Phase 2
Completed N=217
A Study to Evaluate the Long-term Safety, Tolerability and Efficacy of Bimekizumab in Patients With Chronic Plaque Psoriasis
Source: ClinicalTrials.gov NCT03010527 ↗Enrolled (actual)
217
Serious AEs
6.9%
Results posted
Oct 2021
Primary outcomePrimary: Incidence of Treatment Emergent Adverse Events (TEAEs) Adjusted by Duration of Subject Exposure to Treatment — 110.68; 225.26; 206.82 no. of new events per 100 subject-years
Summary
This is a multicenter extension study to assess the long-term safety, tolerability and efficacy of bimekizumab in adult subjects with moderate to severe chronic plaque psoriasis
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Treatment Emergent Adverse Events (TEAEs) Adjusted by Duration of Subject Exposure to Treatment |
110.68; 225.26; 206.82 | — |
| SECONDARY Percentage of Participants With Psoriasis Area Severity Index (PASI90) Response Over Time |
100; 100; 100; 100; 0; 0 | — |
| SECONDARY Percentage of Participants With Investigator´s Global Assessment Response (Clear or Almost Clear With at Least a 2 Category Improvement From Baseline on a 5-point Scale) Over Time |
100; 96.4; 100; 100; 5.4; 10.5 | — |
Eligibility Criteria
Inclusion Criteria
- Subject has provided informed consent
- Subject completes all dosing requirements in feeder study and completes PS0010 study without meeting any withdrawal criteria
- Female subjects of childbearing potential and male subjects with a partner of childbearing potential must continue to use an acceptable method of contraception (as detailed in PS0010) for up to 20 weeks after the last dose of study treatment in PS0011
Exclusion Criteria
- Subject has previously participated in this study.
- Female subjects who plan to become pregnant during the study or within 20 weeks following last dose of study medication. Male subjects who are planning a partner pregnancy during the study or within 20 weeks following the last dose
- Subject has any medical or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the subject's ability to participate in this study.
- Subject must have a negative interferon gamma release assay (IGRA) as measured at Week 8 of PS0010
Data sourced from ClinicalTrials.gov (NCT03010527). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.