Clinical trial NCT03759340: ATI-502 Topical Solution for the Treatment of Alopecia Areata (AA), Alopecia Universalis (AU) and Alopecia Totalis (AT)
Official title: Open-Label Study of ATI-502 Topical Solution for the Treatment of Alopecia Areata (AA), Alopecia Universalis (AU) and Alopecia Totalis (AT)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Alopecia Areata
Alopecia Universalis
Alopecia Totalis
Lead sponsor: Aclaris Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2018-11-30
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This Phase 2, multicenter, open-label study will evaluate the safety, tolerability, efficacy, and durability of efficacy of ATI-502 Topical Solution, 0.46% for the treatment of alopecia areata (AA), alopecia universalis (AU) and alopecia totalis (AT) in adult subjects who completed 24 weeks of treatment with ATI-501 Oral Suspension or Placebo Suspension.
Primary purpose: TREATMENT

Brief summary: This is an open label study of ATI-502 Topical Solution for the treatment of AA, AU, and AT with the following goals:

* To assess the safety, tolerability, and efficacy of ATI-502 Topical Solution in subjects with AA, AU or AT following 24 weeks of treatment with ATI-501 Oral Suspension or Placebo Suspension.
* To assess the ability of ATI-502 Topical Solution to maintain or improve hair regrowth in subjects previously treated with ATI-501 Oral Suspension or Placebo Suspension.

Detailed description: This Phase 2, multicenter, open-label study will evaluate the safety, tolerability, efficacy, and durability of efficacy of ATI-502 Topical Solution, 0.46% for the treatment of alopecia areata (AA), alopecia universalis (AU) and alopecia totalis (AT) in adult subjects who completed 24 weeks of treatment with ATI-501 Oral Suspension or Placebo Suspension.

Subjects who complete 24 weeks of active treatment with ATI-501 Oral Suspension or Placebo Suspension in study ATI-501-AUAT-201 will be assessed for eligibility to enter the study. At Visit 9 in study ATI-501-AUAT-201, subjects who did not experience any adverse events (AEs), serious adverse events (SAEs), or tolerability issues that met study discontinuation criteria in study ATI-501-AUAT-201 and who in the opinion of the investigator are capable of re-growing or maintaining scalp hair and meet the entry criteria are eligible to enroll in this open-label study.

Enrolled subjects will apply ATI-502 Topical Solution, 0.46% BID to the entire scalp and if applicable, the eyebrow(s) and return for safety and efficacy assessments as detailed in the Schedule of Assessments (Table 3). Assessment of response to treatment will be performed at Week 4, Week 8, Week 16, Week 24, and post-treatment Week 28. Safety and tolerability will be evaluated at each study visit by assessment of adverse events, clinical laboratory tests, and vital signs, and at Week 24, and physical examination findings

Eligibility criteria: Inclusion Criteria:

* Subjects must meet the following criteria to be eligible for participation in the study:

  1. Subject must be able to comprehend and willing to sign the Informed Consent Form (ICF).
  2. Male or non-pregnant, non-nursing female ≥ 18 years old at the time of informed consent.
  3. Subject has completed 24 weeks of treatment and the assessments for Visit 9 in study ATI-501-AUAT-201.
  4. Subject has not experienced any AEs, SAEs or tolerability issues that met study discontinuation criteria in ATI-501-AUAT-201.
  5. Subject is capable of regrowing scalp hair or maintaining prior scalp hair regrowth from ATI-501-AUAT-201 in the opinion of the investigator.
  6. If a woman of childbearing potential (WOCBP), must have a negative urine pregnancy test at Visit 1 and agree to: use a highly effective method of birth control for the duration of the study; not be planning a pregnancy during the study duration and use contraception for 30 days after last application of study medication. (Refer to Section 8.4).
  7. 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.
  8. Be willing to maintain the same general hair style throughout the study period. Subjects who shave their scalp must be willing to refrain from shaving their scalp for at least one week or longer prior to each study visit, as determined by the investigator based on visible scalp hair growth. Hair trimming outside the treatment areas to maintain the current hair style is permitted.
  9. Be willing and able to follow all study instructions and to attend all study visits.
  10. Sexually active male subjects must agree to use a barrier method of contraception from the first application of study medication to at least 30 days after the last application of study medication.

Exclusion Criteria:

* Subjects are excluded from this study if any 1 or more of the following criteria is met:

  1. Any study medication discontinuation criteria are met during participation in study ATI-501-AUAT-201.
  2. Females who are nursing, pregnant, or planning to become pregnant for the duration of the study and up to 30 days after the last application of study medication.
  3. 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.
  4. Sensitivity to any of the ingredients in the study medications.
  5. Unwillingness to refrain from weaves, hair extensions, or shaving of the scalp for at least one week or longer prior to each study visit, as determined by the investigator based on visible scalp hair growth the duration of the study.

Primary outcomes:
measure: Change in the Severity of Alopecia Tool (SALT) Score
timeFrame: Baseline to Week 24
Secondary outcomes:
measure: Mean Relative Percent Change From Baseline SALT Score
timeFrame: Baseline to Week 24
measure: Proportion of Subjects Achieving a SALT50 (Defined as a ≥ 50% Improvement From Baseline in SALT) by Visit
timeFrame: Baseline to Week 24
measure: Proportion of Subjects Achieving a SALT 75 (Defined as a ≥ 75% Improvement From Baseline in SALT) by Visit
timeFrame: Baseline to Week 24
measure: Durability of Response
timeFrame: Baseline to Week 24
measure: Change From Baseline in the Physician Global Impression of Severity (PhGIS)
timeFrame: Baseline to Week 24
Other outcomes:
Locations:
city: Rogers
country: United States
facility: Aclaris Investigator Site
state: Arkansas
city: Denver
country: United States
facility: Aclaris Investigator Site
state: Colorado
city: Boynton Beach
country: United States
facility: Aclaris Investigator Site
state: Florida
city: Snellville
country: United States
facility: Aclaris Investigator Site
state: Georgia
city: Clinton Township
country: United States
facility: Aclaris Investigator Site
state: Michigan
city: Detroit
country: United States
facility: Aclaris Investigator SIte
state: Michigan
city: Fridley
country: United States
facility: Aclaris Investigator Site
state: Minnesota
city: Minneapolis
country: United States
facility: Aclaris Investigator Site
state: Minnesota
city: Saint Joseph
country: United States
facility: Aclaris Investigator Site
state: Missouri
city: Omaha
country: United States
facility: Aclaris Investigator Site
state: Nebraska
city: Las Vegas
country: United States
facility: Aclaris Investigator Site
state: Nevada
city: New York
country: United States
facility: Aclaris Investigator Site
state: New York
city: Rochester
country: United States
facility: Aclaris Investigator Site
state: New York
city: Portland
country: United States
facility: Aclaris Investigator Site
state: Oregon
city: Greenville
country: United States
facility: Aclaris Investigator Site
state: South Carolina
city: Knoxville
country: United States
facility: Aclaris Investigator Site
state: Tennessee
city: Nashville
country: United States
facility: Aclaris Investigational Site
state: Tennessee
city: Austin
country: United States
facility: Aclaris Investigational Site
state: Texas
city: Houston
country: United States
facility: Aclaris Investigator Site
state: Texas
city: Lynchburg
country: United States
facility: Aclaris Investigator Site
state: Virginia
Study officials:
References: