Alopecia
Conditions
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.
Interventions
DRUGATI-501 400mg BID (Low dose)
ATI-501 400mg BID oral low dose for oral administration
DRUGATI-501 600mg BID (Mid dose)
ATI-501 600mg BID oral mid dose for oral administration
DRUGATI-501 800mg BID (High dose)
ATI-501 800mg BID high dose for oral administration
DRUGPlacebo
Placebo - oral administration
Sponsors
Aclaris Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Subjects must meet the following criteria to be eligible for participation in the study: 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
Subjects are excluded from this study if any 1 or more of the following criteria is met: 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline in the Severity of Alopecia Tool (SALT) Score at Week 24 | 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
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in the Severity of Alopecia Tool (SALT) Score at Week 24 | 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. |
| Mean Change From Baseline in the Alopecia Density and Extent (ALODEX) Score at Week 24 | Baseline-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. |
| Count of Subjects Achieving at Least a 50% Reduction in Alopecia Density and Extent (ALODEX) Score at Week 24 | Baseline-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. |
| 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 | 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. |
| Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Left Eyebrow | Baseline-Week 24 | 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. |
| Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Right Eyebrow | Baseline-Week 24 | 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. |
| Change in Dermatology Life Quality Index Total Score (DLQI) Between Baseline and Week 24 | Baseline-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. |
| Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Left Eyelash | Baseline-Week 24 | 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. |
| Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Right Eyelash | Baseline-Week 24 | 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. |
| Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Beard, Male Subjects | Baseline-Week 24 | 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. |
| Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Left Eyebrow | Baseline-Week 24 | 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. |
| Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Right Eyebrow | Baseline-Week 24 | 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. |
| Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Right Eyelash | Baseline-Week 24 | 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. |
| Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Left Eyelash | Baseline-Week 24 | 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. |
| Subject Global Impression of Change (SGIC) at Week 24 | Baseline-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. |
| Percent Change From Baseline in the Alopecia Density and Extent Score (ALODEX) at Week 24 | Baseline-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. |
| Change From Baseline in the Subject Global Impression of Severity (SGIS) at Week 24, Patchy Alopecia Areata | Baseline-Week 24 | 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. |
| Change From Baseline in the Subject Global Impression of Severity (SGIS) at Week 24, Alopecia Universalis or Alopecia Totalis | Baseline-Week 24 | 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. |
| Change From Baseline in the Physician Global Impression of Severity (PhGIS) at Week 24, Patchy Alopecia Areata | Baseline-Week 24 | 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. |
| Change From Baseline in the Physician Global Impression of Severity (PhGIS) at Week 24, Alopecia Universalis or Alopecia Totalis | Baseline-Week 24 | 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. |
| Alopecia Impact Assessment (AIA) Patient Reported Outcome Change From Baseline at Week 24 | Baseline-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. |
| Subject Global Impression of Treatment Satisfaction (SGITS) at Week 24, Patchy Alopecia Areata | Baseline-Week 24 | 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. |
| Subject Global Impression of Treatment Satisfaction (SGITS) at Week 24, Alopecia Universalis or Alopecia Totalis | Baseline-Week 24 | 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. |
| Change From Baseline in the Subject Global Satisfaction With Hair Quality (SGSHQ) for Entire Scalp at Week 24, Patchy Alopecia Areata | Baseline-Week 24 | 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. |
| 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 | 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. |
| Physician Global Impression of Change (PhGIC) at Week 24 | Baseline-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. |
| Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Clinician Reported Outcome for Target Patch, Patchy Alopecia Areata | Baseline-Week 24 | 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. |
| Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Clinician Reported Outcome for Entire Scalp, All Patients | Baseline-Week 24 | 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. |
| Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Patient Reported Outcome for Target Patch, Patchy Alopecia Areata | Baseline-Week 24 | 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. |
| Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Patient Reported Outcome for Entire Scalp, All Patients | Baseline-Week 24 | 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. |
| Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Beard, Male Subjects | Baseline-Week 24 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| ATI-501 400mg BID Dosing ATI-501 400mg BID dosing - oral administration
ATI-501 400mg BID dosing: ATI-501 oral low dose | 23 |
| ATI-501 600mg BID Dosing ATI-501 600mg BID dosing - oral administration
ATI-501 600mg BID dosing: ATI-501 oral low dose | 23 |
| ATI-501 800mg BID Dosing ATI-501 800mg BID dosing - oral administration
ATI-501 800mg BID dosing: ATI-501 high dose for oral administration | 22 |
| Placebo Placebo: BID - oral administration | 19 |
| Total | 87 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 2 | 1 | 0 | 2 |
| Overall Study | Lost to Follow-up | 1 | 1 | 1 | 0 |
| Overall Study | Pregnancy | 0 | 1 | 0 | 0 |
| Overall Study | Programmatic Analysis Non-completer | 1 | 0 | 1 | 1 |
| Overall Study | Sponsor Decision | 0 | 0 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 1 | 1 | 1 |
Baseline characteristics
| Characteristic | ATI-501 600mg BID Dosing | Total | ATI-501 400mg BID Dosing | Placebo | ATI-501 800mg BID Dosing |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 6 Participants | 1 Participants | 3 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 21 Participants | 81 Participants | 22 Participants | 16 Participants | 22 Participants |
| Age, Continuous | 40.4 years STANDARD_DEVIATION 13.56 | 40.3 years STANDARD_DEVIATION 13.52 | 38.7 years STANDARD_DEVIATION 12.99 | 41.8 years STANDARD_DEVIATION 16.01 | 40.5 years STANDARD_DEVIATION 12.44 |
| Baseline Scalp-Clinician Reported Outcomes (ClinRO) for Target Patch, AAP subjects only A little hair | 7 Participants | 23 Participants | 6 Participants | 5 Participants | 5 Participants |
| Baseline Scalp-Clinician Reported Outcomes (ClinRO) for Target Patch, AAP subjects only N/A for subjects with AU and AT (>95% hair loss) | 9 Participants | 45 Participants | 12 Participants | 11 Participants | 13 Participants |
| Baseline Scalp-Clinician Reported Outcomes (ClinRO) for Target Patch, AAP subjects only No hair | 7 Participants | 19 Participants | 5 Participants | 3 Participants | 4 Participants |
| Baseline scalp-ClinRO for entire scalp A little hair | 7 Participants | 27 Participants | 4 Participants | 9 Participants | 7 Participants |
| Baseline scalp-ClinRO for entire scalp No hair | 8 Participants | 36 Participants | 11 Participants | 8 Participants | 9 Participants |
| Baseline scalp-ClinRO for entire scalp Some hair | 8 Participants | 24 Participants | 8 Participants | 2 Participants | 6 Participants |
| Baseline scalp-Patient-Reported Outcome for target patch, Alopecia Areata Patchy (AAP) subjects only A little hair | 8 Participants | 25 Participants | 8 Participants | 4 Participants | 5 Participants |
| Baseline scalp-Patient-Reported Outcome for target patch, Alopecia Areata Patchy (AAP) subjects only N/A for subjects with AU and AT (>95% hair loss) | 9 Participants | 45 Participants | 12 Participants | 11 Participants | 13 Participants |
| Baseline scalp-Patient-Reported Outcome for target patch, Alopecia Areata Patchy (AAP) subjects only No hair | 6 Participants | 16 Participants | 3 Participants | 3 Participants | 4 Participants |
| Baseline scalp-Patient-Reported Outcome for target patch, Alopecia Areata Patchy (AAP) subjects only Some hair | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants |
| Baseline Scalp-Patient-Reported Outcome (PRO) for Entire Scalp A little hair | 7 Participants | 27 Participants | 6 Participants | 8 Participants | 6 Participants |
| Baseline Scalp-Patient-Reported Outcome (PRO) for Entire Scalp Most hair | 1 Participants | 4 Participants | 1 Participants | 0 Participants | 2 Participants |
| Baseline Scalp-Patient-Reported Outcome (PRO) for Entire Scalp No hair | 9 Participants | 38 Participants | 11 Participants | 8 Participants | 10 Participants |
| Baseline Scalp-Patient-Reported Outcome (PRO) for Entire Scalp Some hair | 6 Participants | 18 Participants | 5 Participants | 3 Participants | 4 Participants |
| Baseline Severity of Alopecia Tool (SALT) Score Mean | 76 score on a scale STANDARD_DEVIATION 23.4 | 80 score on a scale STANDARD_DEVIATION 25 | 78 score on a scale STANDARD_DEVIATION 26.7 | 85 score on a scale STANDARD_DEVIATION 24.8 | 81 score on a scale STANDARD_DEVIATION 25.8 |
| Baseline Severity of Alopecia Tool (SALT) Scores Percentiles <50% | 2 Participants | 15 Participants | 5 Participants | 3 Participants | 5 Participants |
| Baseline Severity of Alopecia Tool (SALT) Scores Percentiles ≥50% | 21 Participants | 72 Participants | 18 Participants | 16 Participants | 17 Participants |
| Diagnosis Type Alopecia Areata | 14 Participants | 43 Participants | 11 Participants | 9 Participants | 9 Participants |
| Diagnosis Type Alopecia Totalis | 4 Participants | 23 Participants | 8 Participants | 5 Participants | 6 Participants |
| Diagnosis Type Alopecia Universalis | 5 Participants | 21 Participants | 4 Participants | 5 Participants | 7 Participants |
| Duration of alopecia (years) | 9.5 years STANDARD_DEVIATION 9.78 | 11.3 years STANDARD_DEVIATION 10.94 | 13.7 years STANDARD_DEVIATION 11.01 | 11.3 years STANDARD_DEVIATION 12.04 | 10.7 years STANDARD_DEVIATION 11.36 |
| Duration of current episode of alopecia (weeks) | 189.5 weeks STANDARD_DEVIATION 148.31 | 209.3 weeks STANDARD_DEVIATION 163.1 | 224.2 weeks STANDARD_DEVIATION 184.63 | 253.2 weeks STANDARD_DEVIATION 153.59 | 176.3 weeks STANDARD_DEVIATION 162.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 15 Participants | 7 Participants | 3 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 15 Participants | 50 Participants | 10 Participants | 12 Participants | 13 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 0 Participants | 0 Participants | 1 Participants |
| Fitzpatrick Skin Type I - Always Burns | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 2 Participants |
| Fitzpatrick Skin Type II - Burns Easily | 7 Participants | 26 Participants | 5 Participants | 8 Participants | 6 Participants |
| Fitzpatrick Skin Type III - Burns Moderately | 9 Participants | 28 Participants | 7 Participants | 8 Participants | 4 Participants |
| Fitzpatrick Skin Type IV - Burns Minimally | 3 Participants | 13 Participants | 6 Participants | 0 Participants | 4 Participants |
| Fitzpatrick Skin Type VI - Never Burns | 0 Participants | 4 Participants | 2 Participants | 0 Participants | 2 Participants |
| Fitzpatrick Skin Type V - Rarely Burns | 4 Participants | 14 Participants | 3 Participants | 3 Participants | 4 Participants |
| Hair Pull Test - Broken at Borders N/A for subjects with AU and AT (>95% hair loss) | 9 Participants | 45 Participants | 12 Participants | 11 Participants | 13 Participants |
| Hair Pull Test - Broken at Borders No | 12 Participants | 35 Participants | 11 Participants | 6 Participants | 6 Participants |
| Hair Pull Test - Broken at Borders Yes | 2 Participants | 5 Participants | 0 Participants | 1 Participants | 2 Participants |
| Hair pull test - broken hairs N/A for subjects with AU and AT (>95% hair loss) | 9 Participants | 45 Participants | 12 Participants | 11 Participants | 13 Participants |
| Hair pull test - broken hairs No | 12 Participants | 35 Participants | 11 Participants | 6 Participants | 6 Participants |
| Hair pull test - broken hairs Yes | 2 Participants | 5 Participants | 0 Participants | 1 Participants | 2 Participants |
| Hair Pull Test - Dislodged Hairs Abnormal (>2 hairs dislodged) | 5 Participants | 7 Participants | 0 Participants | 1 Participants | 1 Participants |
| Hair Pull Test - Dislodged Hairs N/A for subjects with AU and AT (>95% hair loss) | 9 Participants | 45 Participants | 12 Participants | 11 Participants | 13 Participants |
| Hair Pull Test - Dislodged Hairs Normal (≤2 hairs dislodged) | 9 Participants | 33 Participants | 11 Participants | 6 Participants | 7 Participants |
| Indeterminate hair present No | 19 Participants | 75 Participants | 21 Participants | 16 Participants | 19 Participants |
| Indeterminate hair present Yes | 3 Participants | 11 Participants | 2 Participants | 3 Participants | 3 Participants |
| Ophiasis pattern of hair loss No ophiasis pattern | 19 Participants | 73 Participants | 19 Participants | 17 Participants | 18 Participants |
| Ophiasis pattern of hair loss Ophiasis and Alopecia Areata | 4 Participants | 13 Participants | 4 Participants | 1 Participants | 4 Participants |
| Previous Therapies for Alopecia Biologics or immunosuppressants | 1 Participants | 2 Participants | 0 Participants | 1 Participants | 0 Participants |
| Previous Therapies for Alopecia Corticosteroids | 13 Participants | 54 Participants | 16 Participants | 10 Participants | 15 Participants |
| Previous Therapies for Alopecia DMARDS | 1 Participants | 2 Participants | 0 Participants | 0 Participants | 1 Participants |
| Previous Therapies for Alopecia Laser therapy | 0 Participants | 2 Participants | 1 Participants | 1 Participants | 0 Participants |
| Previous Therapies for Alopecia NB UVB | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants |
| Previous Therapies for Alopecia Other | 2 Participants | 14 Participants | 3 Participants | 3 Participants | 6 Participants |
| Previous Therapies for Alopecia Phototherapy | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Previous Therapies for Alopecia Plaquenil | 0 Participants | 2 Participants | 1 Participants | 1 Participants | 0 Participants |
| Previous Therapies for Alopecia Subjects using prior therapy for alopecia | 18 Participants | 76 Participants | 21 Participants | 16 Participants | 21 Participants |
| Previous Therapies for Alopecia Systemic steroids | 11 Participants | 34 Participants | 11 Participants | 7 Participants | 5 Participants |
| Previous Therapies for Alopecia Topical immunotherapy | 3 Participants | 19 Participants | 8 Participants | 3 Participants | 5 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 2 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 17 Participants | 6 Participants | 3 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 19 Participants | 67 Participants | 17 Participants | 15 Participants | 16 Participants |
| Sex: Female, Male Female | 12 Participants | 56 Participants | 17 Participants | 14 Participants | 13 Participants |
| Sex: Female, Male Male | 11 Participants | 31 Participants | 6 Participants | 5 Participants | 9 Participants |
| Vellus Hair Present No | 18 Participants | 71 Participants | 20 Participants | 15 Participants | 18 Participants |
| Vellus Hair Present Yes | 4 Participants | 15 Participants | 3 Participants | 4 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 23 | 0 / 23 | 0 / 22 | 0 / 19 |
| other Total, other adverse events | 5 / 23 | 2 / 23 | 3 / 22 | 3 / 19 |
| serious Total, serious adverse events | 0 / 23 | 0 / 23 | 0 / 22 | 0 / 19 |
Outcome results
Primary
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.
