AlopeciaPhase 2NCT03594227
ATI-501 Oral Suspension Compared to Placebo in Subjects With Alopecia Areata, Alopecia Universalis or Alopecia Totalis
A Phase 2 study testing ATI-501 400mg BID (Low dose), ATI-501 600mg BID (Mid dose) and ATI-501 800mg BID (High dose) in people with Alopecia, run by Aclaris Therapeutics, Inc. at 25 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alopecia
- What is being tested?
- ATI-501 400mg BID (Low dose), ATI-501 600mg BID (Mid dose) and ATI-501 800mg BID (High dose)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 87 participants
- Where
- 25 sitesUnited States
- Study dates
- 11 Jun 2018to 18 Jun 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
United States25 sites
Aclaris Investigational Site
Austin, Texas, 78745
Aclaris Investigator Site
Boynton Beach, Florida, 33472
Aclaris Investigator Site
Clinton Township, Michigan, 48038
Aclaris Investigator Site
Denver, Colorado, 80210
Aclaris Investigator Site
Detroit, Michigan, 48202
Aclaris Investigator Site
Fridley, Minnesota, 55432
Aclaris Investigator Site
Greenville, South Carolina, 29607
Aclaris Investigator Site
Hot Springs, Arkansas, 71913
Aclaris Investigator Site
Houston, Texas, 77056
Aclaris Investigator Site
Knoxville, Tennessee, 37922
Aclaris Investigator Site
Las Vegas, Nevada, 89148
Aclaris Investigator Site
Lynchburg, Virginia, 24501
Aclaris Investigator Site
Miami, Florida, 33137
Aclaris Investigator Site
Minneapolis, Minnesota, 55455
Aclaris Investigator Site
Nashville, Tennessee, 37215
Aclaris Investigator Site
New York, New York, 10075
Aclaris Investigator Site
Norfolk, Virginia, 23502
Aclaris Investigator Site
Omaha, Nebraska, 68144
Aclaris Investigator Site
Portland, Oregon, 97223
Aclaris Investigator Site
Rochester, New York, 14623
Aclaris Investigator Site
Rogers, Arkansas, 72758
Aclaris Investigator Site
Saint Joseph, Missouri, 64506
Aclaris Investigator Site
San Antonio, Texas, 78213
Aclaris Investigator Site
Sanford, Florida, 32771
Aclaris Investigator Site
Snellville, Georgia, 30078
About this study
Official title: 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
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.
Read the 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.
- Conditions
- Alopecia
- Being tested
- ATI-501 400mg BID (Low dose), ATI-501 600mg BID (Mid dose), ATI-501 800mg BID (High dose), Placebo
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATI-501 400mg BID (Low dose)Drug
Also called Active comparator: Low dose
ATI-501 400mg BID oral low dose for oral administration
ATI-501 600mg BID (Mid dose)Drug
Also called Comparator : Mid dose
ATI-501 600mg BID oral mid dose for oral administration
ATI-501 800mg BID (High dose)Drug
Also called Comparator: high dose - oral administration
ATI-501 800mg BID high dose for oral administration
PlaceboDrug
Placebo - oral administration
| Study group | Role | What they receive |
|---|---|---|
| 400mg BID (Low dose) | Active comparator | ATI-501 low dose - oral administration Receives: Drug: ATI-501 400mg BID (Low dose) |
| 600mg BID (Mid dose) | Active comparator | ATI-501 mid dose - oral administration Receives: Drug: ATI-501 600mg BID (Mid dose) |
| 800mg BID (High dose) | Active comparator | ATI-501 high dose - oral administration Receives: Drug: ATI-501 800mg BID (High dose) |
| Placebo | Placebo comparator | Placebo - oral administration Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline-Week 24
Secondary outcomes (31)
Percent Change From Baseline in the Alopecia Density and Extent Score (ALODEX) at Week 24
The Alopecia Density and Extent (ALODEX) score is a measurement of the amount of scalp with terminal hair loss assessed by the investigator at Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24. ALODEX breaks the scalp up into a grid of 1% scalp surface areas and assigns density rating in each area on a 10 point scale of hair loss (0= no hair loss to 10 = complete baldness). Summation of scores from each 1% scalp surface area provides an overall score which may range from 0 (no scalp hair loss) to 100 (complete baldness). A negative change in the ALODEX score over time represents hair regrowth.
