The primary objective of the study is to evaluate the safety of IMG-007 in adults with Alopecia Areata.
This is a phase 1b/2a, open label study to assess the safety, PK, and efficacy of IMG-007 in adult AA participants with 50% or greater scalp hair loss. The study will consist of two cohorts with three periods: a screening period of up to 5 -weeks, a 16-week treatment period and a 20-week follow- up period. Approximately 6 and 24 participants will be sequentially enrolled into cohort 1 and cohort 2, respectively, to receive three intravenous infusions of IMG-007 over 4 weeks.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
29
Intravenous Infusion
Northwest Arkansas Clinical Trials Center, PLLC/ Hull Dermatology P.A.
Rogers, Arkansas, United States
Torrance Clinical Research Institute Inc.
Lomita, California, United States
Evaluation of Adverse Events in Participants
To evaluate adverse events (AEs) emergent from multiple doses of IMG-007 in adult participants with AA.
Time frame: Adverse events were collected from baseline through the end of the study, a period of up to 24 weeks.
Evaluation of Severity of Alopecia Tool (SALT)
To evaluate the efficacy of multiple doses of IMG-007 in AA participants as measured by the Severity of Alopecia Tool (SALT). The Severity of Alopecia Tool (SALT) is a quantitative assessment of AA severity by the investigator based on scalp terminal hair loss. To evaluate the efficacy of multiple doses of IMG-007 in AA participants as measured by Severity of Alopecia Tool (SALT) on a scale of 0 for no hair loss, and 100 is complete hair loss (higher scores attributes to worse outcomes).
Time frame: Mean percent change from baseline in Severity of ALopecia Tool (SALT) at week 24.
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