An Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis
- Conditions
- lcerative Colitis (UC)Colitis Colitis, Ulcerative Ulcer Gastroenteritis Gastrointestinal Diseases Digestive System Diseases Colonic Diseases Intestinal Diseases Pathologic Processes Inflammatory Bowel Diseases
- Registration Number
- LBCTR2020043428
- Lead Sponsor
- Arena Pharmaceuticals Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 20
Subjects are eligible to enroll into this study if they fulfill ALL of the following:
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. Both men and women subjects agree to use a highly effective method of birth control
throughout the entire study period, from informed consent through the adverse event
reporting period (30 days after the last dose of study treatment), if the possibility of
conception exists. Eligible men and women subjects must also agree not to participate in a
conception process (ie, actively attempt to become pregnant or to impregnate, sperm
donation, in vitro fertilization) during the study and for 30 days after the last dose of study
treatment. Highly effective birth control methods include the following
• Oral, implantable, or injectable contraceptives (starting = 60 days before dosing) in
combination with a diaphragm with vaginal spermicide, cervical cap with vaginal
spermicide, or male condom; hormonal contraceptives (subjects should be consistently
taking the hormonal contraceptive for at least 3 months [90 days] prior to the
Eligibility assessment)
• Standard intrauterine device (IUD; eg, Copper T 380A IUD), intrauterine system (IUS;
eg, LNg 20 IUS - progesterone IUD), progesterone implant, or tubal sterilization
(= 180 days after surgery)
• Vasectomized male subjects using a condom, partner using diaphragm with
spermicide, cervical cap with spermicide, estrogen and progesterone oral
contraceptives (the pill”), estrogen and progesterone transdermal patch, vaginal ring,
or progesterone injection
• 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 trial and the
preferred and usual lifestyle of the subject. Periodic abstinence (calendar,
symptothermal, post-ovulation methods) is not acceptable
Note: Women who are surgically sterile or postmenopausal (defined as: 12 consecutive
months with no menses without an alternative medical cause) are not considered to be of
childbearing potential. If of childbearing potential, female partners of participating male
subjects should agree to utilize a highly effective method of contraception for the duration
of study participation.
4.
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
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ame: Number and Severity of Safety Measures;Timepoints: Up to approximately 5 years;Measure: Evaluation of adverse events;Name: Incidence of treatment-emergent adverse events and serious adverse events;Timepoints: Up to approximately 5 years;Measure: Evaluation of adverse events;Name: Incidence and severity of laboratory abnormalities, and change from baseline in laboratory values (hematology, serum chemistry, coagulation, and urinalysis) ;Timepoints: Up to approximately 5 years;Measure: Laboratory tests (hematology, serum chemistry, coagulation, and urinalysis) ;Name: Incidence of vital sign abnormalities and changes from baseline;Timepoints: Up to approximately 5 years;Measure: Evaluation of vital signs (resting heart rate and systolic and diastolic BP, body temperature, and respiratory rate)
- Secondary Outcome Measures
Name Time Method