Measured: Baseline-Week 24
Mean 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.
Measured: Baseline-Week 24
Mean Change From Baseline in the Alopecia Density and Extent (ALODEX) Score at Week 24
The Alopecia Density and Extent (ALODEX) score is a measurement of the amount of scalp with terminal hair loss assessed by the investigator. ALODEX breaks the scalp up into a grid of 1% scalp surface areas and assigns density rating in each area on a 10 point scale of hair loss (0= no hair loss to 10 = complete baldness). Summation of scores from each 1% scalp surface area provides an overall score which may range from 0 (no scalp hair loss) to 100 (complete baldness). A negative change in the ALODEX score over time represents hair regrowth.
Measured: Baseline-Week 24
Count of Subjects Achieving at Least a 50% Reduction in Alopecia Density and Extent (ALODEX) Score at Week 24
The Alopecia Density and Extent (ALODEX) score is a measurement of the amount of scalp with terminal hair loss assessed by the investigator. ALODEX breaks the scalp up into a grid of 1% scalp surface areas and assigns density rating in each area on a 10 point scale of hair loss (0= no hair loss to 10 = complete baldness). Summation of scores from each 1% scalp surface area provides an overall score which may range from 0 (no scalp hair loss) to 100 (complete baldness). A negative change in the ALODEX score over time represents hair regrowth.
Measured: 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
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.
Measured: Baseline-Week 24
Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Left Eyebrow
The Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome is the investigator's assessment of the subject's facial hair (eyebrow(s), eyelashes,and if male, beard) at a particular point in time. The investigator was instructed to NOT refer to any other assessments to assist with these assessments. The investigator or designee assessed the affected facial hair areas (eyebrows, eyelashes and if male, beard) using a 5 point scale for each target area [1-Full (Target Area Hair); 2-Most (Target Area Hair); 3-Some (Target Area Hair); 4-A Little (Target Area Hair); 5-No (Target Area Hair)]. Change status is categorized as 'Better by x points' when the score decreases from baseline by x points, and as 'Worse by x points' when the score increases by x points.
Measured: Baseline-Week 24
Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Right Eyebrow
The Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome is the investigator's assessment of the subject's facial hair (eyebrow(s), eyelashes,and if male, beard) at a particular point in time. The investigator was instructed to NOT refer to any other assessments to assist with these assessments. The investigator or designee assessed the affected facial hair areas (eyebrows, eyelashes and if male, beard) using a 5 point scale for each target area [1-Full (Target Area Hair); 2-Most (Target Area Hair); 3-Some (Target Area Hair); 4-A Little (Target Area Hair); 5-No (Target Area Hair)]. Change status is categorized as 'Better by x points' when the score decreases from baseline by x points, and as 'Worse by x points' when the score increases by x points.
Measured: Baseline-Week 24
Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Left Eyelash
The Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome is the investigator's assessment of the subject's facial hair (eyebrow(s), eyelashes,and if male, beard) at a particular point in time. The investigator was instructed to NOT refer to any other assessments to assist with these assessments. The investigator or designee assessed the affected facial hair areas (eyebrows, eyelashes and if male, beard) using a 5 point scale for each target area [1-Full (Target Area Hair); 2-Most (Target Area Hair); 3-Some (Target Area Hair); 4-A Little (Target Area Hair); 5-No (Target Area Hair)]. Change status is categorized as 'Better by x points' when the score decreases from baseline by x points, and as 'Worse by x points' when the score increases by x points.
Measured: Baseline-Week 24
Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Right Eyelash
The Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome is the investigator's assessment of the subject's facial hair (eyebrow(s), eyelashes,and if male, beard) at a particular point in time. The investigator was instructed to NOT refer to any other assessments to assist with these assessments. The investigator or designee assessed the affected facial hair areas (eyebrows, eyelashes and if male, beard) using a 5 point scale for each target area [1-Full (Target Area Hair); 2-Most (Target Area Hair); 3-Some (Target Area Hair); 4-A Little (Target Area Hair); 5-No (Target Area Hair)]. Change status is categorized as 'Better by x points' when the score decreases from baseline by x points, and as 'Worse by x points' when the score increases by x points.
Measured: Baseline-Week 24
Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Beard, Male Subjects
The Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome is the investigator's assessment of the subject's facial hair (eyebrow(s), eyelashes,and if male, beard) at a particular point in time. The investigator was instructed to NOT refer to any other assessments to assist with these assessments. The investigator or designee assessed the affected facial hair areas (eyebrows, eyelashes and if male, beard) using a 5 point scale for each target area [1-Full (Target Area Hair); 2-Most (Target Area Hair); 3-Some (Target Area Hair); 4-A Little (Target Area Hair); 5-No (Target Area Hair)]. Change status is categorized as 'Better by x points' when the score decreases from baseline by x points, and as 'Worse by x points' when the score increases by x points.
Measured: Baseline-Week 24
Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Left Eyebrow
The Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome is the patient's assessment of their facial hair (eyebrow(s), eyelashes, and if male, beard) at a particular point in time. The patient assessed the affected facial hair areas (eyebrows, eyelashes and if male, beard) using a 5 point scale for each target area [1-Full (Target Area Hair); 2-Most (Target Area Hair); 3-Some (Target Area Hair); 4-A Little (Target Area Hair); 5-No (Target Area Hair)]. Change status is categorized as 'Better by x points' when the score decreases from baseline by x points, and as 'Worse by x points' when the score increases by x points.
Measured: Baseline-Week 24
Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Right Eyebrow
The Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome is the patient's assessment of their facial hair (eyebrow(s), eyelashes, and if male, beard) at a particular point in time. The patient assessed the affected facial hair areas (eyebrows, eyelashes and if male, beard) using a 5 point scale for each target area [1-Full (Target Area Hair); 2-Most (Target Area Hair); 3-Some (Target Area Hair); 4-A Little (Target Area Hair); 5-No (Target Area Hair)]. Change status is categorized as 'Better by x points' when the score decreases from baseline by x points, and as 'Worse by x points' when the score increases by x points.
Measured: Baseline-Week 24
Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Right Eyelash
The Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome is the patient's assessment of their facial hair (eyebrow(s), eyelashes, and if male, beard) at a particular point in time. The patient assessed the affected facial hair areas (eyebrows, eyelashes and if male, beard) using a 5 point scale for each target area [1-Full (Target Area Hair); 2-Most (Target Area Hair); 3-Some (Target Area Hair); 4-A Little (Target Area Hair); 5-No (Target Area Hair)]. Change status is categorized as 'Better by x points' when the score decreases from baseline by x points, and as 'Worse by x points' when the score increases by x points.
Measured: Baseline-Week 24
Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Left Eyelash
The Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome is the patient's assessment of their facial hair (eyebrow(s), eyelashes, and if male, beard) at a particular point in time. The patient assessed the affected facial hair areas (eyebrows, eyelashes and if male, beard) using a 5 point scale for each target area [1-Full (Target Area Hair); 2-Most (Target Area Hair); 3-Some (Target Area Hair); 4-A Little (Target Area Hair); 5-No (Target Area Hair)]. Change status is categorized as 'Better by x points' when the score decreases from baseline by x points, and as 'Worse by x points' when the score increases by x points.
