An investigator-initiated, multi-center, randomized, double-blind, placebo controlled study of Dupilumab to demonstrate efficacy in subjects with nummular eczema

Conditions

Subjects with nummular eczema

Brief summary

Percent change in EASI score from baseline to week 16

Detailed description

Number of Patients Achieving an Improvement (Decrease) in Physician Global Assessment (PGA) by two or more points at week 16 as compared to week 0 or achieving an absolute PGA of 0 or 1 at Week 16., Eczema Area and Severity Index (EASI) 50 score at week 16 The proportion of subjects who achieve at least a 50% reduction in the EASI score at Week 16 compared to week 0 (Baseline)., Significant histological improvement at week 16. Assessed by reduction of epidermal thickness > 30% or reduction of inflammatory infiltrate > 50 % compared to histological findings on baseline., Change from Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Week 16., Change from Baseline in Pruritus Visual Analog Scale (VAS) Score at Week 16., Change from Baseline in the Global Satisfaction Subscale of the Treatment Satisfaction Questionnaire for Medication (TSQM) Score at Week 16., Safety of Dupilumab will be assessed by Evaluating Adverse Events (AEs).

Related papers

No related papers found yet.

Interventions

DRUGDupixent 300 mg solution for injection in pre-filled syringe

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Percent change in EASI score from baseline to week 16	—

Secondary

Measure	Time frame
Number of Patients Achieving an Improvement (Decrease) in Physician Global Assessment (PGA) by two or more points at week 16 as compared to week 0 or achieving an absolute PGA of 0 or 1 at Week 16., Eczema Area and Severity Index (EASI) 50 score at week 16 The proportion of subjects who achieve at least a 50% reduction in the EASI score at Week 16 compared to week 0 (Baseline)., Significant histological improvement at week 16. Assessed by reduction of epidermal thickness > 30% or reduction of inflammatory infiltrate > 50 % compared to histological findings on baseline., Change from Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Week 16., Change from Baseline in Pruritus Visual Analog Scale (VAS) Score at Week 16., Change from Baseline in the Global Satisfaction Subscale of the Treatment Satisfaction Questionnaire for Medication (TSQM) Score at Week 16., Safety of Dupilumab will be assessed by Evaluating Adverse Events (AEs).	—

Measure

Time frame

Number of Patients Achieving an Improvement (Decrease) in Physician Global Assessment (PGA) by two or more points at week 16 as compared to week 0 or achieving an absolute PGA of 0 or 1 at Week 16., Eczema Area and Severity Index (EASI) 50 score at week 16 The proportion of subjects who achieve at least a 50% reduction in the EASI score at Week 16 compared to week 0 (Baseline)., Significant histological improvement at week 16. Assessed by reduction of epidermal thickness > 30% or reduction of inflammatory infiltrate > 50 % compared to histological findings on baseline., Change from Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Week 16., Change from Baseline in Pruritus Visual Analog Scale (VAS) Score at Week 16., Change from Baseline in the Global Satisfaction Subscale of the Treatment Satisfaction Questionnaire for Medication (TSQM) Score at Week 16., Safety of Dupilumab will be assessed by Evaluating Adverse Events (AEs).

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Countries

Germany

Outcome results

None listed