At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double Blind, Placebo-controlled, Multi-center, Parallel Group Study to Evaluate the Efficacy and Safety of Dupilumab in Patients With Prurigo Nodularis Who Are Inadequately Controlled on Topical Prescription Therapies or When Those Therapies Are Not Advisable
In Brief
A Phase 3 clinical trial evaluating Dupilumab SAR231893, Placebo, and 3 other interventions for Neurodermatitis. Completed, enrolled 151 participants across 63 sites in 8 countries.
Detailed Summary
Primary Objective: To demonstrate the efficacy of dupilumab on itch response in participants with prurigo nodularis (PN), inadequately controlled on topical prescription therapies or when those therapies are not advisable. Secondary Objectives: To demonstrate the efficacy of dupilumab on additional itch endpoints in participants with PN, inadequately controlled on topical prescription therapies or when those therapies are not advisable. To demonstrate efficacy of dupilumab on skin lesions of PN. To demonstrate the improvement in health-related quality of life. To evaluate safety outcome measures. To evaluate immunogenicity of dupilumab.
Study Details
Timeline
Interventions
Pharmaceutical form:Injection solution Route of administration: Subcutaneous
Pharmaceutical form:Injection solution Route of administration: Subcutaneous
Pharmaceutical form: Route of administration: Topical
Pharmaceutical form: Route of administration: Topical
Pharmaceutical form: Route of administration: Topical