Status:
COMPLETED
A Study to Evaluate the Safety, Pharmacokinetics and Efficacy of IMG-007 in Adult Alopecia Areata Participants
Lead Sponsor:
Inmagene LLC
Conditions:
Alopecia Areata (AA)
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
Brief Summary
The primary objective of the study is to evaluate the safety of IMG-007 in adults with Alopecia Areata.
Detailed Description
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...
Eligibility Criteria
Inclusion
- Key
- Male or female aged ≥ 18 and ≤ 65 years
- AA with current episode of hair loss of \> 6 months but \< 8 years
- AA with ≥ 50% scalp involvement as defined as SALT score ≥ 50
- Key
Exclusion
- Known hepatitis B, hepatitis C, or human immunodeficiency virus infection
- Evidence of active or latent tuberculosis (TB)
- History of untreated or inadequately treated TB infection.
- Active infection requiring treatment with systemic antibiotics, antivirals, antifungals, antiparasitics or antiprotozoals at the Screening visit
- Concurrent hair loss due to other etiologies
- Primary "diffuse" type of AA
- Active inflammatory diseases on the scalp that would interfere with the assessment of AA
- History or presence of hair transplants or micropigmentation of the scalp
- Active systemic diseases that may cause hair loss
- Other conditions or laboratory abnormality that could increase the risk associated with study participation or could interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into the study.
Key Trial Info
Start Date :
September 25 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 14 2025
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT06060977
Start Date
September 25 2023
End Date
January 14 2025
Last Update
April 30 2025
Active Locations (17)
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1
Northwest Arkansas Clinical Trials Center, PLLC/ Hull Dermatology P.A.
Rogers, Arkansas, United States, 72758
2
Torrance Clinical Research Institute Inc.
Lomita, California, United States, 90717
3
Alliance Clinical Research of Tampa
Tampa, Florida, United States, 33615
4
Dawes Fretzin Clinical Resarch Group, LLC
Indianapolis, Indiana, United States, 47906