Phase 2
Completed N=255
A Study to Evaluate the Long Term Safety and Efficacy of Bimekizumab in Subjects With Ankylosing Spondylitis
Source: ClinicalTrials.gov NCT03355573 ↗Enrolled (actual)
255
Serious AEs
18.0%
Results posted
Nov 2024
Primary outcomePrimary: Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) During the Study — 92.9 percentage of participants
Summary
This is a study to assess the long term safety and tolerability of bimekizumab in subjects with ankylosing spondylitis
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) During the Study |
92.9 | — |
| PRIMARY Percentage of Participants With Serious Adverse Event (SAE) During the Study |
18.0 | — |
| SECONDARY Percentage of Participants Who Withdrew Due to an Treatment-emergent Adverse Event (TEAE) During the Study |
6.7 | — |
| SECONDARY Percentage of Participants With Axial Spondyloarthritis International Society 40% Response Criteria (ASAS40) at Week 48 Calculated Relative to Baseline of AS0008 |
67.1; 70.5 | — |
| SECONDARY Percentage of Participants With Axial Spondyloarthritis International Society 20% Response Criteria (ASAS20) at Week 48 Calculated Relative to Baseline of AS0008 |
79.9; 84.0 | — |
| SECONDARY Change From Baseline of AS0008 in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score to Week 48 |
-3.79 | — |
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 AS0008 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 investigational medicinal product (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 AS0008. 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 AS0009
Data sourced from ClinicalTrials.gov (NCT03355573). 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.