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Trial details
An Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis
Current status:
Approved
|
Date registered:
02/12/2020
|
Date last updated:
01/12/2020
Trial version(s)
Current: 08/03/2020
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Main Information
Primary registry identifying number
LBCTR2020043428
Protocol number
APD334-303
MOH registration number
2020/2/33126
Trial already registered with the MoPH
Study registered at the country of origin
Type of registration
Prospective
Date of registration in national regulatory agency
04/05/2015
Primary sponsor
Arena Pharmaceuticals Inc.
Primary sponsor: Country of origin
United States of America
Public title
An Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis
Acronym
Scientific title
An Open-Label Extension Study of Etrasimod in Subjects With Moderately to Severely Active Ulcerative Colitis
Acronym
Brief summary of the study: English
The purpose of this open-label extension (OLE) study is to evaluate the safety and efficacy of etrasimod in participants with moderately to severely active ulcerative colitis (UC) who previously received double-blinded treatment (either etrasimod 2 mg per day or placebo) during participation in one of two Phase 3 double-blinded, placebo-controlled studies (either Study APD334-301 or APD334-302).
Brief summary of the study: Arabic
الغرض من هذه الدراسة التمديدية هو تقييم سلامة وفعالية etrasimod في المشاركين الذين يعانون من التهاب القولون التقرحي النشیط بشكل معتدل إلى شدید (UC) و الذين كانوا قد تلقوا سابقًا علاجًا (Etrasimod 2mg or placebo) أثناء المشاركة في واحدة من الدراستين APD334-301 أو APD334-302
Health conditions/problem studied: Specify
Ulcerative Colitis (UC)
Interventions: Specify
Drug: Etrasimod (APD334) 2mg tablet by mouth, once daily up to approximately 5 years or until marketing authorization is obtained in the participant's country, whichever comes first
Key inclusion and exclusion criteria: Inclusion criteria
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 (β-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. Ability to provide written informed consent or assent (parent or legal guardian must provide consent for a subject < 18 years of age or as required per local regulations who has assented to participate in the study) and to be compliant with the schedule of protocol assessments
Key inclusion and exclusion criteria: Gender
Both
Key inclusion and exclusion criteria: Age minimum
16
Key inclusion and exclusion criteria: Age maximum
80
Key inclusion and exclusion criteria: 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 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.
Type of Study
Type
Interventional
Type of intervention
Pharmaceutical
Trial scope
Therapy
Trial scope: Specify scope
Study design: Allocation
N/A: Single arm study
Study design: Masking
Open (masking not used)
Study design: Control
N/A
Study phase
3
Study design: Purpose
Treatment
Study design: Assignment
Single
IMP has market authorization
No
Name of IMP
APD334 (Etrasimod)
Type of IMP
Others
Type of IMP: Specify
Pharmaceutical
Pharmaceutical class
Highly selective sphingosine 1-phosphate (S1P) receptor modulator
Therapeutic indication
Ulcerative Colitis
Therapeutic benefit
Clinical remission of moderately to severely active ulcerative colitis
Biospecimen retention
Samples with DNA**
Biospecimen description
Both Samples with DNA and Samples without DNA will be processed
Target sample size
20
Actual enrollment target size
Date of first enrollment: Type
Anticipated
Date of first enrollment: Date
05/09/2020
Date of study closure: Type
Anticipated
Date of study closure: Date
25/12/2025
Recruitment status
Pending
Date of completion
IPD sharing statement plan
No
IPD sharing statement description
N/A
Additional data URL
Summary Results
Secondary Identifying Numbers
Full name of issuing authority
Secondary identifying number
Clinicaltrials.gov
NCT03950232
European Clinical Trials Database
EudraCT Number 2018-003987-29
Sources of Monetary or Material Support
Name
Arena Pharmaceuticals Inc. USA
Secondary Sponsors
Name
N/A
Contact for Public/Scientific Queries
Contact type
First name
Last name
Address
Country
Telephone
Email
Affiliation
Public
Hasan
Dakkak
Wahat Al Arab Building 3rd floor - Al Arab Street – Barbir – Beirut
Lebanon
0096170027779
hasan.dakkak@iqvia.com
IQVIA
Scientific
Chris
Cabell
6154 Nancy Ridge Dr. ▪ San Diego, CA 92121
United States of America
+18584537200
ccabell@arenapharm.com
Arena Pharmaceuticals
Centers/Hospitals Involved in the Study
Center/Hospital name
Name of principles investigator
Principles investigator speciality
