Atopic Dermatitis MedDRA version: 15.0 Level: LLT Classification code 10003639 Term: Atopic dermatitis System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Sponsors
Regeneron Pharmaceuticals, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female, 18 years or older 2. Chronic Atopic dermatitis for at least 3 years 3. History of inadequate rsponse to a stable (> / = 1 month) regimen of topical corticosteroids or calcineurin inhibitors as treatment for Atopic dermatitis within 3 months before the screening visit Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 96 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 4
Exclusion criteria
Exclusion criteria: 1. Prior treatment with REGN668 2. Presence of certnain laboratory abnormalities at the screening visit 3. Treatment with an investigational drug within 8 weeks 4. Treatment with a live (attenuated) vaccine within 12 weeks before the baseline visit 5. Certain treatments and medical procedures, underaken within a particular timeframe prior to the baseline visit, preclude eligibility for participation in the study 6. Known history of human immunodeficiency virus (HIV) infection 7. History of malignancy within 5 years before the baseline visit, with certain exceptions 8. Planned surgical procedure dirung the length of the patient's participation in this study 9. History of clinical parasite infection 10. Any medical or psychiatric condition which, in the opinion of the investigator or the sponsor’s medical monitor, would place the patient at risk, interfere with participation in the study, or interfere with the interpretation of study results 11. Pregnant or breast-feeding women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to assess the clinical efficacy of repeated subcutaneous (SC) doses of REGN668 in adult patients with moderate-to-severe atopic dermatitis (AD).;Secondary Objective: Secondary objectives include: • To assess the safety and tolerability of repeated SC doses of REGN668 in this patient population • To assess the pharmacodynamics (PD) of repeated SC doses of REGN668 in this patient population • To assess the relationship of AD skin severity, dermatology quality of life (QOL), skin barrier measures, and itch questionnaires to exploratory biomarker analysis;Primary end point(s): The primary endpoint is the percent change in Eczema Area and Severity Index (EASI) score from baseline to week 12.;Timepoint(s) of evaluation of this end point: Throughout the duration of the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints include: • Proportion of patients who achieve an Investigator’s Global Assessment (IGA) score of 0 or 1 at week 12 • Proportion of patients who achieve =50% overall improvement in EASI score from baseline to week 12 (achieving an EASI 50 [50% or greater improvement in EASI score]) is considered by dermatology investigators a clinically significant level of improvement to use as an endpoint. • Change in EASI score from baseline to week 12 • Change (or percent change) in IGA score from baseline to week 12 • Change in % body surface area (BSA), SCORing Atopic Dermatitis (SCORAD) score, Pruritus numerical rating scale (NRS), 5-D Pruritus scale or Quality of Life Index for Atopic Dermatitis (QOLIAD) from baseline to week 12 • Incidence of treatment-emergent adverse events (TEAEs) from baseline through week 20;Timepoint(s) of evaluation of this end point: Throughout the duration of the study | — |
Countries
Czech Republic, Germany, Hungary
Outcome results
None listed