Alopecia Areata (AA)
Conditions
Keywords
IMG-007, Alopecia Areata, Alopecia, Hair Loss, Skin Disease, Immune System Disorder, Dermatologic Agents
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.
Interventions
DRUGIMG-007
Intravenous Infusion
Sponsors
Inmagene LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of Adverse Events in Participants | Adverse events were collected from baseline through the end of the study, a period of up to 24 weeks. | To evaluate adverse events (AEs) emergent from multiple doses of IMG-007 in adult participants with AA. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of Severity of Alopecia Tool (SALT) | Mean percent change from baseline in Severity of ALopecia Tool (SALT) at week 24. | To evaluate the efficacy of multiple doses of IMG-007 in AA participants as measured by the Severity of Alopecia Tool (SALT). The Severity of Alopecia Tool (SALT) is a quantitative assessment of AA severity by the investigator based on scalp terminal hair loss. 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). |
Countries
Canada, United States
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 29 Participants |
| Age, Continuous | 42.2 years STANDARD_DEVIATION 15.51 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Severity of ALopecia Tool (SALT) Score | 78.63 units on a scale STANDARD_DEVIATION 18.401 |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 23 |
| other Total, other adverse events | 2 / 6 | 8 / 23 |
| serious Total, serious adverse events | 0 / 6 | 0 / 23 |
Outcome results
None listed