A Study of ATI-502 Topical Solution for the Treatment of Atopic Dermatitis

February 5, 2020 updated by: Aclaris Therapeutics, Inc.

A Phase 2 Safety Study of ATI-502 Topical Solution in Subjects With Moderate to Severe Atopic Dermatitis

This is an open label, multicenter study designed to evaluate the safety and tolerability of ATI-502 Topical Solution in male and female subjects with moderate or severe atopic dermatitis (AD). Subjects will be required to apply ATI-502 study medication to their identified AD treatment areas. All subjects will be required to complete a safety follow up visit 4 weeks post last study medication application

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
22

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Encinitas, California, United States, 92024
        • Aclaris Investigational Site
      • San Diego, California, United States, 92123
        • Aclaris Investigator Site
    • Minnesota
      • Fridley, Minnesota, United States, 55432
        • Aclaris Investigator Site
    • Ohio
      • Bexley, Ohio, United States, 43209
        • Aclaris Investigational Site
    • Oregon
      • Portland, Oregon, United States, 97223
        • Aclaris Investigational Site
    • Texas
      • Austin, Texas, United States, 78759
        • Aclaris Investigator Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Male or non-pregnant, non-nursing female subjects ≥ 18 years old at the time of informed consent.
  2. Subject must have diagnosis of AD.
  3. Subject must have a diagnosis of moderate or severe AD for a period of ≥6 months prior to the first dose of study medication.
  4. Body surface area involvement must be between 2-20%.
  5. Subject must have an absolute neutrophil count and a platelet count within normal range.
  6. Subject must be willing to refrain from excess of sun exposure.
  7. Subjects must refrain from participating in strenuous exercise that would cause profuse sweating for a period of 6 hours after each treatment application with ATI-502.
  8. 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.
  9. If a woman of childbearing potential (WOCBP), must have a negative serum pregnancy test at Screening and a negative urine pregnancy test at Baseline 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.
  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:

  1. Subject has any signs or symptoms associated with AD therapy which, in the investigator's opinion, might impair evaluation of the AD or which exposes the subject to unacceptable risk by study participation.
  2. Subjects unable to complete the required washout periods. Use of prescription moisturizers within 7 days of Visit 1.
  3. Subject has used any emollients/moisturizers on the planned treatment area (s) within 4 hours of Visit 1.
  4. Subject has clinically infected AD.
  5. Subject is currently using an oral H1 antihistamines (e.g. diphenhydramine, terfenadine) UNLESS the subject is on a stable dose for at least 14 days prior to Visit 1.
  6. Clinically significant laboratory abnormalities at Visit 1 that, in the opinion of the Investigator, would make the subject a poor candidate for the study.
  7. History of, or current, severe, progressive or uncontrolled renal, hepatic, gastrointestinal, pulmonary, cardiovascular, genitourinary (renal disease) or hematological disease, neurologic or cerebral disorders, infectious disease 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 (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 a 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 Visit 2. Subjects on an antibiotic for a non-serious, acute local infection must complete the course prior to enrollment into the study.
  11. Positive serological test for HIV(antibody), HCV (antibody), or HepB (HBsAg). Subjects with herpes zoster 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).

  12. Screening ECG findings of:

    1. QTcF >450msec for males or >470msec for females.
    2. Heart rate < 45 or > 100 beats/minutes (inclusive).
    3. Rhythm disturbance other than sinus arrhythmia or ectopic supraventricular rhythm (ectopic atrial rhythm).
    4. Conduction disturbance including PR >240msec, pre-excitation (delta wave and PR <120msec), second degree or higher AV block.
    5. Acute or chronic signs of ischemia.
    6. Left Bundle Branch Block.
    7. Prior myocardial infarction.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: ATI-502
ATI-502 topical solution applied daily for four weeks.
Drug: ATI-502
Topical Solution

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Subjects withTreatment-Emergent Adverse Events (Safety and Tolerability)
Time Frame: 8 weeks
Treatment emergent adverse events (TEAEs)graded on a 3 point scale of mild, moderate or severe
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Aclaris Therapeutics, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Judy Schynder, MBA, Aclaris Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 10, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 25, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 25, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 25, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 12, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 13, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 17, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 5, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ATI-502-AD-201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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