A study evaluating the effect of filgotinib on sperm parameters in adult males with active rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis or non-radiographic axial spondyloarthritis

INTERVENTION: Product Name: Filgotinib Product Code: GLPG0634 Pharmaceutical Form: Film‐coated tablet INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200‐ Pharmaceutical form of the placebo: Film‐coated tablet Route of administration of the placebo: Oral use CONDITION: Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis and Non‐radiographic Axial Spondyloarthritis ; MedDRA version: 20.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 ‐ Musculoskeletal and connective tissue disorders ; MedDRA version: 20.0 Level: PT Classification code 10002556 Term: Ankylosing spondylitis System Organ Class: 10028395 ‐ Musculoskeletal and connective tissue disorders ; MedDRA version: 20.0 Level: LLT Classification code 10037160 Term: Psoriatic arthritis System Organ Class: 10028395 ‐ Musculoskeletal and connective tissue disorders ; MedDRA version: 20.0 Level: LLT Classification code 10076297 Term: Non‐radiographic axial spondyloarthritis System Organ Class: 10028395 ‐ Musculoskeletal and connective tissue disorders Therapeutic area: Diseases [C] ‐ Musculoskeletal Diseases [C05] PRIMARY OUTCOME: ; Secondary Objective: ‐ To evaluate the effect of filgotinib on testicular function as defined by the proportion of subjects with a = 50% decrease from Baseline in sperm concentration at Week 26; ‐ To evaluate the effect of filgotinib on sperm total motility at Weeks 13 and 26; ‐ To evaluate the effect of filgotinib on total sperm count at Weeks 13 and 26; ‐ To evaluate the effect of filgotinib on the change from Baseline in sperm concentration at Weeks 13 and 26; ‐ To evaluate the effect of filgotinib on ejaculate volume at Weeks 13 and 26; ‐ To evaluate the effect of filgotinib on sperm morphology at Weeks 13 and 26; Main Objective: To evaluate the effect of filgotinib on testicular function as defined by the proportion of subjects with a = 50% decrease from Baseline in sperm concentration at Week 13 Primary end point(s): Proportion of subjects with a = 50% decrease from Baseline in sperm concentration at Week 13. Timepoint(s) of evaluation of this end point: At baseline and at week 13. SECONDARY OUTCOME: ; Secondary end point(s): ‐ The proportion of subjects with a = 50% decrease from Baseline in sperm concentration at Week 26 ; ‐ Change from Baseline in percent motile sperm at Weeks 13 and 26 ; ‐ Change from Baseline in total sperm count at Weeks 13 and 26 ; ‐ Change from Baseline in sperm concentration at Weeks 13 and 26 ; ‐ Change from Baseline in ejaculate volume at Weeks 13 and 26 ; ‐ Change from Baseline in percent normal sperm morphology at Weeks 13 and 26 ; Timepoint(s) of evaluation of this end point: At baseline, at week 13 and at week 26 INCLUSION CRITERIA: ‐ Male between the ages of 21 and 65 (inclusive) on the day of signing informed consent. a) RA, American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) 2010 b) PsA, Classification criteria for Psoriatic Arthritis (CASPAR) criteria c) AS or nrAxSpA, Assessment of Spondyloarthritis International Society (ASAS) criteria for axial spondyloarthritis ‐ For RA, PsA, AS, or nrAxSpA, meets the following criteria: ‐ Diagnosis of rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis (AS) or non‐radiographic axial spondyloarthritis (nrAxSpA) for at least 12 weeks prior to screening, meeting the corresponding specific classification criteria: a) RA: i) Inadequate response or intolerant to an =12‐week course of csDMARD or biological DMARD (bDMARD) therapy for RA