Clinical trial NCT06060977: 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
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Alopecia Areata (AA)
Keywords: IMG-007
Alopecia Areata
Alopecia
Hair Loss
Skin Disease
Immune System Disorder
Dermatologic Agents
Lead sponsor: Inmagene LLC
Sponsor class: INDUSTRY
First posted: 2023-09-29
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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 a 20-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.

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.

Primary outcomes:
measure: Evaluation of Adverse Events in Participants
timeFrame: Baseline, Week 24
Secondary outcomes:
measure: Evaluation of Severity of Alopecia Tool (SALT)
timeFrame: Baseline, Week 24
Other outcomes:
Locations:
city: Rogers
country: United States
facility: Northwest Arkansas Clinical Trials Center, PLLC/ Hull Dermatology P.A.
state: Arkansas
city: Lomita
country: United States
facility: Torrance Clinical Research Institute Inc.
state: California
city: Tampa
country: United States
facility: Alliance Clinical Research of Tampa
state: Florida
city: Indianapolis
country: United States
facility: Dawes Fretzin Clinical Resarch Group, LLC
state: Indiana
city: West Lafayette
country: United States
facility: Options Research Group
state: Indiana
city: Burlington
country: United States
facility: Lahey Hospital & Medical Center
state: Massachusetts
city: Bay City
country: United States
facility: Great Lakes Research Group Inc.
state: Michigan
city: Reno
country: United States
facility: Skin Cancer and Dermatology Institute
state: Nevada
city: Rochester
country: United States
facility: Skin Search of Rochester, Inc.
state: New York
city: Sugar Land
country: United States
facility: Stride Clinical Research LLC
state: Texas
city: Spokane
country: United States
facility: Dermatology Specialists of Spokane
state: Washington
city: Barrie
country: Canada
facility: SimcoMed Health Ltd.
state: Ontario
city: Cobourg
country: Canada
facility: Skin Health
state: Ontario
city: Guelph
country: Canada
facility: Guelph Dermatology Research
state: Ontario
city: Toronto
country: Canada
facility: Research Toronto
state: Ontario
city: Québec
country: Canada
facility: Centre de Recherche Saint-Louis
state: Quebec
city: Montréal
country: Canada
facility: Innovaderm Research Inc.
Study officials:
References: