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

Completed · Phase 2

Conditions studied: Atopic Dermatitis

In brief

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

Key facts

Study ID: NCT03496974
Run by: Janssen Research & Development, LLC
People needed: 38
Starts: 2018-05-21
Expected to finish: 2018-12-11
Last updated by the study team: 2021-03-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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:
Immunosuppressive/immunomodulating drugs (eg, systemic corticosteroids, cyclosporine, mycophenolate-mofetil, IFN-γ, Janus kinase inhibitors, azathioprine, methotrexate, etc.)
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

Where it is running

Florida Academic Centers Research & Education — Coral Gables, Florida, United States

Full record on ClinicalTrials.gov

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