A Study to Assess the Efficacy and Safety of CBP-201 in Adult Subjects With Moderate to Severe Atopic Dermatitis
Condition: Moderate-to-severe Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: CBP-201; placebo
Intervention description: CBP-201 subcutaneous(SC) injection.; subcutaneous(SC) injection
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 226.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This study will evaluate the efficacy, safety, pharmacokinetics and pharmacodynamics of
      CBP-201 in adult subjects with moderate to severe atopic dermatitis.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Be an adult ≥18 and ≤ 75 years of age at the screening visit (Screening) with atopic
             dermatitis according to American Academy of Dermatology Consensus Criteria,
             (Eichenfield 2014)

          2. Present for at least 1 year prior to the baseline visit (Baseline) with an inadequate
             response, in the judgement of the Investigator, to AD treatment with a topical regimen
             of corticosteroids, phosphodiesterase inhibitors or calcineurin inhibitors, or for
             whom topical treatments are otherwise medically inadvisable (eg, because of important
             side effect or safety risks)

          3. Investigator Global Assessment (IGA) score ≥ 3 at Screening and Baseline.

          4. Eczema Area and Severity Index (EASI) score ≥ 16 at Screening and Baseline

          5. Body Surface Area (BSA) for total AD involvement ≥ 10% at Screening and Baseline

          6. Able and willing to apply a stable dose of a bland emollient twice a day to affected
             areas for at least 7 days before Baseline and to continue for the duration of the
             study

          7. Females of child-bearing potential (FCBP) and males who have not undergone a vasectomy
             must abstain from heterosexual activities or agree to use effective contraception
             throughout the entire study period.

        Exclusion Criteria:

          1. Have any of the following laboratory abnormalities at Screening:

               1. Hemoglobin ≤ 90% of the lower limit of normal range (LLN)

               2. White blood cell (WBC) below the LLN

               3. Neutrophil count below the LLN

               4. Platelet count below the LLN

          2. Have undergone treatment with any of the following:

               1. Topical agents such as corticosteroids, phosphodiesterase (PDE) inhibitors, Janus
                  kinase (JAK) inhibitors, tacrolimus or pimecrolimus within 1 week prior to
                  Baseline. Note that low to medium potency topical corticosteroids (TCS) are
                  permitted after randomization to treat AD flares

               2. Prior treatment with dupilumab or any antibody against IL-4Rα or IL-13

               3. Systemic treatment for AD or other condition with steroids or other
                  immunosuppressive/immunomodulating substances, e.g., cyclosporine,
                  mycophenolate-mofetil, azathioprine, methotrexate or oral Janus kinase (JAK)
                  inhibitors within 4 weeks prior to Baseline. Use of steroid inhalers and nasal
                  corticosteroids is allowed.

               4. Cell depleting agents, e.g. rituximab, within 6 months of Baseline or treatment
                  with other biologics within 5 half-lives (if known) or 3 months prior to baseline
                  visit, whichever is longer

               5. Phototherapy (narrow band ultraviolet B [NBUVB], ultraviolet B [UVB], ultraviolet
                  A1 [UVA1], psoralen + ultraviolet A [PUVA]), tanning beds, or any other light
                  emitting device (LED), within 4 weeks of Baseline

               6. ≥ 2 bleach baths within 2 weeks of Baseline

               7. Prescription emollient to treat AD (e.g. Atopiclair®, MimyX®, Epicerum®, etc.)
                  within 2 weeks of Baseline

               8. Any investigational drug within 30 days or within 5 half-lives, whichever is
                  longer, before Baseline.

               9. Live (attenuated) vaccine within 8 weeks of Baseline.

              10. Treatment with systemic traditional Chinese medicine (TCM) or herbal medications
                  within 4 weeks before Baseline or treatment with topical TCM or herbal
                  medications within 1 week before Baseline visit

          3. Have any of the following:

               1. Infection requiring treatment with systemic antibiotics, antivirals,
                  antiparasitics, antiprotozoals, or antifungals within 4 weeks before Baseline, or
                  superficial skin infection, such as impetigo, within 2 weeks before the Baseline
                  (subjects may be rescreened after the infection has resolved)

               2. A history of parasitic infection (e.g. helminth), within 6 months of Baseline

               3. Per investigator judgement, known or suspected history of immunosuppression
                  within 6 months of Baseline, including a history of invasive opportunistic
                  infections, such as aspergillosis, coccidioidomycosis, histoplasmosis, human
                  immunodeficiency virus (HIV), listeriosis, pneumocystosis, or tuberculosis,
                  despite infection resolution; or unusually frequent, recurrent or prolonged
                  infections.

               4. Any history of vernal keratoconjunctivitis (VKC) and atopic keratoconjunctivitis
                  (AKC)

               5. A history of malignancy with the following exceptions: completely treated
                  carcinoma in situ of cervix or non-metastatic squamous or basal cell carcinoma of
                  the skin

               6. Positive results at Screening for hepatitis B surface antigen (HBsAg), hepatitis
                  B core antibody (HBcAb) or hepatitis C antibody with positive HCV RNA polymerase
                  chain reaction; positive HIV serology at screening

               7. An allergy to L-histidine, trehalose or Tween (polysorbate) 80

          4. Women must not be pregnant, planning to become pregnant or breast-feed during the
             study