EUCTR2017-000402-38-AT进行中（未招募）1 期
A Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Testicular Safety of Filgotinib in Adult Males with Moderately to Severely Active Inflammatory Bowel Disease
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 250
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Male
入选标准
- •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:
- •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,
- •Note: Subject also needs to have minimum disease extent of 15 cm from
- •the anal verge
- •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:
- •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
- •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
- •- 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
- 另有 4 项未显示
排除标准
- •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
研究者
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