Phase 2
N=108
A Study to Assess the Safety and Efficacy of Oral Etrasimod in Adult Participants With Eosinophilic Esophagitis
Eosinophilic Esophagitis
Bottom Line
View on ClinicalTrials.gov: NCT04682639 ↗Enrolled (actual)
108
Serious AEs
0.5%
Results posted
Oct 2023
Primary outcome: Primary: Percent Change From Baseline in Esophageal Peak Eosinophil Count (PEC) at Week 16 — -58.4; -39.4; -21.5 Percent change — p=0.0103
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Etrasimod (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Sep 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in Esophageal Peak Eosinophil Count (PEC) at Week 16 |
-58.4; -39.4; -21.5 | 0.0103 sig |
| SECONDARY Absolute Change From Baseline in Dysphagia Symptom Questionnaire (DSQ) Score at Week 16 |
-17.11; -14.78; -19.49 | 0.4894 |
| SECONDARY Absolute Change From Baseline in Esophageal Peak Eosinophil Count (PEC) at Week 16 |
-46.3; -5.7; 8.3 | 0.0565 |
| SECONDARY Percentage Of Participants With Esophageal Peak Eosinophil Count (PEC) Less Than (<) 15 Eosinophils/High Power Field (Eos/Hpf) at Week 16 |
22.0; 12.8; 0 | 0.0007 sig |
| SECONDARY Percentage of Participants With Esophageal Peak Eosinophil Count (PEC) Less Than or Equal to (<=) 6 Eosinophils/High Power Field (Eos/Hpf) at Week 16 |
12.2; 7.7; 0 | 0.0173 sig |
Summary
The purpose of this study is to determine whether oral etrasimod is a safe and effective treatment for active eosinophilic esophagitis (EoE) in adult participants.
Eligibility 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:
- Elemental diet
- EoE food trigger elimination diet
- 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
Data sourced from ClinicalTrials.gov (NCT04682639). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.