NCT03926195

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 109 (actual)
• Sponsor: Galapagos NV · Industry
• Sex: Male
• Age: 21 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Rheumatoid Arthritis
• Psoriatic Arthritis
• Ankylosing Spondylitis
• Non-Radiographical Axial Spondyloarthritis

Interventions

Type	Name	Description
DRUG	Filgotinib	200-mg tablet administered orally once daily
DRUG	Placebo	Placebo to match filgotinib tablet administered orally once daily
DRUG	Standard of Care	Locally approved treatment, accepted by medical experts as a proper treatment for rheumatic conditions, prescribed according to best clinical practice, with no known testicular toxicity.

Timeline

• Start date: 2019-05-28
• Primary completion: 2020-08-14
• Completion: 2023-05-10
• First posted: 2019-04-24
• Last updated: 2024-04-30
• Results posted: 2023-08-01

Locations

71 sites across 8 countries: Bulgaria, Czechia, Estonia, Georgia, Latvia, Poland, Spain, Ukraine

Regulatory

• FDA-regulated drug study