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

Launched by GALAPAGOS NV · Jun 26, 2017

Keywords

ClinConnect Summary

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).

Gender

MALE

Eligibility criteria

• Key Inclusion Criteria:
• • Documented diagnosis of ulcerative colitis (UC) or Crohn's Disease (CD) of at least 4 months. Endoscopic and histopathologic documentation of UC or CD.
• • Have moderately to severely active UC or CD
• Key Exclusion Criteria:
• • Previously or currently documented problems with male reproductive health
• • Current use of sulfasalazine or its use within the 26 weeks leading up to Screening; sulfasalazine is not permitted at any point during the study
• • Current use of corticosteroids at a dosage of \> 20 mg/day of prednisone or equivalent at randomization
• • Indeterminate colitis, ischemic colitis, fulminant colitis, isolated ulcerative proctitis, or toxic mega colon
• • Active tuberculosis (TB) or untreated latent tuberculosis
• • Use of concomitant prohibited medications as outlined by protocol
• • Note: Other protocol defined Inclusion/Exclusion criteria may apply