Trial Outcomes & Findings for ATI-502 Topical Solution for the Treatment of Alopecia Areata (AA), Alopecia Universalis (AU) and Alopecia Totalis (AT) (NCT NCT03759340)
NCT ID: NCT03759340
Last Updated: 2020-10-06
Results Overview
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. For the primary endpoint, the primary efficacy variable was the mean relative percent change from the original baseline visit in study ATI-501-AUAT-201 and the SALT score at Week 24 on study ATI-502-AA-203. This represents the percentage of hair regrowth. It was calculated as the mean of the changes from baseline SALT score to the SALT score at Week 24, divided by baseline SALT score and expressed as a percentage.
TERMINATED
PHASE2
56 participants
Baseline to Week 24
2020-10-06
Participant Flow
Participant milestones
| Measure |
ATI-502 0.46% Topical Solution
Subjects will apply ATI-502 Topical Solution, 0.46% twice-daily for 24 weeks followed by a 4-week post-treatment follow up period.
ATI-502 0.46% Topical Solution: apply ATI-502 Topical Solution, 0.46% Twice a day (BID) to the entire scalp and if applicable, the eyebrow(s).
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|---|---|
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Overall Study
STARTED
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56
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Overall Study
COMPLETED
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0
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Overall Study
NOT COMPLETED
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56
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Reasons for withdrawal
| Measure |
ATI-502 0.46% Topical Solution
Subjects will apply ATI-502 Topical Solution, 0.46% twice-daily for 24 weeks followed by a 4-week post-treatment follow up period.
ATI-502 0.46% Topical Solution: apply ATI-502 Topical Solution, 0.46% Twice a day (BID) to the entire scalp and if applicable, the eyebrow(s).
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|---|---|
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Overall Study
Adverse Event
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2
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Overall Study
Lost to Follow-up
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1
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Overall Study
Withdrawal by Subject
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15
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Overall Study
Study Terminated by Sponsor
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38
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Baseline Characteristics
ATI-502 Topical Solution for the Treatment of Alopecia Areata (AA), Alopecia Universalis (AU) and Alopecia Totalis (AT)
Baseline characteristics by cohort
| Measure |
ATI 502 0.46% Topical Solution
n=56 Participants
Subjects will apply ATI-502 Topical Solution, 0.46% twice-daily for 24 weeks followed by a 4-week post-treatment follow up period.
ATI 502 0.46% Topical Solution: apply ATI-502 Topical Solution, 0.46% Twice a day (BID) to the entire scalp and if applicable, the eyebrow(s)
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|---|---|
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Age, Continuous
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41.1 years
STANDARD_DEVIATION 14.36 • n=5 Participants
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Sex: Female, Male
Female
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35 Participants
n=5 Participants
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Sex: Female, Male
Male
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21 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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6 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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39 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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11 Participants
n=5 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Asian
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2 Participants
n=5 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Black or African American
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8 Participants
n=5 Participants
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Race (NIH/OMB)
White
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42 Participants
n=5 Participants
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Race (NIH/OMB)
More than one race
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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4 Participants
n=5 Participants
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Region of Enrollment
United States
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56 participants
n=5 Participants
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Duration of Current Alopecia Episode (years)
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4.5 years
STANDARD_DEVIATION 3.19 • n=5 Participants
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Duration of Alopecia (years)
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12.6 years
STANDARD_DEVIATION 12.09 • n=5 Participants
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Fitzpatrick Skin Type
I - Always Burns
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2 Participants
n=5 Participants
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Fitzpatrick Skin Type
II - Burns Easily
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19 Participants
n=5 Participants
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Fitzpatrick Skin Type
III - Burns Moderately
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20 Participants
n=5 Participants
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Fitzpatrick Skin Type
IV - Burns Minimally
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6 Participants
n=5 Participants
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Fitzpatrick Skin Type
V - Rarely Burns
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8 Participants
n=5 Participants
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Fitzpatrick Skin Type
VI - Never Burns
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1 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: Baseline to Week 24Population: Only 8 of the 56 enrolled participants had efficacy measures on Day 169 (primary endpoint) of the ATI-502-AA-203 study. Based on this limited data set, the maintenance of, or new hair regrowth cannot be adequately assessed from this study.
