NCT03201445

Study to Evaluate the Testicular Safety of Filgotinib in Adult Males With Moderately to Severely Active Inflammatory Bowel Disease

A Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Testicular Safety of Filgotinib in Adult Males With Moderately to Severely Active Inflammatory Bowel Disease

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 139 (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 testicular safety of filgotinib in adult males with moderately to severely active inflammatory bowel disease (IBD). Results of this study may be pooled with the results of a separate study being conducted in participants with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or non-radiographic axial spondyloarthritis (Protocol GLPG0634-CL-227; NCT03926195) with the same objective. The total planned number of participants in both studies combined will be up to approximately 250 participants.

Detailed description

There are 5 parts to the study: 1) Part A: Double-Blind Phase (DB Phase; Day 1 through Week 13); 2) Part B: DB Phase (after Week 13 through Week 26); 3) Open-label (OL) Filgotinib Phase (after Week 13 study visit for up to 13 weeks); 4) Monitoring Phase (MP; up to 52 weeks); and 5) Long-term Extension (LTE) Phase (after Week 26 or end of OL Filgotinib Phase for up to 195 weeks).

Conditions

• Inflammatory Bowel Disease

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 IBD conditions, prescribed according to best clinical practice, with no known testicular toxicity.

Timeline

• Start date: 2017-07-11
• Primary completion: 2020-11-20
• Completion: 2023-10-24
• First posted: 2017-06-28
• Last updated: 2024-10-09
• Results posted: 2023-12-06

Locations

56 sites across 11 countries: United States, Australia, Austria, Germany, India, New Zealand, Poland, Romania, Russia, Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study