Time frame: Baseline-Week 24
Population: This primary analysis utilized the SALT score with imputation for last observation carried forward (LOCF) and was based on the intent-to-treat population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ATI-501 400mg BID Dosing | Percent Change From Baseline in the Severity of Alopecia Tool (SALT) Score at Week 24 | -25.6 percent | Standard Deviation 39.75 |
| ATI-501 600mg BID Dosing | Percent Change From Baseline in the Severity of Alopecia Tool (SALT) Score at Week 24 | -30.4 percent | Standard Deviation 41.23 |
| ATI-501 800mg BID Dosing | Percent Change From Baseline in the Severity of Alopecia Tool (SALT) Score at Week 24 | -25.9 percent | Standard Deviation 29.86 |
| Placebo | Percent Change From Baseline in the Severity of Alopecia Tool (SALT) Score at Week 24 | -6.3 percent | Standard Deviation 23.36 |
Comparison: The planned sample size is approximately 95 enrolled subjects with approximately 45 subjects enrolled with AT or AU. Because the primary efficacy analysis of mean percent reduction in hair loss using SALT scores is expected to be more sensitive than the SALT50 responder analysis, the power for the primary analysis is also expected to be no less than 80%.p-value: 0.01195% CI: [-33.98, -4.54]Mixed Models Analysis
Comparison: The planned sample size is approximately 95 enrolled subjects with approximately 45 subjects enrolled with AT or AU. Because the primary efficacy analysis of mean percent reduction in hair loss using SALT scores is expected to be more sensitive than the SALT50 responder analysis, the power for the primary analysis is also expected to be no less than 80%.p-value: 0.00195% CI: [-38.8, -9.36]Mixed Models Analysis
Comparison: The planned sample size is approximately 95 enrolled subjects with approximately 45 subjects enrolled with AT or AU. Because the primary efficacy analysis of mean percent reduction in hair loss using SALT scores is expected to be more sensitive than the SALT50 responder analysis, the power for the primary analysis is also expected to be no less than 80%.p-value: 0.0195% CI: [-34.41, -4.67]Mixed Models Analysis
Secondary
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.
Time frame: Baseline-Week 24
Population: Intent-to-treat population using Last Observation Carried Forward to address missing data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ATI-501 400mg BID Dosing | Alopecia Impact Assessment (AIA) Patient Reported Outcome Change From Baseline at Week 24 | -1.9 score on a scale | Standard Deviation 1.89 |
| ATI-501 600mg BID Dosing | Alopecia Impact Assessment (AIA) Patient Reported Outcome Change From Baseline at Week 24 | -1.8 score on a scale | Standard Deviation 2.79 |
| ATI-501 800mg BID Dosing | Alopecia Impact Assessment (AIA) Patient Reported Outcome Change From Baseline at Week 24 | -1.2 score on a scale | Standard Deviation 1.8 |
| Placebo | Alopecia Impact Assessment (AIA) Patient Reported Outcome Change From Baseline at Week 24 | -1.1 score on a scale | Standard Deviation 1.06 |
Secondary
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.
Time frame: Baseline-Week 24
Population: Intent-to-treat population using Last Observation Carried Forward to address missing data.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ATI-501 400mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Beard, Male Subjects | Worse by 3 points | 0 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Beard, Male Subjects | No Change | 4 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Beard, Male Subjects | Better by 1 point | 2 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Beard, Male Subjects | Better by 2 points | 0 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Beard, Male Subjects | Better by 4 points | 0 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Beard, Male Subjects | Worse by 4 points | 0 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Beard, Male Subjects | Worse by 2 points | 0 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Beard, Male Subjects | Worse by 1 point | 0 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Beard, Male Subjects | Better by 3 points | 0 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Beard, Male Subjects | Better by 2 points | 0 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Beard, Male Subjects | Better by 1 point | 1 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Beard, Male Subjects | Better by 4 points | 0 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Beard, Male Subjects | Better by 3 points | 1 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Beard, Male Subjects | No Change | 6 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Beard, Male Subjects | Worse by 1 point | 2 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Beard, Male Subjects | Worse by 2 points | 1 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Beard, Male Subjects | Worse by 3 points | 0 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Beard, Male Subjects | Worse by 4 points | 0 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Beard, Male Subjects | Better by 3 points | 3 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Beard, Male Subjects | No Change | 2 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Beard, Male Subjects | Worse by 1 point | 1 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Beard, Male Subjects | Better by 4 points | 0 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Beard, Male Subjects | Worse by 2 points | 0 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Beard, Male Subjects | Worse by 3 points | 0 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Beard, Male Subjects | Worse by 4 points | 0 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Beard, Male Subjects | Better by 2 points | 3 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Beard, Male Subjects | Better by 1 point | 0 Participants |
| Placebo | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Beard, Male Subjects | Better by 1 point | 2 Participants |
| Placebo | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Beard, Male Subjects | Worse by 3 points | 0 Participants |
| Placebo | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Beard, Male Subjects | Worse by 2 points | 0 Participants |
| Placebo | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Beard, Male Subjects | Better by 4 points | 0 Participants |
| Placebo | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Beard, Male Subjects | No Change | 3 Participants |
| Placebo | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Beard, Male Subjects | Better by 2 points | 0 Participants |
| Placebo | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Beard, Male Subjects | Worse by 1 point | 0 Participants |
| Placebo | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Beard, Male Subjects | Better by 3 points | 0 Participants |
| Placebo | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Beard, Male Subjects | Worse by 4 points | 0 Participants |
p-value: >0.999Wilcoxon (Mann-Whitney)
p-value: 0.277Wilcoxon (Mann-Whitney)
p-value: 0.159Wilcoxon (Mann-Whitney)
Secondary
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.
Time frame: Baseline-Week 24
Population: Intent-to-treat population using Last Observation Carried Forward to address missing data.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ATI-501 400mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Left Eyebrow | Better by 3 points | 1 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Left Eyebrow | Better by 1 point | 4 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Left Eyebrow | No change | 15 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Left Eyebrow | Worse by 1 point | 1 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Left Eyebrow | Worse by 2 points | 2 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Left Eyebrow | Worse by 3 points | 0 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Left Eyebrow | Better by 4 points | 0 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Left Eyebrow | Better by 2 points | 0 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Left Eyebrow | Worse by 4 points | 0 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Left Eyebrow | Worse by 1 point | 0 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Left Eyebrow | Worse by 2 points | 0 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Left Eyebrow | Worse by 3 points | 0 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Left Eyebrow | Worse by 4 points | 0 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Left Eyebrow | Better by 4 points | 1 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Left Eyebrow | Better by 3 points | 0 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Left Eyebrow | Better by 1 point | 5 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Left Eyebrow | No change | 15 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Left Eyebrow | Better by 2 points | 2 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Left Eyebrow | Worse by 3 points | 1 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Left Eyebrow | Worse by 4 points | 0 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Left Eyebrow | No change | 10 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Left Eyebrow | Better by 1 point | 6 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Left Eyebrow | Better by 4 points | 1 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Left Eyebrow | Worse by 1 point | 1 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Left Eyebrow | Better by 2 points | 2 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Left Eyebrow | Worse by 2 points | 0 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Left Eyebrow | Better by 3 points | 1 Participants |
| Placebo | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Left Eyebrow | Better by 1 point | 3 Participants |
| Placebo | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Left Eyebrow | Worse by 3 points | 0 Participants |
| Placebo | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Left Eyebrow | No change | 13 Participants |
| Placebo | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Left Eyebrow | Better by 2 points | 1 Participants |
| Placebo | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Left Eyebrow | Worse by 4 points | 0 Participants |
| Placebo | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Left Eyebrow | Worse by 1 point | 1 Participants |
| Placebo | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Left Eyebrow | Worse by 2 points | 0 Participants |
| Placebo | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Left Eyebrow | Better by 3 points | 1 Participants |
| Placebo | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Left Eyebrow | Better by 4 points | 0 Participants |
p-value: 0.471Wilcoxon (Mann-Whitney)
p-value: 0.457Wilcoxon (Mann-Whitney)
p-value: 0.367Wilcoxon (Mann-Whitney)
Secondary
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.
Time frame: Baseline-Week 24
Population: Intent-to-treat population using Last Observation Carried Forward to address missing data.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ATI-501 400mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Left Eyelash | No Change | 15 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Left Eyelash | Better by 1 point | 3 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Left Eyelash | Better by 2 points | 1 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Left Eyelash | Worse by 3 points | 1 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Left Eyelash | Worse by 4 points | 0 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Left Eyelash | Worse by 2 points | 1 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Left Eyelash | Better by 4 points | 1 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Left Eyelash | Worse by 1 point | 0 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Left Eyelash | Better by 3 points | 1 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Left Eyelash | Better by 4 points | 1 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Left Eyelash | Worse by 4 points | 0 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Left Eyelash | Better by 3 points | 0 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Left Eyelash | Better by 2 points | 1 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Left Eyelash | Better by 1 point | 3 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Left Eyelash | No Change | 15 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Left Eyelash | Worse by 1 point | 3 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Left Eyelash | Worse by 2 points | 0 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Left Eyelash | Worse by 3 points | 0 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Left Eyelash | Better by 3 points | 2 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Left Eyelash | Worse by 3 points | 1 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Left Eyelash | No Change | 12 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Left Eyelash | Worse by 1 point | 1 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Left Eyelash | Worse by 4 points | 0 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Left Eyelash | Better by 4 points | 0 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Left Eyelash | Worse by 2 points | 0 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Left Eyelash | Better by 2 points | 3 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Left Eyelash | Better by 1 point | 3 Participants |
| Placebo | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Left Eyelash | Better by 3 points | 1 Participants |
| Placebo | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Left Eyelash | Worse by 4 points | 0 Participants |
| Placebo | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Left Eyelash | Worse by 2 points | 0 Participants |
| Placebo | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Left Eyelash | No Change | 16 Participants |
| Placebo | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Left Eyelash | Better by 4 points | 0 Participants |
| Placebo | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Left Eyelash | Worse by 3 points | 0 Participants |
| Placebo | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Left Eyelash | Better by 2 points | 0 Participants |
| Placebo | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Left Eyelash | Worse by 1 point | 1 Participants |
| Placebo | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Left Eyelash | Better by 1 point | 1 Participants |
p-value: 0.444Wilcoxon (Mann-Whitney)
p-value: 0.861Wilcoxon (Mann-Whitney)
p-value: 0.182Wilcoxon (Mann-Whitney)
Secondary
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.
Time frame: Baseline-Week 24
Population: Intent-to-treat population using Last Observation Carried Forward to address missing data.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ATI-501 400mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Right Eyebrow | Better by 4 points | 0 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Right Eyebrow | Better by 2 points | 0 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Right Eyebrow | Better by 1 point | 3 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Right Eyebrow | Worse by 1 point | 1 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Right Eyebrow | Worse by 2 points | 1 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Right Eyebrow | Worse by 3 points | 0 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Right Eyebrow | Better by 3 points | 1 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Right Eyebrow | No change | 17 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Right Eyebrow | Worse by 4 points | 0 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Right Eyebrow | Better by 1 point | 6 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Right Eyebrow | Worse by 1 point | 4 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Right Eyebrow | Worse by 2 points | 0 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Right Eyebrow | No change | 12 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Right Eyebrow | Worse by 3 points | 0 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Right Eyebrow | Worse by 4 points | 0 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Right Eyebrow | Better by 4 points | 1 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Right Eyebrow | Better by 3 points | 0 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Right Eyebrow | Better by 2 points | 0 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Right Eyebrow | Better by 4 points | 1 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Right Eyebrow | Better by 3 points | 1 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Right Eyebrow | Worse by 4 points | 0 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Right Eyebrow | Worse by 1 point | 0 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Right Eyebrow | Better by 1 point | 4 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Right Eyebrow | No change | 12 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Right Eyebrow | Better by 2 points | 3 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Right Eyebrow | Worse by 3 points | 1 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Right Eyebrow | Worse by 2 points | 0 Participants |
| Placebo | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Right Eyebrow | No change | 13 Participants |
| Placebo | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Right Eyebrow | Worse by 2 points | 0 Participants |
| Placebo | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Right Eyebrow | Better by 2 points | 1 Participants |
| Placebo | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Right Eyebrow | Better by 1 point | 4 Participants |
| Placebo | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Right Eyebrow | Worse by 3 points | 0 Participants |
| Placebo | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Right Eyebrow | Better by 3 points | 1 Participants |
| Placebo | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Right Eyebrow | Worse by 1 point | 0 Participants |
| Placebo | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Right Eyebrow | Worse by 4 points | 0 Participants |
| Placebo | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Right Eyebrow | Better by 4 points | 0 Participants |
p-value: 0.187Wilcoxon (Mann-Whitney)
p-value: 0.375Wilcoxon (Mann-Whitney)
p-value: 0.581Wilcoxon (Mann-Whitney)
Secondary
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.
Time frame: Baseline-Week 24
Population: Intent-to-treat population using Last Observation Carried Forward to address missing data.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ATI-501 400mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Right Eyelash | Worse by 2 points | 0 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Right Eyelash | Worse by 4 points | 0 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Right Eyelash | Better by 2 points | 1 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Right Eyelash | Better by 3 points | 1 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Right Eyelash | Worse by 3 points | 1 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Right Eyelash | Better by 1 point | 3 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Right Eyelash | Worse by 1 point | 0 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Right Eyelash | Better by 4 points | 1 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Right Eyelash | No Change | 16 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Right Eyelash | Worse by 2 points | 0 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Right Eyelash | No Change | 16 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Right Eyelash | Better by 4 points | 1 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Right Eyelash | Worse by 1 point | 1 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Right Eyelash | Better by 3 points | 0 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Right Eyelash | Worse by 4 points | 0 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Right Eyelash | Worse by 3 points | 0 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Right Eyelash | Better by 2 points | 1 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Right Eyelash | Better by 1 point | 4 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Right Eyelash | Better by 2 points | 3 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Right Eyelash | Better by 4 points | 0 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Right Eyelash | Better by 3 points | 1 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Right Eyelash | Better by 1 point | 4 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Right Eyelash | No Change | 13 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Right Eyelash | Worse by 1 point | 0 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Right Eyelash | Worse by 2 points | 0 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Right Eyelash | Worse by 3 points | 1 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Right Eyelash | Worse by 4 points | 0 Participants |
| Placebo | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Right Eyelash | Better by 4 points | 0 Participants |
| Placebo | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Right Eyelash | Worse by 2 points | 0 Participants |
| Placebo | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Right Eyelash | Better by 2 points | 0 Participants |
| Placebo | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Right Eyelash | Better by 3 points | 1 Participants |
| Placebo | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Right Eyelash | Worse by 4 points | 0 Participants |
| Placebo | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Right Eyelash | No Change | 16 Participants |
| Placebo | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Right Eyelash | Worse by 3 points | 0 Participants |
| Placebo | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Right Eyelash | Worse by 1 point | 1 Participants |
| Placebo | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Clinician Reported Outcome, Right Eyelash | Better by 1 point | 1 Participants |
p-value: 0.258Wilcoxon (Mann-Whitney)
p-value: 0.263Wilcoxon (Mann-Whitney)
p-value: 0.101Wilcoxon (Mann-Whitney)
Secondary
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.
Time frame: Baseline-Week 24
Population: Intent-to-treat population using Last Observation Carried Forward to address missing data.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ATI-501 400mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Beard, Male Subjects | No Change | 4 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Beard, Male Subjects | Worse by 1 point | 0 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Beard, Male Subjects | Better by 3 points | 0 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Beard, Male Subjects | Worse by 2 points | 0 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Beard, Male Subjects | Worse by 4 points | 0 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Beard, Male Subjects | Better by 2 points | 0 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Beard, Male Subjects | Better by 4 points | 0 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Beard, Male Subjects | Better by 1 point | 2 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Beard, Male Subjects | Worse by 3 points | 0 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Beard, Male Subjects | Better by 1 point | 3 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Beard, Male Subjects | Worse by 4 points | 0 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Beard, Male Subjects | Worse by 2 points | 0 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Beard, Male Subjects | Better by 2 points | 1 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Beard, Male Subjects | Better by 4 points | 1 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Beard, Male Subjects | Worse by 3 points | 0 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Beard, Male Subjects | Better by 3 points | 0 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Beard, Male Subjects | Worse by 1 point | 1 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Beard, Male Subjects | No Change | 5 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Beard, Male Subjects | Better by 4 points | 0 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Beard, Male Subjects | Better by 3 points | 1 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Beard, Male Subjects | Better by 2 points | 3 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Beard, Male Subjects | Better by 1 point | 3 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Beard, Male Subjects | No Change | 2 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Beard, Male Subjects | Worse by 1 point | 0 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Beard, Male Subjects | Worse by 2 points | 0 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Beard, Male Subjects | Worse by 3 points | 0 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Beard, Male Subjects | Worse by 4 points | 0 Participants |
| Placebo | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Beard, Male Subjects | Worse by 2 points | 0 Participants |
| Placebo | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Beard, Male Subjects | Better by 1 point | 2 Participants |
| Placebo | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Beard, Male Subjects | Better by 2 points | 0 Participants |
| Placebo | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Beard, Male Subjects | Worse by 4 points | 0 Participants |
| Placebo | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Beard, Male Subjects | Worse by 3 points | 0 Participants |
| Placebo | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Beard, Male Subjects | Better by 3 points | 0 Participants |
| Placebo | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Beard, Male Subjects | Worse by 1 point | 0 Participants |
| Placebo | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Beard, Male Subjects | No Change | 3 Participants |
| Placebo | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Beard, Male Subjects | Better by 4 points | 0 Participants |
p-value: >0.999Wilcoxon (Mann-Whitney)
p-value: 0.911Wilcoxon (Mann-Whitney)
p-value: 0.11Wilcoxon (Mann-Whitney)
Secondary
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.
