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

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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


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
Sarasota, Florida
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Sarasota, FL
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Dallas, Texas
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Dallas, TX
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Dobrich,
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Dobrich,
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Duncansville, Pennsylvania 16635
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Duncansville, PA
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