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

• ClinicalTrials.gov Identifier: NCT06060977
• Recruitment Status: Active, not recruiting
• First Posted: September 29, 2023
• Last Update Posted: May 8, 2024
• Sponsor: Inmagene LLC
• Information provided by (Responsible Party): Inmagene LLC

Tracking Information

• First Submitted Date: September 21, 2023
• First Posted Date: September 29, 2023
• Last Update Posted Date: May 8, 2024
• Actual Study Start Date: September 25, 2023
• Estimated Primary Completion Date: October 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 27, 2023)

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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: September 27, 2023)

• 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.
• 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.
• 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).

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study to Evaluate the Safety, Pharmacokinetics and Efficacy of IMG-007 in Adult Alopecia Areata Participants
• 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
• 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.
• Study Type: Interventional
• Study Phase: Phase 1; Phase 2
• Study Design: Allocation: Non-Randomized; Intervention Model: Sequential Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Alopecia Areata (AA)

Intervention

Drug: IMG-007

Intravenous Infusion

Study Arms

• Experimental: IMG-007 Dose 1
  IMG-007 Dose 1 will be administered intravenously 3 times over 4 weeks
  Intervention: Drug: IMG-007
• Experimental: IMG-007 Dose 2
  IMG-007 Dose 2 will be administered intravenously 3 times over 4 weeks
  Intervention: Drug: IMG-007

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Estimated Enrollment (submitted: September 27, 2023): 30
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: October 2024
• Estimated Primary Completion Date: October 2024 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada, United States

Administrative Information

• NCT Number: NCT06060977
• Other Study ID Numbers: IMG-007-202
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: Inmagene LLC
• Original Responsible Party: Same as current
• Current Study Sponsor: Inmagene LLC
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Inmagene LLC
• Verification Date: May 2024