A Study of Bermekimab (JNJ-77474462) in the Treatment of Participants with Moderate to Severe Atopic Dermatitis

JRCT ID: jRCT2011210006

Registered date:28/04/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Dermatitis, Atopic
• Date of first enrollment: 24/06/2021
• Target sample size: 200
• Countries of recruitment: Canada,Japan,Germany,Japan,Poland,Japan,United States of America,Japan
• Study type: Interventional

Intervention(s)

Placebo :
Placebo will be administered subcutaneously.
Group 1: Placebo
Group 4: Dupilumab

Bermekimab
Bermekimab will be administered subcutaneously.
Group 1: Placebo
Group 2: Bermekimab
Group 3: Bermekimab
Group 4: Dupilumab

Dupilumab
Dupilumab will be administered subcutaneously.
Group 4: Dupilumab

Outcome(s)

• Primary Outcome: Percentage of Participants With Eczema Area and Severity Index (EASI)-75 (Greater Than or Equal to [>=] 75 Percent (%) Improvement From Baseline) for Efficacy of Bermekimab at Week 16

Secondary Outcome

- Percentage of Participants With Both Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) Score of 0 or 1 and a Reduction From Baseline of >=2 Points for Additional Assessments of Bermekimab at Week 16
- Percentage of Participants With Improvement (Reduction) of Eczema-Related Itch Numeric Rating Scale (NRS) Value of >=4 From Baseline to Week 16 Among Participants With a Baseline Itch Value >=4 for Additional Assessments of Bermekimab
- Percentage of Participants With EASI-90 (>=90% improvement in EASI from Baseline) for Additional Assessments of Bermekimab at Week 16
- Percentage of Participants With EASI-75 (Greater Than or Equal to [>=] 75 Percent (%) Improvement From Baseline) for Efficacy of Bermekimab Relative to Dupilumab at Week 16
- Percentage of Participants With EASI-90 (>=90% improvement in EASI from Baseline) for Efficacy of Bermekimab Relative to Dupilumab at Week 16
- Percentage of Participants With Both vIGA-AD Score of 0 or 1 (on a 5-point scale) and a Reduction From Baseline of >=2 Points for Efficacy of Bermekimab Relative to Dupilumab at Week 16
- Percentage of participants With Improvement (Reduction) of Eczema-Related Itch NRS Value of >=4 From Baseline to Week 16 Among Participants With a Baseline Itch Value >=4 for Efficacy of Bermekimab Relative to Dupilumab
- Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
- Number of Participants With Treatment-emergent Serious Adverse Events (SAEs)
- Serum Bermekimab Concentration
- Number of Participants with Anti-Bermekimab Antibodies

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

- Be otherwise healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiograms (ECGs) performed at screening. Any abnormalities, must be consistent with the underlying illness in the study population and this determination must be recorded in the participant's source documents and initialed by the investigator
- Have atopic dermatitis (AD) for at least 1 year (365 days) prior to the first administration of study intervention as determined by the investigator through participant interview and/or review of the medical history
- Have a history of inadequate response to treatment for AD with topical medications or for whom topical treatments are otherwise medically inadvisable (example [eg], due to important side effects or safety risks)
- Be considered, in the opinion of the investigator, a suitable candidate for dupilumab (DUPIXENT) therapy according to their country's approved DUPIXENT product labeling
- Have an eczema area and severity index (EASI) score greater than or equal (>=) to 16 at screening and at baseline
- Have an investigator global assessment (IGA) score >=3 and involved body surface area (BSA) >=10 percent (%) at screening and baseline

Exclude criteria

- Has a current diagnosis or signs or symptoms of severe, progressive, or uncontrolled renal, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
- Has unstable cardiovascular disease, defined as a recent clinical deterioration (eg, unstable angina, rapid atrial fibrillation) in the last 3 months or a cardiac hospitalization within the last 3 months
- Has or has had a serious infection (eg, sepsis, pneumonia, or pyelonephritis), or has been hospitalized or received intravenous (IV) antibiotics for an infection during the 2 months before screening
- Has or has had herpes zoster within the 2 months before screening
- Has a history of being human immunodeficiency virus (HIV) antibody-positive, or tests positive for HIV at screening

Related Information

• Primary Sponsor: Nishikawa Kazuko
• Secondary ID(s): 2020-002587-31,NCT04791319