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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04682639




Registration number
NCT04682639
Ethics application status
Date submitted
19/12/2020
Date registered
24/12/2020

Titles & IDs
Public title
A Study to Assess the Safety and Efficacy of Oral Etrasimod in Adult Participants With Eosinophilic Esophagitis
Scientific title
A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of Etrasimod in Adult Subjects With Eosinophilic Esophagitis
Secondary ID [1] 0 0
C5041009
Secondary ID [2] 0 0
APD334-206
Universal Trial Number (UTN)
Trial acronym
VOYAGE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Eosinophilic Esophagitis 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Inflammatory and Immune System 0 0 0 0
Allergies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Etrasimod
Treatment: Drugs - Placebo
Treatment: Drugs - Etrasimod

Experimental: Etrasimod Dose 1 -

Experimental: Etrasimod Dose 2 -

Placebo comparator: Placebo and Etrasimod - Participants will receive etrasimod matching placebo tablet during the Double-Blind Treatment Period and etrasimod tablet during the Extension Treatment Period.


Treatment: Drugs: Etrasimod
Participants will receive etrasimod tablet by mouth, once daily during the 24-week Double-Blind and 28-week Extension Treatment Periods.

Treatment: Drugs: Placebo
Participants will receive etrasimod matching placebo tablet by mouth, once daily during the 24-week Double-Blind Treatment Period.

Treatment: Drugs: Etrasimod
Participants will receive etrasimod tablet by mouth, once daily during the 28-week Extension Treatment Period.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percent Change From Baseline in Esophageal Peak Eosinophil Count (PEC) at Week 16
Assessment method [1] 0 0
Eosinophils was counted in the areas of greatest eosinophil density. Counts were reported as the number of eosinophils/high power field (eos/hpf) and multiple hpfs analyzed until the PEC was clearly identified after taking into account all biopsies from all esophageal levels.
Timepoint [1] 0 0
Baseline, Week 16
Secondary outcome [1] 0 0
Absolute Change From Baseline in Dysphagia Symptom Questionnaire (DSQ) Score at Week 16
Assessment method [1] 0 0
The DSQ was used to measure the frequency and intensity of dysphagia to solid food. DSQ contained 4 questions, all participants used a diary, and responded to Questions 1 (did you eat solid food) and 2 (did food pass slowly or get stuck). If the participant's answer to Question 2 was 'No', the diary ended for that day. If a participant answered 'Yes', he/she advanced to Questions 3 (did you have to do anything to make the food go down or get relief) and 4 (extent to which the participant experienced pain while swallowing). DSQ score = (Sum of points from questions 2+3 in the daily DSQ)×14 days/(Number of diaries reported with non-missing data). DSQ scores can range from 0 to 84, with a higher score indicating worse dysphagia.
Timepoint [1] 0 0
Baseline, Week 16
Secondary outcome [2] 0 0
Absolute Change From Baseline in Esophageal Peak Eosinophil Count (PEC) at Week 16
Assessment method [2] 0 0
Eosinophils was counted in the areas of greatest eosinophil density. Counts were reported as the number of eosinophils/high power field (eos/hpf) and multiple hpfs analyzed until the PEC was clearly identified after taking into account all biopsies from all esophageal levels.
Timepoint [2] 0 0
Baseline, Week 16
Secondary outcome [3] 0 0
Percentage Of Participants With Esophageal Peak Eosinophil Count (PEC) Less Than (<) 15 Eosinophils/High Power Field (Eos/Hpf) at Week 16
Assessment method [3] 0 0
Timepoint [3] 0 0
Week 16
Secondary outcome [4] 0 0
Percentage of Participants With Esophageal Peak Eosinophil Count (PEC) Less Than or Equal to (<=) 6 Eosinophils/High Power Field (Eos/Hpf) at Week 16
Assessment method [4] 0 0
Timepoint [4] 0 0
Week 16

