A Study to Evaluate Safety and Effectiveness of Cendakimab (CC-93538) in Participants With Moderate to Severe Atopic Dermatitis
Condition: Dermatitis, Atopic; Eczema
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: CC-93538; Placebo
Intervention description: Specified dosages on specified days; Specified dosages on specified days
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 221.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Atopic Dermatitis; Cendakimab; CC-93538

Summary:

      The purpose of this study is to evaluate the effectiveness and safety of 3 dose regimen of
      CC-93538 in adult participants with moderate to severe Atopic Dermatitis (AD).
    

Eligibility criteria:

        Inclusion Criteria:

        Participants must satisfy the following criteria to be enrolled in the study:

          1. Participant must be ≥ 18 years and ≤ 75 years of age and have a body weight of ≥ 40 kg
             (88.2 lb) at the time of signing the informed consent form (ICF).

          2. Participant has chronic atopic dermatitis (AD) as defined by Hanifin and Rajka that
             has been present for ≥ 1 year prior to the baseline visit (Day 1).

          3. Participant has moderate to severe, active, and symptomatic AD defined by meeting all
             of the following criteria on the day of the baseline visit (Day 1):

               1. Body Surface Area (BSA) ≥ 10%, and

               2. EASI score ≥ 16, and

               3. vIGA-AD ≥ 3, and

               4. Pruritus Numeric Rating Scale (NRS) severity score ≥ 4.

          4. Participant must have a documented history of inadequate response to treatment with
             topical medications for at least 4 weeks, unless topical treatments are otherwise
             medically inadvisable or has required systemic therapy for control of disease.

          5. Participant must be willing to apply a stable dose of topical emollient (eg,
             over-the-counter moisturizer, non-medicated emollient, etc.) twice daily for ≥ 7 days
             prior to the Baseline visit and continue application throughout the study.

          6. Participant must commit to avoid prolonged exposure to the sun and not to use tanning
             booths, sun lamps or other ultraviolet light sources during the study.

          7. Participants currently receiving concomitant medications for any reason other than AD,
             such as inhaled corticosteroids, leukotriene receptor antagonists (eg, montelukast),
             or mast cell stabilizers (eg, cromolyn sodium) for asthma, must be on a stable
             regimen, which is defined as not starting a new drug, changing, or stopping dosage
             within 7 days or 5 half-lives (whichever is longer) prior to Day 1 and through the
             treatment duration of the study.

          8. Female participants of childbearing potential must agree to practice a highly
             effective method of contraception.

        Exclusion Criteria:

          1. The presence of any of the following will exclude a participant from enrollment:
             Evidence of an active and/or concurrent inflammatory skin condition (eg, seborrheic
             dermatitis, psoriasis, acute allergic contact dermatitis, etc.) that would interfere
             with the Investigator or participant-driven evaluations of AD.

          2. Evidence of acute AD flare between the Screening and Baseline/ Randomization (eg,
             doubling of the EASI score between Screening and Baseline).

          3. Use of topical treatments that could affect the assessment of AD (eg, corticosteroids,
             calcineurin inhibitors, tars, antibiotic creams, topical antihistamines) within 7 days
             of the Day 1 visit.

          4. Received phototherapy narrowband UVB (NB-UVB) or broad band phototherapy within 4
             weeks prior to the Baseline visit.

          5. Evidence of immunosuppression, participant is receiving, or has received systemic
             immunosuppressive or immunomodulating drugs (eg, azathioprine, cyclosporine, systemic
             corticosteroids, interferon gamma (IFN-γ), Janus kinase inhibitors, methotrexate,
             mycophenolate-mofetil, etc.) within 4 weeks prior to the Baseline visit.

          6. Treatment with immunomodulatory biologics

          7. Concurrent treatment with another IP

          8. Received a live attenuated vaccine within 1 month prior to the first Screening Visit
             or anticipates the need to be vaccinated with a live attenuated vaccine during the
             study.

          9. Active parasitic/helminthic infection or a suspected parasitic/helminthic infection.

         10. Ongoing infection

         11. A history of idiopathic anaphylaxis or a major immunologic reaction (such as
             anaphylactic reaction, anaphylactoid reaction, or serum sickness) to an immunoglobulin
             G (IgG) containing agent. A known hypersensitivity to any ingredient in the
             investigational product (IP) is also exclusionary.