An Open Label Extension Study of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis

Phase 3

Completed

• Conditions: Ulcerative colitis; 10017969

• Registration Number: NL-OMON54866
• Lead Sponsor: Arena Pharmaceuticals, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 18

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
region-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 entroll provided their ES is is * 2 and they meet
one of the following 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 (*-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 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 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 treatm

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 partial or total colectomy during the parent study
6. Subjects requiring treatment with prohibited concomitant medications as
defined in the parent study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The long-term safety profile of etrasimod will be assessed through the<br /><br>following:<br /><br>* Incidence of treatment emergent adverse events (TEAEs) and serious adverse<br /><br>events (SAEs)<br /><br>* Incidence and severity of laboratory abnormalities, and change from baseline<br /><br>in laboratory values (hematology, serum chemistry, coagulation, and urinalysis)<br /><br>* Incidence of vital sign abnormalities and changes from baseline</p><br>