Phase 2
Completed N=183
A Study to Evaluate the Long-Term Safety and Efficacy of Bimekizumab in Subjects With Psoriatic Arthritis
Source: ClinicalTrials.gov NCT03347110 ↗Enrolled (actual)
183
Serious AEs
7.6%
Results posted
Dec 2023
Primary outcomePrimary: Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) During the Study — 80.9 percentage of participants
Summary
This is a study to assess the long-term safety and tolerability of bimekizumab in subjects with psoriatic arthritis
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) During the Study |
80.9 | — |
| PRIMARY Percentage of Participants With Treatment-emergent Serious Adverse Events (SAEs) During the Study |
7.7 | — |
| SECONDARY Percentage of Participants Who Withdrew Due to Treatment-emergent Adverse Event (TEAE) During the Study |
4.9 | — |
| SECONDARY Percentage of Participants With American College of Rheumatology 20% Improvement (ACR20) Response at Week 48 Calculated Relative to Baseline of PA0008 |
79.0 | — |
| SECONDARY Percentage of Participants With American College of Rheumatology 50% Improvement (ACR50) Response at Week 48 Calculated Relative to Baseline of PA0008 |
64.6 | — |
| SECONDARY Percentage of Participants With American College of Rheumatology 70% Improvement (ACR70) Response at Week 48 Calculated Relative to Baseline of PA0008 |
47.5 | — |
| SECONDARY Change From Baseline of PA0008 in Maastricht Ankylosing Spondylitis Enthesitis Index (MASES) at Week 48 Calculated Relative to Baseline of PA0008 |
-2.99 | — |
| SECONDARY Change From Baseline of PA0008 in the Leeds Dactylitis Index (LDI) at Week 48 Calculated Relative to Baseline of PA0008 |
-54.31 | — |
| SECONDARY Percentage of Participants With Psoriasis Area Severity Index (PASI75) Response at Week 48 Calculated Relative to Baseline of PA0008 |
90.0 | — |
| SECONDARY Percentage of Participants With Psoriasis Area Severity Index (PASI90) Response at Week 48 Calculated Relative to Baseline of PA0008 |
80.0 | — |
Eligibility Criteria
Inclusion Criteria
- In the opinion of the Investigator, the subject is expected to benefit from participation in an Open Label Extension (OLE) study
- Subject completed PA0008 without meeting any withdrawal criteria
- Female subjects must be postmenopausal, permanently sterilized or, if of childbearing potential, must be willing to use a highly effective method of contraception
- Male subjects with a partner of childbearing potential must be willing to use a condom when sexually active
Exclusion Criteria
- Female subjects who plan to become pregnant during the study or within 20 weeks following the last dose of IMP. Male subjects who are planning a partner pregnancy during the study or within 20 weeks following the last dose
- Subjects with any current sign or symptom that may indicate a medically significant active infection (except for the common cold) or has had an infection requiring systemic antibiotics within 2 weeks of study entry
- Subjects who meet any withdrawal criteria in PA0008. For any subject with an ongoing Serious Adverse Event, or a history of serious infections (including hospitalizations) in the lead-in study, the Medical Monitor must be consulted prior to the subject's entry into PA0009
Data sourced from ClinicalTrials.gov (NCT03347110). 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.