Health Condition 1: M00-M99- Diseases of the musculoskeletal system and connective tissue
Conditions
Interventions
Intervention1: Double-blind Treatment Phase (Day 1 through Week 13 Study Visit)
Filgotinib Dose A and Placebo to Match Dose B up to 13 Weeks
: Drug: Filgotinib, Tablets administered orally once daily
Sponsors
Galapagos NV
Eligibility
Inclusion criteria
Inclusion criteria: Key inclusion criteria: 1) Males between the ages of 21 and 65 (inclusive) on the day of signing informed consent 2) Diagnosis of RA, PsA, AS, or nrAxSpA for at least 12 weeks prior to Screening, meeting the corresponding specific classification criteria: RA, American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) 2010, PsA, Classification criteria for Psoriatic Arthritis (CASPAR) criteria, AS or nrAxSpA, Assessment of Spondyloarthritis International Society (ASAS) criteria for axial spondyloarthritis, 3) For RA, PsA, AS, or nrAxSpA, subject meets the following criteria: For RA, Inadequate response or intolerant to >=12-weeksâ?? course of csDMARD or biological DMARD (bDMARD) therapy for RA, Have an Clinical Disease Activity Index (CDAI) >10 at Screening For PsA, Inadequate response or intolerant to >=12-weeksâ?? course of csDMARD or bDMARD therapy for PsA, Have a Disease Activity in Psoriatric Arthritis (DAPSA) score >14 at Screening, For Axial Spondyloarthritis (applicable to those with diagnosis of AS or nrAxSpA), Inadequate response or intolerant to at least 2 NSAIDs which may include COX-2 inhibitors prescribed for a total period of >=4 weeks OR to an >=12 week course of csDMARD or biological disease modifying anti-rheumatic drug (bDMARD) therapy for spondyloarthritis, Have a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) >=4 at Screening, At Screening, subjects should have a high-sensitivity C-reactive protein (hsCRP) >0.3 mg/dL OR sacroiliitis according to the modified New York (NY) criteria OR a history of active inflammation on magnetic resonance imaging (MRI) consistent with sacroiliitis within 2 years of screening. 4) The mean of 2 separate semen samples collected at Screening must meet the following minimum criteria (in accordance with Section 6.11 of Protocol) semen volume >=1.5 mL, total sperm/ejaculate >=39 million, sperm concentration >=15 million/mL, sperm total motility >=40%, and normal sperm morphology >=30% Complete list of study inclusion please refer to Sections 4.2 of Protocol
Exclusion criteria
Exclusion criteria: Key Exclusion Criteria: 1) Previously or currently documented problems with male reproductive health including but not limited to primary hypogonadism, secondary hypogonadism, or reduced fertility 2) Use of any prohibited concomitant medication(s) as described in Section 5.3 (and Table 5-1) of Protocol 3) Active tuberculosis or untreated latent tuberculosis (Section 4.2 Inclusion Criteria, 10) 4) Infection with Hepatitis B, Hepatitis C or human immunodeficiency virus (HIV) (Section 4.3, Exclusion Criteria, #22-24) of Protocol Complete list of study exclusion please refer to Sections 4.3 of Protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of this study is: To evaluate the effect of Filgotinib on testicular function as defined by the proportion of subjects with a â?¥50% decrease from Baseline in sperm concentration at Week 13Timepoint: At Week 13 | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the effect of Filgotinib on ejaculate volume at Weeks 13 and 26Timepoint: At Weeks 13 and 26;To evaluate the effect of Filgotinib on sperm morphology at Weeks 13 and 26Timepoint: At Weeks 13 and 26;To evaluate the effect of Filgotinib on sperm total motility at Weeks 13 and 26Timepoint: At Week 13 and Week 26;To evaluate the effect of Filgotinib on testicular function as defined by the proportion of subjects with a â?¥50% decrease from Baseline in sperm concentration at Week 26Timepoint: At Week 26;To evaluate the effect of Filgotinib on the change from Baseline in sperm concentration at Weeks 13 and 26Timepoint: At Weeks 13 and 26;To evaluate the effect of Filgotinib on total sperm count at Weeks 13 and 26Timepoint: At Weeks 13 and 26 | — |
Countries
Belgium, Bulgaria, Czech Republic, Estonia, Georgia, Germany, India, Latvia, Poland, Romania, Russian Federation, Spain, Ukraine
Contacts
Public ContactRajeev Singh
KlinEra Global Services
Outcome results
None listed