Time frame: Baseline-Week 24
Population: Intent-to-treat population using Last Observation Carried Forward to address missing data.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ATI-501 400mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Left Eyebrow | Better by 2 points | 4 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Left Eyebrow | Worse by 1 point | 1 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Left Eyebrow | Worse by 4 points | 0 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Left Eyebrow | Worse by 3 points | 0 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Left Eyebrow | Better by 3 points | 1 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Left Eyebrow | Better by 4 points | 0 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Left Eyebrow | Better by 1 points | 1 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Left Eyebrow | No Change | 16 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Left Eyebrow | Worse by 2 points | 0 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Left Eyebrow | No Change | 14 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Left Eyebrow | Worse by 3 points | 0 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Left Eyebrow | Better by 1 points | 5 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Left Eyebrow | Better by 2 points | 0 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Left Eyebrow | Worse by 2 points | 0 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Left Eyebrow | Worse by 1 point | 3 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Left Eyebrow | Better by 4 points | 1 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Left Eyebrow | Better by 3 points | 0 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Left Eyebrow | Worse by 4 points | 0 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Left Eyebrow | Better by 1 points | 8 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Left Eyebrow | Better by 2 points | 0 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Left Eyebrow | Worse by 1 point | 1 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Left Eyebrow | Worse by 4 points | 0 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Left Eyebrow | Worse by 2 points | 0 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Left Eyebrow | Worse by 3 points | 1 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Left Eyebrow | Better by 4 points | 0 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Left Eyebrow | Better by 3 points | 2 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Left Eyebrow | No Change | 10 Participants |
| Placebo | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Left Eyebrow | Better by 4 points | 0 Participants |
| Placebo | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Left Eyebrow | Worse by 1 point | 2 Participants |
| Placebo | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Left Eyebrow | No Change | 13 Participants |
| Placebo | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Left Eyebrow | Better by 3 points | 0 Participants |
| Placebo | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Left Eyebrow | Better by 1 points | 3 Participants |
| Placebo | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Left Eyebrow | Better by 2 points | 1 Participants |
| Placebo | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Left Eyebrow | Worse by 3 points | 0 Participants |
| Placebo | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Left Eyebrow | Worse by 4 points | 0 Participants |
| Placebo | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Left Eyebrow | Worse by 2 points | 0 Participants |
p-value: 0.407Wilcoxon (Mann-Whitney)
p-value: 0.894Wilcoxon (Mann-Whitney)
p-value: 0.179Wilcoxon (Mann-Whitney)
Secondary
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.
Time frame: Baseline-Week 24
Population: Intent-to-treat population using Last Observation Carried Forward to address missing data.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ATI-501 400mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Left Eyelash | Worse by 3 points | 1 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Left Eyelash | Better by 4 points | 1 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Left Eyelash | Better by 3 points | 0 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Left Eyelash | Better by 2 points | 2 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Left Eyelash | Better by 1 point | 6 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Left Eyelash | No Change | 13 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Left Eyelash | Worse by 1 point | 0 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Left Eyelash | Worse by 2 points | 0 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Left Eyelash | Worse by 4 points | 0 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Left Eyelash | Worse by 2 points | 0 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Left Eyelash | No Change | 15 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Left Eyelash | Better by 3 points | 1 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Left Eyelash | Worse by 1 point | 3 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Left Eyelash | Worse by 4 points | 0 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Left Eyelash | Better by 4 points | 1 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Left Eyelash | Better by 1 point | 1 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Left Eyelash | Better by 2 points | 2 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Left Eyelash | Worse by 3 points | 0 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Left Eyelash | Better by 3 points | 1 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Left Eyelash | Worse by 3 points | 0 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Left Eyelash | Better by 2 points | 2 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Left Eyelash | Better by 1 point | 2 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Left Eyelash | No Change | 14 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Left Eyelash | Worse by 1 point | 2 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Left Eyelash | Worse by 4 points | 0 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Left Eyelash | Worse by 2 points | 1 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Left Eyelash | Better by 4 points | 0 Participants |
| Placebo | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Left Eyelash | Worse by 4 points | 0 Participants |
| Placebo | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Left Eyelash | Better by 1 point | 3 Participants |
| Placebo | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Left Eyelash | Better by 2 points | 0 Participants |
| Placebo | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Left Eyelash | Worse by 3 points | 0 Participants |
| Placebo | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Left Eyelash | Better by 3 points | 0 Participants |
| Placebo | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Left Eyelash | No Change | 14 Participants |
| Placebo | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Left Eyelash | Better by 4 points | 0 Participants |
| Placebo | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Left Eyelash | Worse by 1 point | 2 Participants |
| Placebo | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Left Eyelash | Worse by 2 points | 0 Participants |
p-value: 0.073Wilcoxon (Mann-Whitney)
p-value: 0.66Wilcoxon (Mann-Whitney)
p-value: 0.704Wilcoxon (Mann-Whitney)
Secondary
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.
Time frame: Baseline-Week 24
Population: Intent-to-treat population using Last Observation Carried Forward to address missing data.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ATI-501 400mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Right Eyebrow | Worse by 2 points | 1 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Right Eyebrow | Better by 3 points | 1 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Right Eyebrow | Worse by 1 point | 0 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Right Eyebrow | Better by 1 point | 3 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Right Eyebrow | Worse by 4 points | 0 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Right Eyebrow | Better by 2 points | 2 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Right Eyebrow | Worse by 3 points | 0 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Right Eyebrow | No Change | 16 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Right Eyebrow | Better by 4 points | 0 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Right Eyebrow | No Change | 13 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Right Eyebrow | Worse by 2 points | 0 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Right Eyebrow | Worse by 1 point | 2 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Right Eyebrow | Better by 3 points | 0 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Right Eyebrow | Better by 4 points | 1 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Right Eyebrow | Better by 2 points | 2 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Right Eyebrow | Worse by 3 points | 0 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Right Eyebrow | Better by 1 point | 5 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Right Eyebrow | Worse by 4 points | 0 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Right Eyebrow | No Change | 10 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Right Eyebrow | Better by 4 points | 0 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Right Eyebrow | Better by 3 points | 1 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Right Eyebrow | Better by 2 points | 2 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Right Eyebrow | Better by 1 point | 7 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Right Eyebrow | Worse by 1 point | 1 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Right Eyebrow | Worse by 2 points | 0 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Right Eyebrow | Worse by 3 points | 1 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Right Eyebrow | Worse by 4 points | 0 Participants |
| Placebo | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Right Eyebrow | Worse by 2 points | 0 Participants |
| Placebo | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Right Eyebrow | Better by 1 point | 4 Participants |
| Placebo | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Right Eyebrow | Better by 2 points | 1 Participants |
| Placebo | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Right Eyebrow | Worse by 4 points | 0 Participants |
| Placebo | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Right Eyebrow | Worse by 3 points | 0 Participants |
| Placebo | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Right Eyebrow | Better by 3 points | 0 Participants |
| Placebo | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Right Eyebrow | Worse by 1 point | 2 Participants |
| Placebo | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Right Eyebrow | No Change | 12 Participants |
| Placebo | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Right Eyebrow | Better by 4 points | 0 Participants |
p-value: 0.691Wilcoxon (Mann-Whitney)
p-value: 0.521Wilcoxon (Mann-Whitney)
p-value: 0.262Wilcoxon (Mann-Whitney)
Secondary
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.
Time frame: Baseline-Week 24
Population: Intent-to-treat population using Last Observation Carried Forward to address missing data.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ATI-501 400mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Right Eyelash | Better by 2 points | 2 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Right Eyelash | Worse by 3 points | 0 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Right Eyelash | No Change | 13 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Right Eyelash | Better by 1 point | 7 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Right Eyelash | Worse by 2 points | 0 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Right Eyelash | Better by 3 points | 0 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Right Eyelash | Worse by 4 points | 0 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Right Eyelash | Worse by 1 point | 0 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Right Eyelash | Better by 4 points | 1 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Right Eyelash | No Change | 16 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Right Eyelash | Better by 4 points | 1 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Right Eyelash | Better by 3 points | 1 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Right Eyelash | Better by 2 points | 1 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Right Eyelash | Better by 1 point | 3 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Right Eyelash | Worse by 1 point | 1 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Right Eyelash | Worse by 2 points | 0 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Right Eyelash | Worse by 3 points | 0 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Right Eyelash | Worse by 4 points | 0 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Right Eyelash | Better by 2 points | 2 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Right Eyelash | No Change | 12 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Right Eyelash | Better by 3 points | 1 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Right Eyelash | Worse by 1 point | 1 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Right Eyelash | Worse by 2 points | 1 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Right Eyelash | Better by 4 points | 0 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Right Eyelash | Worse by 4 points | 0 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Right Eyelash | Worse by 3 points | 1 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Right Eyelash | Better by 1 point | 4 Participants |
| Placebo | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Right Eyelash | Better by 2 points | 0 Participants |
| Placebo | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Right Eyelash | Worse by 2 points | 0 Participants |
| Placebo | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Right Eyelash | No Change | 15 Participants |
| Placebo | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Right Eyelash | Better by 1 point | 2 Participants |
| Placebo | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Right Eyelash | Worse by 3 points | 0 Participants |
| Placebo | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Right Eyelash | Better by 3 points | 0 Participants |
| Placebo | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Right Eyelash | Worse by 1 point | 2 Participants |
| Placebo | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Right Eyelash | Better by 4 points | 0 Participants |
| Placebo | Change From Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)-Patient Reported Outcome, Right Eyelash | Worse by 4 points | 0 Participants |
p-value: 0.009Wilcoxon (Mann-Whitney)
p-value: 0.154Wilcoxon (Mann-Whitney)
p-value: 0.289Wilcoxon (Mann-Whitney)
Secondary
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.
Time frame: Baseline-Week 24
Population: Intent-to-treat population using Last Observation Carried Forward to address missing data.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ATI-501 400mg BID Dosing | Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Clinician Reported Outcome for Entire Scalp, All Patients | Worse by 2 points | 0 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Clinician Reported Outcome for Entire Scalp, All Patients | Worse by 1 point | 1 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Clinician Reported Outcome for Entire Scalp, All Patients | Worse by 4 points | 0 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Clinician Reported Outcome for Entire Scalp, All Patients | Better by 1 point | 7 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Clinician Reported Outcome for Entire Scalp, All Patients | Better by 2 points | 3 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Clinician Reported Outcome for Entire Scalp, All Patients | Better by 3 points | 1 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Clinician Reported Outcome for Entire Scalp, All Patients | Worse by 3 points | 0 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Clinician Reported Outcome for Entire Scalp, All Patients | No change | 11 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Clinician Reported Outcome for Entire Scalp, All Patients | Better by 4 points | 0 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Clinician Reported Outcome for Entire Scalp, All Patients | No change | 10 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Clinician Reported Outcome for Entire Scalp, All Patients | Worse by 2 points | 0 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Clinician Reported Outcome for Entire Scalp, All Patients | Worse by 1 point | 1 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Clinician Reported Outcome for Entire Scalp, All Patients | Better by 3 points | 0 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Clinician Reported Outcome for Entire Scalp, All Patients | Better by 4 points | 1 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Clinician Reported Outcome for Entire Scalp, All Patients | Better by 2 points | 2 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Clinician Reported Outcome for Entire Scalp, All Patients | Worse by 4 points | 0 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Clinician Reported Outcome for Entire Scalp, All Patients | Worse by 3 points | 0 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Clinician Reported Outcome for Entire Scalp, All Patients | Better by 1 point | 9 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Clinician Reported Outcome for Entire Scalp, All Patients | No change | 10 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Clinician Reported Outcome for Entire Scalp, All Patients | Better by 4 points | 0 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Clinician Reported Outcome for Entire Scalp, All Patients | Better by 3 points | 1 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Clinician Reported Outcome for Entire Scalp, All Patients | Better by 2 points | 3 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Clinician Reported Outcome for Entire Scalp, All Patients | Better by 1 point | 8 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Clinician Reported Outcome for Entire Scalp, All Patients | Worse by 1 point | 0 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Clinician Reported Outcome for Entire Scalp, All Patients | Worse by 2 points | 0 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Clinician Reported Outcome for Entire Scalp, All Patients | Worse by 3 points | 0 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Clinician Reported Outcome for Entire Scalp, All Patients | Worse by 4 points | 0 Participants |
| Placebo | Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Clinician Reported Outcome for Entire Scalp, All Patients | Worse by 2 points | 0 Participants |
| Placebo | Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Clinician Reported Outcome for Entire Scalp, All Patients | Better by 1 point | 8 Participants |
| Placebo | Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Clinician Reported Outcome for Entire Scalp, All Patients | Better by 2 points | 1 Participants |
| Placebo | Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Clinician Reported Outcome for Entire Scalp, All Patients | Worse by 4 points | 0 Participants |
| Placebo | Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Clinician Reported Outcome for Entire Scalp, All Patients | Worse by 3 points | 0 Participants |
| Placebo | Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Clinician Reported Outcome for Entire Scalp, All Patients | Better by 3 points | 0 Participants |
| Placebo | Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Clinician Reported Outcome for Entire Scalp, All Patients | Worse by 1 point | 0 Participants |
| Placebo | Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Clinician Reported Outcome for Entire Scalp, All Patients | No change | 10 Participants |
| Placebo | Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Clinician Reported Outcome for Entire Scalp, All Patients | Better by 4 points | 0 Participants |
p-value: 0.827Wilcoxon (Mann-Whitney)
p-value: 0.742Wilcoxon (Mann-Whitney)
p-value: 0.462Wilcoxon (Mann-Whitney)
Secondary
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.