Measured: Baseline-Week 24
Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Beard, Male Subjects
The Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome is the patient's assessment of their facial hair (eyebrow(s), eyelashes, and if male, beard) at a particular point in time. The patient assessed the affected facial hair areas (eyebrows, eyelashes and if male, beard) using a 5 point scale for each target area [1-Full (Target Area Hair); 2-Most (Target Area Hair); 3-Some (Target Area Hair); 4-A Little (Target Area Hair); 5-No (Target Area Hair)]. Change status is categorized as 'Better by x points' when the score decreases from baseline by x points, and as 'Worse by x points' when the score increases by x points.
Measured: Baseline-Week 24
Change From Baseline in the Subject Global Impression of Severity (SGIS) at Week 24, Patchy Alopecia Areata
The Subject Global Impression of Severity (SGIS) is a 5-point descriptive scale completed by subjects to capture the subject's assessment of disease severity at a particular timepoint. Scores of 1 to 5 are assigned to responses Mild to Extremely Severe, respectively. Change status is categorized as 'Better by x points' when the score decreases from baseline by x points, and as 'Worse by x points' when the score increases by x points.
Measured: Baseline-Week 24
Change From Baseline in the Subject Global Impression of Severity (SGIS) at Week 24, Alopecia Universalis or Alopecia Totalis
The Subject Global Impression of Severity (SGIS) is a 5-point descriptive scale completed by subjects to capture the subject's assessment of disease severity at a particular timepoint. Scores of 1 to 5 are assigned to responses Mild to Extremely Severe, respectively. Change status is categorized as 'Better by x points' when the score decreases from baseline by x points, and as 'Worse by x points' when the score increases by x points.
Measured: Baseline-Week 24
Change From Baseline in the Physician Global Impression of Severity (PhGIS) at Week 24, Patchy Alopecia Areata
The Physician Global Impression of Severity (PhGIS) is a 5-point descriptive scale completed by investigators and is used to capture the investigator's assessment of the subject's disease severity at a particular timepoint. Scores of 1 to 5 are assigned to responses Mild to Extremely Severe, respectively. Change status is categorized as 'Better by x points' when the score decreases from baseline by x points, and as 'Worse by x points' when the score increases by x points.
Measured: Baseline-Week 24
Change From Baseline in the Physician Global Impression of Severity (PhGIS) at Week 24, Alopecia Universalis or Alopecia Totalis
The Physician Global Impression of Severity (PhGIS) is a 5-point descriptive scale completed by investigators and is used to capture the investigator's assessment of the subject's disease severity at a particular timepoint. Scores of 1 to 5 are assigned to responses Mild to Extremely Severe, respectively. Change status is categorized as 'Better by x points' when the score decreases from baseline by x points, and as 'Worse by x points' when the score increases by x points.
Measured: Baseline-Week 24
Alopecia Impact Assessment (AIA) Patient Reported Outcome Change From Baseline at Week 24
The Alopecia Impact Assessment (AIA) is a 13-item patient reported outcome questionnaire which measures the subject's experience with impacts related to alopecia (inclusive of all 3 subtypes observed on study) in managing appearance, worry, sadness, loss of confidence, self-consciousness, embarrassment, feeling unattractive, limitation of social activities, limitation of physical activities, unwanted attention, sweat in eyes, debris in eyes, and debris in nose. The AIA has a recall period of "over the past seven days". An 11-point NRS with anchors "0 - Not at all [impact]" and "10 - Extremely [impact]" (e.g., "Not at all bothersome" and "Extremely bothersome"; "Not at all worried" and "Extremely worried") is utilized. The AIA produces single-item (0-10) and mean total (0-10) scores, with higher scores indicating higher levels of impact.
Measured: Baseline-Week 24
Subject Global Impression of Treatment Satisfaction (SGITS) at Week 24, Patchy Alopecia Areata
The Subject Global Impression of Treatment Satisfaction (SGITS) is a 7-point descriptive scale completed by subjects. Scale response options ranged from "1. Extremely Satisfied" to "7. Extremely Dissatisfied" and are used to capture how satisfied or dissatisfied they are with the study medication treatment received for their alopecia areata.
