- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03585296
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
Study Type
Interventional
Enrollment (Actual)
22
Phase
- 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
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California
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Encinitas, California, United States, 92024
- Aclaris Investigational Site
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San Diego, California, United States, 92123
- Aclaris Investigator Site
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Minnesota
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Fridley, Minnesota, United States, 55432
- Aclaris Investigator Site
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Ohio
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Bexley, Ohio, United States, 43209
- Aclaris Investigational Site
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Oregon
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Portland, Oregon, United States, 97223
- Aclaris Investigational Site
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Texas
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Austin, Texas, United States, 78759
- Aclaris Investigator Site
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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
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Male or non-pregnant, non-nursing female subjects ≥ 18 years old at the time of informed consent.
- Subject must have diagnosis of AD.
- Subject must have a diagnosis of moderate or severe AD for a period of ≥6 months prior to the first dose of study medication.
- Body surface area involvement must be between 2-20%.
- Subject must have an absolute neutrophil count and a platelet count within normal range.
- Subject must be willing to refrain from excess of sun exposure.
- 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.
- 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.
- 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.
- 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:
- 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.
- Subjects unable to complete the required washout periods. Use of prescription moisturizers within 7 days of Visit 1.
- Subject has used any emollients/moisturizers on the planned treatment area (s) within 4 hours of Visit 1.
- Subject has clinically infected AD.
- 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.
- Clinically significant laboratory abnormalities at Visit 1 that, in the opinion of the Investigator, would make the subject a poor candidate for the study.
- 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.
- 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.
- Evidence of active or latent bacterial (including tuberculosis) or viral infections at the time of enrollment or history of incompletely treated or untreated tuberculosis. Subjects who have completed therapy for latent tuberculosis may participate.
- History of 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.
- 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).
Screening ECG findings of:
- QTcF >450msec for males or >470msec for females.
- Heart rate < 45 or > 100 beats/minutes (inclusive).
- Rhythm disturbance other than sinus arrhythmia or ectopic supraventricular rhythm (ectopic atrial rhythm).
- Conduction disturbance including PR >240msec, pre-excitation (delta wave and PR <120msec), second degree or higher AV block.
- Acute or chronic signs of ischemia.
- Left Bundle Branch Block.
- 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 |
Intervention / Treatment |
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Experimental: ATI-502
ATI-502 topical solution applied daily for four weeks.
|
Topical Solution
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Subjects withTreatment-Emergent Adverse Events (Safety and Tolerability)
Time Frame: 8 weeks
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Treatment emergent adverse events (TEAEs)graded on a 3 point scale of mild, moderate or severe
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8 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- 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)
July 10, 2018
Primary Completion (Actual)
April 25, 2019
Study Completion (Actual)
April 25, 2019
Study Registration Dates
First Submitted
June 25, 2018
First Submitted That Met QC Criteria
July 12, 2018
First Posted (Actual)
July 13, 2018
Study Record Updates
Last Update Posted (Actual)
February 17, 2020
Last Update Submitted That Met QC Criteria
February 5, 2020
Last Verified
August 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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.
Clinical Trials on Atopic Dermatitis
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Catalysis SLCompletedAtopic Dermatitis | Atopic Dermatitis Eczema | Atopic Dermatitis and Related Conditions | Atopic Dermatitis \(AD\)Serbia
-
Jacob Pontoppidan ThyssenThe Novo Nordic FoundationRecruitingAtopic Dermatitis | Atopic Dermatitis Eczema | Atopic Dermatitis FlareDenmark
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ShaperonRecruitingAtopic Dermatitis | Atopic Dermatitis Eczema | Atopic Dermatitis of ScalpUnited States
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AmgenCompletedDermatitis, Atopic DermatitisCanada, United States, Japan
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SanofiCompletedAtopic Dermatitis | Dermatitis AtopicChina
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SanofiCompletedDermatitis AtopicSaudi Arabia, Kuwait, United Arab Emirates
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National Institute of Allergy and Infectious Diseases...Atopic Dermatitis Research NetworkCompletedAtopic Dermatitis (AD) | Non-atopic Healthy ControlsUnited States
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