An Open-Label Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 702

Inclusion Criteria

1. Must have met the eligibility criteria and have been enrolled in one of the two Phase 3 studies (APD334-301 or APD334-302) or other qualified regional-specific studies and also meet the following additional criteria:
a. Subjects previously enrolled in Study APD334-301 must have either:
I. Completed the Week 12 visit whose UC condition in the opinion of the Investigator has not improved or has worsened, compared with baseline (Week 0/Day 1), may be eligible to enroll 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
or
II. Completed the Week 52 visit
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 APD334-302 must have completed the Week 12 visit
2. Eligible women of childbearing potential must fulfill the following on 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 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. Nonpregnant 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 woman of child-bearing potential trial participant and that the vasectomized partner has received medical assessment of the surgical success
- Sexual abstinence (complete sexual abstinence defined as refraining from heterosexual intercourse for the entire period of risk associated with study treatments). The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical study and the preferred and usual lifestyle of the subject. Periodic abstinence (calendar, symptothermal, post-ovulation methods) is not acceptable
c. A male subject with a pregnant or nonpregnant female of child-bearing potential partner must agree to using condoms during treatment and for 30 days following treatment.
4. Ability to provide

Exclusion Criteria

Subjects who meet ANY of the following exclusion criteria will NOT be eligible for enrollment into the study:
1. If 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 UC flare) from parent study
3. Day 1 pre-dose sitting vital sign assessment: heart rate (HR) < 50 bpm OR systolic blood pressure (BP) < 90 mm Hg OR diastolic BP < 55 mm Hg
4. Day 1 pre-dose 12-lead electrocardiogram (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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the safety of long-term administration of etrasimod in subjects with moderately to severely active ulcerative colitis (UC);Secondary Objective: To assess the long-term efficacy of etrasimod in subjects with moderately to severely active UC;Primary end point(s): • Incidence of treatment-emergent adverse events and serious adverse events (SAEs)<br>• Incidence and severity of laboratory abnormalities, and change from baseline in laboratory values (hematology, serum chemistry, coagulation, and urinalysis)<br>• Incidence of vital sign abnormalities and changes from baseline;Timepoint(s) of evaluation of this end point: Week 2, 4, 8, 12, 24, 36, 52, 64, 76, 88, 104, 116, 128, 140, 156, 168, 180, 192, 208, 220, 232, 244, 260, 2-week and 4-week Follow-up visit<br>

Secondary Outcome Measures

Name	Time	Method

Updated 7/12/2021

An Open-Label Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis

Recruitment & Eligibility

Study & Design

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