A clinical trial to evaluate the testicular safety of Filgotinib in adult males with Moderately to Severely Active Inflammatory Bowel Disease
- Conditions
- To evaluate the testicular safety of filgotinib in adult males with moderately to severely Active Inflammatory Bowel DiseaseMedDRA version: 20.1Level: LLTClassification code 10045365Term: Ulcerative colitisSystem Organ Class: 100000004856MedDRA version: 20.0Level: LLTClassification code 10013099Term: Disease CrohnsSystem Organ Class: 100000004856Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- EUCTR2017-000402-38-AT
- Lead Sponsor
- Gilead Sciences, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 250
For a full list please see the study protocol.
- Males between the age of 21 and 65 (inclusive) on the day of signing informed consent
- Documented diagnosis of UC or CD of at least 4 months duration.
Documentation must include endoscopic and histopathologic documentation, as follows:
a) 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
b) 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
- Moderately to severely active UC, or moderately to severely active CD,
assessed locally and defined by:
a) UC
I) Mayo Clinic Score (MCS; Appendix 3) = 6, PGA of 2 or 3, and
endoscopic subscore = 2, at Screening or in the prior 90 days
b) CD
I) CDAI total score (Appendix 9) = 220, AND
ii) Evidence of active inflammation, with a total score of = 6 by the
Simple Endoscopic Activity Score in Crohn's Disease (SES-CD; Appendix
10), 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
- 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
b) immunomodulators
c) TNFa antagonists
d) vedolizumab
e) Ustekinumab (criterion applicable only to subjects with CD)
- May be receiving 1 or more of the following drugs (subjects on these
therapies must be willing to remain on stable doses for the noted times):
a) 5-aminosalicylate (5-ASA) compounds provided the dose prescribed
has been stable for at least 4 weeks prior to randomization; dose must
remain stable for the first 13 weeks after randomization
b) Azathioprine, 6-MP, or MTX provided the dose prescribed has been
stable for 4 weeks prior to randomization; dose of MTX must remain
stable for 26 weeks and dose of AZA/6-MP must remain stable for first
13 weeks but can be adjusted if indicated between 13 and 26 weeks.
c) Corticosteroid therapy (prednisone prescribed at a stable dose = 20
mg/day or budesonide prescribed at a stable dose of = 9 mg/day); dose
should not be changed during the first 13 weeks. A steroid taper should
only commence after Week 13.
- The mean of 2 separate semen samples collected at the Screening visit
must meet the following minimum criteria (in accordance with Section
6.13 and Figure 6-1): semen volume = 1.5 mL, total sperm per ejaculate
= 39 million, sperm concentration = 15 million per mL, sperm total
motility = 40%, and normal sperm morphology = 30%
- LH, FSH, inhibin B, and total testosterone values within 20% of laboratory normal reference ranges at Screening
- Be up to date on colorectal cancer surveillance as per local guidelines prior to screening.
Are the
For a full list please see the study protocol.
- 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, Klinefelter’s syndrome)
- Prior diagnosis of male infertility (including reduced fertility), or history of anti-sperm antibodies
- Clinically significant (per judgment of investigator) varicocele or spermatocele
- History of radiation to the testicles
- History of clinically significant trauma to, or surgery on, the testicles, including vasectomy
- Current treatment with antiandrogen therapy (including but not limited to spironolactone or oral ketoconazole), or treatment within 4 weeks of Screening
- Current treatment with testosterone replacement therapy, or treatment within 12 weeks of Screening
- Presence of disorders of sperm transport (including but not limited to retrograde ejaculation and immotile cilia syndrome)
- Clinically significant urinary tract infection, prostatitis, epididymitis, including sexually transmitted infection within 4 weeks of Screening
- Current use of sulfasalazine or use of sulfasalazine within 26 weeks of Screening; sulfasalazine is not permitted at any point during the study
- Use of any TNFa antagonist or vedolizumab within 8 weeks prior to screening, ustekinumab 12 weeks prior to screening, or any other biologic agent within 8 weeks prior to Screening or within 5 half-lives of the biologic agent prior to screening, whichever is longer
- 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 of the CDAI to
assess response to therapy, or would possibly confound the evaluation
of benefit from treatment with filgotinib
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method