IMG-007
DrugIntravenous Infusion
NCT Number: NCT06060977
The primary objective of the study is to evaluate the safety of IMG-007 in adults with Alopecia Areata.
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Notify Me18 year–65 year
All sexes
Interventional
Phase 1 / Phase 2
SimcoMed Health Ltd., Barrie, Ontario, Canada
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Key Inclusion Criteria:
Key Exclusion Criteria:
Intravenous Infusion
Time frame: Adverse events were collected from baseline through the end of the study, a period of up to 24 weeks.
To evaluate adverse events (AEs) emergent from multiple doses of IMG-007 in adult participants with AA.
Time frame: Mean percent change from baseline in Severity of ALopecia Tool (SALT) at week 24.
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).
Inmagene LLC
Industry
A Phase 1b/2a Study to Evaluate the Safety, Pharmacokinetics and Efficacy of IMG-007 in Adult Alopecia Areata Participants With 50% or Greater Scalp Hair Loss
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