A Study of ATI-502 Topical Solution for the Treatment of Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: ATI-502
Intervention description: Topical Solution
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 22.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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
    

Eligibility 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.