Status:
COMPLETED
A Study to Evaluate the Long Term Safety and Efficacy of Bimekizumab in Subjects With Ankylosing Spondylitis
Lead Sponsor:
UCB Biopharma SRL
Conditions:
Ankylosing Spondylitis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a study to assess the long term safety and tolerability of bimekizumab in subjects with ankylosing spondylitis
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 28 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 19 2022
Estimated Enrollment :
255 Patients enrolled
Trial Details
Trial ID
NCT03355573
Start Date
November 28 2017
End Date
October 19 2022
Last Update
November 21 2024
Active Locations (50)
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1
As0009 30
Sarasota, Florida, United States, 34239
2
AS0009 1
Duncansville, Pennsylvania, United States, 16635
3
AS0009 6
Dallas, Texas, United States, 75231
4
As0009 156
Dobrich, Bulgaria