Safety and Pharmacokinetic Study of ATI-50002 in Subjects With Alopecia Universalis (AU) and Alopecia Totalis (AT)

Aclaris Therapeutics, Inc.11 enrolled

Overview

The primary objective is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of ATI-50002 Topical Solution compared to vehicle in subjects with AU and AT.

This study is designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of ATI-50002 Topical Solution in patients with Alopecia Universalis and Alopecia Totalis. Concentrations of ATI-50002 in the blood and skin will be assessed after 28 days of treatment with ATI-50002 Topical Solution.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Alopecia Universalis (AU)Alopecia Totalis (AT)

Interventions

VehicleDRUG

Vehicle Topical Solution

ATI-50002DRUG

ATI-50002 Topical Solution

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Able to comprehend and willing to sign an Informed Consent Form (ICF). * Male or non-pregnant, non-nursing female ≥18 years old at the time of informed consent. * Have a clinical diagnosis of stable, clinically typical, AU or AT. * Have a duration of the current episode of AU or AT for a minimum of 6 months and a maximum of seven years. * Be willing and able to follow all study instructions and to attend all study visits. Exclusion Criteria: * Females who are nursing, pregnant, or planning to become pregnant for the duration of the study including 30 days after the last application of study medication. * Patchy alopecia areata, diffuse alopecia areata or a history of an atypical pattern of Alopecia Areata (AA) (e.g., ophiasis, sisaihpo). * Active skin disease on the scalp (such as psoriasis or seborrheic dermatitis) or a history of skin disease on the scalp that in the opinion of the investigator would interfere with the study assessments of efficacy or safety. * Active scalp trauma or other condition affecting the scalp that, in the investigator's opinion, may affect the course of AU or AT or interfere with the study conduct or evaluations. * The presence of a permanent or difficult to remove hairpiece or wig that will, in the opinion of the investigator, interfere with study assessments if not removed at each visit.

Locations (2)

Aclaris Investigational Site

New York, New York, United States

Aclaris Investigational Site

New York, New York, United States

Outcomes

Primary Outcomes

Double Blind Period: ATI-50002 Levels in Scalp Biopsy (ng/g) - Pharmacodynamic (PD) Population at Day 2 and Day 29

ATI-50002 levels in scalp biopsies taken at Visits 3 (Day 2) and 7 (Day 29).

Time frame: Day 2 - Day 29

Secondary Outcomes

Open Label Extension: Mean Change From Baseline in the Severity of Alopecia Tool (SALT) Score at Week 52

The Severity of Alopecia Tool (SALT) score is a physician administered scale measuring the amount of scalp without any terminal hair. Possible scores range from 0 (no scalp hair loss) to 100 (complete scalp hair loss). A negative change in the SALT score over time represents hair regrowth.

Time frame: Baseline - Week 52

Open Label Extension: Mean Change From Baseline in the Severity of Alopecia Tool (SALT) Score at Week 40

Time frame: Baseline - Week 40

Open Label Extension: Mean Change From Baseline in the Severity of Alopecia Tool (SALT) Score at Week 28

Time frame: Baseline - Week 28

Open Label Extension: Change From Baseline in Alopecia Density and Extent Score (ALODEX) at Week 28

The Alopecia Density and Extent (ALODEX) score is a measurement of the amount of scalp with terminal hair loss assessed by the investigator. ALODEX breaks the scalp up into a grid of 1% scalp surface areas and assigns density rating in each area on a 10 point scale of hair loss (0= no hair loss to 10 = complete baldness). Summation of scores from each 1% scalp surface area provides an overall score which may range from 0 (no scalp hair loss) to 100 (complete baldness). A negative change in the ALODEX score over time represents hair regrowth.

Data from ClinicalTrials.gov

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Time frame: Baseline - Week 28

Open Label Extension: Change From Baseline in Alopecia Density and Extent Score (ALODEX) at Week 40

Time frame: Baseline - Week 40

Open Label Extension: Change From Baseline in Alopecia Density and Extent Score (ALODEX) at Week 52

Time frame: Baseline - Week 52

Open Label Extension: Mean Change in Subject's Eyebrow Assessment (SEA) at Week 28

The Subject Eyebrow Assessment (SEA) is the subject's assessment of the appearance of eyebrow hair present on the affected eyebrow(s) at a particular point in time. The SEA is a five-point VRS ranging from "0 - No eyebrow hair", "1 - A little eyebrow hair", "2 - Some eyebrow hair", "3 - Most eyebrow hair", and "4 - Full eyebrow hair" with a recall period of "right now". A positive change over time represents eyebrow regrowth (better outcome).

