ATI-501 Oral Suspension Compared to Placebo in Subjects With Alopecia Areata, Alopecia Universalis or Alopecia Totalis

NCT03594227 | Completed Phase 2 Results FDA Drug

• 1 other identifier: ATI-501-AUAT-201
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 25

Brief Summary

This Phase 2, multicenter, randomized study will evaluate the safety, tolerability and efficacy of ATI-501 for the treatment of Alopecia Areata (AA), Alopecia Universalis (AU) or Alopecia Totalis (AT) in adult subjects.

Conditions

Alopecia

Outcome Measures

Primary Outcomes (1)

• Percent Change From Baseline in the Severity of Alopecia Tool (SALT) Score at Week 24

  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. 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 by adding the percentage hair loss in the various areas (i.e. top, back, each side) of the scalp. The primary efficacy variable was the percent change from baseline in SALT score at Week 24. This was calculated as the mean of the changes from Baseline (Visit 2) SALT score to Week 24 (Visit 10) SALT score, divided by Baseline SALT score and expressed as a percentage.

  Baseline-Week 24

Secondary Outcomes (31)

• Percent Change From Baseline in the Alopecia Density and Extent Score (ALODEX) at Week 24

  Baseline-Week 24

• Mean Change From Baseline in the Severity of Alopecia Tool (SALT) Score at Week 24

  Baseline-Week 24

• Mean Change From Baseline in the Alopecia Density and Extent (ALODEX) Score at Week 24

  Baseline-Week 24

• Count of Subjects Achieving at Least a 50% Reduction in Alopecia Density and Extent (ALODEX) Score at Week 24

  Baseline-Week 24

• Count of Subjects in Each Treatment Arm Achieving at Least a 50% Reduction in Severity of Alopecia Tool (SALT) Score at Week 24 Compared to Baseline

  Baseline-Week 24

Study Arms (4)

400mg BID (Low dose)

ACTIVE COMPARATOR

ATI-501 low dose - oral administration

Drug: ATI-501 400mg BID (Low dose)

600mg BID (Mid dose)

ACTIVE COMPARATOR

ATI-501 mid dose - oral administration

Drug: ATI-501 600mg BID (Mid dose)

800mg BID (High dose)

ACTIVE COMPARATOR

ATI-501 high dose - oral administration

Drug: ATI-501 800mg BID (High dose)

Placebo

PLACEBO COMPARATOR

Placebo - oral administration

Drug: Placebo

Interventions

ATI-501 400mg BID (Low dose) DRUG

ATI-501 400mg BID oral low dose for oral administration

Also known as: Active comparator: Low dose

400mg BID (Low dose)

ATI-501 600mg BID (Mid dose) DRUG

ATI-501 600mg BID oral mid dose for oral administration

Also known as: Comparator : Mid dose

600mg BID (Mid dose)

ATI-501 800mg BID (High dose) DRUG

ATI-501 800mg BID high dose for oral administration

Also known as: Comparator: high dose - oral administration

800mg BID (High dose)

Placebo DRUG

Placebo - oral administration

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must meet the following criteria to be eligible for participation in the study:
• 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 Alopecia Areata (AA), Alopecia Universalis (AU), or Alopecia Totalis (AT).
• If the subject is a woman of childbearing potential (WOCBP), she must have:
• Negative urine and serum pregnancy tests at Screening (Visit 1); and
• A negative urine pregnancy test at Baseline (Visit 2); and
• Agree to not be planning a pregnancy during the study duration and use a highly effective method of contraception for the duration of the study and 30 days after the last dose of study medication. (Refer to Section 8.4.2).
• Be in good general health and free of any known disease state or physical condition which, in the investigator's opinion, might impair evaluation of the subject or which might expose the subject to an unacceptable risk by study participation.
• Be willing to maintain the same hair style and hair dyeing throughout the study period.
• Subjects taking hormonal replacement therapies must be on stable doses for 6 months prior to enrollment and remain on a maintenance dose throughout the study.
• Subjects taking thyroid replacement medication must be on stable doses for 6 months prior to enrollment and remain on a maintenance dose throughout the study.
• Sexually active male subjects whose partner is a WOCBP must agree to use a barrier method of contraception from the first dose of study medication to at least 30 days after the last dose of study medication.

