EUCTR2020-005900-21-DE
Active, not recruiting
Phase 1
A Phase 2a, Multicenter, Randomized, Placebo-Controlled, Double-Blind, Interventional Study to Assess the Efficacy, Safety, Pharmacokinetics, and Immunogenicity of Multiple IV doses of Bermekimab for the Treatment of Adult Participants with Moderate-to-Severe Atopic Dermatitis
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Moderate to Severe Atopic Dermatitis
- Sponsor
- Janssen-Cilag International NV
- Enrollment
- 60
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. \=18 to \=65 years old
- •2\. be otherwise healthy on the basis of physical examination and medical history.
- •3\. have AD for at least 1 year prior to the first administration of study intervention.
- •4\. have a history of inadequate response to treatment for AD with topical medications, or for whom topical treatments are otherwise medically inadvisable.
- •5\. have an EASI score \=16 at screening and at baseline.
- •6\. have an IGA score \=3 at screening and at baseline.
- •7\. have an involved BSA \=10% at screening and at baseline.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
Exclusion Criteria
- •1\. has a current diagnosis or signs or symptoms of severe, progressive, or uncontrolled systemic disturbances.
- •2\. has unstable cardiovascular disease.
- •3\. has signs and symptoms or a history of lymphoproliferative disease.
- •4\. a history of malignancy within 5 years before screening.
- •5\. has a history of chronic or recurrent infectious disease.
- •6\. has or has had a serious infection during the 2 months before screening.
Outcomes
Primary Outcomes
Not specified
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