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Clinical Trials/NCT03594227
NCT03594227CompletedPhase 2

A Randomized, Double-Blind, Placebo-Controlled Multicenter Study to Evaluate the Safety, Tolerability and Efficacy of ATI-501 Oral Suspension Compared to Placebo in Adult Subjects With Alopecia Areata, Alopecia Universalis or Alopecia Totalis

Aclaris Therapeutics, Inc.2 sites in 1 country87 target enrollmentStarted: June 11, 2018Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Completed
Enrollment
87
Locations
2
Primary Endpoint
Percent Change From Baseline in the Severity of Alopecia Tool (SALT) Score at Week 24
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Detailed Description

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. Subjects will be required to have a clinical diagnosis of stable AA, AU, or AT. A total of approximately 80 subjects will be randomized.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Other
Masking
Triple (Participant, Care Provider, Investigator)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •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.

Exclusion Criteria

  • •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).
  • •Plaquenil within 2 months of Baseline (Visit 2).
  • •Janus kinase (JAK) inhibitors (oral or topical) within 6 months of Baseline (Visit 2).
  • •Intralesional steroids or platelet rich plasma injections in the scalp within 1 month of Baseline (Visit 2).
  • •Topical treatments on the scalp with anthralin, bimatoprost, corticosteroids, diphencyprone, diphenylcyclopropenone (DPCP), squaric acid dibutylester (SADBE), minoxidil, pimecrolimus, or tacrolimus within 1 month of Baseline (Visit 2).
  • •Phototherapy (narrow band Ultraviolet B [NB UVB] or broadband therapy) within 4 weeks of Baseline (Visit 2).
  • •Participation in an investigational drug or device trial in which administration of an investigational drug or device occurred within 30 days or 5 half-lives (whichever is longer) of Baseline (Visit 2).
  • •Any condition possibly affecting oral drug absorption, e.g., gastrectomy, clinically significant diabetic gastroenteropathy, or certain types of bariatric surgery such as gastric bypass. Procedures such as gastric banding are not exclusionary.
  • •Unwillingness to refrain from weaves, hair extensions, or shaving of the scalp for at least two weeks prior to a study visit, at the discretion of the investigator, based on the ability to assess hair growth.
  • •Vaccination with a live or attenuated vaccine within 6 weeks prior to Baseline (Visit 2) or planned vaccination with these vaccines at any time during treatment or within 6 weeks following discontinuation of study medication.

Arms & Interventions

Placebo

Placebo Comparator

Placebo - oral administration

Intervention: Placebo (Drug)

400mg BID (Low dose)

Active Comparator

ATI-501 low dose - oral administration

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

600mg BID (Mid dose)

Active Comparator

ATI-501 mid dose - oral administration

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

800mg BID (High dose)

Active Comparator

ATI-501 high dose - oral administration

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

Outcomes

Primary Outcomes

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

Time Frame: Baseline-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.

Secondary Outcomes

  • Count of Subjects Achieving at Least a 50% Reduction in Alopecia Density and Extent (ALODEX) Score at Week 24(Baseline-Week 24)
  • Percent Change From Baseline in the Alopecia Density and Extent Score (ALODEX) at Week 24(Baseline-Week 24)
  • Mean Change From Baseline in the Alopecia Density and Extent (ALODEX) Score at Week 24(Baseline-Week 24)
  • Mean Change From Baseline in the Severity of Alopecia Tool (SALT) Score at Week 24(Baseline-Week 24)
  • Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Left Eyebrow(Baseline-Week 24)
  • Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Right Eyebrow(Baseline-Week 24)
  • Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Left Eyelash(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)
  • Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Right Eyelash(Baseline-Week 24)
  • Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Beard, Male Subjects(Baseline-Week 24)
  • Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Left Eyebrow(Baseline-Week 24)
  • Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Right Eyebrow(Baseline-Week 24)
  • Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Right Eyelash(Baseline-Week 24)
  • Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Left Eyelash(Baseline-Week 24)
  • Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Beard, Male Subjects(Baseline-Week 24)
  • Change From Baseline in the Subject Global Impression of Severity (SGIS) at Week 24, Patchy Alopecia Areata(Baseline-Week 24)
  • Change From Baseline in the Subject Global Impression of Severity (SGIS) at Week 24, Alopecia Universalis or Alopecia Totalis(Baseline-Week 24)
  • Change From Baseline in the Physician Global Impression of Severity (PhGIS) at Week 24, Patchy Alopecia Areata(Baseline-Week 24)
  • Change From Baseline in the Physician Global Impression of Severity (PhGIS) at Week 24, Alopecia Universalis or Alopecia Totalis(Baseline-Week 24)
  • Alopecia Impact Assessment (AIA) Patient Reported Outcome Change From Baseline at Week 24(Baseline-Week 24)
  • Subject Global Impression of Treatment Satisfaction (SGITS) at Week 24, Patchy Alopecia Areata(Baseline-Week 24)
  • Subject Global Impression of Treatment Satisfaction (SGITS) at Week 24, Alopecia Universalis or Alopecia Totalis(Baseline-Week 24)
  • Change From Baseline in the Subject Global Satisfaction With Hair Quality (SGSHQ) for Entire Scalp at Week 24, Patchy Alopecia Areata(Baseline-Week 24)
  • Change From Baseline in the Subject Global Satisfaction With Hair Quality (SGSHQ) for Entire Scalp at Week 24, Alopecia Universalis or Alopecia Totalis(Baseline-Week 24)
  • Change in Dermatology Life Quality Index Total Score (DLQI) Between Baseline and Week 24(Baseline-Week 24)
  • Subject Global Impression of Change (SGIC) at Week 24(Baseline-Week 24)
  • Physician Global Impression of Change (PhGIC) at Week 24(Baseline-Week 24)
  • Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Clinician Reported Outcome for Target Patch, Patchy Alopecia Areata(Baseline-Week 24)
  • Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Clinician Reported Outcome for Entire Scalp, All Patients(Baseline-Week 24)
  • Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Patient Reported Outcome for Target Patch, Patchy Alopecia Areata(Baseline-Week 24)
  • Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Patient Reported Outcome for Entire Scalp, All Patients(Baseline-Week 24)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (2)

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