Clinical trial

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

Name

GLPG0634-CL-227

Description

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.

Trial arms

Trial start

2019-05-28

Estimated PCD

2020-08-14

Trial end

2023-05-10

Status

Completed

Phase

Early phase I

Treatment

Filgotinib

200-mg tablet administered orally once daily

Arms:

Filgotinib

Other names:

GS-6034, Jyseleca®

Placebo

Placebo to match filgotinib tablet administered orally once daily

Arms:

Placebo

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.

Arms:

Filgotinib, Placebo

Size

109

Primary endpoint

Percentage of Participants With a ≥ 50% Decrease From Baseline in Sperm Concentration at Week 13

Baseline to Week 13

Eligibility criteria

Key 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 Key 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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 109, 'type': 'ACTUAL'}}

Updated at

2024-04-30

1 organization

3 products

4 indications

Product

Filgotinib

Indication

Rheumatoid Arthritis

Indication

Psoriatic Arthritis

Indication