Measured: Baseline-Week 24
Subject Global Impression of Treatment Satisfaction (SGITS) at Week 24, Alopecia Universalis or Alopecia Totalis
The Subject Global Impression of Treatment Satisfaction (SGITS) is a 7-point descriptive scale completed by subjects. Scale response options ranged from "1. Extremely Satisfied" to "7. Extremely Dissatisfied" and are used to capture how satisfied or dissatisfied they are with the study medication treatment received for their alopecia areata.
Measured: Baseline-Week 24
Change From Baseline in the Subject Global Satisfaction With Hair Quality (SGSHQ) for Entire Scalp at Week 24, Patchy Alopecia Areata
The investigator or study staff instructed the subject to answer the Subject Global Satisfaction with Hair Quality (SGSHQ) questionnaire in relation to their satisfaction with the quality of scalp hair at the time of questionnaire completion (ie "right now"). Subjects assessed their satisfaction with the quality of their scalp hair on a 7-point satisfaction scale from extremely satisfied to extremely dissatisfied at the visits. Change status is categorized as 'Better by x points' when the score decreases from baseline by x points, and as 'Worse by x points' when the score increases by x points.
Measured: 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
The investigator or study staff instructed the subject to answer the Subject Global Satisfaction with Hair Quality (SGSHQ) questionnaire in relation to their satisfaction with the quality of scalp hair at the time of questionnaire completion (ie "right now"). Subjects assessed their satisfaction with the quality of their scalp hair on a 7-point satisfaction scale from extremely satisfied to extremely dissatisfied at the visits. Change status is categorized as 'Better by x points' when the score decreases from baseline by x points, and as 'Worse by x points' when the score increases by x points.
Measured: Baseline-Week 24
Change in Dermatology Life Quality Index Total Score (DLQI) Between Baseline and Week 24
The 10 question Dermatology Life Quality Index (DLQI) questionnaire was completed by subjects at Baseline, Week 4, Week 12, and Week 24. When completing the questionnaire, subjects were instructed to think of their hair loss in place of "skin problem" and "skin" as referenced in the questionnaire. Possible summary scores could range from 0 to 30 with higher scores indicating a worse outcome.
Measured: Baseline-Week 24
Subject Global Impression of Change (SGIC) at Week 24
The Subject Global Impression of Change (SGIC) is a 7-point descriptive scale completed by subjects at Week 24 (Intent-to-treat population with reported data falling within the windowed Week 24 visit timeframe). Scale response options ranged from "1. Very much improved" to "7. Very much worse" and are used to capture the subject's overall impression of change for his/her alopecia during the treatment period.
Measured: Baseline-Week 24
Physician Global Impression of Change (PhGIC) at Week 24
The Physician Global Impression of Change (PhGIC) is a 7-point descriptive scale completed by investigators at Week 24 (Intent-to-treat population with reported data falling within the windowed Week 24 visit timeframe). Scale response options ranged from "1. Very much improved" to "7. Very much worse" and are used to capture the investigator's overall impression of change for the subject's alopecia during the treatment period.
Measured: Baseline-Week 24
Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Clinician Reported Outcome for Target Patch, Patchy Alopecia Areata
The Scalp Clinician Reported Outcome for Target Patch provides the investigator's assessment for Patchy Alopecia Areata (AAP) patients regarding the appearance of the patient's target patch (identified by the patient as his or her most bothersome area of scalp hair loss at Baseline). The assessment was completed by investigators at Baseline, Week 2, Week 12, and Week 24. The assessment has a recall period of "right now" and includes a five-point VRS ranging from "Full hair, scalp of the target patch completely covered with hair" to "no hair, scalp of the target patch completely exposed." The instrument produces a score of 1 to 5, with lower scores indicating more hair covering the patient's target patch. Change status is categorized as 'Better by x points' when the score decreases from baseline by x points, and as 'Worse by x points' when the score increases by x points.
