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

• Register: EUCTR
• Last refreshed on: 30 September 2024
• Main ID: EUCTR2018-003987-29-PT
• Date of registration: 28/10/2019
• Prospective Registration: Yes
• Primary sponsor: Arena Pharmaceuticals Inc. a wholly owned subsidiary of Pfizer Inc.
• Public title: An Open-Label Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis
• Scientific title: An Open-Label Extension Study of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC OLE
• Date of first enrolment: 02/03/2020
• Target sample size: 900
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2018-003987-29
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no Number of treatment arms in the trial: 1
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Argentina, Australia, Austria, Belarus, Belgium, Bulgaria, Canada, Chile, China, Colombia, Croatia, Czech Republic, Czechia, Denmark, Egypt, Estonia, France, Georgia, Germany, Hungary, India, Israel, Italy, Japan, Korea, Republic of, Latvia, Lebanon, Lithuania, Mexico, Moldova, Republic of, Netherlands, Poland, Portugal, Romania, Russian Federation, Serbia, Slovakia, South Africa, Spain, Switzerland, Thailand, Türkiye, Ukraine, United Kingdom, United States

Contacts

• Name: Christophe Dubreuil
• Affiliation: Arena Pharmaceuticals Inc. a wholly owned subsidiary of Pfizer Inc.

• Name: Christophe Dubreuil
• Affiliation: Arena Pharmaceuticals Inc. a wholly owned subsidiary of Pfizer Inc.

Key inclusion & exclusion criteria

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 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 a
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 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

Age minimum:
Age maximum:
Gender: Female: yes Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Ulcerative Colitis
MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.1 Level: LLT Classification code 10045366 Term: Ulcerative colitis, unspecified System Organ Class: 10017947 - Gastrointestinal disorders

Intervention(s)

Product Name: Etrasimod Product Code: APD334 Pharmaceutical Form: Tablet INN or Proposed INN: etrasimod L-arginine CAS Number: 1206123-97-8 Current Sponsor code: APD334 L-arginine; PF-07915503-94 (L-arginine salt) Other descriptive name: AR401959 L-arginine Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2-

Primary Outcome(s)

Primary end point(s): ¿ Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) ¿ Incidence and severity of laboratory abnormalities, and change from treatment baseline in laboratory values (hematology, serum chemistry, coagulation, and urinalysis) ¿ Incidence of vital sign abnormalities and changes from treatment baseline

Secondary Objective: To assess the long-term efficacy of etrasimod in subjects with moderately to severely active UC

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

Main Objective: To assess the safety of long-term administration of etrasimod in subjects with moderately to severely active ulcerative colitis (UC)

Secondary Outcome(s)

Secondary end point(s): ¿ The proportion of subjects achieving clinical remission at Week 52 and 104 among subjects achieving clinical remission at study entry ¿ The proportion of subjects achieving clinical response at Weeks 52 and 104 ¿ Change from baseline in the Total Mayo Score (TMS) at Weeks 52 and 104 ¿ Change from baseline from Partial Mayo Score (PMS) at Weeks 52, 104, 156, 208 and 260 ¿ The proportion of subjects achieving endoscopic improvement at Weeks 52 and 104

Timepoint(s) of evaluation of this end point: Weeks 52, 104, 156, 208 and 260

Secondary ID(s)

APD334-303

NCT03950232

2018-003987-29-SK

125154

Source(s) of Monetary Support

Arena Pharmaceuticals Inc. a wholly owned subsidiary of Pfizer Inc.

Ethics review

Status: Approved
Approval date: 02/03/2020
Contact:

Results

• Date Posted: 01/01/1900