Study to Evaluate the Testicular Safety of Filgotinib in Adult Males With Moderately to Severely Active Inflammatory Bowel Disease
Stopped early · Phase 2 · Has a placebo group
Conditions studied: Inflammatory Bowel Disease
In brief
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.
Key facts
- Study ID
- NCT03201445
- Run by
- Lakefront Biotherapeutics NV
- People needed
- 139
- Starts
- 2017-07-11
- Expected to finish
- 2023-10-24
- Last updated by the study team
- 2024-10-09
Who can join
Age: 21 and older, up to 65. Sex: male. Healthy volunteers: not accepted.
Where it is running
- Florida Research Institute — Lakewood Rch, Florida, United States
- University of Miami Crohn's and Colitis Center — Miami, Florida, United States
- One Health Research Clinic, Inc — Norcross, Georgia, United States
- Delta Research Partners — Monroe, Louisiana, United States
- Clinical Research Institute of Michigan, LLC — Chesterfield, Michigan, United States
- Great Lakes Gastroenterology Research, LLC — Mentor, Ohio, United States
- Gastro One — Germantown, Tennessee, United States
- Texas Clinical Research Institute — Arlington, Texas, United States
- Texas Digestive Disease Consultants — Southlake, Texas, United States
- Monash Medical Centre — Clayton, Victoria, Australia
- AKH Wien - Universitatsklinik fur Innere Medizin III — Vienna, Austria
- Medizinische Hochschule Hannover — Hanover, Germany
- Surat Institute of Digestive Sciences — Surat, Gujarat, India
- Seth GS medical college and KEM hospital — Pārel, Mumbai, India
- Kaizen Hospital — Ahmedabad, India
- SP Medical college & AG Hospitals — Bīkaner, India
- Maharaja Agrasen Hospital — Dehli, India
- Nizam's Institute of Medical Sciences — Hyderabad, India
- SR Kalla Memorial Gastro and General Hospital — Jaipur, India
- SMS Medical College and Hospital — Jaipur, India
- Om Sai Onco Surgery Center — Kolhāpur, India
- Institute of Post Graduate Medical Education and Research (IPGMER) — Kolkata, India
- Radha Krishna Critical Care & General Hospital — Kota, India
- Dayanand Medical College & Hospital — Ludhiana, India
- Naval Medical Center San Diego — San Diego, California, United States
Full record on ClinicalTrials.gov
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