Time frame: Baseline-Week 24
Population: Intent-to-treat population using Last Observation Carried Forward to address missing data.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ATI-501 400mg BID Dosing | Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Clinician Reported Outcome for Target Patch, Patchy Alopecia Areata | Better by 1 point | 0 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Clinician Reported Outcome for Target Patch, Patchy Alopecia Areata | Worse by 1 point | 0 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Clinician Reported Outcome for Target Patch, Patchy Alopecia Areata | Better by 3 points | 4 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Clinician Reported Outcome for Target Patch, Patchy Alopecia Areata | Worse by 2 points | 0 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Clinician Reported Outcome for Target Patch, Patchy Alopecia Areata | Worse by 4 points | 0 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Clinician Reported Outcome for Target Patch, Patchy Alopecia Areata | Better by 2 points | 1 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Clinician Reported Outcome for Target Patch, Patchy Alopecia Areata | Better by 4 points | 0 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Clinician Reported Outcome for Target Patch, Patchy Alopecia Areata | Worse by 3 points | 0 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Clinician Reported Outcome for Target Patch, Patchy Alopecia Areata | No change | 6 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Clinician Reported Outcome for Target Patch, Patchy Alopecia Areata | Worse by 4 points | 0 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Clinician Reported Outcome for Target Patch, Patchy Alopecia Areata | Worse by 2 points | 0 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Clinician Reported Outcome for Target Patch, Patchy Alopecia Areata | Better by 2 points | 1 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Clinician Reported Outcome for Target Patch, Patchy Alopecia Areata | Worse by 1 point | 2 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Clinician Reported Outcome for Target Patch, Patchy Alopecia Areata | No change | 2 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Clinician Reported Outcome for Target Patch, Patchy Alopecia Areata | Worse by 3 points | 0 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Clinician Reported Outcome for Target Patch, Patchy Alopecia Areata | Better by 3 points | 5 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Clinician Reported Outcome for Target Patch, Patchy Alopecia Areata | Better by 4 points | 1 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Clinician Reported Outcome for Target Patch, Patchy Alopecia Areata | Better by 1 point | 3 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Clinician Reported Outcome for Target Patch, Patchy Alopecia Areata | No change | 2 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Clinician Reported Outcome for Target Patch, Patchy Alopecia Areata | Better by 4 points | 1 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Clinician Reported Outcome for Target Patch, Patchy Alopecia Areata | Better by 3 points | 1 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Clinician Reported Outcome for Target Patch, Patchy Alopecia Areata | Better by 2 points | 0 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Clinician Reported Outcome for Target Patch, Patchy Alopecia Areata | Better by 1 point | 4 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Clinician Reported Outcome for Target Patch, Patchy Alopecia Areata | Worse by 1 point | 1 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Clinician Reported Outcome for Target Patch, Patchy Alopecia Areata | Worse by 2 points | 0 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Clinician Reported Outcome for Target Patch, Patchy Alopecia Areata | Worse by 3 points | 0 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Clinician Reported Outcome for Target Patch, Patchy Alopecia Areata | Worse by 4 points | 0 Participants |
| Placebo | Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Clinician Reported Outcome for Target Patch, Patchy Alopecia Areata | Worse by 2 points | 0 Participants |
| Placebo | Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Clinician Reported Outcome for Target Patch, Patchy Alopecia Areata | Better by 1 point | 0 Participants |
| Placebo | Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Clinician Reported Outcome for Target Patch, Patchy Alopecia Areata | Better by 2 points | 0 Participants |
| Placebo | Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Clinician Reported Outcome for Target Patch, Patchy Alopecia Areata | Worse by 4 points | 0 Participants |
| Placebo | Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Clinician Reported Outcome for Target Patch, Patchy Alopecia Areata | Worse by 3 points | 0 Participants |
| Placebo | Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Clinician Reported Outcome for Target Patch, Patchy Alopecia Areata | Better by 3 points | 2 Participants |
| Placebo | Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Clinician Reported Outcome for Target Patch, Patchy Alopecia Areata | Worse by 1 point | 1 Participants |
| Placebo | Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Clinician Reported Outcome for Target Patch, Patchy Alopecia Areata | No change | 5 Participants |
| Placebo | Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Clinician Reported Outcome for Target Patch, Patchy Alopecia Areata | Better by 4 points | 0 Participants |
p-value: 0.341Wilcoxon (Mann-Whitney)
p-value: 0.203Wilcoxon (Mann-Whitney)
p-value: 0.327Wilcoxon (Mann-Whitney)
Secondary
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.
Time frame: Baseline-Week 24
Population: Intent-to-treat population using Last Observation Carried Forward to address missing data.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ATI-501 400mg BID Dosing | Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Patient Reported Outcome for Entire Scalp, All Patients | Worse by 2 points | 0 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Patient Reported Outcome for Entire Scalp, All Patients | Worse by 1 point | 1 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Patient Reported Outcome for Entire Scalp, All Patients | Worse by 4 points | 0 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Patient Reported Outcome for Entire Scalp, All Patients | Better by 1 point | 5 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Patient Reported Outcome for Entire Scalp, All Patients | Better by 2 points | 4 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Patient Reported Outcome for Entire Scalp, All Patients | Better by 3 points | 2 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Patient Reported Outcome for Entire Scalp, All Patients | Worse by 3 points | 0 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Patient Reported Outcome for Entire Scalp, All Patients | No change | 11 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Patient Reported Outcome for Entire Scalp, All Patients | Better by 4 points | 0 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Patient Reported Outcome for Entire Scalp, All Patients | No change | 8 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Patient Reported Outcome for Entire Scalp, All Patients | Worse by 2 points | 0 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Patient Reported Outcome for Entire Scalp, All Patients | Worse by 1 point | 1 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Patient Reported Outcome for Entire Scalp, All Patients | Better by 3 points | 1 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Patient Reported Outcome for Entire Scalp, All Patients | Better by 4 points | 1 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Patient Reported Outcome for Entire Scalp, All Patients | Better by 2 points | 2 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Patient Reported Outcome for Entire Scalp, All Patients | Worse by 4 points | 0 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Patient Reported Outcome for Entire Scalp, All Patients | Worse by 3 points | 0 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Patient Reported Outcome for Entire Scalp, All Patients | Better by 1 point | 10 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Patient Reported Outcome for Entire Scalp, All Patients | No change | 8 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Patient Reported Outcome for Entire Scalp, All Patients | Better by 4 points | 0 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Patient Reported Outcome for Entire Scalp, All Patients | Better by 3 points | 1 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Patient Reported Outcome for Entire Scalp, All Patients | Better by 2 points | 5 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Patient Reported Outcome for Entire Scalp, All Patients | Better by 1 point | 7 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Patient Reported Outcome for Entire Scalp, All Patients | Worse by 1 point | 1 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Patient Reported Outcome for Entire Scalp, All Patients | Worse by 2 points | 0 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Patient Reported Outcome for Entire Scalp, All Patients | Worse by 3 points | 0 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Patient Reported Outcome for Entire Scalp, All Patients | Worse by 4 points | 0 Participants |
| Placebo | Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Patient Reported Outcome for Entire Scalp, All Patients | Worse by 2 points | 0 Participants |
| Placebo | Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Patient Reported Outcome for Entire Scalp, All Patients | Better by 1 point | 7 Participants |
| Placebo | Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Patient Reported Outcome for Entire Scalp, All Patients | Better by 2 points | 1 Participants |
| Placebo | Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Patient Reported Outcome for Entire Scalp, All Patients | Worse by 4 points | 0 Participants |
| Placebo | Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Patient Reported Outcome for Entire Scalp, All Patients | Worse by 3 points | 0 Participants |
| Placebo | Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Patient Reported Outcome for Entire Scalp, All Patients | Better by 3 points | 0 Participants |
| Placebo | Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Patient Reported Outcome for Entire Scalp, All Patients | Worse by 1 point | 0 Participants |
| Placebo | Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Patient Reported Outcome for Entire Scalp, All Patients | No change | 11 Participants |
| Placebo | Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Patient Reported Outcome for Entire Scalp, All Patients | Better by 4 points | 0 Participants |
p-value: 0.469Wilcoxon (Mann-Whitney)
p-value: 0.219Wilcoxon (Mann-Whitney)
p-value: 0.196Wilcoxon (Mann-Whitney)
Secondary
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.
Time frame: Baseline-Week 24
Population: Intent-to-treat population using Last Observation Carried Forward to address missing data.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ATI-501 400mg BID Dosing | Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Patient Reported Outcome for Target Patch, Patchy Alopecia Areata | Worse by 2 points | 0 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Patient Reported Outcome for Target Patch, Patchy Alopecia Areata | Worse by 1 point | 1 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Patient Reported Outcome for Target Patch, Patchy Alopecia Areata | Worse by 4 points | 0 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Patient Reported Outcome for Target Patch, Patchy Alopecia Areata | Better by 1 point | 0 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Patient Reported Outcome for Target Patch, Patchy Alopecia Areata | Better by 2 points | 1 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Patient Reported Outcome for Target Patch, Patchy Alopecia Areata | Better by 3 points | 3 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Patient Reported Outcome for Target Patch, Patchy Alopecia Areata | Worse by 3 points | 0 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Patient Reported Outcome for Target Patch, Patchy Alopecia Areata | No change | 4 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Patient Reported Outcome for Target Patch, Patchy Alopecia Areata | Better by 4 points | 2 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Patient Reported Outcome for Target Patch, Patchy Alopecia Areata | No change | 1 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Patient Reported Outcome for Target Patch, Patchy Alopecia Areata | Worse by 2 points | 0 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Patient Reported Outcome for Target Patch, Patchy Alopecia Areata | Worse by 1 point | 3 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Patient Reported Outcome for Target Patch, Patchy Alopecia Areata | Better by 3 points | 4 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Patient Reported Outcome for Target Patch, Patchy Alopecia Areata | Better by 4 points | 1 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Patient Reported Outcome for Target Patch, Patchy Alopecia Areata | Better by 2 points | 3 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Patient Reported Outcome for Target Patch, Patchy Alopecia Areata | Worse by 4 points | 0 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Patient Reported Outcome for Target Patch, Patchy Alopecia Areata | Worse by 3 points | 0 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Patient Reported Outcome for Target Patch, Patchy Alopecia Areata | Better by 1 point | 2 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Patient Reported Outcome for Target Patch, Patchy Alopecia Areata | No change | 2 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Patient Reported Outcome for Target Patch, Patchy Alopecia Areata | Better by 4 points | 1 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Patient Reported Outcome for Target Patch, Patchy Alopecia Areata | Better by 3 points | 1 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Patient Reported Outcome for Target Patch, Patchy Alopecia Areata | Better by 2 points | 0 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Patient Reported Outcome for Target Patch, Patchy Alopecia Areata | Better by 1 point | 4 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Patient Reported Outcome for Target Patch, Patchy Alopecia Areata | Worse by 1 point | 1 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Patient Reported Outcome for Target Patch, Patchy Alopecia Areata | Worse by 2 points | 0 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Patient Reported Outcome for Target Patch, Patchy Alopecia Areata | Worse by 3 points | 0 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Patient Reported Outcome for Target Patch, Patchy Alopecia Areata | Worse by 4 points | 0 Participants |
| Placebo | Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Patient Reported Outcome for Target Patch, Patchy Alopecia Areata | Worse by 2 points | 0 Participants |
| Placebo | Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Patient Reported Outcome for Target Patch, Patchy Alopecia Areata | Better by 1 point | 5 Participants |
| Placebo | Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Patient Reported Outcome for Target Patch, Patchy Alopecia Areata | Better by 2 points | 1 Participants |
| Placebo | Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Patient Reported Outcome for Target Patch, Patchy Alopecia Areata | Worse by 4 points | 0 Participants |
| Placebo | Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Patient Reported Outcome for Target Patch, Patchy Alopecia Areata | Worse by 3 points | 0 Participants |
| Placebo | Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Patient Reported Outcome for Target Patch, Patchy Alopecia Areata | Better by 3 points | 1 Participants |
| Placebo | Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Patient Reported Outcome for Target Patch, Patchy Alopecia Areata | Worse by 1 point | 0 Participants |
| Placebo | Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Patient Reported Outcome for Target Patch, Patchy Alopecia Areata | No change | 1 Participants |
| Placebo | Change From Baseline in Alopecia Scalp Appearance Assessment (ASAA): Scalp-Patient Reported Outcome for Target Patch, Patchy Alopecia Areata | Better by 4 points | 0 Participants |
p-value: 0.836Wilcoxon (Mann-Whitney)
p-value: 0.54Wilcoxon (Mann-Whitney)
p-value: 0.672Wilcoxon (Mann-Whitney)
Secondary
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.
Time frame: Baseline-Week 24
Population: Intent-to-treat population using Last Observation Carried Forward to address missing data.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ATI-501 400mg BID Dosing | Change From Baseline in the Physician Global Impression of Severity (PhGIS) at Week 24, Alopecia Universalis or Alopecia Totalis | Worse by 2 points | 0 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in the Physician Global Impression of Severity (PhGIS) at Week 24, Alopecia Universalis or Alopecia Totalis | Worse by 1 point | 0 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in the Physician Global Impression of Severity (PhGIS) at Week 24, Alopecia Universalis or Alopecia Totalis | Worse by 4 points | 0 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in the Physician Global Impression of Severity (PhGIS) at Week 24, Alopecia Universalis or Alopecia Totalis | Better by 1 point | 5 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in the Physician Global Impression of Severity (PhGIS) at Week 24, Alopecia Universalis or Alopecia Totalis | Better by 2 points | 0 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in the Physician Global Impression of Severity (PhGIS) at Week 24, Alopecia Universalis or Alopecia Totalis | Better by 3 points | 1 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in the Physician Global Impression of Severity (PhGIS) at Week 24, Alopecia Universalis or Alopecia Totalis | Worse by 3 points | 0 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in the Physician Global Impression of Severity (PhGIS) at Week 24, Alopecia Universalis or Alopecia Totalis | No change | 6 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in the Physician Global Impression of Severity (PhGIS) at Week 24, Alopecia Universalis or Alopecia Totalis | Better by 4 points | 0 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in the Physician Global Impression of Severity (PhGIS) at Week 24, Alopecia Universalis or Alopecia Totalis | No change | 7 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in the Physician Global Impression of Severity (PhGIS) at Week 24, Alopecia Universalis or Alopecia Totalis | Worse by 2 points | 0 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in the Physician Global Impression of Severity (PhGIS) at Week 24, Alopecia Universalis or Alopecia Totalis | Worse by 1 point | 0 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in the Physician Global Impression of Severity (PhGIS) at Week 24, Alopecia Universalis or Alopecia Totalis | Better by 3 points | 0 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in the Physician Global Impression of Severity (PhGIS) at Week 24, Alopecia Universalis or Alopecia Totalis | Better by 4 points | 1 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in the Physician Global Impression of Severity (PhGIS) at Week 24, Alopecia Universalis or Alopecia Totalis | Better by 2 points | 1 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in the Physician Global Impression of Severity (PhGIS) at Week 24, Alopecia Universalis or Alopecia Totalis | Worse by 4 points | 0 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in the Physician Global Impression of Severity (PhGIS) at Week 24, Alopecia Universalis or Alopecia Totalis | Worse by 3 points | 0 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in the Physician Global Impression of Severity (PhGIS) at Week 24, Alopecia Universalis or Alopecia Totalis | Better by 1 point | 0 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in the Physician Global Impression of Severity (PhGIS) at Week 24, Alopecia Universalis or Alopecia Totalis | No change | 5 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in the Physician Global Impression of Severity (PhGIS) at Week 24, Alopecia Universalis or Alopecia Totalis | Better by 4 points | 1 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in the Physician Global Impression of Severity (PhGIS) at Week 24, Alopecia Universalis or Alopecia Totalis | Better by 3 points | 2 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in the Physician Global Impression of Severity (PhGIS) at Week 24, Alopecia Universalis or Alopecia Totalis | Better by 2 points | 2 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in the Physician Global Impression of Severity (PhGIS) at Week 24, Alopecia Universalis or Alopecia Totalis | Better by 1 point | 3 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in the Physician Global Impression of Severity (PhGIS) at Week 24, Alopecia Universalis or Alopecia Totalis | Worse by 1 point | 0 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in the Physician Global Impression of Severity (PhGIS) at Week 24, Alopecia Universalis or Alopecia Totalis | Worse by 2 points | 0 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in the Physician Global Impression of Severity (PhGIS) at Week 24, Alopecia Universalis or Alopecia Totalis | Worse by 3 points | 0 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in the Physician Global Impression of Severity (PhGIS) at Week 24, Alopecia Universalis or Alopecia Totalis | Worse by 4 points | 0 Participants |
| Placebo | Change From Baseline in the Physician Global Impression of Severity (PhGIS) at Week 24, Alopecia Universalis or Alopecia Totalis | Worse by 2 points | 0 Participants |
| Placebo | Change From Baseline in the Physician Global Impression of Severity (PhGIS) at Week 24, Alopecia Universalis or Alopecia Totalis | Better by 1 point | 3 Participants |
| Placebo | Change From Baseline in the Physician Global Impression of Severity (PhGIS) at Week 24, Alopecia Universalis or Alopecia Totalis | Better by 2 points | 0 Participants |
| Placebo | Change From Baseline in the Physician Global Impression of Severity (PhGIS) at Week 24, Alopecia Universalis or Alopecia Totalis | Worse by 4 points | 0 Participants |
| Placebo | Change From Baseline in the Physician Global Impression of Severity (PhGIS) at Week 24, Alopecia Universalis or Alopecia Totalis | Worse by 3 points | 0 Participants |
| Placebo | Change From Baseline in the Physician Global Impression of Severity (PhGIS) at Week 24, Alopecia Universalis or Alopecia Totalis | Better by 3 points | 0 Participants |
| Placebo | Change From Baseline in the Physician Global Impression of Severity (PhGIS) at Week 24, Alopecia Universalis or Alopecia Totalis | Worse by 1 point | 0 Participants |
| Placebo | Change From Baseline in the Physician Global Impression of Severity (PhGIS) at Week 24, Alopecia Universalis or Alopecia Totalis | No change | 7 Participants |
| Placebo | Change From Baseline in the Physician Global Impression of Severity (PhGIS) at Week 24, Alopecia Universalis or Alopecia Totalis | Better by 4 points | 0 Participants |
p-value: 0.341Wilcoxon (Mann-Whitney)
p-value: >0.999Wilcoxon (Mann-Whitney)
p-value: 0.068Wilcoxon (Mann-Whitney)
Secondary
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.
