A Study to Evaluate the Long Term Safety and Efficacy of Bimekizumab in Subjects With Ankylosing Spondylitis

Completed · Phase 2

Conditions studied: Ankylosing Spondylitis

In brief

This is a study to assess the long term safety and tolerability of bimekizumab in subjects with ankylosing spondylitis

Key facts

Study ID

NCT03355573

Run by

UCB Biopharma SRL

People needed

255

Starts

2017-11-28

Expected to finish

2022-10-19

Last updated by the study team

2024-11-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• As0009 30 — Sarasota, Florida, United States
• AS0009 1 — Duncansville, Pennsylvania, United States
• AS0009 6 — Dallas, Texas, United States
• As0009 156 — Dobrich, Bulgaria
• As0009 151 — Plovdiv, Bulgaria
• As0009 155 — Plovdiv, Bulgaria
• As0009 150 — Rousse, Bulgaria
• As0009 101 — Québec, Canada
• As0009 205 — Brno, Czechia
• As0009 207 — Olomouc, Czechia
• As0009 208 — Pardubice, Czechia
• As0009 201 — Prague, Czechia
• As0009 202 — Prague, Czechia
• As0009 211 — Prague, Czechia
• As0009 210 — Praha 11 Chodov, Czechia
• As0009 203 — Zlín, Czechia
• As0009 304 — Hamburg, Germany
• As0009 301 — Ratingen, Germany
• As0009 400 — Budapest, Hungary
• As0009 403 — Budapest, Hungary
• As0009 401 — Veszprém, Hungary
• As0009 466 — Bydgoszcz, Poland
• As0009 453 — Elblag, Poland
• As0009 456 — Elblag, Poland
• As0009 455 — Krakow, Poland

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.