A Study to Assess Subcutaneous Lirentelimab (AK002) in Atopic Dermatitis

Key Inclusion Criteria:

1. Subject is able to understand the information on the study, has the capacity toconsent, and has provided written informed consent.

2. Male or female aged ≥18 and ≤80 years at the time of signing the informed consentform.

3. Chronic AD (as defined by the American Academy of Dermatology Consensus Criteria) (Eichenfield, 2014) that has been present for at least 3 years before the screeningvisit.

4. Documented recent history of inadequate response to treatment with topicalmedications such as topical corticosteroids, calcineurin inhibitors, JAK inhibitors,or PDE4 inhibitors (crisaborole) for at least 4 weeks in the 6 months prior toscreening, or subjects for whom these topical treatments are otherwise medicallyinadvisable (e.g., because of side effects or safety risks).

5. Subjects who are biologic naive or biologic-exposed. Biologic-exposed includespatients who have demonstrated secondary loss of response, intolerance, or lack ofcontinued access to biologics due to economic reasons.

6. EASI score of ≥16 at screening and at baseline.

7. Involvement of at least 10% or more of BSA at screening and at baseline.

8. An IGA score of 3 or above on a scale from 0-4 at screening and at baseline.

9. The subject should have applied a stable dose of non-medicated, non-prescription,topical emollient at least twice daily for 7 consecutive days immediately before thebaseline visit.

Key Exclusion Criteria:

1. Current use of biologics for any indication.

2. Demonstrated lack of primary response to treatment with a biologic for the treatmentof AD defined as no response to treatment despite complete adherence to theprescribed regimen for at least 3 months (primary non-responders).

3. Use of any of the following treatments within 4 weeks prior to the baseline visit orany condition that in the opinion of the Investigator is likely to require suchtreatment(s) during the first 4 weeks of study treatment: (i) phototherapy for AD; (ii) immunosuppressive or immunomodulatory drugs, including but not limited tosystemic calcineurin inhibitors (e.g., cyclosporin, tacrolimus), mTOR inhibitors (e.g., sirolimus, everolimus), anti-metabolites (e.g., azathioprine, methotrexate, 6-mercaptopurine, leflunomide, mycophenolate mofetil), alkylating agents (e.g.,cyclophosphamide), TNF inhibitors (e.g., infliximab, adalimumab), eosinophildepleting drugs (e.g., pramipexole), and systemic corticosteroids; (iii) oral JAKinhibitors within 8 weeks of the baseline visit.

4. Treatment with biologics: (i) any cell-depleting agents including but not limited torituximab within 6 months prior to the baseline visit or until lymphocyte countreturns to normal, whichever is longer; (ii) other biologics (e.g., dupilumab,omalizumab, etc) within 5 half-lives, if known, or 8 weeks prior to baseline visit,whichever is longer.

5. Use of any topical corticosteroids, topical calcineurin inhibitors, topical JAKinhibitors (e.g., ruxolitinib), or topical PDE4 inhibitors (crisaborole) for thetreatment of AD within 1 week prior to the baseline visit.

6. Regular use (more than 2 visits per week) of a tanning booth/parlor within 4 weeksof the screening visit.

7. Treatment with chemotherapy or radiotherapy in the preceding 6 months.

8. Presence of skin comorbidities/concomitant conditions that may interfere with studyassessments or interpretation of study results.

9. Planned or anticipated use of any prohibited medications.

10. History of malignancy except carcinoma in situ in the cervix, early-stage prostatecancer, or non-melanoma skin cancers.

11. Any disease, condition (medical or surgical), or cardiac abnormality that in theopinion of the Investigator would place the subject at increased risk.