Safety and Efficacy of Oral Etrasimod in Adult Participants With Moderate-to-Severe Alopecia Areata (NCT04556734) | Clinical Trial Compass
CompletedPhase 2
Safety and Efficacy of Oral Etrasimod in Adult Participants With Moderate-to-Severe Alopecia Areata
United States80 participantsStarted 2020-07-29
Plain-language 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).
Who can participate
Age range18 Years – 70 Years
SexALL
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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 \<95 at Screening and Day 1/Baseline.
* Current episode of hair loss for ≥6 months but \<5 years
* Stable disease condition (no significant growth of hair) in the last 6 months as assessed by the Investigator
* Willing to keep the same hair style and color (eg, hair products, process, and timing for hair appointments) for the duration of the study
Key Exclusion Criteria:
* History of male or female pattern hair loss \>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
What they're measuring
1
Percent Change From Baseline in Severity of Alopecia Tool I (SALT I) at Week 24: DB Treatment Period
Timeframe: DB Treatment Period: Baseline (before dose on Day 1), Week 24