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

Phase 1

• Conditions: lcerative Colitis; MedDRA version: 20.1Level: LLTClassification code 10045365Term: Ulcerative colitisSystem Organ Class: 10017947 - Gastrointestinal disorders; MedDRA version: 20.1Level: LLTClassification code 10045366Term: Ulcerative colitis, unspecifiedSystem Organ Class: 10017947 - Gastrointestinal disorders; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2018-003987-29-DE
• Lead Sponsor: Arena Pharmaceuticals Inc. a wholly owned subsidiary of Pfizer Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-09-30
• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 900

Inclusion Criteria

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 or APD334-210 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) sub-score = 2 at 2 timepoints at least 7 days and no more than 14 days apart
• RB + stool frequency (SF) sub-score = 4 at 2 timepoints at least 7 days and no more than 14 days apart
• RB sub-score = 2 or RB + SF sub-scores = 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 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 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 childbearing potential 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 inf

Exclusion Criteria

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 of 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 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