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CompletedPhase 1/2

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

Key facts

Who runs it
Inmagene LLC
Where
Bay City, Burlington, Indianapolis, Lomita, Reno, Rochester, Rogers, Spokane, Sugar Land, Tampa, and West Lafayette, United StatesSee the 11 sitesAlso in 1 other country, 6 sites
Trial code
Status
Completed
Phase
Phase 1/2
People taking part
29 people enrolled
Started
25 Sept 2023
Ended
14 Jan 2025
Type of study
Interventional, 2 groups
Treatments tested
  • IMG-007
Record updated
9 February 2026

Who can take part

Age
18 years to 65 years
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 13 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Active infection requiring treatment with systemic antibiotics, antivirals, antifungals, antiparasitics or antiprotozoals at the Screening visit
  • Concurrent hair loss due to other etiologies
  • 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 inflammatory diseases on the scalp that would interfere with the assessment of AA
  • 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
  • Primary "diffuse" type of AA
  • History or presence of hair transplants or micropigmentation of the scalp

Where in United States

Also in 1 other country, 6 sites

  • Great Lakes Research Group, Inc.Bay City, United StatesNo longer taking part
  • Lahey Hospital & Medical CenterBurlington, United StatesNo longer taking part
  • Dawes Fretzin Clinical Resarch Group, LLCIndianapolis, United StatesNo longer taking part
  • Torrance Clinical Research Institute, Inc.Lomita, United StatesNo longer taking part
  • Skin Cancer and Dermatology InstituteReno, United StatesNo longer taking part
  • Skin Search of Rochester, Inc.Rochester, United StatesNo longer taking part
  • Northwest Arkansas Clinical Trials Center, PLLC/ Hull Dermatology P.A.Rogers, United StatesNo longer taking part
  • Dermatology Specialists of SpokaneSpokane, United StatesNo longer taking part
  • Stride Clinical Research LLCSugar Land, United StatesNo longer taking part
  • Alliance Clinical Research of TampaTampa, United StatesNo longer taking part
  • Options Research GroupWest Lafayette, United StatesNo longer taking part

About the trial

What the trial wants to find out

The primary objective of the study is to evaluate the safety of IMG-007 in adults with Alopecia Areata.

The 2 groups in the trial

  • IMG-007 Dose 1 (300 mg)Treatment being tested

    IMG-007 Dose 1 (300 mg) will be administered intravenously 3 times over 4 weeks

    Treatment: IMG-007

  • IMG-007 Dose 2 (600 mg)Treatment being tested

    IMG-007 Dose 2 (600 mg) will be administered intravenously 3 times over 4 weeks

    Treatment: IMG-007

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
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
Record updated
9 February 2026