Ethical approval
American University of Beirut Medical Center
Dr. Alaa Sharara
Gastroenterology
Approved
Hotel Dieu de France Hospital
Dr. Cesar Yaghi
Gastroenterology
Approved
Saint George University Medical Center
Dr. Said Farhat
Gastroenterology
Approved
Ethics Review
Ethics approval obtained
Approval date
Contact name
Contact email
Contact phone
American University of Beirut Medical Center
03/09/2020
Dr. Deborah Mukherji
N/A
009611350000
Saint George Hospital University Medical Center
09/07/2020
Dr. Michel Daher
NA
009611441000
Hotel Dieu de France
03/06/2020
Pr. Sami Richa
cue@usj.edu.lb
009611421229
Countries of Recruitment
Name
Australia
Austria
Belgium
Brazil
Bulgaria
Canada
Chile
China
Croatia
Czech Republic
Denmark
Estonia
France
Germany
Hungary
India
Italy
Republic of Korea
Republic of Moldova
Netherlands
Poland
Portugal
Russian Federation
Republic of Serbia
Slovakia
South Africa
Spain
Taiwan
Thailand
Turkey
Ukraine
United Kingdom
United States of America
Belarus
Latvia
Lithuania
Georgia
Lebanon
Health Conditions or Problems Studied
Condition
Code
Keyword
Ulcerative Colitis
Ulcerative colitis (K51)
Colitis Colitis, Ulcerative Ulcer Gastroenteritis Gastrointestinal Diseases Digestive System Diseases Colonic Diseases Intestinal Diseases Pathologic Processes Inflammatory Bowel Diseases
Interventions
Intervention
Description
Keyword
Drug
APD334 (Etrasimod) 2mg tablet
Etrasimod
Primary Outcomes
Name
Time points
Measure
Number and Severity of Safety Measures
Up to approximately 5 years
Evaluation of adverse events
Incidence of treatment-emergent adverse events and serious adverse events
Up to approximately 5 years
Evaluation of adverse events
Incidence and severity of laboratory abnormalities, and change from baseline in laboratory values (hematology, serum chemistry, coagulation, and urinalysis)
Up to approximately 5 years
Laboratory tests (hematology, serum chemistry, coagulation, and urinalysis)
Incidence of vital sign abnormalities and changes from baseline
Up to approximately 5 years
Evaluation of vital signs (resting heart rate and systolic and diastolic BP, body temperature, and respiratory rate)
Key Secondary Outcomes
Name
Time points
Measure
Proportion of Participants Achieving Clinical Remission
Week 52, Week 104, Week 156, Week 208, and Week 260
Mayo Component Sub-scores
Proportion of Participants Achieving Clinical Response
Week 52, Week 104, Week 156, Week 208, and Week 260
Mayo Component Sub-scores
Proportion of Participants Achieving Symptomatic Remission
Week 52, Week 104, Week 156, Week 208, and Week 260
Mayo Component Sub-scores
Proportion of Participants Achieving Non-invasive Response
Week 12, Week 24, Week 36, Week 52, Week 104, Week 156, Week 208, and Week 260
Mayo Component Sub-scores
Proportion of Participants Remaining in Clinical Remission
Week 12, Week 52, Week 104, Week 156, Week 208, and Week 260
Mayo Component Sub-scores
Proportion of Participants Achieving Symptomatic Response
Week 12, Week 24, Week 36, Week 52, Week 104, Week 156, Week 208, and Week 260
Mayo Component Sub-scores
Longitudinal change from both Open-Label Extension and Parent Study
Week 12, Week 24, Week 36, Week 52, Week 104, Week 156, Week 208, and Week 260
Mayo Component Sub-scores
Proportion of Participants With Remission and Response
Week 12, Week 52, up to Week 260
Total Mayo Clinic Score
Percentage of Participants With Histologic Improvement at Each Visit With Endoscopy
Up to approximately Week 260
Geboes, Robarts, and Nancy Histopathology Scores
Percentage of Participants With Histologic Remission at Each Visit With Endoscopy
Up to Week 260
Geboes, Robarts, and Nancy Histopathology Scores
Time to Loss of Response
Up to Week 260
Mayo Component Sub-scores
Proportion of Participants With Improvement in Extraintestinal Manifestations (EIMs) in Participants With EIMs at Baseline
Baseline, Week 12, Week 52, Week 104, Week 156, Week 208, and Week 260
N/A
Trial Results
Summary results in Lebanon
Study results globally
Date of posting of results summaries
Date of first journal publication of results
Results URL link
Baseline characteristics
Participant flow
Adverse events
Outcome measures
URL to protocol files
Link(s) to publications related to the study
Changes History
Change
Date
Addition of N/A for secondary Sponsor
29/09/2020
Addition of Lebanon in countries of recruitment
29/09/2020
Addition of AUBMC IRB approval (instead of HDF)
29/09/2020
Addition of SGUMC IRB approval
22/10/2020
Addition of MOH registration number: 1st IL granted on 20/10/2020
22/10/2020
Addition of HDF IRB Approval
01/12/2020
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