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

Completed · Phase 2 · Has a placebo group

Conditions studied: Atopic Dermatitis, Eczema

In brief

Key facts

Study ID: NCT04021862
Run by: Janssen Research & Development, LLC
People needed: 87
Starts: 2019-10-16
Expected to finish: 2020-11-19
Last updated by the study team: 2025-02-04

Who can join

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

You may qualify if…

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.

You may not qualify if…

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.)

Where it is running

Beach Clinical Research Inc — Huntington Beach, California, United States
Florida Academic Dermatology Centers — Coral Gables, Florida, United States
Doral Medical Research — Doral, Florida, United States
Floridian Research Institute — Miami, Florida, United States
Florida International Medical Research — Miami, Florida, United States
Premier Research Associate, Inc — Miami, Florida, United States
CNS HealthCare — Orlando, Florida, United States
Avita Clinical Research — Tampa, Florida, United States
Forcare Clinical Research Inc — Tampa, Florida, United States
Advanced Medical Research — Sandy Springs, Georgia, United States
Dawes Fretzin Clinical Research Group — Indianapolis, Indiana, United States
Randall Dermatology & Cosmetic Surgery — West Lafayette, Indiana, United States
Revival Research Institute LLC — Troy, Michigan, United States
ClinOhio Research Services — Columbus, Ohio, United States
Helios Clinical Research, LLC — Milan, Tennessee, United States
Progressive Clinical Research — San Antonio, Texas, United States
Dominion Medical Associates, Inc. — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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