A Study to Evaluate the Safety, Pharmacokinetics and Efficacy of IMG-007 in Adult Alopecia Areata Participants
- Registration Number
- NCT06060977
- Lead Sponsor
- Inmagene LLC
- 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 periods: a screening period of up to 5 -weeks, a 16-week treatment period and an 8-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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 29
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description IMG-007 Dose 1 IMG-007 IMG-007 Dose 1 will be administered intravenously 3 times over 4 weeks IMG-007 Dose 2 IMG-007 IMG-007 Dose 2 will be administered intravenously 3 times over 4 weeks
- Primary Outcome Measures
Name Time Method Evaluation of Adverse Events in Participants Baseline, Week 24 To evaluate adverse events (AEs) emergent from multiple doses of IMG-007 in adult participants with AA.
- Secondary Outcome Measures
Name Time Method Evaluation of Severity of Alopecia Tool (SALT) Baseline, Week 24 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).
Related Research Topics
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Trial Locations
- Locations (17)
Northwest Arkansas Clinical Trials Center, PLLC/ Hull Dermatology P.A.
🇺🇸Rogers, Arkansas, United States
Torrance Clinical Research Institute Inc.
🇺🇸Lomita, California, United States
Alliance Clinical Research of Tampa
🇺🇸Tampa, Florida, United States
Dawes Fretzin Clinical Resarch Group, LLC
🇺🇸Indianapolis, Indiana, United States
Options Research Group
🇺🇸West Lafayette, Indiana, United States
Lahey Hospital & Medical Center
🇺🇸Burlington, Massachusetts, United States
Great Lakes Research Group Inc.
🇺🇸Bay City, Michigan, United States
Skin Cancer and Dermatology Institute
🇺🇸Reno, Nevada, United States
Skin Search of Rochester, Inc.
🇺🇸Rochester, New York, United States
Stride Clinical Research LLC
🇺🇸Sugar Land, Texas, United States
Scroll for more (7 remaining)Northwest Arkansas Clinical Trials Center, PLLC/ Hull Dermatology P.A.🇺🇸Rogers, Arkansas, United States