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 parent studies (APD334-301 or APD334-302) and also meet the
following additional criteria:
a. Subjects previously enrolled in Study APD334-301 must have either:
I. Completed the Week 12 visit and have been assessed to have active
UC that had deteriorated from baseline and meet one of the following
criteria:
• Absolute RB = 2 on 2-consecutive days, and confirmation of ES = 2 at
or after the Week 12 assessment
• Absolute RB + SF = 4 on 2-consecutive days, and confirmation of ES =
2 at or after the Week 12 assessment
• Absolute RB = 2 or RB + SF = 4 (in any order) on 2-consecutive days,
and confirmation of ES = 2 at or after the Week 12 assessment
or
II. Completed the Week 52 visit
Note: An endoscopic evaluation is required, however 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:
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. A female who is of childbearing potential must agree to using a highly
effective contraception method during treatment and for 4 weeks
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 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 must agree to using condoms during treatment and for 4
weeks following treatment.
4. Ability to provide written informed consent or assent (parent or legal
guardian must provide consent for a subject < 18 years of age or as
required per local regulations who has assented to participate in the
study) and to be compliant with the schedule of protocol assessments.
Enrollment of subjects < 18 years should be conducted only if acceptable
according to local laws and regulations.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Numb

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 from parent
etrasimod study
3. Day 1 pre-dose sitting vital sign assessment: heart rate < 50 bpm and
systolic BP < 90 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 QTcF = 450 ms (males) or QTcF =
470 ms (females)
5. Subjects requiring colectomy during the parent study
6. Subjects requiring treatment with prohibited medications as defined in the parent study
Exclusions related to laboratory results:
7. Laboratory values that meet study treatment discontinuation rules
Note: In the case of any abnormal laboratory results, laboratory tests
may be repeated once and if these results are within normal range, the
subject is eligible for enrollment.

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,<br>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, 2018, 220, 232, 244, 260, <br>2 week Follow-up visit

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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