NCT03315689

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Dec 2017

Shorter than P25 for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 17, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 20, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

December 14, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2019

Completed
1 year until next milestone

Results Posted

Study results publicly available

July 2, 2020

Completed
Last Updated

July 2, 2020

Status Verified

June 1, 2020

Enrollment Period

1.5 years

First QC Date

October 17, 2017

Results QC Date

May 29, 2020

Last Update Submit

June 18, 2020

Conditions

Alopecia Universalis (AU)Alopecia Totalis (AT)

Outcome Measures

Primary Outcomes (1)

  • 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).

    Day 2 - Day 29

Secondary Outcomes (21)

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

    Baseline - Week 52

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

    Baseline - Week 40

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

    Baseline - Week 28

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

    Baseline - Week 28

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

    Baseline - Week 40

  • +16 more secondary outcomes

Study Arms (2)

Vehicle

PLACEBO COMPARATOR

Vehicle

Drug: Vehicle

Active

EXPERIMENTAL

ATI-50002 Topical Solution

Drug: ATI-50002

Interventions

VehicleDRUG

Vehicle Topical Solution

Vehicle
ATI-50002DRUG

ATI-50002 Topical Solution

Active

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Aclaris Investigational Site

New York, New York, 10032, United States

Location

Aclaris Investigational Site

New York, New York, 10075, United States

Location

MeSH Terms

Conditions

Alopecia universalis

Results Point of Contact

Title
Marco Cardillo, Clinical Trial Manager
Organization
Aclaris Therapeutics, Inc.
mcardillo@aclaristx.com
484-540-6299

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 17, 2017

First Posted

October 20, 2017

Study Start

December 14, 2017

Primary Completion

June 20, 2019

Study Completion

June 20, 2019

Last Updated

July 2, 2020

Results First Posted

July 2, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations

US(2)