A Phase II Study of Bermekimab (MABp1) in Patients With Moderate to Severe Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: Bermekimab Monoclonal Antibody 200 mg; Bermekimab Monoclonal Antibody 400 mg
Intervention description: 200 mg subcutaneous injection; 400 mg subcutaneous injection
Intervention MeSH terms: Antineoplastic Agents, Immunological; Antibodies; Immunoglobulins; Antibodies, Monoclonal
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 38.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      A Phase 2 study of Bermekimab (MABp1) in patients with atopic dermatitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written informed consent provided by the patient

          -  Age 18 years or greater

          -  Chronic Atopic Dermatitis present for at least 3 years

          -  Disease is not responsive to topical medications, or for whom topical treatments are
             not indicated or desired.

          -  Willing and able to comply with all clinic visits and study-related procedures

          -  EASI score ≥16 at screening and baseline visits

          -  IGA score ≥3 at screening and baseline visits

          -  ≥10% body surface area (BSA) of AD involvement at screening and baseline visits

          -  Documented recent history (within 6 months before the screening visit) of inadequate
             response to treatment with topical medications or for whom topical treatments are
             otherwise medically inadvisable or undesired.

        Exclusion Criteria:

          -  Treatment with an investigational drug within 8 weeks of baseline visit

          -  Having received the following treatments within 4 weeks before the baseline visit, 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:

               1. Immunosuppressive/immunomodulating drugs (eg, systemic corticosteroids,
                  cyclosporine, mycophenolate-mofetil, IFN-γ, Janus kinase inhibitors,
                  azathioprine, methotrexate, etc.)

               2. Phototherapy for AD

          -  Treatment with topical corticosteroids (TCS) or topical calcineurin inhibitors (TCI)
             within 1 week before the baseline visit

          -  Initiation of treatment during the screening period with prescription moisturizers or
             moisturizers containing additives such as ceramide, hyaluronic acid, urea, or
             filaggrin degradation products during the screening period (patients may continue
             using 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.

          -  History of severe allergic or anaphylactic reactions to monoclonal antibodies.

          -  Administration of any live (attenuated) vaccine within 4 weeks prior to the baseline.

          -  Any history of dysplasia or history of malignancy (including lymphoma and leukemia)
             other than a successfully treated non-metastatic cutaneous squamous cell carcinoma,
             basal cell carcinoma or localized carcinoma in situ of the cervix

          -  Active chronic or acute infection requiring treatment with systemic antibiotics,
             antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before the
             baseline visit, or superficial skin infections within 1 week before the baseline
             visit. NOTE: patients may be rescreened after infection resolves

          -  Known or suspected history of immunosuppression, including history of invasive
             opportunistic infections (eg, tuberculosis [TB], histoplasmosis, listeriosis,
             coccidioidomycosis, pneumocystosis, 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 with hepatitis B surface antigen (HBsAg) or hepatitis C antibody at the
             screening visit

          -  Presence of skin comorbidities that may interfere with study assessments

          -  Severe concomitant illness(es) that, in the investigator's judgment, would adversely
             affect the patient's participation in the study. Examples include, but are not limited
             to, patients with short life expectancy, patients with uncontrolled diabetes (HbA1c ≥
             9%), patients with cardiovascular conditions (eg, stage III or IV cardiac failure
             according to the New York Heart Association classification), severe renal conditions
             (eg, patients on dialysis), hepato-biliary conditions (eg, Child-Pugh class B or C),
             neurological conditions (eg, demyelinating diseases), active major autoimmune diseases
             (eg, lupus, inflammatory bowel disease, rheumatoid arthritis, etc.), other severe
             endocrinological, gastrointestinal, metabolic, pulmonary or lymphatic diseases. The
             specific justification for patients excluded under this criterion will be noted in
             study documents (chart notes, case report forms [CRFs], etc.)

          -  Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed
             during the study

          -  Where relevant, women unwilling to use adequate birth control