A Study to Evaluate the Long Term Safety and Efficacy of Bimekizumab in Subjects With Ankylosing Spondylitis
Status: | Active, not recruiting |
---|---|
Conditions: | Arthritis, Neurology, Neurology |
Therapuetic Areas: | Neurology, Rheumatology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 10/28/2018 |
Start Date: | November 28, 2017 |
End Date: | December 2022 |
A Multicenter, Open-Label Extension Study to Evaluate the Long Term Safety and Efficacy of Bimekizumab in Subjects With Ankylosing Spondylitis
This is a study to assess the long term safety and tolerability of bimekizumab in subjects
with ankylosing spondylitis
with ankylosing spondylitis
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
We found this trial at
4
sites
Click here to add this to my saved trials