Psoriatic Arthritis MedDRA version: 20.0 Level: LLT Classification code 10037160 Term: Psoriatic arthritis System Organ Class: 100000004859
Conditions
Sponsors
UCB Biopharma SPRL
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 PA0008 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 180 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
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. The medical monitor must be consulted prior to subject's entry into PA0009 in such cases. - Subjects who meet any withdrawal criteria in PA0008. 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 PA0009
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Assess the long-term safety and tolerability of bimekizumab administered over a period of up to 2 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 Safety Follow-Up Visit (up to Week 120) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 3. Subjects who withdrew due to an Adverse Event (AE) during the study 4. ACR20 (American College of Rheumatology 20% Improvement) Response at Week 48 calculated relative to Baseline of PA0008 5. ACR20 (American College of Rheumatology 20% Improvement) Response at Week 48 calculated relative to PA0009 entry value 6. ACR50 (American College of Rheumatology 50% Improvement) Response at Week 48 calculated relative to Baseline of PA0008 7. ACR50 (American College of Rheumatology 50% Improvement) Response at Week 48 calculated relative to PA0009 entry value 8. ACR70 (American College of Rheumatology 70% Improvement) Response at Week 48 calculated relative to Baseline of PA0008 9. ACR70 (American College of Rheumatology 70% Improvement) Response at Week 48 calculated relative to PA0009 entry value 10. Change from PA0008 Baseline in Maastricht Ankylosing Spondylitis Enthesitis Index (MASES) at Week 48 11. Change from PA0009 entry value in Maastricht Ankylosing Spondylitis Enthesitis Index (MASES) at Week 48 12. Change from PA0008 Baseline in the Leeds Dactylitis Index (LDI) at Week 48 13. Change from PA0009 entry value in the Leeds Dactylitis Index (LDI) at Week 48 14. PASI75 (Psoriasis Area Severity Index) Response at Week 48 calculated relative to Baseline of PA0008 15. PASI75 (Psoriasis Area Severity Index) Response at Week 48 calculated relative to PA0009 entry value 16. PASI90 (Psoriasis Area Severity Index) Response at Week 48 calculated relative to Baseline of PA0008 17. PASI90 (Psoriasis Area Severity Index) Response at Week 48 calculated relative to PA0009 entry;Timepoint(s) of evaluation of this end point: 1-3: From Entry Visit (Visit 1) until Safety Follow-Up Visit (up to Week 120) 4,6,8,10,12,14,16 : Baseline of PA0008, Week 48 5,7,9,11,13,15,17: PA0009 Entry Visit, Week 48 | — |
Countries
Czech Republic, Germany, Hungary, Poland, Russian Federation, United States
Contacts
Public ContactClin Trial Reg & Results Disclosure
UCB BIOSCIENCES GmbH
Outcome results
None listed