Health Condition 1: K509- Crohns disease, unspecified Health Condition 2: null- Moderately to Severely Active Ulcerative Colitis
Conditions
Interventions
Intervention1: Filgotinib 200mg oral tablet
: Filgotinib 200mg oral tablet once daily 26 weeks
Control Intervention1: Placebo to match Filgotinib 200mg oral tablet: Placebo to match Filgotinib 200mg o
Sponsors
Gilead Sciences Inc
Eligibility
Inclusion criteria
Inclusion criteria: 1) Able to understand and willing to sign the informed consent as approved by the IRB/IEC. Written consent must be provided before initiating any Screening evaluations. Subjects must have read and understood the informed consent form (ICF), must fully understand the requirements of the study, and must be willing to comply with all study visits and assessments; subjects who cannot read or understand the ICF may not be enrolled in the study by a guardian or any other individual. 2) Males between the age of 21 and 65 (inclusive) on the day of signing informed consent 3) Body mass index (kg/m2) of >= 18.5 to determined by the investigator 4) Documented diagnosis of UC or CD of at least 4 months duration. Documentation must include endoscopic and histopathologic documentation, as follows: UC i) Medical record documentation of, or an endoscopy report dated >= 4 months before randomization, which shows features consistent with UC, determined by the procedure performing physician, AND ii) Medical record documentation of, or a histopathology report indicating features consistent with UC as determined by the pathologist, AND Note: Subject also needs to have minimum disease extent of 15 cm from the anal verge CD i) Medical record documentation of, or an ileocolonoscopy (full colonoscopy with intubation of terminal ileum) reported dated >= 4 months before randomization, which shows features consistent with CD, determined by the procedure performing physician, AND ii) Medical record documentation of, or a histopathology report indicating features consistent with, CD as determined by the pathologist 5) Moderately to severely active UC, or moderately to severely active CD, assessed locally and defined by: a) UC i) Mayo Clinic Score >= 6, PGA of 2 or 3, and endoscopic subscore >= 2, at Screening or in the prior 90 days b) CD i) CDAI total score >= 220, AND ii) Evidence of active inflammation, with a total score of >= 6 by the Simple Endoscopic Activity Score in Crohnâ??s Disease (SES-CD), OR if disease is limited to the ileum and/or right colon, a combined SES-CD score >= 4 in these 2 segments, at Screening or in the prior 90 days 6) Previously demonstrated an inadequate clinical response, loss of response to, or intolerance of at least one of the following agents (depending on current country treatment recommendations/guidelines): a) Corticosteroids i) Active disease despite a history of at least an induction regimen of a dose equivalent to prednisone >=20 mg daily for 2 weeks or intravenously (IV) for 1 week, OR ii) Two failed attempts to taper steroids below a dose equivalent of 10 mg daily prednisone, OR iii) History of steroid intolerance including, but not limited to, Cushingâ??s syndrome, osteopenia/osteoporosis, hyperglycemia, insomnia, serious infections, depression, allergic reactions, mood disturbances, or any other condition that contributed to discontinuation of the agent b) Immunomodulators i) Active disease despite a history of at least a 12-week regimen of oral azathioprine (>= 2 mg/kg/day) or 6 MP (>= 1 mg/kg/day), or
Exclusion criteria
Exclusion criteria: 1) Previously documented problems with male reproductive health including, but not limited to, known hypothalamic-pituitary disorders (eg, pituitary macroadenomas, pituitary infarction, hyperprolactinemia, panhypopituitarism), primary hypogonadism (eg, cryptorchidism, Klinefelterâ??s syndrome) 2) Prior diagnosis of male infertility (including reduced fertility), or history of anti-sperm antibodies 3) Clinically significant (per judgment of investigator) varicocele or spermatocele 4) History of radiation to the testicles 5) History of clinically significant trauma to, or surgery on, the testicles, including vasectomy 6) Current treatment with antiandrogen therapy (including but not limited to spironolactone or oral ketoconazole), or treatment within 4 weeks of Screening 7) Current treatment with testosterone replacement therapy, or treatment within 12 weeks of Screening 8) Current treatment with 5-α reductase inhibitors (including but not limited to finasteride and dutasteride) 9) Current treatment with alpha-1 blockers (including but not limited to tamsulosin, doxazosin, prazosin) 10) Current use of sulfasalazine or use of sulfasalazine within 26 weeks of Screening; sulfasalazine is not permitted at any point during the study 11) Current use of alkylating agents or any recognized testicular toxin within 26 weeks of Screening (may be discussed with Gilead Medical Monitor or designee) 12) Treatment with cyclosporine or other calcineurin inhibitors within 30 days of Screening 13) Use of any TNFα antagonist or vedolizumab within 8 weeks prior to Screening, ustekinumab within 12 weeks prior to Screening, or any other biologic agent within 8 weeks prior to Screening or within 5 times the half-life of the biologic agent prior to Screening, whichever is longer 14) Use of any prohibited concomitant medication(s) 15) Known hypersensitivity to filgotinib, its metabolites, or formulation excipients 16) Presence of disorders of sperm transport including, but not limited to, retrograde ejaculation and immotile cilia syndrome 17) Clinically significant urinary tract infection, prostatitis, epididymitis, including sexually transmitted infection within 4 weeks of Screening 18) Positive urine test for amphetamines or cocaine; positive test to opioids without a prescription, or heavy tobacco use (current use of >= 2 packs per day equivalent) 19) Uncontrolled thyroid dysfunction (eg, untreated hypothyroidism or hyperthyroidism) 20) Any sexual dysfunction of a nature that would prevent sperm collection in accordance with protocol guidance (phosphodiesterase inhibitors, however, are permitted during the study) 21) History of major surgery or trauma within 30 days prior to Screening, or anticipated need for major surgery during the study 22) History of total colectomy, subtotal colectomy, partial or hemi-colectomy, ileostomy, colostomy, or anticipated need for any of these interventions during the study 23) Currently have complications of CD as any of the following: a) Symptomatic strictures, OR b) Severe (impassable) rectal/anal stenosis, OR c) Fistulae, OR d) Short bowel syndrome, OR e) Any other complications which could preclude the use
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the effect of filgotinib on testicular function as defined by the proportion of subjects with a â?¥ 50% decrease from baseline in sperm concentration at Week 13 Timepoint: Week 13 | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the effect of filgotinib on sperm total motility at Weeks 13 and 26 ï?· To evaluate the effect of filgotinib on total sperm count at Weeks 13 and 26 ï?· To evaluate the effect of filgotinib on the change from baseline in sperm concentration at Weeks 13 and 26 ï?· To evaluate the effect of filgotinib on ejaculate volume at Weeks 13 and 26 To evaluate the effect of filgotinib on sperm morphology at Weeks 13 and 26Timepoint: Week 13 Week 26 | — |
Countries
Australia, Austria, Belgium, Canada, Germany, Hungary, Iceland, India, Ireland, Italy, Netherlands, New Zealand, Norway, Poland, Portugal, Russian Federation, Sri Lanka, Sweden, Switzerland, Ukraine, United Kingdom, United States of America
Contacts
Public ContactMr Rajeev Singh
Klinera Corporation India
Outcome results
None listed