A Study to Evaluate the Safety and Efficacy of Bermekimab in Patients With Moderate to Severe Atopic Dermatitis
Condition: Atopic Dermatitis; Eczema
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: Bermekimab Monoclonal Antibody; Placebo
Intervention description: Bermekimab 400 mg or 800 mg will be administered subcutaneously.; Placebo will be administered subcutaneously.
Intervention MeSH terms: Antibodies; Antibodies, Monoclonal
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 87.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      A Study to Evaluate the Safety and Efficacy of Bermekimab in Patients With Moderate to Severe
      Atopic Dermatitis
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female, at least 18 years

          -  Willing and able to attend all clinic visits and comply with study-related procedures

          -  Participant can understand and complete study-related questionnaires

          -  Written informed consent provided by the participant

          -  Chronic atopic dermatitis present for at least 3 years

          -  Eczema Area and Severity Index Score (EASI) score greater than or equal to (>=) 16 at
             screening and baseline visits

          -  Investigators Global Assessment (IGA) >= 3 at screening and baseline visits

          -  Baseline pruritis numerical rating scale average score for maximum intensity of at
             least 3, based on the average of daily pruritis numerical rating scale scores for
             maximum itch intensity reported during the 7 days prior to randomization

          -  Has applied a stable dose of topical moisturizer twice daily for at least 7
             consecutive days immediately prior to the baseline visit and is willing to continue
             this regimen on a daily basis for the duration of the study

          -  >= 10 percent (%) body surface area (BSA) of Atopic Dermatitis (AD) involvement at
             screening and baseline visits

          -  Documented recent history (within 6 months prior to screening) of inadequate response
             to treatment with topical medications, or participants for whom topical treatments are
             medically inadvisable (because of important side effects or safety risks): (a)
             Inadequate response is defined as failure to achieve and maintain remission or a low
             disease activity state (comparable to an IGA score of 0-2), despite treatment with a
             daily regimen of topical corticosteroids of medium to higher potency (with or without
             topical calcineurin inhibitors as appropriate), applied for at least 28 days or for
             the maximum duration recommended by the product prescribing information, whichever is
             shorter; (b) Participants with documented systemic treatment for atopic dermatitis in
             the preceding 6 months are also considered to be inadequate responders to topical
             treatments and are potentially eligible for treatment with MABp1, after appropriate
             washout; (c) Important side effects or risks are those that outweigh the potential
             treatment benefits, and include: intolerance to treatment, hypersensitivity reactions,
             significant skin atrophy, and adverse systemic effects; and (d) Acceptable
             documentation includes contemporaneous chart notes that record topical medication
             prescription and treatment outcome, or investigator documentation based on
             communication with the participant's treating physician.

        Exclusion Criteria:

          -  Participants has been treated for AD with any investigational drug of chemical or
             biologic nature within a minimum of 30 days or 5 half-lives (whichever is longer) of
             the drug prior to baseline

          -  Treatment with bermekimab at any time in the past

          -  Treatment with immunosuppressive/immunomodulatory drugs or phototherapy for atopic
             dermatitis within 4 weeks of baseline, or any condition that, in the opinion of the
             investigator, is likely to require such treatment(s) during the first 4 weeks of study
             treatment

          -  Treatment with topical corticosteroids or topical calcineurin inhibitors for the
             treatment of AD within 14 days prior to baseline

          -  Treatment with biologics as follows: (a) Any cell-depleting agents including, but not
             limited to, rituximab, within 5 half-lives (if known) or 30 days prior to baseline
             visit, or until lymphocyte count returns to normal, whichever is longer; (b) Other
             biologics: within 5 half-lives (if known) or 30 days prior to baseline visit,
             whichever is longer

          -  Initiation of treatment of atopic dermatitis with prescription moisturizers or
             moisturizers containing additives such as ceramide, hyaluronic acid, urea, or
             filaggrin degradation products during the screening period (participants may continue
             to use stable doses of such moisturizers if initiated before the screening visit)

          -  Regular use (more than 2 visits per week) of a tanning booth/parlor within 4 weeks of
             the screening visit

          -  Planned or anticipated use of any prohibited medications and procedures during study
             treatment

          -  Treatment with a live (attenuated) vaccine within 30 days prior to the screening visit

          -  Active chronic or acute infection requiring treatment with systemic antibiotics,
             antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks prior to the
             baseline visit, or superficial skin infections within 1 week prior to the baseline
             visit

          -  Known or suspected history of immunosuppression, including history of invasive
             opportunistic infections (for example, tuberculosis, histoplasmosis, listeriosis,
             coccidioidomycosis, pneumocystis, aspergillosis) despite infection resolution; or
             unusually frequent, recurrent, or prolonged infections, per investigator judgment

          -  History of human immunodeficiency virus (HIV) infection or positive HIV serology at
             screening

          -  Positive for hepatitis B surface antigen, hepatitis B core antibody, or hepatitis C
             antibody at the screening visit

          -  At baseline, presence of any conditions listed as criteria for study drug
             discontinuation

          -  Presence of skin comorbidities that may interfere with study assessments

          -  History of malignancy within 5 years before the screening visit, except completely
             treated in situ carcinoma of the cervix, and completely treated and resolved
             non-metastatic squamous or basal cell carcinoma of the skin diagnosed active
             endoparasitic infections; suspected or high risk of endoparasitic, unless clinical and
             (if necessary) laboratory assessments have ruled out active infection before
             randomization

          -  Severe concomitant illness(es) that, in the investigator's judgment, would adversely
             affect the Participant's participation in the study. Examples include, but are not
             limited to, participants with short life expectancy, participants with uncontrolled
             diabetes (HbA1c >= 9%), participants with cardiovascular conditions (for example,
             stage III or IV cardiac failure according to the New York Heart Association
             classification), severe renal conditions (for example, participants on dialysis),
             hepato-biliary conditions (for example, Child-Pugh class B or C), neurological
             conditions (for example, demyelinating diseases), active major autoimmune diseases
             (for example, lupus, inflammatory bowel disease, rheumatoid arthritis, etc.), other
             severe endocrinological, gastrointestinal, metabolic, pulmonary or lymphatic diseases.
             The specific justification for participants excluded under this criterion will be
             noted in study documents (chart notes, case report forms [CRFs], etc.)

          -  Planned or anticipated major surgical procedure during the participant's participation
             in this study

          -  Membership of the investigational team or his/her immediate family

          -  Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed
             during the study

          -  Women unwilling to use adequate birth control, if of reproductive potential and
             sexually active. Adequate birth control is defined as consistent practice of an
             effective and accepted method of contraception throughout the duration of the study
             and for 120 days after the last dose of study drug. These methods include hormonal
             contraceptives, intrauterine device, double barrier contraception (that is, condom +
             diaphragm), or male partner with a documented vasectomy

          -  History of severe allergic or anaphylactic reactions to monoclonal antibodies

          -  Any other medical or psychological condition (including relevant laboratory
             abnormalities at screening) that, in the opinion the investigator, may suggest a new
             and/or insufficiently understood disease, may present an unreasonable risk to the
             study participant as a result of his/her participation in the study, may make
             participant's participation unreliable, or may interfere with study assessments. The
             specific justification for participant excluded under this criterion will be noted in
             study documents (chart notes, case report forms, etc.)