Measured: Baseline-Week 24
Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Clinician Reported Outcome for Entire Scalp, All Patients
The Scalp Clinician Reported Outcome for Entire Scalp was completed for patients with Patchy Alopecia Areata, Alopecia Universalis, and Alopecia Totalis and assesses the appearance of the patient's whole scalp. The assessment was completed by investigators at Baseline, Week 2, Week 12, and Week 24. The assessment has a recall period of "right now" and includes a five-point VRS ranging from "Full hair, whole scalp completely covered with hair" to "no hair, whole scalp completely exposed." The instrument produces a score of 1 to 5, with lower scores indicating more hair covering the patient's whole scalp. Change status is categorized as 'Better by x points' when the score decreases from baseline by x points, and as 'Worse by x points' when the score increases by x points.
Measured: Baseline-Week 24
Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Patient Reported Outcome for Target Patch, Patchy Alopecia Areata
The Scalp Patient Reported Outcome for Target Patch was completed by patients with Patchy Alopecia Areata (AAP) and assesses the appearance of the subject's target patch (identified by the subject as his or her most bothersome area of scalp hair loss at Baseline). The assessment was completed by AAP subjects at Baseline, Week 2, Week 12, and Week 24. The assessment has a recall period of "right now" and includes a five-point VRS ranging from "Full hair, scalp of the target patch completely covered with hair" to "no hair, scalp of the target patch completely exposed." The instrument produces a score of 1 to 5, with lower scores indicating more hair covering the subject's target patch. Change status is categorized as 'Better by x points' when the score decreases from baseline by x points, and as 'Worse by x points' when the score increases by x points.
Measured: Baseline-Week 24
Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Patient Reported Outcome for Entire Scalp, All Patients
The Scalp Patient Reported Outcome for Entire Scalp was completed by patients with Patchy Alopecia Areata, Alopecia Universalis, and Alopecia Totalis and assesses the appearance of the patient's whole scalp. The assessment was completed by patients at Baseline, Week 2, Week 12, and Week 24. The assessment has a recall period of "right now" and includes a five-point VRS ranging from "Full hair, whole scalp completely covered with hair" to "no hair, whole scalp completely exposed." The instrument produces a score of 1 to 5, with lower scores indicating more hair covering the patient's target patch. Change status is categorized as 'Better by x points' when the score decreases from baseline by x points, and as 'Worse by x points' when the score increases by x points.
Measured: Baseline-Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2018
- Study start11 Jun 2018
- Primary completion6 Jun 2019
- Study completion18 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AlopeciaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aclaris Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Susan Moran, RN, Study chair, Aclaris Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03594227
- Sponsor's protocol ID
- ATI-501-AUAT-201
- Status last verified
- Jun 2020
- First submitted
- 26 Jun 2018
- Last updated
- 16 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03594227
- Acronym / sponsor ID
- ATI-501-AUAT-201
- Conditions
- Alopecia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Aclaris Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 11 Jun 2018 (actual)
- Primary completion
- 6 Jun 2019 (actual)
- Study completion
- 18 Jun 2019 (actual)
- First posted
- 20 Jul 2018 (actual)
- Results
- Posted 16 Sep 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 400mg BID (Low dose) | Active comparator | Drug: ATI-501 400mg BID (Low dose)ATI-501 low dose - oral administration |
| 600mg BID (Mid dose) | Active comparator | Drug: ATI-501 600mg BID (Mid dose)ATI-501 mid dose - oral administration |
| 800mg BID (High dose) | Active comparator | Drug: ATI-501 800mg BID (High dose)ATI-501 high dose - oral administration |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo - oral administration |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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:
- 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.
Key exclusion criteria (24 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ATI-501 400mg BID (Low dose)Also: Active comparator: Low doseATI-501 400mg BID oral low dose for oral administration | Drug | 400mg BID (Low dose) |
| ATI-501 600mg BID (Mid dose)Also: Comparator : Mid doseATI-501 600mg BID oral mid dose for oral administration | Drug | 600mg BID (Mid dose) |
| ATI-501 800mg BID (High dose)Also: Comparator: high dose - oral administrationATI-501 800mg BID high dose for oral administration | Drug | 800mg BID (High dose) |
| PlaceboPlacebo - oral administration | Drug | Placebo |
Primary outcome
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.