Time frame: Week 4 - Week 28

Open Label Extension: Mean Change in Subject's Eyebrow Assessment (SEA) at Week 40

Time frame: Week 4 - Week 40

Open Label Extension: Mean Change in Subject's Eyebrow Assessment (SEA) at Week 52

Time frame: Week 4 - Week 52

Open Label Extension: Mean Change in Clinician's Eyebrow Assessment (CEA) at Week 28

The Clinician's Eyebrow Assessment (CEA) is the investigator's assessment of the appearance of eyebrow hair present on the affected eyebrow(s) at a particular point in time. The CEA is a five-point VRS ranging from "0 - No eyebrow hair", "1 - A little eyebrow hair", "2 - Some eyebrow hair", "3 - Most eyebrow hair", and "4 - Full eyebrow hair" with a recall period of "right now". A positive change over time represents eyebrow regrowth (better outcome).

Time frame: Week 4 - Week 28

Open Label Extension: Mean Change in Clinician's Eyebrow Assessment (CEA) at Week 40

Time frame: Week 4 - Week 40

Open Label Extension: Mean Change in Clinician's Eyebrow Assessment (CEA) at Week 52

Time frame: Week 4 - Week 52

Open Label Extension: Subject Global Impression of Treatment Satisfaction (SGIS) Week 28

The Subject Global Impression of Treatment Satisfaction (SGIS) is a 7-point descriptive scale with a recall period of "right now". The SGIS was completed by subjects during the Open Label period of the study. Scale response options ranged from "1: Extremely Satisfied", "2: Moderately Satisfied", "3: A little Satisfied", "4: Neither Satisfied or Dissatisfied", "5: A little Dissatisfied", "6: Moderately Dissatisfied", or "7: Extremely Dissatisfied" and are used to capture how satisfied or dissatisfied subjects are with the study medication treatment received for their alopecia areata.

Time frame: Week 28

Open Label Extension: Subject Global Impression of Treatment Satisfaction (SGIS) Week 40

Time frame: Week 40

Open Label Extension: Subject Global Impression of Treatment Satisfaction (SGIS) Week 52

Time frame: Week 52

Open Label Extension: Severity of Alopecia Tool (SALT) Scores, Relative Percent Regrowth (%) at Week 24 From Baseline

The Severity of Alopecia Tool (SALT) score is a physician administered scale measuring the amount of scalp without any terminal hair assessed by the investigator. A positive percent change over time represents hair regrowth (better outcome).

Time frame: Baseline - Week 24

Open Label Extension: Severity of Alopecia Tool (SALT Scores), Relative Percent Regrowth (%) at Week 40 From Baseline

Time frame: Baseline - Week 40

Open Label Extension: The Severity of Alopecia Tool (SALT) Scores, Relative Percent Regrowth (%) at Week 52 From Baseline

Time frame: Baseline - Week 52

Open Label Extension: The Alopecia Density and Extent (ALODEX) Scores, Relative Percent Regrowth (%) at 24 Weeks

The Alopecia Density and Extent (ALODEX) score is a measurement of the amount of scalp with terminal hair loss assessed by the investigator. ALODEX breaks the scalp up into a grid of 1% scalp surface areas and assigns density rating in each area on a 10 point scale of hair loss (0= no hair loss to 10 = complete baldness). Summation of scores from each 1% scalp surface area provides an overall score which may range from 0 (no scalp hair loss) to 100 (complete baldness). A positive percent change over time represents hair regrowth (better outcome).

Time frame: Baseline - Week 24

Open Label Extension: The Alopecia Density and Extent (ALODEX) Scores, Relative Percent Regrowth (%) at 40 Weeks

The Alopecia Density and Extent (ALODEX) score is a measurement of the amount of scalp with terminal hair loss assessed by the investigator at Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24. ALODEX breaks the scalp up into a grid of 1% scalp surface areas and assigns density rating in each area on a 10 point scale of hair loss (0= no hair loss to 10 = complete baldness). Summation of scores from each 1% scalp surface area provides an overall score which may range from 0 (no scalp hair loss) to 100 (complete baldness). A positive percent change over time represents hair regrowth (better outcome).

Time frame: Baseline - Week 40

Open Label Extension: The Alopecia Density and Extent (ALODEX) Scores, Relative Percent Regrowth (%) at 52 Weeks

The Alopecia Density and Extent (ALODEX) score is a measurement of the amount of scalp with terminal hair loss assessed by the investigator. ALODEX breaks the scalp up into a grid of 1% scalp surface areas and assigns density rating in each area on a 10 point scale of hair loss (0= no hair loss to 10 = complete baldness). Summation of scores from each 1% scalp surface area provides an overall score which may range from 0 (no scalp hair loss) to 100 (complete baldness). A positive percent change over time represents hair regrowth (better outcome).

Time frame: Baseline - Week 52