Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Lakefront Biotherapeutics NV
With
Gilead Sciences
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).
Age
21–65
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | Study to Evaluate the Testicular Safety of Filgotinib in Adult Males With Moderately to Severely Active Inflammatory Bowel Disease