Eligibility
Key inclusion criteria
* Have an eosinophilic esophagitis (EoE) diagnosis prior to screening and histologically active disease with an esophageal peak eosinophil count (PEC) of = 15 eosinophils per high powered field (eos/hpf)
* Have dysphagia, defined as solid food going down slowly or getting stuck in the throat with an average frequency of = 2 episodes per week over 2 weeks during the Screening period

Inclusion Criteria for the Extension Treatment Period

* Completion of the Week 24 study visit [including esophagogastroduodenoscopy (EGD)]
* Compliance with study procedures during the Double-Blind Treatment Period as assessed by the Investigator
* No notable safety concerns during the Double-Blind Treatment Period, as determined by the Investigator
* Willing to comply with all study visits and procedures for the Extension Treatment Period
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* History of any of the non-EoE conditions or procedures that may interfere with the evaluation of or affect the histologic (eg eosinophilic gastritis), endoscopic (eg, high-grade esophageal stenosis), or symptom endpoints (eg, esophageal resection) of the study
* Undergone dilation of an esophageal stricture within 12 weeks prior to Screening EGD
* Use of corticosteroids for the treatment of EoE within 8 weeks prior to Screening EGD
* Discontinue, initiate, or change dosing (dosage/frequency) of the following therapies for EoE within 8 weeks prior to Screening EGD. Participants on any of the following therapy need to stay on a stable regimen during study participation:

1. Elemental diet
2. EoE food trigger elimination diet
3. Proton pump inhibitor (PPI) therapy
* Used any immunotherapy/desensitization including oral immunotherapy (OIT) or sublingual immunotherapy (SLIT) within 12 months prior to the Screening EGD. Note: Stable (ie, = 6 months prior to the Screening EGD) subcutaneous immunotherapy (SCIT) is permitted. Participants on SCIT need to stay on a stable treatment during study participation
* Used any protocol-specified immunomodulatory therapies within the protocol-specified timeframe prior to Baseline (eg, dupilumab, benralizumab, omalizumab, or infliximab within 12 weeks; a sphingosine-1-phosphate receptor modulator at any time)
* Use of any investigational agent or device within 12 weeks prior to Baseline
* Females who are pregnant