You may not qualify if:

• Subjects are excluded from this study if any 1 or more of the following criteria is met:
• Females who are nursing, pregnant, or planning to become pregnant for the duration of the study and up to 30 days after the last dose of study medication.
• Diffuse AA or a history of an atypical pattern of AA.
• Concomitant hair loss disorder (by history or physical exam) such as androgenetic alopecia (AGA) or scarring alopecia.
• Active skin disease on the scalp or a history of skin disease on the scalp that in the opinion of the investigator would interfere with 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 AA, 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.
• History of, or current, severe, progressive or uncontrolled autoimmune, metabolic, hepatic, endocrine, renal, gastrointestinal, pulmonary, cardiovascular, genitourinary, or hematological disease, neurologic or cerebral disorders, or coagulation disorders that, as determined by the Investigator, would preclude participation in and completion of study assessments.
• History of, current or suspected systemic or cutaneous malignancy and /or lymphoproliferative disease, other than subjects with a history of adequately treated and well healed and completely cleared non-melanoma skin cancers (e.g. basal or squamous cell carcinoma) treated successfully at least 1 year prior to study entry with no evidence of disease.
• Evidence of active or latent bacterial (including tuberculosis) or viral infections at the time of enrollment, or history of incompletely treated or untreated tuberculosis. Subjects who have completed therapy for latent tuberculosis may participate.
• History of serious local infection (e.g., cellulitis, abscess) or systemic infection including but not limited to a history of treated infection (e.g., pneumonia, septicemia) within 3 months prior to Baseline. Subjects on an antibiotic for a nonserious, acute local infection must complete the course prior to enrollment into the study.
• Positive for HIV, Hepatitis B or C. Subjects with serologic evidence of Hepatitis B vaccination (HepB surface Ab without the presence of Hep B surface Ag will be allowed to participate).
• History of recurrent herpes zoster (more than one episode) or disseminated herpes zoster (a single episode) or disseminated herpes simplex (single episode) or cytomegalovirus (CMV) that resolved less than 2 months before study enrollment. Subjects with a history of frequent outbreaks of Herpes Simplex Virus (defined as 4 or more outbreaks a year).
• Subjects who have received any of the following treatments for the timeframes specified below:
• Disease Modifying Anti-Rheumatic Drugs (DMARDS), Biologics or immunosuppressants, including but not limited to: anakinra, adalimumab, azathioprine, corticosteroids, cyclosporine, etanercept, infliximab, methotrexate, TNF inhibitors, ustekinumab within 1 month or 5 half-lives (whichever is greater) of Baseline (Visit 2).

Sponsors & Collaborators

• Aclaris Therapeutics, Inc.: lead

Study Sites (25)

Aclaris Investigator Site

Hot Springs, Arkansas, 71913, United States

Location

Aclaris Investigator Site

Rogers, Arkansas, 72758, United States

Location

Aclaris Investigator Site

Denver, Colorado, 80210, United States

Location

Aclaris Investigator Site

Boynton Beach, Florida, 33472, United States

Location

Aclaris Investigator Site

Miami, Florida, 33137, United States

Location

Aclaris Investigator Site

Sanford, Florida, 32771, United States

Location

Aclaris Investigator Site

Snellville, Georgia, 30078, United States

Location

Aclaris Investigator Site

Clinton Township, Michigan, 48038, United States

Location

Aclaris Investigator Site

Detroit, Michigan, 48202, United States

Location

Aclaris Investigator Site

Fridley, Minnesota, 55432, United States

Location

Aclaris Investigator Site

Minneapolis, Minnesota, 55455, United States

Location

Aclaris Investigator Site

Saint Joseph, Missouri, 64506, United States

Location

Aclaris Investigator Site

Omaha, Nebraska, 68144, United States

Location

Aclaris Investigator Site

Las Vegas, Nevada, 89148, United States

Location

Aclaris Investigator Site

New York, New York, 10075, United States

Location

Aclaris Investigator Site

Rochester, New York, 14623, United States

Location

Aclaris Investigator Site

Portland, Oregon, 97223, United States

Location

Aclaris Investigator Site

Greenville, South Carolina, 29607, United States

Location

Aclaris Investigator Site

Knoxville, Tennessee, 37922, United States

Location

Aclaris Investigator Site

Nashville, Tennessee, 37215, United States

Location

Aclaris Investigational Site

Austin, Texas, 78745, United States

Location

Aclaris Investigator Site

Houston, Texas, 77056, United States

Location

Aclaris Investigator Site

San Antonio, Texas, 78213, United States

Location

Aclaris Investigator Site

Lynchburg, Virginia, 24501, United States

Location

Aclaris Investigator Site

Norfolk, Virginia, 23502, United States

Location

MeSH Terms

Conditions

Alopecia

Interventions

BID protein, human; Administration, Oral

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Results Point of Contact

• Title: Marco Cardillo, Clinical Trial Manager
• Organization: Aclaris Therapeutics, Inc.

mcardillo@aclaristx.com

484-540-6299

Study Officials

• Susan Moran, RN

  Aclaris Therapeutics

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2018
• First Posted: July 20, 2018
• Study Start: June 11, 2018
• Primary Completion: June 6, 2019
• Study Completion: June 18, 2019
• Last Updated: September 16, 2020
• Results First Posted: September 16, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (25)