A Study to Evaluate the Safety, Pharmacokinetics and Efficacy of IMG-007 in Adult Alopecia Areata Participants

Launched by INMAGENE LLC · Sep 27, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called IMG-007 for adults with a condition known as Alopecia Areata (AA), which causes hair loss. The main goal of the study is to find out if IMG-007 is safe for people with AA. To be part of this trial, participants must be between 18 and 65 years old and have had hair loss for more than 6 months but less than 8 years, with a significant amount of scalp involvement (at least 50% of their scalp affected).

While participating in the trial, eligible individuals can expect close monitoring to ensure their safety while taking IMG-007. However, some people may not be able to join the study, especially those with certain medical conditions like active infections or specific types of hair loss unrelated to AA. This trial is currently active but not recruiting new participants, meaning they are not accepting new volunteers at this time.

Gender

ALL

Eligibility criteria

• Key Inclusion Criteria:
• • 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 Criteria:
• • 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.