Phase 2
N=140
A Study to Assess the Safety and Efficacy of Etrasimod in Subjects With Moderate-to-Severe Atopic Dermatitis
Atopic Dermatitis
Bottom Line
View on ClinicalTrials.gov: NCT04162769 ↗Enrolled (actual)
140
Serious AEs
1.3%
Results posted
Nov 2022
Primary outcome: Primary: Double-blind Treatment Period: Percent Change in Eczema Area and Severity Index (EASI) Score — -58.68; -57.18; -48.41 Percent change — p==0.1198
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Etrasimod 1 mg (Drug); Etrasimod 2 mg (Drug); Etrasimod matching placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Arena Pharmaceuticals
- Primary completion
- Sep 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Double-blind Treatment Period: Percent Change in Eczema Area and Severity Index (EASI) Score |
-58.68; -57.18; -48.41 | =0.1198 |
| SECONDARY Double-blind Treatment Period: Percentage of Participants Achieving EASI-75 |
27.7; 38.3; 26.1 | =0.9826 |
| SECONDARY Double-blind Treatment Period: Percentage of Participants Achieving a Validated Investigator Global Assessment (vIGA) 0 or 1 Score and a Reduction From Baseline of >= 2 Points |
14.9; 29.8; 13.0 | =0.7694 |
| SECONDARY Double-blind Treatment Period: Percent Change in Weekly Peak Pruritus Numerical Rating Scale (NRS) From an Itch Daily Diary |
-38.401; -35.044; -24.374 | =0.0558 |
| SECONDARY Double-blind Treatment Period: Percentage of Participants With Improvement (Reduction) in Peak Pruritus NRS Greater Than or Equal to (>=)3 From an Itch Daily Diary |
45.0; 45.0; 41.0 | =0.7143 |
| SECONDARY Double-blind Treatment Period: Percentage of Participants Achieving EASI-50 |
61.7; 66.0; 52.2 | =0.3981 |
| SECONDARY Double-blind Treatment Period: Percentage of Participants Achieving EASI-90 |
19.1; 14.9; 10.9 | =0.2690 |
| SECONDARY Double-blind Treatment Period: Percent Change in Percent Body Surface Area (BSA) |
-34.725; -45.153; -31.913 | =0.7163 |
| SECONDARY Open-label Extension (OLE) Period: Percent Change in EASI |
-45.39 | — |
| SECONDARY OLE Period: Number of Participants Achieving a EASI-75 Score |
65 | — |
| SECONDARY OLE Period: Number of Participants Achieving a Validated Investigator Global Assessment (vIGA) 0 or 1 Score and a Reduction From Baseline of ≥ 2 Points |
31 | — |
| SECONDARY OLE Period: Percent Change in SCORing Atopic Dermatitis (SCORAD) Total Score |
-64.27 | — |
| SECONDARY OLE Period: Percent Change in Percent BSA |
-68.47 | — |
| SECONDARY OLE Period: Percent Change in Weekly Peak Pruritus NRS From an Itch Daily Diary |
-36.87 | — |
| SECONDARY OLE Period: Change in Patient-Oriented Eczema Measure (POEM) |
-6.3 | — |
| SECONDARY OLE Period: Change in Dermatology Life Quality Index (DLQI) |
-5.4 | — |
| SECONDARY OLE Period: Change in Patient Global Assessment (PGA) of Disease |
1.23 | — |
Summary
The purpose of this study is to determine whether etrasimod is a safe and effective treatment for moderate-to-severe atopic dermatitis (AD).
Eligibility Criteria
Inclusion criteria
- Participants with chronic atopic dermatitis, defined by Hanifin and Rajka criteria, that has been present for at least 1 year prior to the Screening Visit
- Participants with Eczema Area and Severity Index (EASI) ≥ 12 at the Screening Visit and ≥ 16 at the Baseline Visit
- Participants with validated Investigator's Global Assessment (vIGA) score ≥ 3 (on the 0 to 4 vIGA scale, in which 3 = moderate and 4 = severe) involvement at the Screening and Baseline visits
Exclusion Criteria
- Presence of skin comorbidities that would interfere with study assessments of the underlying disease.
Data sourced from ClinicalTrials.gov (NCT04162769). 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.