A Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Effect of Filgotinib on Semen Parameters in Adult Males With Active Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis or Non-radiographic Axial Spondyloarthritis
Overview
- Phase
- Phase 2
- Intervention
- Filgotinib
- Conditions
- Rheumatoid Arthritis
- Sponsor
- Galapagos NV
- Enrollment
- 109
- Locations
- 70
- Primary Endpoint
- Percentage of Participants With a ≥ 50% Decrease From Baseline in Sperm Concentration at Week 13
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
The primary objective of this study is to evaluate the effect of filgotinib on semen parameters in adult males with active rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or non-radiographic axial spondyloarthritis.
Results of this study may be pooled with the results of a separate study being conducted in participants with inflammatory bowel disease (Protocol GS-US-418-4279; NCT03201445) with the same objective.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Diagnosis of active rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis or, non-radiographic axial spondyloarthritis for at least 12 weeks prior to screening, meeting the corresponding specific disease classification criteria as specified in the protocol
Exclusion Criteria
- •Previously documented problems with male reproductive health
- •Prior diagnosis of male infertility
- •Use of any prohibited concomitant medication as outlined by protocol
- •Note: Other protocol-defined Inclusion/Exclusion criteria may apply.
Arms & Interventions
Filgotinib
Participants received filgotinib 200 milligrams (mg) tablet, orally, once daily up to Week 13 in the double-blind (DB) phase. At Week 13, participants who were arthritis responders, were unblinded and received open-label (OL) treatment filgotinib 200 mg, tablet, orally, once daily up to approximately 143 weeks (until Week 156) in the extension (EXT) phase and participants who were arthritis nonresponders discontinued blinded study drug and started standard of care (SOC) treatment in the EXT phase. Participants on DB treatment or OL filgotinib who entered the monitoring phase (if their sperm parameters met ≥50% decrease threshold in pre-specified semen parameters) discontinued the study drug and started SOC for up to 52 weeks.
Intervention: Filgotinib
Filgotinib
Participants received filgotinib 200 milligrams (mg) tablet, orally, once daily up to Week 13 in the double-blind (DB) phase. At Week 13, participants who were arthritis responders, were unblinded and received open-label (OL) treatment filgotinib 200 mg, tablet, orally, once daily up to approximately 143 weeks (until Week 156) in the extension (EXT) phase and participants who were arthritis nonresponders discontinued blinded study drug and started standard of care (SOC) treatment in the EXT phase. Participants on DB treatment or OL filgotinib who entered the monitoring phase (if their sperm parameters met ≥50% decrease threshold in pre-specified semen parameters) discontinued the study drug and started SOC for up to 52 weeks.
Intervention: Standard of Care
Placebo
Participants received placebo (matched to filgotinib) tablet, orally, once daily up to Week 13 in the DB phase. At Week 13, participants were unblinded and started SOC treatment in the EXT phase for up to approximately 143 weeks (until Week 156). Participants who entered the monitoring phase (if their sperm parameters met ≥50% decrease threshold in pre-specified semen parameters) continued on SOC treatment.
Intervention: Placebo
Placebo
Participants received placebo (matched to filgotinib) tablet, orally, once daily up to Week 13 in the DB phase. At Week 13, participants were unblinded and started SOC treatment in the EXT phase for up to approximately 143 weeks (until Week 156). Participants who entered the monitoring phase (if their sperm parameters met ≥50% decrease threshold in pre-specified semen parameters) continued on SOC treatment.
Intervention: Standard of Care
Outcomes
Primary Outcomes
Percentage of Participants With a ≥ 50% Decrease From Baseline in Sperm Concentration at Week 13
Time Frame: Baseline to Week 13
Baseline for sperm/semen parameters was the mean of 2 evaluable semen samples at screening. The normal range for sperm concentration is ≥15 million sperms/mL. Percentage change = (\[mean at Week 13 - baseline\] / baseline) × 100; value at Week 13 was the mean of 2 evaluable samples collected at Week 13.
Secondary Outcomes
- Change From Baseline in Sperm Total Motility at Week 13(Baseline, Week 13)
- Percentage of Participants With a ≥ 50% Decrease From Baseline in Sperm Concentration at Week 26(Baseline to Week 26)
- Change From Baseline in Sperm Total Motility at Week 26(Baseline, Week 26)
- Change From Baseline in Total Sperm Count at Week 13(Baseline, Week 13)
- Change From Baseline in Total Sperm Count at Week 26(Baseline, Week 26)
- Change From Baseline in Sperm Concentration at Week 13(Baseline, Week 13)
- Change From Baseline in Sperm Concentration at Week 26(Baseline, Week 26)
- Change From Baseline in Ejaculate Volume at Week 13(Baseline, Week 13)
- Change From Baseline in Ejaculate Volume at Week 26(Baseline, Week 26)
- Change From Baseline in Percent Normal Sperm Morphology at Week 13(Baseline, Week 13)
- Change From Baseline in Percent Normal Sperm Morphology at Week 26(Baseline, Week 26)