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. For the primary endpoint, the primary efficacy variable was the mean relative percent change from the original baseline visit in study ATI-501-AUAT-201 and the SALT score at Week 24 on study ATI-502-AA-203. This represents the percentage of hair regrowth. It was calculated as the mean of the changes from baseline SALT score to the SALT score at Week 24, divided by baseline SALT score and expressed as a percentage.
Outcome measures
| Measure |
ATI 502 0.46% Topical Solution
n=8 Participants
Subjects will apply ATI-502 Topical Solution, 0.46% twice-daily for 24 weeks followed by a 4-week post-treatment follow up period.
ATI 502 0.46% Topical Solution: apply ATI-502 Topical Solution, 0.46% Twice a day (BID) to the entire scalp and if applicable, the eyebrow(s)
|
|---|---|
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Change in the Severity of Alopecia Tool (SALT) Score
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-15.72 Percent Change from Baseline
Standard Deviation 35.383
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SECONDARY outcome
Timeframe: Baseline to Week 24Population: Due to the premature termination of the study, the secondary efficacy endpoint analyses were not performed.
Mean Relative Percent Change from Baseline (from the current study ATI-502-AA-203) in Severity of Alopecia Tool (SALT). SALT score is on a percent scale where 0% is no hair loss and 100 % is total hair loss. A lower SALT score is a better outcome. A higher relative percent change is better.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to Week 24Population: Due to the premature termination of the study, the secondary efficacy endpoint analyses were not performed.
Proportion of subjects achieving a SALT 50 (defined as a ≥ 50% improvement from baseline in SALT) by visit 6. SALT score is on a percent scale where 0% is no hair loss and 100 % is total hair loss.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to Week 24Population: Due to the premature termination of the study, the secondary efficacy endpoint analyses were not performed.
Proportion of subjects achieving SALT 75 (defined as a ≥ 75% improvement from baseline in SALT) by visit 6 SALT score is on a percent scale where 0% is no hair loss and 100 % is total hair loss. A bigger percent change is a more positive score.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to Week 24Population: Due to the premature termination of the study, the secondary efficacy endpoint analyses were not performed.
Durability of response: Proportion of subjects achieving a SALT 50 or SALT 75 at Week 24 (in study ATI-501-AUAT-201) and maintaining that response at week 24 in ATI-502-AA-203 study.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to Week 24Population: Due to the premature termination of the study, the secondary efficacy endpoint analyses were not performed.
Change from Baseline in the PhGIS by visit. The PhGIS is a 5 point scale from Mild to Extremely Severe. Mild is a better outcome.
Outcome measures
Outcome data not reported
Adverse Events
ATI 502 0.46% Topical Solution
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
ATI 502 0.46% Topical Solution
n=56 participants at risk
Subjects will apply ATI-502 Topical Solution, 0.46% twice-daily for 24 weeks followed by a 4-week post-treatment follow up period.
ATI 502 0.46% Topical Solution: apply ATI-502 Topical Solution, 0.46% Twice a day (BID) to the entire scalp and if applicable, the eyebrow(s)
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|---|---|
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Ear and labyrinth disorders
Ear pain
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1.8%
1/56 • Number of events 1 • Treatment Period = 24 weeks; Reporting of non-serious AEs started with each subject's first study medication application and continued until the end of the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until the end of the subject's last visit.
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General disorders
Application site dryness
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3.6%
2/56 • Number of events 2 • Treatment Period = 24 weeks; Reporting of non-serious AEs started with each subject's first study medication application and continued until the end of the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until the end of the subject's last visit.
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General disorders
Application site pruritus
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3.6%
2/56 • Number of events 2 • Treatment Period = 24 weeks; Reporting of non-serious AEs started with each subject's first study medication application and continued until the end of the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until the end of the subject's last visit.
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General disorders
Application site rash
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1.8%
1/56 • Number of events 1 • Treatment Period = 24 weeks; Reporting of non-serious AEs started with each subject's first study medication application and continued until the end of the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until the end of the subject's last visit.
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Infections and infestations
Folliculitis
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1.8%
1/56 • Number of events 1 • Treatment Period = 24 weeks; Reporting of non-serious AEs started with each subject's first study medication application and continued until the end of the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until the end of the subject's last visit.
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Infections and infestations
Nasopharyngitis
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1.8%
1/56 • Number of events 1 • Treatment Period = 24 weeks; Reporting of non-serious AEs started with each subject's first study medication application and continued until the end of the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until the end of the subject's last visit.