Time frame: Baseline-Week 24
Population: Intent-to-treat population using Last Observation Carried Forward to address missing data.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ATI-501 400mg BID Dosing | Change From Baseline in the Physician Global Impression of Severity (PhGIS) at Week 24, Patchy Alopecia Areata | Worse by 2 points | 0 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in the Physician Global Impression of Severity (PhGIS) at Week 24, Patchy Alopecia Areata | Better by 4 points | 0 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in the Physician Global Impression of Severity (PhGIS) at Week 24, Patchy Alopecia Areata | Worse by 1 point | 1 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in the Physician Global Impression of Severity (PhGIS) at Week 24, Patchy Alopecia Areata | Better by 1 point | 1 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in the Physician Global Impression of Severity (PhGIS) at Week 24, Patchy Alopecia Areata | Better by 3 points | 1 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in the Physician Global Impression of Severity (PhGIS) at Week 24, Patchy Alopecia Areata | Worse by 4 points | 0 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in the Physician Global Impression of Severity (PhGIS) at Week 24, Patchy Alopecia Areata | Worse by 3 points | 0 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in the Physician Global Impression of Severity (PhGIS) at Week 24, Patchy Alopecia Areata | No Change | 5 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in the Physician Global Impression of Severity (PhGIS) at Week 24, Patchy Alopecia Areata | Better by 2 points | 3 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in the Physician Global Impression of Severity (PhGIS) at Week 24, Patchy Alopecia Areata | No Change | 4 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in the Physician Global Impression of Severity (PhGIS) at Week 24, Patchy Alopecia Areata | Worse by 2 points | 0 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in the Physician Global Impression of Severity (PhGIS) at Week 24, Patchy Alopecia Areata | Worse by 1 point | 2 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in the Physician Global Impression of Severity (PhGIS) at Week 24, Patchy Alopecia Areata | Better by 3 points | 0 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in the Physician Global Impression of Severity (PhGIS) at Week 24, Patchy Alopecia Areata | Better by 4 points | 1 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in the Physician Global Impression of Severity (PhGIS) at Week 24, Patchy Alopecia Areata | Better by 2 points | 4 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in the Physician Global Impression of Severity (PhGIS) at Week 24, Patchy Alopecia Areata | Worse by 3 points | 0 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in the Physician Global Impression of Severity (PhGIS) at Week 24, Patchy Alopecia Areata | Better by 1 point | 3 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in the Physician Global Impression of Severity (PhGIS) at Week 24, Patchy Alopecia Areata | Worse by 4 points | 0 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in the Physician Global Impression of Severity (PhGIS) at Week 24, Patchy Alopecia Areata | No Change | 6 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in the Physician Global Impression of Severity (PhGIS) at Week 24, Patchy Alopecia Areata | Better by 4 points | 0 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in the Physician Global Impression of Severity (PhGIS) at Week 24, Patchy Alopecia Areata | Better by 3 points | 0 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in the Physician Global Impression of Severity (PhGIS) at Week 24, Patchy Alopecia Areata | Better by 2 points | 1 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in the Physician Global Impression of Severity (PhGIS) at Week 24, Patchy Alopecia Areata | Better by 1 point | 2 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in the Physician Global Impression of Severity (PhGIS) at Week 24, Patchy Alopecia Areata | Worse by 1 point | 0 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in the Physician Global Impression of Severity (PhGIS) at Week 24, Patchy Alopecia Areata | Worse by 2 points | 0 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in the Physician Global Impression of Severity (PhGIS) at Week 24, Patchy Alopecia Areata | Worse by 3 points | 0 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in the Physician Global Impression of Severity (PhGIS) at Week 24, Patchy Alopecia Areata | Worse by 4 points | 0 Participants |
| Placebo | Change From Baseline in the Physician Global Impression of Severity (PhGIS) at Week 24, Patchy Alopecia Areata | Worse by 2 points | 0 Participants |
| Placebo | Change From Baseline in the Physician Global Impression of Severity (PhGIS) at Week 24, Patchy Alopecia Areata | Better by 1 point | 3 Participants |
| Placebo | Change From Baseline in the Physician Global Impression of Severity (PhGIS) at Week 24, Patchy Alopecia Areata | Better by 2 points | 0 Participants |
| Placebo | Change From Baseline in the Physician Global Impression of Severity (PhGIS) at Week 24, Patchy Alopecia Areata | Worse by 4 points | 0 Participants |
| Placebo | Change From Baseline in the Physician Global Impression of Severity (PhGIS) at Week 24, Patchy Alopecia Areata | Worse by 3 points | 0 Participants |
| Placebo | Change From Baseline in the Physician Global Impression of Severity (PhGIS) at Week 24, Patchy Alopecia Areata | Better by 3 points | 0 Participants |
| Placebo | Change From Baseline in the Physician Global Impression of Severity (PhGIS) at Week 24, Patchy Alopecia Areata | Worse by 1 point | 2 Participants |
| Placebo | Change From Baseline in the Physician Global Impression of Severity (PhGIS) at Week 24, Patchy Alopecia Areata | No Change | 4 Participants |
| Placebo | Change From Baseline in the Physician Global Impression of Severity (PhGIS) at Week 24, Patchy Alopecia Areata | Better by 4 points | 0 Participants |
p-value: 0.248Wilcoxon (Mann-Whitney)
p-value: 0.15Wilcoxon (Mann-Whitney)
p-value: 0.546Wilcoxon (Mann-Whitney)
Secondary
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.
Time frame: Baseline-Week 24
Population: Intent-to-treat population using Last Observation Carried Forward to address missing data. One patient was excluded from the analysis based on the visit windowing conventions that was previously established. This patient's Week 24 SGIS occurred at Day 128, which is outside of the window for inclusion of results at Week 24.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ATI-501 400mg BID Dosing | Change From Baseline in the Subject Global Impression of Severity (SGIS) at Week 24, Alopecia Universalis or Alopecia Totalis | Worse by 2 points | 0 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in the Subject Global Impression of Severity (SGIS) at Week 24, Alopecia Universalis or Alopecia Totalis | Worse by 1 point | 0 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in the Subject Global Impression of Severity (SGIS) at Week 24, Alopecia Universalis or Alopecia Totalis | Worse by 4 points | 0 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in the Subject Global Impression of Severity (SGIS) at Week 24, Alopecia Universalis or Alopecia Totalis | Better by 1 point | 2 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in the Subject Global Impression of Severity (SGIS) at Week 24, Alopecia Universalis or Alopecia Totalis | Better by 2 points | 2 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in the Subject Global Impression of Severity (SGIS) at Week 24, Alopecia Universalis or Alopecia Totalis | Better by 3 points | 1 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in the Subject Global Impression of Severity (SGIS) at Week 24, Alopecia Universalis or Alopecia Totalis | Worse by 3 points | 0 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in the Subject Global Impression of Severity (SGIS) at Week 24, Alopecia Universalis or Alopecia Totalis | No change | 6 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in the Subject Global Impression of Severity (SGIS) at Week 24, Alopecia Universalis or Alopecia Totalis | Better by 4 points | 0 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in the Subject Global Impression of Severity (SGIS) at Week 24, Alopecia Universalis or Alopecia Totalis | No change | 6 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in the Subject Global Impression of Severity (SGIS) at Week 24, Alopecia Universalis or Alopecia Totalis | Worse by 2 points | 0 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in the Subject Global Impression of Severity (SGIS) at Week 24, Alopecia Universalis or Alopecia Totalis | Worse by 1 point | 1 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in the Subject Global Impression of Severity (SGIS) at Week 24, Alopecia Universalis or Alopecia Totalis | Better by 3 points | 0 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in the Subject Global Impression of Severity (SGIS) at Week 24, Alopecia Universalis or Alopecia Totalis | Better by 4 points | 1 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in the Subject Global Impression of Severity (SGIS) at Week 24, Alopecia Universalis or Alopecia Totalis | Better by 2 points | 1 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in the Subject Global Impression of Severity (SGIS) at Week 24, Alopecia Universalis or Alopecia Totalis | Worse by 4 points | 0 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in the Subject Global Impression of Severity (SGIS) at Week 24, Alopecia Universalis or Alopecia Totalis | Worse by 3 points | 0 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in the Subject Global Impression of Severity (SGIS) at Week 24, Alopecia Universalis or Alopecia Totalis | Better by 1 point | 0 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in the Subject Global Impression of Severity (SGIS) at Week 24, Alopecia Universalis or Alopecia Totalis | No change | 4 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in the Subject Global Impression of Severity (SGIS) at Week 24, Alopecia Universalis or Alopecia Totalis | Better by 4 points | 1 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in the Subject Global Impression of Severity (SGIS) at Week 24, Alopecia Universalis or Alopecia Totalis | Better by 3 points | 3 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in the Subject Global Impression of Severity (SGIS) at Week 24, Alopecia Universalis or Alopecia Totalis | Better by 2 points | 2 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in the Subject Global Impression of Severity (SGIS) at Week 24, Alopecia Universalis or Alopecia Totalis | Better by 1 point | 3 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in the Subject Global Impression of Severity (SGIS) at Week 24, Alopecia Universalis or Alopecia Totalis | Worse by 1 point | 0 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in the Subject Global Impression of Severity (SGIS) at Week 24, Alopecia Universalis or Alopecia Totalis | Worse by 2 points | 0 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in the Subject Global Impression of Severity (SGIS) at Week 24, Alopecia Universalis or Alopecia Totalis | Worse by 3 points | 0 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in the Subject Global Impression of Severity (SGIS) at Week 24, Alopecia Universalis or Alopecia Totalis | Worse by 4 points | 0 Participants |
| Placebo | Change From Baseline in the Subject Global Impression of Severity (SGIS) at Week 24, Alopecia Universalis or Alopecia Totalis | Worse by 2 points | 0 Participants |
| Placebo | Change From Baseline in the Subject Global Impression of Severity (SGIS) at Week 24, Alopecia Universalis or Alopecia Totalis | Better by 1 point | 2 Participants |
| Placebo | Change From Baseline in the Subject Global Impression of Severity (SGIS) at Week 24, Alopecia Universalis or Alopecia Totalis | Better by 2 points | 0 Participants |
| Placebo | Change From Baseline in the Subject Global Impression of Severity (SGIS) at Week 24, Alopecia Universalis or Alopecia Totalis | Worse by 4 points | 0 Participants |
| Placebo | Change From Baseline in the Subject Global Impression of Severity (SGIS) at Week 24, Alopecia Universalis or Alopecia Totalis | Worse by 3 points | 0 Participants |
| Placebo | Change From Baseline in the Subject Global Impression of Severity (SGIS) at Week 24, Alopecia Universalis or Alopecia Totalis | Better by 3 points | 0 Participants |
| Placebo | Change From Baseline in the Subject Global Impression of Severity (SGIS) at Week 24, Alopecia Universalis or Alopecia Totalis | Worse by 1 point | 0 Participants |
| Placebo | Change From Baseline in the Subject Global Impression of Severity (SGIS) at Week 24, Alopecia Universalis or Alopecia Totalis | No change | 8 Participants |
| Placebo | Change From Baseline in the Subject Global Impression of Severity (SGIS) at Week 24, Alopecia Universalis or Alopecia Totalis | Better by 4 points | 0 Participants |
p-value: 0.194Wilcoxon (Mann-Whitney)
p-value: >0.999Wilcoxon (Mann-Whitney)
p-value: 0.011Wilcoxon (Mann-Whitney)
Secondary
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.
Time frame: Baseline-Week 24
Population: Intent-to-treat population using Last Observation Carried Forward to address missing data.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ATI-501 400mg BID Dosing | Change From Baseline in the Subject Global Impression of Severity (SGIS) at Week 24, Patchy Alopecia Areata | Worse by 2 points | 2 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in the Subject Global Impression of Severity (SGIS) at Week 24, Patchy Alopecia Areata | Worse by 1 point | 0 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in the Subject Global Impression of Severity (SGIS) at Week 24, Patchy Alopecia Areata | Better by 2 points | 3 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in the Subject Global Impression of Severity (SGIS) at Week 24, Patchy Alopecia Areata | Worse by 4 points | 0 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in the Subject Global Impression of Severity (SGIS) at Week 24, Patchy Alopecia Areata | Better by 3 points | 2 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in the Subject Global Impression of Severity (SGIS) at Week 24, Patchy Alopecia Areata | Worse by 3 points | 0 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in the Subject Global Impression of Severity (SGIS) at Week 24, Patchy Alopecia Areata | Better by 1 point | 1 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in the Subject Global Impression of Severity (SGIS) at Week 24, Patchy Alopecia Areata | No change | 3 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in the Subject Global Impression of Severity (SGIS) at Week 24, Patchy Alopecia Areata | Better by 4 points | 0 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in the Subject Global Impression of Severity (SGIS) at Week 24, Patchy Alopecia Areata | No change | 5 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in the Subject Global Impression of Severity (SGIS) at Week 24, Patchy Alopecia Areata | Worse by 2 points | 0 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in the Subject Global Impression of Severity (SGIS) at Week 24, Patchy Alopecia Areata | Worse by 1 point | 1 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in the Subject Global Impression of Severity (SGIS) at Week 24, Patchy Alopecia Areata | Better by 4 points | 1 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in the Subject Global Impression of Severity (SGIS) at Week 24, Patchy Alopecia Areata | Better by 3 points | 2 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in the Subject Global Impression of Severity (SGIS) at Week 24, Patchy Alopecia Areata | Better by 1 point | 3 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in the Subject Global Impression of Severity (SGIS) at Week 24, Patchy Alopecia Areata | Worse by 3 points | 0 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in the Subject Global Impression of Severity (SGIS) at Week 24, Patchy Alopecia Areata | Better by 2 points | 2 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in the Subject Global Impression of Severity (SGIS) at Week 24, Patchy Alopecia Areata | Worse by 4 points | 0 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in the Subject Global Impression of Severity (SGIS) at Week 24, Patchy Alopecia Areata | No change | 3 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in the Subject Global Impression of Severity (SGIS) at Week 24, Patchy Alopecia Areata | Better by 1 point | 3 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in the Subject Global Impression of Severity (SGIS) at Week 24, Patchy Alopecia Areata | Better by 4 points | 0 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in the Subject Global Impression of Severity (SGIS) at Week 24, Patchy Alopecia Areata | Better by 3 points | 0 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in the Subject Global Impression of Severity (SGIS) at Week 24, Patchy Alopecia Areata | Better by 2 points | 2 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in the Subject Global Impression of Severity (SGIS) at Week 24, Patchy Alopecia Areata | Worse by 1 point | 1 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in the Subject Global Impression of Severity (SGIS) at Week 24, Patchy Alopecia Areata | Worse by 2 points | 0 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in the Subject Global Impression of Severity (SGIS) at Week 24, Patchy Alopecia Areata | Worse by 3 points | 0 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in the Subject Global Impression of Severity (SGIS) at Week 24, Patchy Alopecia Areata | Worse by 4 points | 0 Participants |
| Placebo | Change From Baseline in the Subject Global Impression of Severity (SGIS) at Week 24, Patchy Alopecia Areata | Worse by 2 points | 1 Participants |
| Placebo | Change From Baseline in the Subject Global Impression of Severity (SGIS) at Week 24, Patchy Alopecia Areata | Better by 2 points | 1 Participants |
| Placebo | Change From Baseline in the Subject Global Impression of Severity (SGIS) at Week 24, Patchy Alopecia Areata | Better by 3 points | 0 Participants |
| Placebo | Change From Baseline in the Subject Global Impression of Severity (SGIS) at Week 24, Patchy Alopecia Areata | Worse by 4 points | 0 Participants |
| Placebo | Change From Baseline in the Subject Global Impression of Severity (SGIS) at Week 24, Patchy Alopecia Areata | Worse by 3 points | 0 Participants |
| Placebo | Change From Baseline in the Subject Global Impression of Severity (SGIS) at Week 24, Patchy Alopecia Areata | Better by 1 point | 3 Participants |
| Placebo | Change From Baseline in the Subject Global Impression of Severity (SGIS) at Week 24, Patchy Alopecia Areata | Worse by 1 point | 0 Participants |
| Placebo | Change From Baseline in the Subject Global Impression of Severity (SGIS) at Week 24, Patchy Alopecia Areata | No change | 4 Participants |
| Placebo | Change From Baseline in the Subject Global Impression of Severity (SGIS) at Week 24, Patchy Alopecia Areata | Better by 4 points | 0 Participants |
p-value: 0.43Wilcoxon (Mann-Whitney)
p-value: 0.288Wilcoxon (Mann-Whitney)
p-value: 0.582Wilcoxon (Mann-Whitney)
Secondary
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.
