A Study to Assess the Safety and Efficacy of Oral Etrasimod in Adult Participants With Eosinophilic Esophagitis

• Register: ClinicalTrials.gov
• Last refreshed on: 13 May 2024
• Main ID: NCT04682639
• Date of registration: 19/12/2020
• Prospective Registration: No
• Primary sponsor: Pfizer
• Public title: A Study to Assess the Safety and Efficacy of Oral Etrasimod in Adult Participants With Eosinophilic Esophagitis VOYAGE
• 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
• Date of first enrolment: December 15, 2020
• Target sample size: 108
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT04682639
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Sequential Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 2

Countries of recruitment

Australia, Belgium, Canada, Germany, Netherlands, Spain, Switzerland, United States

Contacts

• Name: Pfizer CT.gov Call Center
• Affiliation: Pfizer

Key inclusion & exclusion criteria

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

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



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Eosinophilic Esophagitis

Intervention(s)

Drug: Placebo

Drug: Etrasimod

Primary Outcome(s)

Percent Change From Baseline in Esophageal Peak Eosinophil Count (PEC) at Week 16 [Time Frame: Baseline, Week 16]

Secondary Outcome(s)

Absolute Change From Baseline in Dysphagia Symptom Questionnaire (DSQ) Score at Week 16 [Time Frame: Baseline, Week 16]

Percentage Of Participants With Esophageal Peak Eosinophil Count (PEC) Less Than (<) 15 Eosinophils/High Power Field (Eos/Hpf) at Week 16 [Time Frame: Week 16]

Absolute Change From Baseline in Esophageal Peak Eosinophil Count (PEC) at Week 16 [Time Frame: Baseline, Week 16]

Percentage of Participants With Esophageal Peak Eosinophil Count (PEC) Less Than or Equal to (<=) 6 Eosinophils/High Power Field (Eos/Hpf) at Week 16 [Time Frame: Week 16]

Secondary ID(s)

C5041009

APD334-206

2020-003226-23

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Arena is a wholly owned subsidiary of Pfizer

Results

• Results available: Yes
• Date Posted: 26/10/2023
• URL: https://clinicaltrials.gov/ct2/show/results/NCT04682639