ATI-501 Oral Suspension Compared to Placebo in Subjects With Alopecia Areata, Alopecia Universalis or Alopecia Totalis
NCT ID: NCT03594227
Last Updated: 2020-09-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
87 participants
INTERVENTIONAL
2018-06-11
2019-06-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
TRIPLE
Study Groups
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400mg BID (Low dose)
ATI-501 low dose - oral administration
ATI-501 400mg BID (Low dose)
ATI-501 400mg BID oral low dose for oral administration
600mg BID (Mid dose)
ATI-501 mid dose - oral administration
ATI-501 600mg BID (Mid dose)
ATI-501 600mg BID oral mid dose for oral administration
800mg BID (High dose)
ATI-501 high dose - oral administration
ATI-501 800mg BID (High dose)
ATI-501 800mg BID high dose for oral administration
Placebo
Placebo - oral administration
Placebo
Placebo - oral administration
Interventions
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ATI-501 400mg BID (Low dose)
ATI-501 400mg BID oral low dose for oral administration
ATI-501 600mg BID (Mid dose)
ATI-501 600mg BID oral mid dose for oral administration
ATI-501 800mg BID (High dose)
ATI-501 800mg BID high dose for oral administration
Placebo
Placebo - oral administration
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. Able to comprehend and willing to sign an Informed Consent Form (ICF).
2. Male or non-pregnant, non-nursing female ≥ 18 years old at the time of informed consent.
3. Have a clinical diagnosis of stable Alopecia Areata (AA), Alopecia Universalis (AU), or Alopecia Totalis (AT).
4. 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).
5. 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.
6. Be willing to maintain the same hair style and hair dyeing throughout the study period.
7. 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.
8. 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.
9. 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
1. 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.
2. Diffuse AA or a history of an atypical pattern of AA.
3. Concomitant hair loss disorder (by history or physical exam) such as androgenetic alopecia (AGA) or scarring alopecia.
4. 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.
5. 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.
6. 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.
7. 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.
8. 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.
9. 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.
10. 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.
11. 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).
12. 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).
13. 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).
14. 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).
15. 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.
16. 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.
17. 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.
18 Years
ALL
Yes
Sponsors
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Aclaris Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Susan Moran, RN
Role: STUDY_CHAIR
Aclaris Therapeutics
Locations
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Aclaris Investigator Site
Hot Springs, Arkansas, United States
Aclaris Investigator Site
Rogers, Arkansas, United States
Aclaris Investigator Site
Denver, Colorado, United States
Aclaris Investigator Site
Boynton Beach, Florida, United States
Aclaris Investigator Site
Miami, Florida, United States
Aclaris Investigator Site
Sanford, Florida, United States
Aclaris Investigator Site
Snellville, Georgia, United States
Aclaris Investigator Site
Clinton Township, Michigan, United States
Aclaris Investigator Site
Detroit, Michigan, United States
Aclaris Investigator Site
Fridley, Minnesota, United States
Aclaris Investigator Site
Minneapolis, Minnesota, United States
Aclaris Investigator Site
Saint Joseph, Missouri, United States
Aclaris Investigator Site
Omaha, Nebraska, United States
Aclaris Investigator Site
Las Vegas, Nevada, United States
Aclaris Investigator Site
New York, New York, United States
Aclaris Investigator Site
Rochester, New York, United States
Aclaris Investigator Site
Portland, Oregon, United States
Aclaris Investigator Site
Greenville, South Carolina, United States
Aclaris Investigator Site
Knoxville, Tennessee, United States
Aclaris Investigator Site
Nashville, Tennessee, United States
Aclaris Investigational Site
Austin, Texas, United States
Aclaris Investigator Site
Houston, Texas, United States
Aclaris Investigator Site
San Antonio, Texas, United States
Aclaris Investigator Site
Lynchburg, Virginia, United States
Aclaris Investigator Site
Norfolk, Virginia, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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ATI-501-AUAT-201
Identifier Type: -
Identifier Source: org_study_id
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