A Study to Evaluate the Long Term Safety and Efficacy of Bimekizumab in Subjects With Ankylosing … (NCT03355573) | Clinical Trial Compass
CompletedPhase 2
A Study to Evaluate the Long Term Safety and Efficacy of Bimekizumab in Subjects With Ankylosing Spondylitis
United States, Bulgaria255 participantsStarted 2017-11-28
Plain-language summary
This is a study to assess the long term safety and tolerability of bimekizumab in subjects with ankylosing spondylitis
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) During the Study
Timeframe: From Entry Visit (Visit 1) until Safety Follow Up (up to Week 224)
2
Percentage of Participants With Serious Adverse Event (SAE) During the Study
Timeframe: From Entry Visit (Visit 1) until Safety Follow Up (up to Week 224)