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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ATI-502 | Experimental | ATI-502 topical solution applied daily for four weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ATI-502 | Drug | Topical Solution |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects withTreatment-Emergent Adverse Events (Safety and Tolerability) | Treatment emergent adverse events (TEAEs)graded on a 3 point scale of mild, moderate or severe | 8 weeks |
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Inclusion Criteria:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Judy Schynder, MBA | Aclaris Therapeutics | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aclaris Investigational Site | Encinitas | California | 92024 | United States | ||
| Aclaris Investigator Site |
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| ID | Title | Description |
|---|---|---|
| FG000 | ATI-502 | 0.46% Solution applied twice a day for 28 days |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | ATI-502 | ATI-502 topical solution applied daily for four weeks. ATI-502: Topical Solution |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Subjects withTreatment-Emergent Adverse Events (Safety and Tolerability) | Treatment emergent adverse events (TEAEs)graded on a 3 point scale of mild, moderate or severe | Posted | Count of Participants | Participants | 8 weeks |
|
|
56 days
An AE is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered casually related to the product. In clinical studies, an AE can include an undesirable medical condition occurring at any time, including baseline or washout periods, even if no study treatment has been administered.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ATI-502 | ATI-502 topical solution applied daily for four weeks. ATI-502: Topical Solution |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cellulitis | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chalazion | Eye disorders | MedDRA (21.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Executive Director Clinical Operations | Aclaris Therapeutics | 4843242144 | jschnyder@aclaristx.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 17, 2018 | Jan 22, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 14, 2019 | Jan 22, 2020 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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| San Diego |
| California |
| 92123 |
| United States |
| Aclaris Investigator Site | Fridley | Minnesota | 55432 | United States |
| Aclaris Investigational Site | Bexley | Ohio | 43209 | United States |
| Aclaris Investigational Site | Portland | Oregon | 97223 | United States |
| Aclaris Investigator Site | Austin | Texas | 78759 | United States |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
| 0 |
| 22 |
| 1 |
| 22 |
| 7 |
| 22 |
| Abdominal pain | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
|
| Conjunctivitis | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
|
| Gastroenteritis | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
|
| Gastroenteritis viral | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA (21.1) | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA (21.1) | Systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA (21.1) | Systematic Assessment |
|
| Hyponatremia | Metabolism and nutrition disorders | MedDRA (21.1) | Systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (21.1) | Systematic Assessment |
|
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA (21.1) | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (21.1) | Systematic Assessment |
|
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| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |