Clinical trial NCT03315689: Safety and Pharmacokinetic Study of ATI-50002 in Subjects With Alopecia Universalis (AU) and Alopecia Totalis (AT)
Official title: A Randomized, Double-blind, Vehicle-controlled Multicenter Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of ATI-50002 Topical Solution Administered Twice-Daily for 28 Days in Adult Subjects With Alopecia Universalis and Alopecia Totalis With a 12-Month Long-Term Open-Label Extension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alopecia Universalis (AU)
Alopecia Totalis (AT)
Lead sponsor: Aclaris Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2017-10-20
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Double Blind Period: ATI-50002 Levels in Scalp Biopsy (ng/g) - Pharmacodynamic (PD) Population at Day 2 and Day 29
timeFrame: Day 2 - Day 29
Secondary outcomes:
measure: Open Label Extension: Mean Change From Baseline in the Severity of Alopecia Tool (SALT) Score at Week 52
timeFrame: Baseline - Week 52
measure: Open Label Extension: Mean Change From Baseline in the Severity of Alopecia Tool (SALT) Score at Week 40
timeFrame: Baseline - Week 40
measure: Open Label Extension: Mean Change From Baseline in the Severity of Alopecia Tool (SALT) Score at Week 28
timeFrame: Baseline - Week 28
measure: Open Label Extension: Change From Baseline in Alopecia Density and Extent Score (ALODEX) at Week 28
timeFrame: Baseline - Week 28
measure: Open Label Extension: Change From Baseline in Alopecia Density and Extent Score (ALODEX) at Week 40
timeFrame: Baseline - Week 40
measure: Open Label Extension: Change From Baseline in Alopecia Density and Extent Score (ALODEX) at Week 52
timeFrame: Baseline - Week 52
measure: Open Label Extension: Mean Change in Subject's Eyebrow Assessment (SEA) at Week 28
timeFrame: Week 4 - Week 28
measure: Open Label Extension: Mean Change in Subject's Eyebrow Assessment (SEA) at Week 40
timeFrame: Week 4 - Week 40
measure: Open Label Extension: Mean Change in Subject's Eyebrow Assessment (SEA) at Week 52
timeFrame: Week 4 - Week 52
measure: Open Label Extension: Mean Change in Clinician's Eyebrow Assessment (CEA) at Week 28
timeFrame: Week 4 - Week 28
measure: Open Label Extension: Mean Change in Clinician's Eyebrow Assessment (CEA) at Week 40
timeFrame: Week 4 - Week 40
measure: Open Label Extension: Mean Change in Clinician's Eyebrow Assessment (CEA) at Week 52
timeFrame: Week 4 - Week 52
measure: Open Label Extension: Subject Global Impression of Treatment Satisfaction (SGIS) Week 28
timeFrame: Week 28
measure: Open Label Extension: Subject Global Impression of Treatment Satisfaction (SGIS) Week 40
timeFrame: Week 40
measure: Open Label Extension: Subject Global Impression of Treatment Satisfaction (SGIS) Week 52
timeFrame: Week 52
measure: Open Label Extension: Severity of Alopecia Tool (SALT) Scores, Relative Percent Regrowth (%) at Week 24 From Baseline
timeFrame: Baseline - Week 24
measure: Open Label Extension: Severity of Alopecia Tool (SALT Scores), Relative Percent Regrowth (%) at Week 40 From Baseline
timeFrame: Baseline - Week 40
measure: Open Label Extension: The Severity of Alopecia Tool (SALT) Scores, Relative Percent Regrowth (%) at Week 52 From Baseline
timeFrame: Baseline - Week 52
measure: Open Label Extension: The Alopecia Density and Extent (ALODEX) Scores, Relative Percent Regrowth (%) at 24 Weeks
timeFrame: Baseline - Week 24
measure: Open Label Extension: The Alopecia Density and Extent (ALODEX) Scores, Relative Percent Regrowth (%) at 40 Weeks
timeFrame: Baseline - Week 40
measure: Open Label Extension: The Alopecia Density and Extent (ALODEX) Scores, Relative Percent Regrowth (%) at 52 Weeks
timeFrame: Baseline - Week 52
Other outcomes:
Locations:
city: New York
country: United States
facility: Aclaris Investigational Site
state: New York
city: New York
country: United States
facility: Aclaris Investigational Site
state: New York
Study officials:
References: