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

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ClinicalTrials.gov Identifier: NCT03585296
Recruitment Status : Recruiting
First Posted : July 13, 2018
Last Update Posted : September 27, 2018
Sponsor:
Information provided by (Responsible Party):
Aclaris Therapeutics, Inc.

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Drug: ATI-502 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Safety Study of ATI-502 Topical Solution in Subjects With Moderate to Severe Atopic Dermatitis
Actual Study Start Date : July 10, 2018
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
Experimental: ATI-502
ATI-502 topical solution applied daily for four weeks.
Drug: ATI-502
Topical Solution




Primary Outcome Measures :
  1. Incidence of Treatment-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


Secondary Outcome Measures :
  1. Atopic Dermatitis (SAD) assessment score) [ Time Frame: 8 weeks ]
    Change in sign of Atopic Dermatitis (SAD) assessment score at end of study.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03585296


Contacts
Contact: Judy Schynder, RN 484-329-2144 jschnyder@aclaristx.com

Locations
United States, California
Aclaris Investigational Site Recruiting
Encinitas, California, United States, 92024
Contact: Judy Schnyder         
Aclaris Investigator Site Recruiting
San Diego, California, United States, 92123
Contact: Judy Schnyder         
United States, Minnesota
Aclaris Investigator Site Recruiting
Fridley, Minnesota, United States, 55432
Contact: Judy Schnyder         
United States, Ohio
Aclaris Investigational Site Recruiting
Bexley, Ohio, United States, 43209
Contact: Judy Schnyder         
United States, Oregon
Aclaris Investigational Site Recruiting
Portland, Oregon, United States, 97223
Contact: Judy Schnyder         
United States, Texas
Aclaris Investigator Site Recruiting
Austin, Texas, United States, 78759
Contact: Judy Schnyder         
Sponsors and Collaborators
Aclaris Therapeutics, Inc.
Investigators
Study Chair: Judy Schynder, RN Aclaris Therapeutics

Responsible Party: Aclaris Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03585296     History of Changes
Other Study ID Numbers: ATI-502-AD-201
First Posted: July 13, 2018    Key Record Dates
Last Update Posted: September 27, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Pharmaceutical Solutions