An Open-Label Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis
- Conditions
- lcerative ColitisMedDRA version: 20.1Level: LLTClassification code 10045365Term: Ulcerative colitisSystem Organ Class: 100000004856MedDRA version: 20.1Level: LLTClassification code 10045366Term: Ulcerative colitis, unspecifiedSystem Organ Class: 100000004856Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- EUCTR2018-003987-29-AT
- Lead Sponsor
- Arena Pharmaceuticals Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 912
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
or
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.
- 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 childbearing
potential partner must agree to using condoms during treatment and for
30 days following treatment.
4. Ability to provide written informed consent or assent (parent or l
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 <
55 mm Hg
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
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 (TEAEs) and serious adverse events (SAEs)<br>• Incidence and severity of laboratory abnormalities, and change from<br>treatment baseline in laboratory values (hematology, serum chemistry,<br>coagulation, and urinalysis)<br>• Incidence of vital sign abnormalities and changes from treatment<br>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, 2- week and 4-week Follow-up visit<br>
- Secondary Outcome Measures
Name Time Method Secondary end point(s): • The proportion of subjects achieving clinical remission at Week 52 and<br>104 among subjects achieving clinical remission at study entry<br>• The proportion of subjects achieving clinical response at Weeks 52 and<br>104<br>• Change from baseline in the Total Mayo Score (TMS) at Weeks 52 and 104<br>• Change from baseline from Partial Mayo Score (PMS) at Weeks 52,<br>104, 156, and 260<br>• The proportion of subjects achieving endoscopic improvement at<br>Weeks 52 and 104;Timepoint(s) of evaluation of this end point: Weeks 52, 104, 156, and 260