Time frame: Baseline-Week 24
Population: Intent-to-treat population using Last Observation Carried Forward to address missing data.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ATI-501 400mg BID Dosing | Change From Baseline in the Subject Global Satisfaction With Hair Quality (SGSHQ) for Entire Scalp at Week 24, Alopecia Universalis or Alopecia Totalis | Better by 6 points | 0 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in the Subject Global Satisfaction With Hair Quality (SGSHQ) for Entire Scalp at Week 24, Alopecia Universalis or Alopecia Totalis | Better by 5 points | 1 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in the Subject Global Satisfaction With Hair Quality (SGSHQ) for Entire Scalp at Week 24, Alopecia Universalis or Alopecia Totalis | Better by 4 points | 2 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in the Subject Global Satisfaction With Hair Quality (SGSHQ) for Entire Scalp at Week 24, Alopecia Universalis or Alopecia Totalis | Better by 3 points | 3 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in the Subject Global Satisfaction With Hair Quality (SGSHQ) for Entire Scalp at Week 24, Alopecia Universalis or Alopecia Totalis | Better by 2 points | 0 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in the Subject Global Satisfaction With Hair Quality (SGSHQ) for Entire Scalp at Week 24, Alopecia Universalis or Alopecia Totalis | Better by 1 point | 0 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in the Subject Global Satisfaction With Hair Quality (SGSHQ) for Entire Scalp at Week 24, Alopecia Universalis or Alopecia Totalis | No change | 5 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in the Subject Global Satisfaction With Hair Quality (SGSHQ) for Entire Scalp at Week 24, Alopecia Universalis or Alopecia Totalis | Worse by 1 point | 0 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in the Subject Global Satisfaction With Hair Quality (SGSHQ) for Entire Scalp at Week 24, Alopecia Universalis or Alopecia Totalis | Worse by 2 points | 1 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in the Subject Global Satisfaction With Hair Quality (SGSHQ) for Entire Scalp at Week 24, Alopecia Universalis or Alopecia Totalis | Worse by 3 points | 0 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in the Subject Global Satisfaction With Hair Quality (SGSHQ) for Entire Scalp at Week 24, Alopecia Universalis or Alopecia Totalis | Worse by 4 points | 0 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in the Subject Global Satisfaction With Hair Quality (SGSHQ) for Entire Scalp at Week 24, Alopecia Universalis or Alopecia Totalis | Worse by 5 points | 0 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in the Subject Global Satisfaction With Hair Quality (SGSHQ) for Entire Scalp at Week 24, Alopecia Universalis or Alopecia Totalis | Worse by 6 points | 0 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in the Subject Global Satisfaction With Hair Quality (SGSHQ) for Entire Scalp at Week 24, Alopecia Universalis or Alopecia Totalis | Better by 3 points | 3 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in the Subject Global Satisfaction With Hair Quality (SGSHQ) for Entire Scalp at Week 24, Alopecia Universalis or Alopecia Totalis | Worse by 6 points | 0 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in the Subject Global Satisfaction With Hair Quality (SGSHQ) for Entire Scalp at Week 24, Alopecia Universalis or Alopecia Totalis | Worse by 4 points | 0 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in the Subject Global Satisfaction With Hair Quality (SGSHQ) for Entire Scalp at Week 24, Alopecia Universalis or Alopecia Totalis | Worse by 1 point | 0 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in the Subject Global Satisfaction With Hair Quality (SGSHQ) for Entire Scalp at Week 24, Alopecia Universalis or Alopecia Totalis | Better by 4 points | 1 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in the Subject Global Satisfaction With Hair Quality (SGSHQ) for Entire Scalp at Week 24, Alopecia Universalis or Alopecia Totalis | Better by 6 points | 1 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in the Subject Global Satisfaction With Hair Quality (SGSHQ) for Entire Scalp at Week 24, Alopecia Universalis or Alopecia Totalis | Worse by 3 points | 0 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in the Subject Global Satisfaction With Hair Quality (SGSHQ) for Entire Scalp at Week 24, Alopecia Universalis or Alopecia Totalis | Worse by 2 points | 0 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in the Subject Global Satisfaction With Hair Quality (SGSHQ) for Entire Scalp at Week 24, Alopecia Universalis or Alopecia Totalis | Better by 1 point | 0 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in the Subject Global Satisfaction With Hair Quality (SGSHQ) for Entire Scalp at Week 24, Alopecia Universalis or Alopecia Totalis | Better by 2 points | 2 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in the Subject Global Satisfaction With Hair Quality (SGSHQ) for Entire Scalp at Week 24, Alopecia Universalis or Alopecia Totalis | Better by 5 points | 0 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in the Subject Global Satisfaction With Hair Quality (SGSHQ) for Entire Scalp at Week 24, Alopecia Universalis or Alopecia Totalis | Worse by 5 points | 1 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in the Subject Global Satisfaction With Hair Quality (SGSHQ) for Entire Scalp at Week 24, Alopecia Universalis or Alopecia Totalis | No change | 1 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in the Subject Global Satisfaction With Hair Quality (SGSHQ) for Entire Scalp at Week 24, Alopecia Universalis or Alopecia Totalis | Worse by 4 points | 0 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in the Subject Global Satisfaction With Hair Quality (SGSHQ) for Entire Scalp at Week 24, Alopecia Universalis or Alopecia Totalis | Better by 3 points | 1 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in the Subject Global Satisfaction With Hair Quality (SGSHQ) for Entire Scalp at Week 24, Alopecia Universalis or Alopecia Totalis | Better by 2 points | 0 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in the Subject Global Satisfaction With Hair Quality (SGSHQ) for Entire Scalp at Week 24, Alopecia Universalis or Alopecia Totalis | Worse by 6 points | 0 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in the Subject Global Satisfaction With Hair Quality (SGSHQ) for Entire Scalp at Week 24, Alopecia Universalis or Alopecia Totalis | Better by 1 point | 2 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in the Subject Global Satisfaction With Hair Quality (SGSHQ) for Entire Scalp at Week 24, Alopecia Universalis or Alopecia Totalis | No change | 3 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in the Subject Global Satisfaction With Hair Quality (SGSHQ) for Entire Scalp at Week 24, Alopecia Universalis or Alopecia Totalis | Worse by 5 points | 0 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in the Subject Global Satisfaction With Hair Quality (SGSHQ) for Entire Scalp at Week 24, Alopecia Universalis or Alopecia Totalis | Worse by 1 point | 0 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in the Subject Global Satisfaction With Hair Quality (SGSHQ) for Entire Scalp at Week 24, Alopecia Universalis or Alopecia Totalis | Worse by 2 points | 1 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in the Subject Global Satisfaction With Hair Quality (SGSHQ) for Entire Scalp at Week 24, Alopecia Universalis or Alopecia Totalis | Worse by 3 points | 1 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in the Subject Global Satisfaction With Hair Quality (SGSHQ) for Entire Scalp at Week 24, Alopecia Universalis or Alopecia Totalis | Better by 6 points | 0 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in the Subject Global Satisfaction With Hair Quality (SGSHQ) for Entire Scalp at Week 24, Alopecia Universalis or Alopecia Totalis | Better by 5 points | 5 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in the Subject Global Satisfaction With Hair Quality (SGSHQ) for Entire Scalp at Week 24, Alopecia Universalis or Alopecia Totalis | Better by 4 points | 0 Participants |
| Placebo | Change From Baseline in the Subject Global Satisfaction With Hair Quality (SGSHQ) for Entire Scalp at Week 24, Alopecia Universalis or Alopecia Totalis | Worse by 3 points | 0 Participants |
| Placebo | Change From Baseline in the Subject Global Satisfaction With Hair Quality (SGSHQ) for Entire Scalp at Week 24, Alopecia Universalis or Alopecia Totalis | Worse by 1 point | 0 Participants |
| Placebo | Change From Baseline in the Subject Global Satisfaction With Hair Quality (SGSHQ) for Entire Scalp at Week 24, Alopecia Universalis or Alopecia Totalis | Better by 3 points | 2 Participants |
| Placebo | Change From Baseline in the Subject Global Satisfaction With Hair Quality (SGSHQ) for Entire Scalp at Week 24, Alopecia Universalis or Alopecia Totalis | Better by 6 points | 0 Participants |
| Placebo | Change From Baseline in the Subject Global Satisfaction With Hair Quality (SGSHQ) for Entire Scalp at Week 24, Alopecia Universalis or Alopecia Totalis | No change | 5 Participants |
| Placebo | Change From Baseline in the Subject Global Satisfaction With Hair Quality (SGSHQ) for Entire Scalp at Week 24, Alopecia Universalis or Alopecia Totalis | Better by 1 point | 2 Participants |
| Placebo | Change From Baseline in the Subject Global Satisfaction With Hair Quality (SGSHQ) for Entire Scalp at Week 24, Alopecia Universalis or Alopecia Totalis | Better by 4 points | 0 Participants |
| Placebo | Change From Baseline in the Subject Global Satisfaction With Hair Quality (SGSHQ) for Entire Scalp at Week 24, Alopecia Universalis or Alopecia Totalis | Better by 5 points | 0 Participants |
| Placebo | Change From Baseline in the Subject Global Satisfaction With Hair Quality (SGSHQ) for Entire Scalp at Week 24, Alopecia Universalis or Alopecia Totalis | Better by 2 points | 1 Participants |
| Placebo | Change From Baseline in the Subject Global Satisfaction With Hair Quality (SGSHQ) for Entire Scalp at Week 24, Alopecia Universalis or Alopecia Totalis | Worse by 2 points | 0 Participants |
| Placebo | Change From Baseline in the Subject Global Satisfaction With Hair Quality (SGSHQ) for Entire Scalp at Week 24, Alopecia Universalis or Alopecia Totalis | Worse by 6 points | 0 Participants |
| Placebo | Change From Baseline in the Subject Global Satisfaction With Hair Quality (SGSHQ) for Entire Scalp at Week 24, Alopecia Universalis or Alopecia Totalis | Worse by 5 points | 0 Participants |
| Placebo | Change From Baseline in the Subject Global Satisfaction With Hair Quality (SGSHQ) for Entire Scalp at Week 24, Alopecia Universalis or Alopecia Totalis | Worse by 4 points | 0 Participants |
p-value: 0.522Wilcoxon (Mann-Whitney)
p-value: 0.104Wilcoxon (Mann-Whitney)
p-value: 0.414Wilcoxon (Mann-Whitney)
Secondary
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.