31 secondary outcomes
Percent Change From Baseline in the Alopecia Density and Extent Score (ALODEX) at Week 24
Time frame: Baseline-Week 24
Mean Change From Baseline in the Severity of Alopecia Tool (SALT) Score at Week 24
Time frame: Baseline-Week 24
Mean Change From Baseline in the Alopecia Density and Extent (ALODEX) Score at Week 24
Time frame: Baseline-Week 24
Count of Subjects Achieving at Least a 50% Reduction in Alopecia Density and Extent (ALODEX) Score at Week 24
Time frame: 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
Time frame: Baseline-Week 24
Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Left Eyebrow
Time frame: Baseline-Week 24
Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Right Eyebrow
Time frame: Baseline-Week 24
Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Left Eyelash
Time frame: Baseline-Week 24
Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Right Eyelash
Time frame: Baseline-Week 24
Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Beard, Male Subjects
Time frame: Baseline-Week 24
Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Left Eyebrow
Time frame: Baseline-Week 24
Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Right Eyebrow
Time frame: Baseline-Week 24
Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Right Eyelash
Time frame: Baseline-Week 24
Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Left Eyelash
Time frame: Baseline-Week 24
Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Beard, Male Subjects
Time frame: Baseline-Week 24
Change From Baseline in the Subject Global Impression of Severity (SGIS) at Week 24, Patchy Alopecia Areata
Time frame: Baseline-Week 24
Change From Baseline in the Subject Global Impression of Severity (SGIS) at Week 24, Alopecia Universalis or Alopecia Totalis
Time frame: Baseline-Week 24
Change From Baseline in the Physician Global Impression of Severity (PhGIS) at Week 24, Patchy Alopecia Areata
Time frame: Baseline-Week 24
Change From Baseline in the Physician Global Impression of Severity (PhGIS) at Week 24, Alopecia Universalis or Alopecia Totalis
Time frame: Baseline-Week 24
Alopecia Impact Assessment (AIA) Patient Reported Outcome Change From Baseline at Week 24
Time frame: Baseline-Week 24
Subject Global Impression of Treatment Satisfaction (SGITS) at Week 24, Patchy Alopecia Areata
Time frame: Baseline-Week 24
Subject Global Impression of Treatment Satisfaction (SGITS) at Week 24, Alopecia Universalis or Alopecia Totalis
Time frame: Baseline-Week 24
Change From Baseline in the Subject Global Satisfaction With Hair Quality (SGSHQ) for Entire Scalp at Week 24, Patchy Alopecia Areata
Time frame: 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
Time frame: Baseline-Week 24
Change in Dermatology Life Quality Index Total Score (DLQI) Between Baseline and Week 24
Time frame: Baseline-Week 24
Subject Global Impression of Change (SGIC) at Week 24
Time frame: Baseline-Week 24
Physician Global Impression of Change (PhGIC) at Week 24
Time frame: Baseline-Week 24
Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Clinician Reported Outcome for Target Patch, Patchy Alopecia Areata
Time frame: Baseline-Week 24
Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Clinician Reported Outcome for Entire Scalp, All Patients
Time frame: Baseline-Week 24
Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Patient Reported Outcome for Target Patch, Patchy Alopecia Areata
Time frame: Baseline-Week 24
Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Patient Reported Outcome for Entire Scalp, All Patients
Time frame: Baseline-Week 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan Moran, RN study chair
Aclaris Therapeutics
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ATI-501 400mg BID (Low dose), ATI-501 600mg BID (Mid dose) and ATI-501 800mg BID (High dose) in people with Alopecia, run by Aclaris Therapeutics, Inc. at 25 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change From Baseline in the Severity of Alopecia Tool (SALT) Score at Week 24 (time frame: Baseline-Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2020.