A Phase II Study of Bermekimab (MABp1) in Patients With Moderate to Severe Atopic Dermatitis

Janssen Research & Development, LLC38 enrolled

Overview

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

A Phase 2, Open Label, Dose Escalation Study of Bermekimab (MABp1) in Patients with Moderate to Severe Atopic Dermatitis. The study is multi center and will consist of two dose levels: Group A (n=9): patients will receive a total of 4 x 200mg subcutaneous injections of bermekimab. Dosing will occur weekly from visit 1 to visit 4, inclusive. Group B (n=20): patients will receive a total of 8 x 400 mg subcutaneous injections of bermedimkb. Dosing will occur weekly from visit 1 to visit 8, inclusive.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Atopic Dermatitis

Interventions

Bermekimab Monoclonal Antibody 200 mgDRUG

200 mg subcutaneous injection

Bermekimab Monoclonal Antibody 400 mgDRUG

400 mg subcutaneous injection

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Florida Academic Centers Research & Education

Coral Gables, Florida, United States

Outcomes

Primary Outcomes

Number of Patients With Treatment Emergent Adverse Events (TEAEs)

Safety and tolerability endpoints were evaluated by monitoring all the adverse events from clinical and laboratory reporting, vital signs, physical examinations, ECG and urinalysis. All the Adverse Events that the subjects experienced from Visit 1 Day 1 (Post-injection) until 7 days after the last administration of the study drug were captured in the clinical database. AEs are coded using medical dictionary - MedDRA Version 21.0 and the severity was assigned using CTCAE version 4.03.

Time frame: From Visit 1 (Post-injection) until 7 days after the last administration of the study drug.

Secondary Outcomes

Change in Eczema Area and Severity Index (EASI) Score, From Baseline to Week 7 (or Last Visit)

EASI score will assess severity and extent of AD with respect to erythema, excoriation, infiltration and lichenification at 4 anatomic sites of the body: lower and upper extremities, trunk and head. The total EASI score shall be in a range of 0 to 72 points (from no disease to maximum disease severity, respectively). Group A: Change= (Baseline - Week 4 score); Group B: Change= (Baseline - Week 7 score)

Time frame: Group A: Baseline to Week 4; Group B: Baseline to Week 7

Pharmacokinetics (PK) Assessment at Week 7

An enzyme-linked immunosorbent assay (ELISA) has been developed to specifically measure bermekimab levels in human plasma. Blood will be drawn into a single 6 ml Na-Heparin collection tube at each PK collection time point. These samples will be collected per the study lab manual and immediately shipped to the Sponsor for PK analysis. The PK samples will also be used to test for the presence of antibodies against bermekimab. PK sample collection time points are as follows: Group A: Pre-dose at visits 1-5; visit 5 is reported Group B: Pre-dose at visit 1, visit 3, visit 5 and visit 8; visit 8 is reported

Time frame: Group A: Week 4; Group B: Week 7

Number of Patients Achieving Investigator's Global Assessment (IGA) Response (0 or 1) at Week 7

Data from ClinicalTrials.gov

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