the proportion of patients with a reduction in complete Mayo score |
| Secondary | To demonstrate similarity of effect of maintenance treatment with IV formulations of PB016 and Entyvio® on clinical response rate | Change from baseline to Week 52 | Clinical response rate at Week 52 |
| Secondary | To demonstrate similarity of effect of IV PB016 and Entyvio® on partial Mayo score | Change from baseline up to week 52 | Change from Baseline in partial Mayo score |
| Secondary | To demonstrate similarity of effect of IV PB016 and Entyvio® on clinical remission rate | Change from baseline up to week 52 | Clinical remission rate |
| Secondary | To demonstrate similarity of effect of IV PB016 and Entyvio® on mucosal healing rate | Change from baseline up to week 52 | Mucosal healing rate |
| Secondary | To demonstrate similarity of effect of IV PB016 and Entyvio® on corticosteroid-free remission rate | Change from baseline to Week 52 | Corticosteroid-free remission rate, defined as the proportion of patients using oral corticosteroids at Baseline who have discontinued corticosteroids and are in clinical remission at Week 52 |
| Secondary | To compare the safety profiles of PB016 and Entyvio® | Change from baseline up to week 54 | * Number of patients with adverse events (AEs) and serious adverse events (SAEs) * Number of patients discontinuing treatment due to AEs or SAEs |
| Secondary | To demonstrate similarity of IV PB016 and Entyvio® on immunogenicity | Change from baseline up to week 52 | Number of patients with anti-drug antibodies (ADAs) and neutralizing antibodies (NAb) |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05771155
GET https://conductscience.org/api/trials/v1/NCT05771155/registered