CBP-201 in Adolescent and Adult Patients With Moderate-to-severe Atopic Dermatitis

Inclusion Criteria:

• Able to provide written informed consent or assent (as per local law).
• Adults and adolescents of any sex or gender (12 years of age or older)
• Body weight ≥ 40 kg at Screening
• Diagnosis of chronic Atopic Dermatitis as defined according to American Academy ofDermatology Consensus Criteria (Eichenfield 2014), present ≥ 3 year before Screening. Atopic Dermatitis history with ALL the following disease activity criteria:

1. Involvement of ≥ 10% BSA at Screening and Baseline (Day 1).
2. An EASI score of ≥ 16 at Screening and Baseline (Day 1).
3. An IGA score of ≥ 3 at Screening and Baseline (Day 1).
4. Baseline weekly average of daily PP-NRS ≥ 4 at Baseline (Day1). • Participant has applied a Sponsor approved emollient twice a day for at least 14days before the Baseline Visit and agree to continue at least daily use during studyparticipation. • Documented recent history (within 180 days before Screening) of inadequate responseto treatment with TCS or topical immunomodulator medication or for whom topicaltreatments are otherwise medically inadvisable (e.g., important side effects or safetyrisks).

• Participants must agree to avoid the use of prohibited AD medications throughoutthe duration of the study.
• In the opinion of the Investigator, participant is willing and able to complywith all study visits and study-related procedures.
• Female patients of childbearing potential who are sexually active with anon-sterilized male partner should have a confirmed negative serum beta-humanchorionic gonadotropin test at Visit 1 and agrees to use acceptable forms ofbirth control.

Exclusion Criteria:

• No current or past history of:

1. Other active skin diseases (e.g., psoriasis, lupus erythematosus etc.) or skininfections (bacterial, fungal, or viral) that require systemic treatment within 4weeks of Screening Visit or would interfere with the assessment of AD lesions.
2. History of recurrent herpes herpeticum in the prior 12 months or more than 2 episodesof herpes herpeticum in past 2 years.
3. Non-skin related active infection requiring systemic treatment with parenteralanti-infectives within 30 days or oral anti-infectives within 14 days before theBaseline Visit (Visit 2).
4. Active human immunodeficiency virus (HIV) defined as a confirmed positive anti-HIVantibody test.
5. Tuberculosis requiring treatment within the past 12 months before Screening. Note:Evaluation of tuberculosis will be according to local guidelines as per standard ofcare.
6. Active Hepatitis B virus (HBV) or hepatitis C virus (HCV).
7. HCV: HCV ribonucleic acid (RNA) detectable in any subject with anti-HCV antibody (HCVAb). • Participant may not have any of the following conditions:
8. Known primary immunodeficiency or immunocompromised
9. History of malignancy within 5 years before the Screening Visit except for completelytreated in situ carcinoma of the cervix or completely treated and resolved basal cellcarcinoma of the skin.
10. A helminth parasitic infection diagnosed within 6 months before Visit 1 that has notbeen treated with or has failed to respond to standard of care therapy.
11. History of chronic alcohol or drug abuse including chronic use of cannabis (e.g.,inhalation and/or consumption of marijuana more than once per week) within 12 monthsbefore screening.
12. History of attempted suicide or is at significant risk of suicide.
13. History of anaphylaxis after administration of a biologic medication or vaccine.
14. History of hypersensitivity (including anaphylaxis) to an immunoglobulin product (plasma-derived or recombinant, e.g., monoclonal antibody) or to any of the study drugexcipients [L-histidine, trehalose, or Tween (polysorbate) 80].
15. Any disorder, including, but not limited to cardiovascular, gastrointestinal, hepatic,renal, neurological, musculoskeletal, infectious, endocrine, metabolic, hematological,psychiatric, or major physical impairment that is not stable in the opinion of theInvestigator and could: affect participant safety, alter the findings of the study orthe interpretation of study results, impede the participant's ability to complete theentire duration of the study, or would require frequent bursts of systemiccorticosteroids.

• Participant may not have Prior/Concomitant Therapy as follows: a. Receipt of live (attenuated) vaccines within 30 days of Baseline (Day 1) NOTE: Receiptof inactive/killed vaccines (e.g., influenza) or mRNA vaccines (e.g., COVID) are permittedprovided that they are not given within 5 days before/after any of the study visits. b. Receipt or donation of any blood product in the 28 days before Baseline (Day 1). NOTE: Patients who are not willing to abstain from donating blood and/or plasma fromScreening and for the 112 days after last dose of study drug should not be enrolled.

• Participant is unable or unwilling to discontinue current prohibited AD treatments withindefined washout windows below and in prohibited medications Section 6.11, as applicable,before Baseline (Visit 2):

1. Systemic JAK inhibitors including but not limited to ruxolitinib, tofacitinib,baricitinib, upadacitinib, abrocitinib and filgotinib within 60 days
2. Lymphocyte depleting agents such as rituximab within 6 months or when lymphocytecounts return to normal whichever is longer
3. Systemic therapy for AD including but not limited to corticosteroids, methotrexate,cyclosporine, azathioprine, phosphodiesterase type 4 (PDE-4) inhibitors, ormycophenolate mofetil within 4 weeks
4. Targeted biologic treatments (as listed in prohibited medication Section 6.11) within 5 half-lives (if known) or 12 weeks, whichever is longer
5. At any time prior to baseline, patient did not respond favorably to previous dupilumabor other anti-IL4Rα or anti-IL-13 treatment (e.g., therapy failure, patientexperienced an adverse reaction to treatment)
6. Oral or parenteral traditional Chinese medicine within 4 weeks
7. Topical treatments other than the Sponsor permitted emollient, including but notlimited to TCS, TCI, PDE-4, antihistamines, or JAKi within 2 weeks
8. Phototherapy treatment, laser therapy, tanning booth, or extended sun exposure thatcould affect disease severity or interfere with disease assessments within 4 weeks
9. Use of bleach baths in the prior 2 weeks
10. Topical anti-infectives within 2 weeks
11. Emollients only available by prescription within 2 weeks including those containingceramide, hyaluronic acid, urea, filaggrin, Vitamin D or Vitamin E, even if notprescribed Prior/Concurrent Clinical Study Experience

• Receipt of any experimental systemic medications in the 42 days before Baseline (Day 1), or 5 half-lives (if known), whichever is longer.
• Previous enrollment in a CBP-201 treatment protocol and having received at least 1 dose of active study drug.
• Concurrent enrollment in another trial where the patient is receiving anexperimental intervention. Have the following laboratory abnormalities at Screening:

1. Hemoglobin ≤ 10 g/dL
2. Platelet count < 100,000 cells/µL
3. Eosinophil count > 1500 cells/ µL
4. Total creatine phosphokinase (CPK) > 3 times the upper limit of the normal (ULN)
5. Alanine aminotransferase (ALT) ≥ 2.0xULN
6. Aspartate aminotransferase (AST) ≥ 2.0x ULN
7. Total Bilirubin ≥ 1.5x ULN (an isolated bilirubin >1.5x ULN is acceptable if bilirubinis fractionated, and the direct bilirubin is < 35% or if the participant has knownGilbert's Syndrome)
8. Alkaline Phosphatase >2x ULN

• Abnormal ECG at screening per investigator assessment.
• Major surgery, requiring anesthesia, within 6 weeks before Baseline (Day 1), orplanned in-patient surgery or hospitalization during study participation.