| Eligibility |
Inclusion Criteria:
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- 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 of
Dermatology 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 14
days before the Baseline Visit and agree to continue at least daily use during study
participation.
• Documented recent history (within 180 days before Screening) of inadequate response
to treatment with TCS or topical immunomodulator medication or for whom topical
treatments are otherwise medically inadvisable (e.g., important side effects or safety
risks).
- Participants must agree to avoid the use of prohibited AD medications throughout
the duration of the study.
- In the opinion of the Investigator, participant is willing and able to comply
with all study visits and study-related procedures.
- Female patients of childbearing potential who are sexually active with a
non-sterilized male partner should have a confirmed negative serum beta-human
chorionic gonadotropin test at Visit 1 and agrees to use acceptable forms of
birth control.
Exclusion Criteria:
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No current or past history of:
1. Other active skin diseases (e.g., psoriasis, lupus erythematosus etc.) or skin
infections (bacterial, fungal, or viral) that require systemic treatment within 4
weeks 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 episodes
of herpes herpeticum in past 2 years.
3. Non-skin related active infection requiring systemic treatment with parenteral
anti-infectives within 30 days or oral anti-infectives within 14 days before the
Baseline Visit (Visit 2).
4. Active human immunodeficiency virus (HIV) defined as a confirmed positive anti-HIV
antibody 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 of
care.
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 (HCV
Ab).
•
Participant may not have any of the following conditions:
1. Known primary immunodeficiency or immunocompromised
2. History of malignancy within 5 years before the Screening Visit except for completely
treated in situ carcinoma of the cervix or completely treated and resolved basal cell
carcinoma of the skin.
3. A helminth parasitic infection diagnosed within 6 months before Visit 1 that has not
been treated with or has failed to respond to standard of care therapy.
4. 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 months
before screening.
5. History of attempted suicide or is at significant risk of suicide.
6. History of anaphylaxis after administration of a biologic medication or vaccine.
7. History of hypersensitivity (including anaphylaxis) to an immunoglobulin product
(plasma-derived or recombinant, e.g., monoclonal antibody) or to any of the study drug
excipients [L-histidine, trehalose, or Tween (polysorbate) 80].
8. 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 the
Investigator and could: affect participant safety, alter the findings of the study or
the interpretation of study results, impede the participant's ability to complete the
entire duration of the study, or would require frequent bursts of systemic
corticosteroids.
- Participant may not have Prior/Concomitant Therapy as follows:
a. Receipt of live (attenuated) vaccines within 30 days of Baseline (Day 1) NOTE: Receipt
of inactive/killed vaccines (e.g., influenza) or mRNA vaccines (e.g., COVID) are permitted
provided 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 from
Screening 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 within
defined 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 lymphocyte
counts 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, or
mycophenolate 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 dupilumab
or other anti-IL4Ra or anti-IL-13 treatment (e.g., therapy failure, patient
experienced 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 not
limited to TCS, TCI, PDE-4, antihistamines, or JAKi within 2 weeks
8. Phototherapy treatment, laser therapy, tanning booth, or extended sun exposure that
could 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 containing
ceramide, hyaluronic acid, urea, filaggrin, Vitamin D or Vitamin E, even if not
prescribed 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 an
experimental 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 bilirubin
is fractionated, and the direct bilirubin is < 35% or if the participant has known
Gilbert'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), or
planned in-patient surgery or hospitalization during study participation.
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