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

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ClinicalTrials.gov Identifier: NCT06060977
Recruitment Status : Recruiting
First Posted : September 29, 2023
Last Update Posted : March 6, 2024
Sponsor:
Information provided by (Responsible Party):
Inmagene LLC

Study Description
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Brief Summary:
The primary objective of the study is to evaluate the safety of IMG-007 in adults with Alopecia Areata.

Condition or disease Intervention/treatment Phase
Alopecia Areata (AA) Drug: IMG-007 Phase 1 Phase 2

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : September 25, 2023
Estimated Primary Completion Date : October 2024
Estimated Study Completion Date : October 2024

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Arms and Interventions
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Arm Intervention/treatment
Experimental: IMG-007 Dose 1
IMG-007 Dose 1 will be administered intravenously 3 times over 4 weeks
 Drug: IMG-007
Intravenous Infusion
Experimental: IMG-007 Dose 2
IMG-007 Dose 2 will be administered intravenously 3 times over 4 weeks
 Drug: IMG-007
Intravenous Infusion


Outcome Measures
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Primary Outcome Measures :
  1. Evaluation of Adverse Events in Participants [ Time Frame: Baseline, Week 24 ]
    To evaluate adverse events (AEs) emergent from multiple doses of IMG-007 in adult participants with AA.


Secondary Outcome Measures :
  1. Pharmacokinetic characterization [ Time Frame: Baseline, Week 24 ]
    To characterize the pharmacokinetic (PK) profile of multiple doses of IMG-007 in terms of the central compartment clearance (CL) in AA participants.

  2. Pharmacokinetic characterization [ Time Frame: Baseline, Week 24 ]
    To characterize the pharmacokinetic (PK) profile of multiple doses of IMG-007 in terms of the central compartment volume (Vc) in AA participants.

  3. Evaluation of Severity of Alopecia Tool (SALT) [ Time Frame: Baseline, Week 16 ]
    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).


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06060977


Contacts
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Contact: Duong Nguyen 858-346-7751 nguyend@inmagenebio.com

Locations
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Sponsors and Collaborators
Inmagene LLC
More Information
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Responsible Party: Inmagene LLC
ClinicalTrials.gov Identifier: NCT06060977    
Other Study ID Numbers: IMG-007-202
First Posted: September 29, 2023    Key Record Dates
Last Update Posted: March 6, 2024
Last Verified: January 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Inmagene LLC:
IMG-007
Alopecia Areata
Alopecia
Hair Loss
 Skin Disease
Immune System Disorder
Dermatologic Agents
Additional relevant MeSH terms:
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Alopecia
Alopecia Areata
Hypotrichosis
 Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical