A Study to Evaluate the Safety, Pharmacokinetics and Efficacy of IMG-007 in Adult Alopecia Areata Participants
Alopecia Areata (AA)
About this trial
This is an interventional treatment trial for Alopecia Areata (AA) focused on measuring IMG-007, Alopecia Areata, Alopecia, Hair Loss, Skin Disease, Immune System Disorder, Dermatologic Agents
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.
Sites / Locations
- Torrance Clinical Research Institute Inc.Recruiting
- Dawes Fretzin Clinical Resarch Group, LLCRecruiting
- Options Research Group
- Stride Clinical Research LLCRecruiting
- Skin HealthRecruiting
- Guelph Dermatology Research
- Research Toronto
- Centre de Recherche Saint-LouisRecruiting
- Innovaderm Research Inc.Recruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
IMG-007 Dose 1
IMG-007 Dose 2
IMG-007 Dose 1 will be administered intravenously 3 times over 4 weeks
IMG-007 Dose 2 will be administered intravenously 3 times over 4 weeks