Phase 2
N=80
Safety and Efficacy of Oral Etrasimod in Adult Participants With Moderate-to-Severe Alopecia Areata
Alopecia Areata
Bottom Line
View on ClinicalTrials.gov: NCT04556734 ↗Enrolled (actual)
80
Serious AEs
1.4%
Results posted
Jun 2024
Primary outcome: Primary: Percent Change From Baseline in Severity of Alopecia Tool I (SALT I) at Week 24: DB Treatment Period — -13.79; -21.43; 0.35 Percent change of scalp surface area — p=0.2579
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
- Jun 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in Severity of Alopecia Tool I (SALT I) at Week 24: DB Treatment Period |
-13.79; -21.43; 0.35 | 0.2579 |
| SECONDARY Change From Baseline in SALT I at Week 24: DB Treatment Period |
-8.87; -8.62; 0.36 | 0.1283 |
| SECONDARY Percentage of Participants Who Achieved Greater Than or Equal to (>=) 30%, >= 50% and >=75% Improvement From Baseline in SALT I at Week 24: DB Treatment Period |
23.5; 36.0; 12.5; 11.8; 28.0; 12.5 | 0.4067 |
Summary
The purpose of this study is to evaluate the safety and efficacy of etrasimod monotherapy (2 milligrams [mg] and 3 mg) in participants with moderate-to-severe alopecia areata (AA).
Eligibility Criteria
Key Inclusion Criteria
- Men or women between ≥18 and ≤70 years of age at the time of informed consent
- Moderate-to-severe alopecia areata as assessed by a SALT score of ≥25 and Hamilton stage III or >Ludwig stage II
- Other types of alopecia (eg, cicatricial/scarring alopecia [including central centrifugal cicatricial alopecia], traction alopecia, or telogen effluvium) or other diseases that could cause hair loss
- Active scalp inflammation, scalp infection, scalp psoriasis, or any other scalp condition that may interfere with the SALT assessment
- Previous use of Janus kinase (JAK) inhibitor (oral or topical), including participation in clinical studies of JAK inhibitors
Data sourced from ClinicalTrials.gov (NCT04556734). 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.