A Study of Bermekimab for the Treatment of Adult Participants With Moderate-to-Severe Atopic Dermatitis
NCT ID: NCT04990440
Last Updated: 2023-05-24
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
6 participants
INTERVENTIONAL
2021-09-02
2022-03-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
DOUBLE
Study Groups
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Part A: Bermekimab Dose 1
Participants will receive bermekimab Dose 1 or placebo as an intravenous (IV) infusion weekly from Week 0 to Week 15.
Bermekimab
Participants will receive bermekimab IV.
Placebo
Participants will receive placebo IV.
Part B: Bermekimab Dose 2
Participants will receive bermekimab Dose 2 or placebo as an IV infusion weekly from Week 0 to Week 15.
Bermekimab
Participants will receive bermekimab IV.
Placebo
Participants will receive placebo IV.
Part C: Bermekimab Dose 3
Participants will receive bermekimab or placebo at a higher or lower dose (not less than \[\<\] Dose 1) than Part B, but with a maximum dose of Dose 3 IV weekly based on pharmacokinetic (PK), pharmacodynamic (PD), efficacy, and safety analysis.
Bermekimab
Participants will receive bermekimab IV.
Placebo
Participants will receive placebo IV.
Interventions
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Bermekimab
Participants will receive bermekimab IV.
Placebo
Participants will receive placebo IV.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have a history of inadequate response to treatment for AD with topical medications or for whom topical treatments are otherwise medically inadvisable (example, due to important side effects or safety risks)
* Have an Eczema Area and Severity Index (EASI) score greater than or equal to (\>=) 16 at screening and at baseline
* Must sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study
* Must be willing to undergo 4 skin biopsies
* Have an Investigator Global Assessment (IGA) score \>=3 at screening and at baseline
* Have an involved body surface area (BSA) \>=10 percent (%) at screening and at baseline
Exclusion Criteria
* Has ever received any Human interleukin-1 (IL-1) antagonist (example, including but not limited to anakinra, rilonacept)
18 Years
65 Years
ALL
No
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
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Dawes Fretzin Clinical Research Group
Indianapolis, Indiana, United States
Clinical Research Institute of Michigan, LLC
Chesterfield, Michigan, United States
Vital Prospects Clinical Research Institute, PC
Tulsa, Oklahoma, United States
Modern Research Associates
Dallas, Texas, United States
Progressive Clinical Research
San Antonio, Texas, United States
Texas Dermatology and Laser Specialists
San Antonio, Texas, United States
CARE - Centro de Alergia y Enfermedades Respiratorias
Buenos Aires, , Argentina
Conexa Investigacion Clinica S.A.
CABA, , Argentina
STAT Research S.A.
CABA, , Argentina
Clínica Adventista Belgrano
CABA, , Argentina
CINME - Centro de Investigaciones Metabolicas
Ciudad de Buenos Aires, , Argentina
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2020-005900-21
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
77474462ADM2003
Identifier Type: OTHER
Identifier Source: secondary_id
CR109057
Identifier Type: -
Identifier Source: org_study_id
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