Phase 2 Randomized Double-blind Study to Assess Topical Zabalafin Hydrogel Vs Vehicle in Mild to Moderate AD.

Inclusion Criteria:

1. Male/female participants who are ≥2 years of age on the day of providing documentedinformed consent/assent.

2. Have a clinical diagnosis of Atopic Dermatitis (AD) according to the criteria ofHanifin and Rajka (1980) at the Screening visit and a history of AD for at least 6months (3 months for children under the age of 6).

3. Mild to moderate AD indicated by vIGA (Validated Investigator's Global Assessment)score of 2 (mild) or 3 (moderate) at Screening and at Day 1 prior to application ofstudy intervention.

4. Have AD on the head (including face, but excluding hair-bearing scalp), neck, trunk (excluding groin and genitals), or limbs, covering at least ≥2% of total BSA (bodysurface area) and not more than 20% at Screening and at Day 1 (Visit 1).

5. Participants who have at least 1 lesion that measures approximately 5 cm2 or more atScreening and Day 1. Lesion must be representative of the participant's atopicdermatitis and not be located on the hands, feet, or genitalia.

6. Have an Eczema Area and Severity Index (EASI) total score of ≥3 to ≤21 at Screeningand at Day 1.

7. Have a peak pruritus Numeric Rating Scale (NRS) score of at least 4 at Screening andat Day 1.

8. All allowed oral and topical medications (Protocol Section 6.5) must be stableregimens within the 14 days prior to Day 1.

9. Willing to refrain from using any topical products, including cosmetics and skincleansers on the AD lesions during the study intervention application period (Section 6.5.1).

10. Participants who are willing and able to comply with all study procedures, includingscheduled visits, proper administration of study intervention application, lifestyleconsiderations.

11. A female participant is eligible to participate if she is not pregnant, notbreastfeeding, and at least one of the following conditions applies:

• Not a woman of childbearing potential (WOCBP) OR

• A WOCBP who agrees to follow the contraceptive guidance in Section 10.4. Maleparticipants are eligible to participate if they agree to follow thecontraceptive guidance

Exclusion Criteria:

1. Unstable course of AD (spontaneously improving or rapidly deteriorating) asdetermined by the investigator in the 4 weeks prior to Day 1.

2. Concurrent conditions and history of other diseases:

3. Any other concomitant skin disorder, pigmentation, or extensive scarring that,in the opinion of the investigator, may interfere with the evaluation of ADlesions or compromise participant safety.

4. The presence of AD lesions only on the hands or feet without prior history ofinvolvement of other classical areas of involvement such as the face or thefolds.

5. Other types of atopic dermatitis.

6. Has recent or anticipated concomitant use of systemic or topical therapies thatmight alter the course of AD in the opinion of the investigator

7. Ultraviolet (UV) light therapy or prolonged exposure to artificial sources of UVradiation within 2 weeks prior to Screening and/or intention to have such exposureduring the study.

8. Use of any of the following treatments within the indicated washout period beforeDay

9. 5 half-lives or 12 weeks, whichever is longer - biologic agents (e.g.dupilumab).

10. 4 weeks - systemic corticosteroids or adrenocorticotropic hormone analogs,cyclosporin, methotrexate, azathioprine, or other systemic immunosuppressive orimmunomodulating agents (e.g. mycophenolate or tacrolimus).

11. Two weeks - systemic antibiotics.

12. One week - use of other topical treatments for AD (other than blandemollients).

13. One week - topical antiviral agents, topical antibacterial agents, topicalantifungal agents, topical corticosteroid agents.

14. One week - oral antibiotics

15. Has undergone treatment within 5 years for any cancer except non-melanoma skincancers, squamous cell carcinoma, basal cell carcinoma. Participants with adequatelytreated or excised non-metastatic basal cell or squamous cell cancer of the skin, orcervical carcinoma in situ are allowed.

16. Active or potentially recurrent dermatologic condition other than AD that mayconfound evaluation in the opinion of the investigator.

17. Current or recent history (within 3 months) of severe, progressive, or uncontrolledrenal, hepatic, hematological, gastrointestinal, metabolic, endocrine, pulmonary,cardiovascular, or neurological disease.

18. Have had a systemic infection within the past 3 months requiring hospitalization.

19. Have required the use of parenteral antimicrobial, antivirals, antiprotozoals,antifungals, janus kinase inhibitors (JAK), tyrosine kinase inhibitors (TYK2, orphosphodiesterase 4 (PDE4) inhibitors, monoclonal antibodies (mABs), or otherparenteral therapies as judged to be clinically significant by the Investigatorwithin the past 3 months.

20. Has undergone significant trauma or major surgery within 3 months prior to screeningor has major surgery planned during the study.

21. Known hypersensitivity to zabalafin or any component of the hydrogel vehicle.

22. Has a presence of depression per the Depression and Anxiety Disorder Score (DASS)scale that is not controlled with medication or is in remission, or the presence ofsevere depression or suicidal ideation or behavior. Participants with severedepression/suicidal ideation/behavior should be referred to appropriate medicalprofessionals for evaluation.

23. A WOCBP who has a positive serum pregnancy test within 24 hours prior torandomization or treatment allocation. Note: If 24 hours have elapsed between the screening pregnancy test and the firstdose of study intervention, another serum pregnancy test must be performed and mustbe negative for participant to start receiving study intervention.

24. Has received a live or live-attenuated vaccine within 30 days prior to the firstdose of study intervention. Administration of killed vaccine and mRNA vaccines areallowed. Note: Any licensed COVID-19 vaccine (including for Emergency Use) is allowed in thestudy if they are Messenger Ribonucleic Acid (mRNA) vaccines,replication-incompetent adenoviral vaccines, or inactivated vaccines. These vaccineswill be treated just as any other concomitant therapy. Investigational vaccines (ie,those not licensed or approved for Emergency Use) are not allowed. Prior/Concurrent Clinical Study Experience:

25. Current treatment or treatment within 90 days or 5 half-lives (whichever is longer)before Day 1 with another investigational medication or current enrollment inanother investigational drug protocol. Other Exclusion Criteria:

26. Investigator site staff members directly involved in the conduct of the study andtheir family members; site staff members otherwise supervised by the investigator,are not eligible.

27. Has a history of alcohol or substance abuse within 6 months prior to Screening thatin the opinion of the investigator will preclude participation in the study.

28. Have any medical or psychiatric condition which, in the opinion of the Investigatoror the Sponsor's Medical Monitor, would place the participant at risk, interferewith participation in the study, or interfere with the interpretation of studyresults.