EUCTR2018-003987-29-AT进行中（未招募）1 期
An Open-Label Extension Study of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC OLE
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 912
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
- All
入选标准
- •1. Must have met the eligibility criteria and have been enrolled in the
- •qualified Phase 2 and 3 parent studies listed below or other qualified
- •region-specific studies and meet the following additional criteria:
- •a. Subjects previously enrolled in Study APD334-301 must have either:
- •I. Completed the Week 52 visit
- •II. completed the Week 12 visit and whose UC condition in the opinion of
- •the Investigator has not improved or has worsened, compared with
- •baseline (Week 0/Day 1 in the parent study), provided their ES is = 2
- •and they meet one of the following entry criteria:
- •Rectal bleeding (RB) subscore = 2 at 2 timepoints at least 7 days and
- •no more than 14 days apart
- •RB + stool frequency (SF) subscore = 4 at 2 timepoints at least 7 days
- •and no more than 14 days apart
- •RB subscore = 2 or RB + SF subscores = 4 (in any order) at 2
- •timepoints at least 7 days and no more than 14 days apart
- •Note: For subjects discontinuing prior to Week 52, an endoscopic
- •evaluation is required to confirm eligibility for the OLE. An endoscopy
- •should be scheduled upon the appearance of UC symptoms but no more
- •than 14 days after the second timepoint for entry criteria above. A
- •proctosigmoidoscopy does not need to be repeated if performed within the last 4 weeks
- •b. Subjects previously enrolled in study APD334-302 must have
- •completed the Week 12 visit
- •2. Eligible women of childbearing potential must fulfill the following on
- •Week0/Day 1:
- •a. Have a negative urine beta-human chorionic gonadotropin (ß-hCG)
- •pregnancy test
- •b. Not breastfeeding
- •3. Females must meet either a or b of the following criteria and males must meet criterion c to qualify for the study:
- •a. A nonpregnant female who is not of childbearing potential must meet
- •1 of the following:
- •- Postmenopausal, defined as no menses for 12 months without an
- •alternative medical cause;
- •- Permanent sterilization procedure, such as hysterectomy, bilateral
- •salpingectomy, or bilateral oophorectomy.
- •b. A female of childbearing potential must agree to using a highly
- •effective contraception method during treatment and for 30 days
- •following treatment that can achieve a failure rate of less than 1% per
- •year when used consistently and correctly.
- •The following are considered highly effective birth control methods:
- •- Combined (estrogen and progestogen containing) hormonal
- •contraception associated with inhibition of ovulation, which may be oral,
- •intravaginal, or transdermal.
- •- Progestogen-only hormonal contraception associated with inhibition of
- •ovulation, which may be oral, injected, or implanted.
- •- Intrauterine device (IUD).
- •- Intrauterine hormone-releasing system.
- •- Bilateral tubal occlusion.
- •- Vasectomized partner, provided that partner is the sole sexual partner
- •of the WOCBP trial subject and that the vasectomized partner has
- •received medical assessment of the surgical success.
- 另有 11 项未显示
排除标准
- •Subjects who meet ANY of the following exclusion criteria will NOT be
- •eligible for enrollment into the study:
- •1. the Investigator considers the subject to be unsuitable for any reason
- •to participate in the OLE study
- •Exclusions related to general health:
- •2. Experienced an adverse event that led to discontinuation (except
- •when such an event is related to worsening disease) from parent study
- •3. Week0/Day 1 pre-dose sitting vital sign assessment: heart rate (HR)
- •< 50 bpm OR systolic blood pressure (BP) < 90 mm Hg OR diastolic BP <
- •4. Week0/Day 1 pre-dose 12-lead ECG in the supine position showing a second or third-degree AV block, periods of asystole > 3 seconds, PR interval > 200 ms, or Fridericia's corrected QT interval (QTcF) = 450 ms (men) or QTcF = 470 ms (women)
- •5. Subjects requiring colectomy during the parent study
- •6. Subjects requiring treatment with prohibited medications as defined in the parent study
研究者
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