Ankylosing Spondylitis MedDRA version: 20.0 Level: PT Classification code 10002556 Term: Ankylosing spondylitis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Sponsors
UCB Biopharma SRL
Eligibility
Sex/Gender
All
Inclusion criteria
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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 260 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 25
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Assess the long-term safety and tolerability of bimekizumab administered over a period of up to 4 years.;Secondary Objective: Assess the long-term efficacy of bimekizumab.;Primary end point(s): 1. Incidence of Treatment-Emergent Adverse Events (TEAEs) during the study 2. Incidence of Serious Adverse Event (SAE) during the study;Timepoint(s) of evaluation of this end point: 1-2. From Entry Visit (Visit 1) until Last Visit (up to Week 208) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 3. Subjects who withdrew due to a Treatment-Emergent Adverse Event (TEAE) during the study 4. Subjects with Axial Spondyloarthritis International Society 40 % response criteria (ASAS40) at Week 48 calculated relative to Baseline of AS0008 5. Subjects with Axial Spondyloarthritis International Society 20 % response criteria (ASAS20) at Week 48 calculated relative to Baseline of AS0008 6. Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) to Week 48 ;Timepoint(s) of evaluation of this end point: 3: From Entry Visit (Visit 1) until Last Visit (up to Week 208) 4-6: Baseline of AS0008, Week 48 | — |
Countries
Bulgaria, Czech Republic, Germany, Hungary, Spain
Contacts
Public ContactClin Trial Reg & Results Disclosure
UCB Biosciences GmbH
Outcome results
None listed