Time frame: Baseline-Week 24
Population: Intent-to-treat population using Last Observation Carried Forward to address missing data.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ATI-501 400mg BID Dosing | Change From Baseline in the Subject Global Satisfaction With Hair Quality (SGSHQ) for Entire Scalp at Week 24, Patchy Alopecia Areata | Better by 6 points | 4 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in the Subject Global Satisfaction With Hair Quality (SGSHQ) for Entire Scalp at Week 24, Patchy Alopecia Areata | Better by 5 points | 1 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in the Subject Global Satisfaction With Hair Quality (SGSHQ) for Entire Scalp at Week 24, Patchy Alopecia Areata | Better by 4 points | 0 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in the Subject Global Satisfaction With Hair Quality (SGSHQ) for Entire Scalp at Week 24, Patchy Alopecia Areata | Better by 3 points | 1 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in the Subject Global Satisfaction With Hair Quality (SGSHQ) for Entire Scalp at Week 24, Patchy Alopecia Areata | Better by 2 points | 0 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in the Subject Global Satisfaction With Hair Quality (SGSHQ) for Entire Scalp at Week 24, Patchy Alopecia Areata | Better by 1 points | 0 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in the Subject Global Satisfaction With Hair Quality (SGSHQ) for Entire Scalp at Week 24, Patchy Alopecia Areata | No change | 4 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in the Subject Global Satisfaction With Hair Quality (SGSHQ) for Entire Scalp at Week 24, Patchy Alopecia Areata | Worse by 1 point | 1 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in the Subject Global Satisfaction With Hair Quality (SGSHQ) for Entire Scalp at Week 24, Patchy Alopecia Areata | Worse by 2 points | 0 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in the Subject Global Satisfaction With Hair Quality (SGSHQ) for Entire Scalp at Week 24, Patchy Alopecia Areata | Worse by 3 points | 0 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in the Subject Global Satisfaction With Hair Quality (SGSHQ) for Entire Scalp at Week 24, Patchy Alopecia Areata | Worse by 4 points | 0 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in the Subject Global Satisfaction With Hair Quality (SGSHQ) for Entire Scalp at Week 24, Patchy Alopecia Areata | Worse by 5 points | 0 Participants |
| ATI-501 400mg BID Dosing | Change From Baseline in the Subject Global Satisfaction With Hair Quality (SGSHQ) for Entire Scalp at Week 24, Patchy Alopecia Areata | Worse by 6 points | 0 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in the Subject Global Satisfaction With Hair Quality (SGSHQ) for Entire Scalp at Week 24, Patchy Alopecia Areata | Better by 3 points | 0 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in the Subject Global Satisfaction With Hair Quality (SGSHQ) for Entire Scalp at Week 24, Patchy Alopecia Areata | Worse by 6 points | 0 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in the Subject Global Satisfaction With Hair Quality (SGSHQ) for Entire Scalp at Week 24, Patchy Alopecia Areata | Worse by 4 points | 0 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in the Subject Global Satisfaction With Hair Quality (SGSHQ) for Entire Scalp at Week 24, Patchy Alopecia Areata | Worse by 1 point | 0 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in the Subject Global Satisfaction With Hair Quality (SGSHQ) for Entire Scalp at Week 24, Patchy Alopecia Areata | Better by 4 points | 1 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in the Subject Global Satisfaction With Hair Quality (SGSHQ) for Entire Scalp at Week 24, Patchy Alopecia Areata | Better by 6 points | 4 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in the Subject Global Satisfaction With Hair Quality (SGSHQ) for Entire Scalp at Week 24, Patchy Alopecia Areata | Worse by 3 points | 0 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in the Subject Global Satisfaction With Hair Quality (SGSHQ) for Entire Scalp at Week 24, Patchy Alopecia Areata | Worse by 2 points | 0 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in the Subject Global Satisfaction With Hair Quality (SGSHQ) for Entire Scalp at Week 24, Patchy Alopecia Areata | Better by 1 points | 2 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in the Subject Global Satisfaction With Hair Quality (SGSHQ) for Entire Scalp at Week 24, Patchy Alopecia Areata | Better by 2 points | 3 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in the Subject Global Satisfaction With Hair Quality (SGSHQ) for Entire Scalp at Week 24, Patchy Alopecia Areata | Better by 5 points | 0 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in the Subject Global Satisfaction With Hair Quality (SGSHQ) for Entire Scalp at Week 24, Patchy Alopecia Areata | Worse by 5 points | 0 Participants |
| ATI-501 600mg BID Dosing | Change From Baseline in the Subject Global Satisfaction With Hair Quality (SGSHQ) for Entire Scalp at Week 24, Patchy Alopecia Areata | No change | 4 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in the Subject Global Satisfaction With Hair Quality (SGSHQ) for Entire Scalp at Week 24, Patchy Alopecia Areata | Worse by 4 points | 0 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in the Subject Global Satisfaction With Hair Quality (SGSHQ) for Entire Scalp at Week 24, Patchy Alopecia Areata | Better by 3 points | 1 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in the Subject Global Satisfaction With Hair Quality (SGSHQ) for Entire Scalp at Week 24, Patchy Alopecia Areata | Better by 2 points | 0 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in the Subject Global Satisfaction With Hair Quality (SGSHQ) for Entire Scalp at Week 24, Patchy Alopecia Areata | Worse by 6 points | 0 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in the Subject Global Satisfaction With Hair Quality (SGSHQ) for Entire Scalp at Week 24, Patchy Alopecia Areata | Better by 1 points | 1 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in the Subject Global Satisfaction With Hair Quality (SGSHQ) for Entire Scalp at Week 24, Patchy Alopecia Areata | No change | 2 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in the Subject Global Satisfaction With Hair Quality (SGSHQ) for Entire Scalp at Week 24, Patchy Alopecia Areata | Worse by 5 points | 0 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in the Subject Global Satisfaction With Hair Quality (SGSHQ) for Entire Scalp at Week 24, Patchy Alopecia Areata | Worse by 1 point | 0 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in the Subject Global Satisfaction With Hair Quality (SGSHQ) for Entire Scalp at Week 24, Patchy Alopecia Areata | Worse by 2 points | 1 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in the Subject Global Satisfaction With Hair Quality (SGSHQ) for Entire Scalp at Week 24, Patchy Alopecia Areata | Worse by 3 points | 1 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in the Subject Global Satisfaction With Hair Quality (SGSHQ) for Entire Scalp at Week 24, Patchy Alopecia Areata | Better by 6 points | 0 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in the Subject Global Satisfaction With Hair Quality (SGSHQ) for Entire Scalp at Week 24, Patchy Alopecia Areata | Better by 5 points | 1 Participants |
| ATI-501 800mg BID Dosing | Change From Baseline in the Subject Global Satisfaction With Hair Quality (SGSHQ) for Entire Scalp at Week 24, Patchy Alopecia Areata | Better by 4 points | 2 Participants |
| Placebo | Change From Baseline in the Subject Global Satisfaction With Hair Quality (SGSHQ) for Entire Scalp at Week 24, Patchy Alopecia Areata | Worse by 3 points | 0 Participants |
| Placebo | Change From Baseline in the Subject Global Satisfaction With Hair Quality (SGSHQ) for Entire Scalp at Week 24, Patchy Alopecia Areata | Worse by 1 point | 0 Participants |
| Placebo | Change From Baseline in the Subject Global Satisfaction With Hair Quality (SGSHQ) for Entire Scalp at Week 24, Patchy Alopecia Areata | Better by 3 points | 1 Participants |
| Placebo | Change From Baseline in the Subject Global Satisfaction With Hair Quality (SGSHQ) for Entire Scalp at Week 24, Patchy Alopecia Areata | Better by 6 points | 0 Participants |
| Placebo | Change From Baseline in the Subject Global Satisfaction With Hair Quality (SGSHQ) for Entire Scalp at Week 24, Patchy Alopecia Areata | No change | 4 Participants |
| Placebo | Change From Baseline in the Subject Global Satisfaction With Hair Quality (SGSHQ) for Entire Scalp at Week 24, Patchy Alopecia Areata | Better by 1 points | 1 Participants |
| Placebo | Change From Baseline in the Subject Global Satisfaction With Hair Quality (SGSHQ) for Entire Scalp at Week 24, Patchy Alopecia Areata | Better by 4 points | 1 Participants |
| Placebo | Change From Baseline in the Subject Global Satisfaction With Hair Quality (SGSHQ) for Entire Scalp at Week 24, Patchy Alopecia Areata | Better by 5 points | 0 Participants |
| Placebo | Change From Baseline in the Subject Global Satisfaction With Hair Quality (SGSHQ) for Entire Scalp at Week 24, Patchy Alopecia Areata | Better by 2 points | 0 Participants |
| Placebo | Change From Baseline in the Subject Global Satisfaction With Hair Quality (SGSHQ) for Entire Scalp at Week 24, Patchy Alopecia Areata | Worse by 2 points | 0 Participants |
| Placebo | Change From Baseline in the Subject Global Satisfaction With Hair Quality (SGSHQ) for Entire Scalp at Week 24, Patchy Alopecia Areata | Worse by 6 points | 0 Participants |
| Placebo | Change From Baseline in the Subject Global Satisfaction With Hair Quality (SGSHQ) for Entire Scalp at Week 24, Patchy Alopecia Areata | Worse by 5 points | 0 Participants |
| Placebo | Change From Baseline in the Subject Global Satisfaction With Hair Quality (SGSHQ) for Entire Scalp at Week 24, Patchy Alopecia Areata | Worse by 4 points | 0 Participants |
p-value: 0.361Wilcoxon (Mann-Whitney)
p-value: 0.182Wilcoxon (Mann-Whitney)
p-value: 0.815Wilcoxon (Mann-Whitney)
Secondary
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.
Time frame: Baseline-Week 24
Population: Intent-to-treat population using Last Observation Carried Forward to address missing data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ATI-501 400mg BID Dosing | Change in Dermatology Life Quality Index Total Score (DLQI) Between Baseline and Week 24 | -1.5 score on a scale | Standard Deviation 4.33 |
| ATI-501 600mg BID Dosing | Change in Dermatology Life Quality Index Total Score (DLQI) Between Baseline and Week 24 | -5.3 score on a scale | Standard Deviation 5.21 |
| ATI-501 800mg BID Dosing | Change in Dermatology Life Quality Index Total Score (DLQI) Between Baseline and Week 24 | -1.7 score on a scale | Standard Deviation 3.97 |
| Placebo | Change in Dermatology Life Quality Index Total Score (DLQI) Between Baseline and Week 24 | -1.7 score on a scale | Standard Deviation 5.99 |
p-value: 0.88295% CI: [-2.53, 2.94]Mixed Models Analysis
p-value: 0.01195% CI: [-6.31, -0.84]Mixed Models Analysis
p-value: 0.99995% CI: [-2.76, 2.76]Mixed Models Analysis
Secondary
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.
Time frame: Baseline-Week 24
Population: Intent-to-treat population using Last Observation Carried Forward to address missing data.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ATI-501 400mg BID Dosing | Count of Subjects Achieving at Least a 50% Reduction in Alopecia Density and Extent (ALODEX) Score at Week 24 | 6 Participants |
| ATI-501 600mg BID Dosing | Count of Subjects Achieving at Least a 50% Reduction in Alopecia Density and Extent (ALODEX) Score at Week 24 | 7 Participants |
| ATI-501 800mg BID Dosing | Count of Subjects Achieving at Least a 50% Reduction in Alopecia Density and Extent (ALODEX) Score at Week 24 | 5 Participants |
| Placebo | Count of Subjects Achieving at Least a 50% Reduction in Alopecia Density and Extent (ALODEX) Score at Week 24 | 1 Participants |
p-value: 0.12495% CI: [0.7, 31.8]Mixed Models Analysis
p-value: 0.07995% CI: [0.8, 38.3]Mixed Models Analysis
p-value: 0.17795% CI: [0.5, 27.7]Mixed Models Analysis
Secondary
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.
Time frame: Baseline-Week 24
Population: Intent-to-treat population using Last Observation Carried Forward to address missing data.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ATI-501 400mg BID Dosing | 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 | 6 Participants |
| ATI-501 600mg BID Dosing | 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 | 7 Participants |
| ATI-501 800mg BID Dosing | 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 | 5 Participants |
| Placebo | 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 | 1 Participants |
p-value: 0.12495% CI: [0.7, 31.8]Mixed Models Analysis
p-value: 0.07995% CI: [0.8, 38.3]Mixed Models Analysis
p-value: 0.17795% CI: [0.5, 27.7]Mixed Models Analysis
Secondary
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.
Time frame: Baseline-Week 24
Population: Intent-to-treat population using Last Observation Carried Forward to address missing data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ATI-501 400mg BID Dosing | Mean Change From Baseline in the Alopecia Density and Extent (ALODEX) Score at Week 24 | -17.6 score on a scale | Standard Deviation 26.93 |
| ATI-501 600mg BID Dosing | Mean Change From Baseline in the Alopecia Density and Extent (ALODEX) Score at Week 24 | -22.2 score on a scale | Standard Deviation 28.99 |
| ATI-501 800mg BID Dosing | Mean Change From Baseline in the Alopecia Density and Extent (ALODEX) Score at Week 24 | -20.7 score on a scale | Standard Deviation 25.04 |
| Placebo | Mean Change From Baseline in the Alopecia Density and Extent (ALODEX) Score at Week 24 | -3.2 score on a scale | Standard Deviation 8.42 |
p-value: 0.00895% CI: [-24.95, -3.84]Mixed Models Analysis
p-value: <0.00195% CI: [-29.56, -8.45]Mixed Models Analysis
p-value: 0.00195% CI: [-28.18, -6.86]Mixed Models Analysis
Secondary
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.
Time frame: Baseline-Week 24
Population: Intent-to-treat population using Last Observation Carried Forward to address missing data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ATI-501 400mg BID Dosing | Mean Change From Baseline in the Severity of Alopecia Tool (SALT) Score at Week 24 | -14.6 score on a scale | Standard Deviation 23.67 |
| ATI-501 600mg BID Dosing | Mean Change From Baseline in the Severity of Alopecia Tool (SALT) Score at Week 24 | -18.6 score on a scale | Standard Deviation 27.29 |
| ATI-501 800mg BID Dosing | Mean Change From Baseline in the Severity of Alopecia Tool (SALT) Score at Week 24 | -20.9 score on a scale | Standard Deviation 26.5 |
| Placebo | Mean Change From Baseline in the Severity of Alopecia Tool (SALT) Score at Week 24 | -3.3 score on a scale | Standard Deviation 8.21 |
p-value: 0.02595% CI: [-21.14, -1.45]Mixed Models Analysis
p-value: 0.00395% CI: [-25.1, -5.4]Mixed Models Analysis
p-value: <0.00195% CI: [-27.49, -7.6]Mixed Models Analysis
Secondary
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.
Time frame: Baseline-Week 24
Population: Intent-to-treat population using LOCF to address missing data.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| ATI-501 400mg BID Dosing | Percent Change From Baseline in the Alopecia Density and Extent Score (ALODEX) at Week 24 | -26.88 percent | Standard Error 5.165 |
| ATI-501 600mg BID Dosing | Percent Change From Baseline in the Alopecia Density and Extent Score (ALODEX) at Week 24 | -32.24 percent | Standard Error 5.165 |
| ATI-501 800mg BID Dosing | Percent Change From Baseline in the Alopecia Density and Extent Score (ALODEX) at Week 24 | -26.87 percent | Standard Error 5.281 |
| Placebo | Percent Change From Baseline in the Alopecia Density and Extent Score (ALODEX) at Week 24 | -7.70 percent | Standard Error 5.683 |
p-value: 0.01395% CI: [-34.33, -4.02]Mixed Models Analysis
p-value: 0.00295% CI: [-39.69, -9.38]Mixed Models Analysis
p-value: 0.01495% CI: [-34.48, -3.86]Mixed Models Analysis
Secondary
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.
Time frame: Baseline-Week 24
Population: Intent-to-treat population using Last Observation Carried Forward (LOCF) to address missing data. Per SAP, the allowed window days for Week 24 visit are 155-182. There were 4 patients in the 400mg group, 4 patients in the 600mg group, 3 patients in the 800mg group, and 5 patients in the placebo group who fell outside this window.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ATI-501 400mg BID Dosing | Physician Global Impression of Change (PhGIC) at Week 24 | Much worse | 0 Participants |
| ATI-501 400mg BID Dosing | Physician Global Impression of Change (PhGIC) at Week 24 | No change | 8 Participants |
| ATI-501 400mg BID Dosing | Physician Global Impression of Change (PhGIC) at Week 24 | A little improved | 2 Participants |
| ATI-501 400mg BID Dosing | Physician Global Impression of Change (PhGIC) at Week 24 | Very much worse | 0 Participants |
| ATI-501 400mg BID Dosing | Physician Global Impression of Change (PhGIC) at Week 24 | A little worse | 1 Participants |
| ATI-501 400mg BID Dosing | Physician Global Impression of Change (PhGIC) at Week 24 | Much improved | 3 Participants |
| ATI-501 400mg BID Dosing | Physician Global Impression of Change (PhGIC) at Week 24 | Very much improved | 5 Participants |
| ATI-501 600mg BID Dosing | Physician Global Impression of Change (PhGIC) at Week 24 | No change | 7 Participants |
| ATI-501 600mg BID Dosing | Physician Global Impression of Change (PhGIC) at Week 24 | Very much improved | 7 Participants |
| ATI-501 600mg BID Dosing | Physician Global Impression of Change (PhGIC) at Week 24 | Much improved | 0 Participants |
| ATI-501 600mg BID Dosing | Physician Global Impression of Change (PhGIC) at Week 24 | A little improved | 5 Participants |
| ATI-501 600mg BID Dosing | Physician Global Impression of Change (PhGIC) at Week 24 | A little worse | 0 Participants |
| ATI-501 600mg BID Dosing | Physician Global Impression of Change (PhGIC) at Week 24 | Much worse | 0 Participants |
| ATI-501 600mg BID Dosing | Physician Global Impression of Change (PhGIC) at Week 24 | Very much worse | 0 Participants |
| ATI-501 800mg BID Dosing | Physician Global Impression of Change (PhGIC) at Week 24 | Much improved | 6 Participants |
| ATI-501 800mg BID Dosing | Physician Global Impression of Change (PhGIC) at Week 24 | No change | 4 Participants |
| ATI-501 800mg BID Dosing | Physician Global Impression of Change (PhGIC) at Week 24 | A little worse | 1 Participants |
| ATI-501 800mg BID Dosing | Physician Global Impression of Change (PhGIC) at Week 24 | Very much worse | 0 Participants |
| ATI-501 800mg BID Dosing | Physician Global Impression of Change (PhGIC) at Week 24 | Much worse | 0 Participants |
| ATI-501 800mg BID Dosing | Physician Global Impression of Change (PhGIC) at Week 24 | Very much improved | 3 Participants |
| ATI-501 800mg BID Dosing | Physician Global Impression of Change (PhGIC) at Week 24 | A little improved | 5 Participants |
| Placebo | Physician Global Impression of Change (PhGIC) at Week 24 | A little improved | 5 Participants |
| Placebo | Physician Global Impression of Change (PhGIC) at Week 24 | Much improved | 0 Participants |
| Placebo | Physician Global Impression of Change (PhGIC) at Week 24 | No change | 7 Participants |
| Placebo | Physician Global Impression of Change (PhGIC) at Week 24 | Very much improved | 2 Participants |
| Placebo | Physician Global Impression of Change (PhGIC) at Week 24 | Very much worse | 0 Participants |
| Placebo | Physician Global Impression of Change (PhGIC) at Week 24 | Much worse | 0 Participants |
| Placebo | Physician Global Impression of Change (PhGIC) at Week 24 | A little worse | 0 Participants |
p-value: 0.584Wilcoxon (Mann-Whitney)
p-value: 0.287Wilcoxon (Mann-Whitney)
p-value: 0.144Wilcoxon (Mann-Whitney)
Secondary
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.
