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

Primary Purpose

Alopecia Areata (AA)

Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
IMG-007
Sponsored by
Inmagene LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arm Type

Experimental

Experimental

Arm Label

IMG-007 Dose 1

IMG-007 Dose 2

Arm Description

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

Outcomes

Primary Outcome Measures

Evaluation of Adverse Events in Participants
To evaluate adverse events (AEs) emergent from multiple doses of IMG-007 in adult participants with AA.

Secondary Outcome Measures

Pharmacokinetic characterization
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
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)
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).

Full Information

First Posted
September 21, 2023
Last Updated
October 23, 2023
Sponsor
Inmagene LLC
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1. Study Identification

Unique Protocol Identification Number
NCT06060977
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 25, 2023 (Actual)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
October 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Inmagene LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alopecia Areata (AA)
Keywords
IMG-007, Alopecia Areata, Alopecia, Hair Loss, Skin Disease, Immune System Disorder, Dermatologic Agents

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
IMG-007 Dose 1
Arm Type
Experimental
Arm Description
IMG-007 Dose 1 will be administered intravenously 3 times over 4 weeks
Arm Title
IMG-007 Dose 2
Arm Type
Experimental
Arm Description
IMG-007 Dose 2 will be administered intravenously 3 times over 4 weeks
Intervention Type
Drug
Intervention Name(s)
IMG-007
Intervention Description
Intravenous Infusion
Primary Outcome Measure Information:
Title
Evaluation of Adverse Events in Participants
Description
To evaluate adverse events (AEs) emergent from multiple doses of IMG-007 in adult participants with AA.
Time Frame
Baseline, Week 24
Secondary Outcome Measure Information:
Title
Pharmacokinetic characterization
Description
To characterize the pharmacokinetic (PK) profile of multiple doses of IMG-007 in terms of the central compartment clearance (CL) in AA participants.
Time Frame
Baseline, Week 24
Title
Pharmacokinetic characterization
Description
To characterize the pharmacokinetic (PK) profile of multiple doses of IMG-007 in terms of the central compartment volume (Vc) in AA participants.
Time Frame
Baseline, Week 24
Title
Evaluation of Severity of Alopecia Tool (SALT)
Description
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).
Time Frame
Baseline, Week 16

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Duong Nguyen
Phone
858-346-7751
Email
nguyend@inmagenebio.com
Facility Information:
Facility Name
Torrance Clinical Research Institute Inc.
City
Lomita
State/Province
California
ZIP/Postal Code
90717
Country
United States
Individual Site Status
Recruiting
Facility Name
Dawes Fretzin Clinical Resarch Group, LLC
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
47906
Country
United States
Individual Site Status
Recruiting
Facility Name
Options Research Group
City
West Lafayette
State/Province
Indiana
ZIP/Postal Code
47906
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Stride Clinical Research LLC
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77479
Country
United States
Individual Site Status
Recruiting
Facility Name
Skin Health
City
Cobourg
State/Province
Ontario
ZIP/Postal Code
K9A0Z4
Country
Canada
Individual Site Status
Recruiting
Facility Name
Guelph Dermatology Research
City
Guelph
State/Province
Ontario
ZIP/Postal Code
N1L0B7
Country
Canada
Individual Site Status
Not yet recruiting
Facility Name
Research Toronto
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M2W2N4
Country
Canada
Individual Site Status
Not yet recruiting
Facility Name
Centre de Recherche Saint-Louis
City
Québec
State/Province
Quebec
ZIP/Postal Code
G1W4R4
Country
Canada
Individual Site Status
Recruiting
Facility Name
Innovaderm Research Inc.
City
Montréal
Country
Canada
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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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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