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Other
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/12/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/06/2023
Sample size
Target
Accrual to date
Final
108
Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC
Recruitment hospital [1] 0 0
Sunshine University Private Hospital - Birtinya
Recruitment hospital [2] 0 0
Mater Misericordiae Ltd - Brisbane South
Recruitment hospital [3] 0 0
Buderim Eye Centre (OCT Facility) - Buderim
Recruitment hospital [4] 0 0
Dr Shiran DeSilva Respiratory Clinic - Mackay
Recruitment hospital [5] 0 0
Mackay Discount Drug Store - Mackay
Recruitment hospital [6] 0 0
Mater Misericordiae Hospital - Mackay
Recruitment hospital [7] 0 0
Queensland X-Ray - Mackay
Recruitment hospital [8] 0 0
Vision Eye Institute Mackay - Mackay
Recruitment hospital [9] 0 0
Coastal Digestive Health - Maroochydore
Recruitment hospital [10] 0 0
Coral Sea Clinical Research Institute - North Mackay
Recruitment hospital [11] 0 0
Elizabeth Specialist Suites (PFT Facility) - Elizabeth Vale
Recruitment hospital [12] 0 0
Lyell McEwin Hospital. - Elizabeth Vale
Recruitment hospital [13] 0 0
Lyell McEwin Hospital - Elizabeth Vale
Recruitment hospital [14] 0 0
Modbury Hospital (OCT Facility) - Modbury
Recruitment hospital [15] 0 0
Box Hill Eye Surgeons (OCT Facility) - Box Hill North
Recruitment hospital [16] 0 0
Eastern Clinical Research Unit - Box Hill
Recruitment hospital [17] 0 0
Eastern Health - Box Hill
Recruitment hospital [18] 0 0
Retina Specialists Victoria (OCT Facility) - Camberwell
Recruitment hospital [19] 0 0
The Northern Hospital - Epping
Recruitment hospital [20] 0 0
Footscray Hospital - Footscray
Recruitment hospital [21] 0 0
Vision Eye Institute - Melbourne
Recruitment hospital [22] 0 0
MCES Practice Pty Ltd operating as Comprehensive Eye Surgeons (OCT Facility) - Bellfield
Recruitment hospital [23] 0 0
Queensland Respiratory Services ,Pulse Oceanside Medical{PFT Facility ) - Birtinya
Recruitment postcode(s) [1] 0 0
4575 - Birtinya
Recruitment postcode(s) [2] 0 0
4101 - Brisbane South
Recruitment postcode(s) [3] 0 0
4558 - Buderim
Recruitment postcode(s) [4] 0 0
4740 - Mackay
Recruitment postcode(s) [5] 0 0
4558 - Maroochydore
Recruitment postcode(s) [6] 0 0
4740 - North Mackay
Recruitment postcode(s) [7] 0 0
5112 - Elizabeth Vale
Recruitment postcode(s) [8] 0 0
5092 - Modbury
Recruitment postcode(s) [9] 0 0
3129 - Box Hill North
Recruitment postcode(s) [10] 0 0
3128 - Box Hill
Recruitment postcode(s) [11] 0 0
3124 - Camberwell
Recruitment postcode(s) [12] 0 0
3076 - Epping
Recruitment postcode(s) [13] 0 0
3011 - Footscray
Recruitment postcode(s) [14] 0 0
3011 - Melbourne
Recruitment postcode(s) [15] 0 0
3081 - Bellfield
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Idaho
Country [8] 0 0
United States of America
State/province [8] 0 0
Illinois
Country [9] 0 0
United States of America
State/province [9] 0 0
Indiana
Country [10] 0 0
United States of America
State/province [10] 0 0
Kansas
Country [11] 0 0
United States of America
State/province [11] 0 0
Louisiana
Country [12] 0 0
United States of America
State/province [12] 0 0
Minnesota
Country [13] 0 0
United States of America
State/province [13] 0 0
Nebraska
Country [14] 0 0
United States of America
State/province [14] 0 0
New Jersey
Country [15] 0 0
United States of America
State/province [15] 0 0
North Carolina
Country [16] 0 0
United States of America
State/province [16] 0 0
Ohio
Country [17] 0 0
United States of America
State/province [17] 0 0
Oklahoma
Country [18] 0 0
United States of America
State/province [18] 0 0
Pennsylvania
Country [19] 0 0
United States of America
State/province [19] 0 0
South Dakota
Country [20] 0 0
United States of America
State/province [20] 0 0
Tennessee
Country [21] 0 0
United States of America
State/province [21] 0 0
Texas
Country [22] 0 0
United States of America
State/province [22] 0 0
Utah
Country [23] 0 0
United States of America
State/province [23] 0 0
Virginia
Country [24] 0 0
Belgium
State/province [24] 0 0
Brugge
Country [25] 0 0
Belgium
State/province [25] 0 0
Roeselare
Country [26] 0 0
Belgium
State/province [26] 0 0
Tournai
Country [27] 0 0
Canada
State/province [27] 0 0
Ontario
Country [28] 0 0
Germany
State/province [28] 0 0
Berlin
Country [29] 0 0
Netherlands
State/province [29] 0 0
Amsterdam
Country [30] 0 0
Spain
State/province [30] 0 0
Alicante
Country [31] 0 0
Spain
State/province [31] 0 0
Madrid
Country [32] 0 0
Spain
State/province [32] 0 0
Zaragoza
Country [33] 0 0
Switzerland
State/province [33] 0 0
Zurich

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pfizer
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Arena is a wholly owned subsidiary of Pfizer
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

TypeOther DetailsAttachment
Study protocol
Statistical analysis plan



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT04682639