Time frame: Baseline-Week 24
Population: Intent-to-treat population using Last Observation Carried Forward (LOCF) to address missing data. Per SAP, the allowed window days for Week 24 visit are 155-182. There were 4 patients in the 400mg group, 4 patients in the 600mg group, 3 patients in the 800mg group, and 5 patients in the placebo group who fell outside this window.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ATI-501 400mg BID Dosing | Subject Global Impression of Change (SGIC) at Week 24 | Very much improved | 5 Participants |
| ATI-501 400mg BID Dosing | Subject Global Impression of Change (SGIC) at Week 24 | Much worse | 0 Participants |
| ATI-501 400mg BID Dosing | Subject Global Impression of Change (SGIC) at Week 24 | A little worse | 0 Participants |
| ATI-501 400mg BID Dosing | Subject Global Impression of Change (SGIC) at Week 24 | Much improved | 3 Participants |
| ATI-501 400mg BID Dosing | Subject Global Impression of Change (SGIC) at Week 24 | Very much worse | 0 Participants |
| ATI-501 400mg BID Dosing | Subject Global Impression of Change (SGIC) at Week 24 | A little improved | 4 Participants |
| ATI-501 400mg BID Dosing | Subject Global Impression of Change (SGIC) at Week 24 | No change | 7 Participants |
| ATI-501 600mg BID Dosing | Subject Global Impression of Change (SGIC) at Week 24 | Much worse | 0 Participants |
| ATI-501 600mg BID Dosing | Subject Global Impression of Change (SGIC) at Week 24 | No change | 7 Participants |
| ATI-501 600mg BID Dosing | Subject Global Impression of Change (SGIC) at Week 24 | A little improved | 5 Participants |
| ATI-501 600mg BID Dosing | Subject Global Impression of Change (SGIC) at Week 24 | A little worse | 0 Participants |
| ATI-501 600mg BID Dosing | Subject Global Impression of Change (SGIC) at Week 24 | Very much worse | 0 Participants |
| ATI-501 600mg BID Dosing | Subject Global Impression of Change (SGIC) at Week 24 | Much improved | 1 Participants |
| ATI-501 600mg BID Dosing | Subject Global Impression of Change (SGIC) at Week 24 | Very much improved | 6 Participants |
| ATI-501 800mg BID Dosing | Subject Global Impression of Change (SGIC) at Week 24 | No change | 3 Participants |
| ATI-501 800mg BID Dosing | Subject Global Impression of Change (SGIC) at Week 24 | Very much improved | 2 Participants |
| ATI-501 800mg BID Dosing | Subject Global Impression of Change (SGIC) at Week 24 | Much improved | 7 Participants |
| ATI-501 800mg BID Dosing | Subject Global Impression of Change (SGIC) at Week 24 | A little improved | 6 Participants |
| ATI-501 800mg BID Dosing | Subject Global Impression of Change (SGIC) at Week 24 | A little worse | 1 Participants |
| ATI-501 800mg BID Dosing | Subject Global Impression of Change (SGIC) at Week 24 | Much worse | 0 Participants |
| ATI-501 800mg BID Dosing | Subject Global Impression of Change (SGIC) at Week 24 | Very much worse | 0 Participants |
| Placebo | Subject Global Impression of Change (SGIC) at Week 24 | A little improved | 6 Participants |
| Placebo | Subject Global Impression of Change (SGIC) at Week 24 | Very much worse | 0 Participants |
| Placebo | Subject Global Impression of Change (SGIC) at Week 24 | Much worse | 0 Participants |
| Placebo | Subject Global Impression of Change (SGIC) at Week 24 | Much improved | 1 Participants |
| Placebo | Subject Global Impression of Change (SGIC) at Week 24 | Very much improved | 1 Participants |
| Placebo | Subject Global Impression of Change (SGIC) at Week 24 | A little worse | 0 Participants |
| Placebo | Subject Global Impression of Change (SGIC) at Week 24 | No change | 6 Participants |
p-value: 0.27Wilcoxon (Mann-Whitney)
p-value: 0.319Wilcoxon (Mann-Whitney)
p-value: 0.094Wilcoxon (Mann-Whitney)
Secondary
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.
Time frame: Baseline-Week 24
Population: Intent-to-treat population using Last Observation Carried Forward to address missing data.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ATI-501 400mg BID Dosing | Subject Global Impression of Treatment Satisfaction (SGITS) at Week 24, Alopecia Universalis or Alopecia Totalis | Extremely satisfied | 1 Participants |
| ATI-501 400mg BID Dosing | Subject Global Impression of Treatment Satisfaction (SGITS) at Week 24, Alopecia Universalis or Alopecia Totalis | Moderately dissatisfied | 1 Participants |
| ATI-501 400mg BID Dosing | Subject Global Impression of Treatment Satisfaction (SGITS) at Week 24, Alopecia Universalis or Alopecia Totalis | A little dissatisfied | 1 Participants |
| ATI-501 400mg BID Dosing | Subject Global Impression of Treatment Satisfaction (SGITS) at Week 24, Alopecia Universalis or Alopecia Totalis | Moderately satisfied | 3 Participants |
| ATI-501 400mg BID Dosing | Subject Global Impression of Treatment Satisfaction (SGITS) at Week 24, Alopecia Universalis or Alopecia Totalis | Extremely dissatisfied | 1 Participants |
| ATI-501 400mg BID Dosing | Subject Global Impression of Treatment Satisfaction (SGITS) at Week 24, Alopecia Universalis or Alopecia Totalis | A little satisfied | 1 Participants |
| ATI-501 400mg BID Dosing | Subject Global Impression of Treatment Satisfaction (SGITS) at Week 24, Alopecia Universalis or Alopecia Totalis | Neither satisfied or dissatisfied | 4 Participants |
| ATI-501 600mg BID Dosing | Subject Global Impression of Treatment Satisfaction (SGITS) at Week 24, Alopecia Universalis or Alopecia Totalis | Moderately dissatisfied | 1 Participants |
| ATI-501 600mg BID Dosing | Subject Global Impression of Treatment Satisfaction (SGITS) at Week 24, Alopecia Universalis or Alopecia Totalis | Neither satisfied or dissatisfied | 3 Participants |
| ATI-501 600mg BID Dosing | Subject Global Impression of Treatment Satisfaction (SGITS) at Week 24, Alopecia Universalis or Alopecia Totalis | A little satisfied | 2 Participants |
| ATI-501 600mg BID Dosing | Subject Global Impression of Treatment Satisfaction (SGITS) at Week 24, Alopecia Universalis or Alopecia Totalis | A little dissatisfied | 0 Participants |
| ATI-501 600mg BID Dosing | Subject Global Impression of Treatment Satisfaction (SGITS) at Week 24, Alopecia Universalis or Alopecia Totalis | Extremely dissatisfied | 1 Participants |
| ATI-501 600mg BID Dosing | Subject Global Impression of Treatment Satisfaction (SGITS) at Week 24, Alopecia Universalis or Alopecia Totalis | Moderately satisfied | 1 Participants |
| ATI-501 600mg BID Dosing | Subject Global Impression of Treatment Satisfaction (SGITS) at Week 24, Alopecia Universalis or Alopecia Totalis | Extremely satisfied | 1 Participants |
| ATI-501 800mg BID Dosing | Subject Global Impression of Treatment Satisfaction (SGITS) at Week 24, Alopecia Universalis or Alopecia Totalis | Neither satisfied or dissatisfied | 1 Participants |
| ATI-501 800mg BID Dosing | Subject Global Impression of Treatment Satisfaction (SGITS) at Week 24, Alopecia Universalis or Alopecia Totalis | Extremely satisfied | 3 Participants |
| ATI-501 800mg BID Dosing | Subject Global Impression of Treatment Satisfaction (SGITS) at Week 24, Alopecia Universalis or Alopecia Totalis | Moderately satisfied | 5 Participants |
| ATI-501 800mg BID Dosing | Subject Global Impression of Treatment Satisfaction (SGITS) at Week 24, Alopecia Universalis or Alopecia Totalis | A little satisfied | 1 Participants |
| ATI-501 800mg BID Dosing | Subject Global Impression of Treatment Satisfaction (SGITS) at Week 24, Alopecia Universalis or Alopecia Totalis | A little dissatisfied | 0 Participants |
| ATI-501 800mg BID Dosing | Subject Global Impression of Treatment Satisfaction (SGITS) at Week 24, Alopecia Universalis or Alopecia Totalis | Moderately dissatisfied | 1 Participants |
| ATI-501 800mg BID Dosing | Subject Global Impression of Treatment Satisfaction (SGITS) at Week 24, Alopecia Universalis or Alopecia Totalis | Extremely dissatisfied | 2 Participants |
| Placebo | Subject Global Impression of Treatment Satisfaction (SGITS) at Week 24, Alopecia Universalis or Alopecia Totalis | A little satisfied | 1 Participants |
| Placebo | Subject Global Impression of Treatment Satisfaction (SGITS) at Week 24, Alopecia Universalis or Alopecia Totalis | Extremely dissatisfied | 1 Participants |
| Placebo | Subject Global Impression of Treatment Satisfaction (SGITS) at Week 24, Alopecia Universalis or Alopecia Totalis | Moderately dissatisfied | 1 Participants |
| Placebo | Subject Global Impression of Treatment Satisfaction (SGITS) at Week 24, Alopecia Universalis or Alopecia Totalis | Moderately satisfied | 2 Participants |
| Placebo | Subject Global Impression of Treatment Satisfaction (SGITS) at Week 24, Alopecia Universalis or Alopecia Totalis | Extremely satisfied | 1 Participants |
| Placebo | Subject Global Impression of Treatment Satisfaction (SGITS) at Week 24, Alopecia Universalis or Alopecia Totalis | A little dissatisfied | 1 Participants |
| Placebo | Subject Global Impression of Treatment Satisfaction (SGITS) at Week 24, Alopecia Universalis or Alopecia Totalis | Neither satisfied or dissatisfied | 3 Participants |
p-value: 0.883Wilcoxon (Mann-Whitney)
p-value: 0.954Wilcoxon (Mann-Whitney)
p-value: 0.295Wilcoxon (Mann-Whitney)
Secondary
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.
Time frame: Baseline-Week 24
Population: Intent-to-treat population using Last Observation Carried Forward to address missing data.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ATI-501 400mg BID Dosing | Subject Global Impression of Treatment Satisfaction (SGITS) at Week 24, Patchy Alopecia Areata | Extremely satisfied | 5 Participants |
| ATI-501 400mg BID Dosing | Subject Global Impression of Treatment Satisfaction (SGITS) at Week 24, Patchy Alopecia Areata | Moderately dissatisfied | 1 Participants |
| ATI-501 400mg BID Dosing | Subject Global Impression of Treatment Satisfaction (SGITS) at Week 24, Patchy Alopecia Areata | A little dissatisfied | 1 Participants |
| ATI-501 400mg BID Dosing | Subject Global Impression of Treatment Satisfaction (SGITS) at Week 24, Patchy Alopecia Areata | Moderately satisfied | 2 Participants |
| ATI-501 400mg BID Dosing | Subject Global Impression of Treatment Satisfaction (SGITS) at Week 24, Patchy Alopecia Areata | Extremely dissatisfied | 1 Participants |
| ATI-501 400mg BID Dosing | Subject Global Impression of Treatment Satisfaction (SGITS) at Week 24, Patchy Alopecia Areata | A little satisfied | 0 Participants |
| ATI-501 400mg BID Dosing | Subject Global Impression of Treatment Satisfaction (SGITS) at Week 24, Patchy Alopecia Areata | Neither satisfied or dissatisfied | 0 Participants |
| ATI-501 600mg BID Dosing | Subject Global Impression of Treatment Satisfaction (SGITS) at Week 24, Patchy Alopecia Areata | Moderately dissatisfied | 1 Participants |
| ATI-501 600mg BID Dosing | Subject Global Impression of Treatment Satisfaction (SGITS) at Week 24, Patchy Alopecia Areata | Neither satisfied or dissatisfied | 2 Participants |
| ATI-501 600mg BID Dosing | Subject Global Impression of Treatment Satisfaction (SGITS) at Week 24, Patchy Alopecia Areata | A little satisfied | 0 Participants |
| ATI-501 600mg BID Dosing | Subject Global Impression of Treatment Satisfaction (SGITS) at Week 24, Patchy Alopecia Areata | A little dissatisfied | 0 Participants |
| ATI-501 600mg BID Dosing | Subject Global Impression of Treatment Satisfaction (SGITS) at Week 24, Patchy Alopecia Areata | Extremely dissatisfied | 1 Participants |
| ATI-501 600mg BID Dosing | Subject Global Impression of Treatment Satisfaction (SGITS) at Week 24, Patchy Alopecia Areata | Moderately satisfied | 2 Participants |
| ATI-501 600mg BID Dosing | Subject Global Impression of Treatment Satisfaction (SGITS) at Week 24, Patchy Alopecia Areata | Extremely satisfied | 5 Participants |
| ATI-501 800mg BID Dosing | Subject Global Impression of Treatment Satisfaction (SGITS) at Week 24, Patchy Alopecia Areata | Neither satisfied or dissatisfied | 2 Participants |
| ATI-501 800mg BID Dosing | Subject Global Impression of Treatment Satisfaction (SGITS) at Week 24, Patchy Alopecia Areata | Extremely satisfied | 2 Participants |
| ATI-501 800mg BID Dosing | Subject Global Impression of Treatment Satisfaction (SGITS) at Week 24, Patchy Alopecia Areata | Moderately satisfied | 2 Participants |
| ATI-501 800mg BID Dosing | Subject Global Impression of Treatment Satisfaction (SGITS) at Week 24, Patchy Alopecia Areata | A little satisfied | 0 Participants |
| ATI-501 800mg BID Dosing | Subject Global Impression of Treatment Satisfaction (SGITS) at Week 24, Patchy Alopecia Areata | A little dissatisfied | 0 Participants |
| ATI-501 800mg BID Dosing | Subject Global Impression of Treatment Satisfaction (SGITS) at Week 24, Patchy Alopecia Areata | Moderately dissatisfied | 1 Participants |
| ATI-501 800mg BID Dosing | Subject Global Impression of Treatment Satisfaction (SGITS) at Week 24, Patchy Alopecia Areata | Extremely dissatisfied | 1 Participants |
| Placebo | Subject Global Impression of Treatment Satisfaction (SGITS) at Week 24, Patchy Alopecia Areata | A little satisfied | 1 Participants |
| Placebo | Subject Global Impression of Treatment Satisfaction (SGITS) at Week 24, Patchy Alopecia Areata | Extremely dissatisfied | 2 Participants |
| Placebo | Subject Global Impression of Treatment Satisfaction (SGITS) at Week 24, Patchy Alopecia Areata | Moderately dissatisfied | 1 Participants |
| Placebo | Subject Global Impression of Treatment Satisfaction (SGITS) at Week 24, Patchy Alopecia Areata | Moderately satisfied | 0 Participants |
| Placebo | Subject Global Impression of Treatment Satisfaction (SGITS) at Week 24, Patchy Alopecia Areata | Extremely satisfied | 1 Participants |
| Placebo | Subject Global Impression of Treatment Satisfaction (SGITS) at Week 24, Patchy Alopecia Areata | A little dissatisfied | 1 Participants |
| Placebo | Subject Global Impression of Treatment Satisfaction (SGITS) at Week 24, Patchy Alopecia Areata | Neither satisfied or dissatisfied | 2 Participants |
p-value: 0.098Wilcoxon (Mann-Whitney)
p-value: 0.082Wilcoxon (Mann-Whitney)
p-value: 0.313Wilcoxon (Mann-Whitney)