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Infections and infestations
Pyuria
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1.8%
1/56 • Number of events 1 • Treatment Period = 24 weeks; Reporting of non-serious AEs started with each subject's first study medication application and continued until the end of the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until the end of the subject's last visit.
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Infections and infestations
Upper respiratory tract infection
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5.4%
3/56 • Number of events 3 • Treatment Period = 24 weeks; Reporting of non-serious AEs started with each subject's first study medication application and continued until the end of the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until the end of the subject's last visit.
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Injury, poisoning and procedural complications
Ankle fracture
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1.8%
1/56 • Number of events 1 • Treatment Period = 24 weeks; Reporting of non-serious AEs started with each subject's first study medication application and continued until the end of the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until the end of the subject's last visit.
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Injury, poisoning and procedural complications
Foot fracture
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1.8%
1/56 • Number of events 1 • Treatment Period = 24 weeks; Reporting of non-serious AEs started with each subject's first study medication application and continued until the end of the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until the end of the subject's last visit.
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Injury, poisoning and procedural complications
Muscle strain
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3.6%
2/56 • Number of events 2 • Treatment Period = 24 weeks; Reporting of non-serious AEs started with each subject's first study medication application and continued until the end of the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until the end of the subject's last visit.
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Investigations
White blood cell count increased
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1.8%
1/56 • Number of events 1 • Treatment Period = 24 weeks; Reporting of non-serious AEs started with each subject's first study medication application and continued until the end of the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until the end of the subject's last visit.
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Musculoskeletal and connective tissue disorders
Arthritis
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1.8%
1/56 • Number of events 1 • Treatment Period = 24 weeks; Reporting of non-serious AEs started with each subject's first study medication application and continued until the end of the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until the end of the subject's last visit.
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Musculoskeletal and connective tissue disorders
Osteoarthritis
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1.8%
1/56 • Number of events 1 • Treatment Period = 24 weeks; Reporting of non-serious AEs started with each subject's first study medication application and continued until the end of the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until the end of the subject's last visit.
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Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
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1.8%
1/56 • Number of events 1 • Treatment Period = 24 weeks; Reporting of non-serious AEs started with each subject's first study medication application and continued until the end of the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until the end of the subject's last visit.
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Nervous system disorders
Carpal tunnel syndrome
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1.8%
1/56 • Number of events 1 • Treatment Period = 24 weeks; Reporting of non-serious AEs started with each subject's first study medication application and continued until the end of the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until the end of the subject's last visit.
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Psychiatric disorders
Insomnia
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1.8%
1/56 • Number of events 1 • Treatment Period = 24 weeks; Reporting of non-serious AEs started with each subject's first study medication application and continued until the end of the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until the end of the subject's last visit.
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Skin and subcutaneous tissue disorders
Dermal cyst
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1.8%
1/56 • Number of events 1 • Treatment Period = 24 weeks; Reporting of non-serious AEs started with each subject's first study medication application and continued until the end of the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until the end of the subject's last visit.
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Skin and subcutaneous tissue disorders
Dermatitis
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3.6%
2/56 • Number of events 2 • Treatment Period = 24 weeks; Reporting of non-serious AEs started with each subject's first study medication application and continued until the end of the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until the end of the subject's last visit.
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Skin and subcutaneous tissue disorders
Dyshidrotic eczema
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1.8%
1/56 • Number of events 2 • Treatment Period = 24 weeks; Reporting of non-serious AEs started with each subject's first study medication application and continued until the end of the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until the end of the subject's last visit.
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Skin and subcutaneous tissue disorders
Night sweats
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1.8%
1/56 • Number of events 1 • Treatment Period = 24 weeks; Reporting of non-serious AEs started with each subject's first study medication application and continued until the end of the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until the end of the subject's last visit.
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Skin and subcutaneous tissue disorders
Pruritus
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1.8%
1/56 • Number of events 1 • Treatment Period = 24 weeks; Reporting of non-serious AEs started with each subject's first study medication application and continued until the end of the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until the end of the subject's last visit.
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Vascular disorders
Hot flush
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1.8%
1/56 • Number of events 1 • Treatment Period = 24 weeks; Reporting of non-serious AEs started with each subject's first study medication application and continued until the end of the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until the end of the subject's last visit.
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Additional Information
Marco Cardillo, Clinical Trial Manager
Aclaris Therapeutics, Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place