CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 109 enrolled
Drug / intervention
Filgotinib +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03926195
NCT03926195Phase 2Completed
CompareCT.gov

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

Lakefront Biotherapeutics NV·interventional·Posted Apr 24, 2019·Updated Apr 30, 2024

In Brief

A Phase 2 clinical trial evaluating Filgotinib, Placebo, and 1 other intervention for Rheumatoid Arthritis and 3 related conditions. Completed, enrolled 109 participants across 71 sites in 8 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Non-Radiographical Axial Spondyloarthritis
CountriesBulgaria, Czechia, Estonia, Georgia, Latvia, Poland, Spain, Ukraine
CollaboratorsGilead Sciences

Timeline

Phase 2CompletedFinished
2020202120222023202420252026
First PostedApr 24, 2019
Enrollment StartMay 28, 2019
Primary CompletionAug 14, 2020
Study CompletionMay 10, 2023
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 7.2 years ago

Interventions

Filgotinibdrug

200-mg tablet administered orally once daily

Placebodrug

Placebo to match filgotinib tablet administered orally once daily

Standard of Caredrug

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.