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 BIOSCIENCES GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - An Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written Informed Consent Form (ICF) is signed and dated by the subject or by legal representative. - Subject or legal representative is considered reliable and capable of adhering to the protocol (eg, able to understand and complete questionnaires), visit schedule, or medication intake according to the judgment of the Investigator. - 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. - An Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written Informed Consent Form (ICF) is signed and dated by the subject or by legal representative. - Subject or legal representative is considered reliable and capable of adhering to the protocol (eg, able to understand and complete questionnaires), visit schedule, or medication intake according to the judgment of the Investigator. - Female subjects must be postmenopausal, permanently sterilized (eg, tubal occlusion, hysterectomy, bilateral salpingectomy) or, if of childbearing potential (and engaged in sexual activity that could result in procreation), must be willing to use a highly effective method of contraception until 20 weeks after last administration of IMP, and have a negative pregnancy test at the last visit of AS0008. - Male subjects with a partner of childbearing potential must be willing to use a condom when sexually active , up until 20 weeks after the last administration of IMP (anticipated 5 half lives). 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 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 Adverse Event (AE) 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 an Adverse Event (AE) during the study 4. Subjects with Axial Spondyloarthritis International Society 40 % response criteria (ASAS40) at Week 48 calculated relative to Baseline 5. Subjects with Axial Spondyloarthritis International Society 40 % response criteria (ASAS40) at Week 48 calculated relative to AS0009 entry value 6. Subjects with Axial Spondyloarthritis International Society 20% response criteria (ASAS20) at Week 48 calculated relative to Baseline 7. Subjects with Axial Spondyloarthritis International Society 20% response criteria (ASAS20) at Week 48 calculated relative to AS0009 entry value 8. Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) to Week 48 9. Change from AS0009 entry value 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, 8: Baseline of AS0008, Week 48 5, 7, 9: AS0009 Entry Visit, Week 48 | — |
Countries
Hungary
Contacts
Public ContactClin Trial Reg & Results Disclosure
UCB Biosciences GmbH
Outcome results
None listed