Overview

This trial has been completed.

Condition atopic dermatitis
Treatments dupilumab, placebo
Phase phase 3
Sponsor Regeneron Pharmaceuticals
Collaborator Sanofi
Start date September 2014
End date November 2015
Trial size 739 participants
Trial identifier NCT02260986, R668-AD-1224

Summary

The purpose is to demonstrate efficacy and long term safety of dupilumab in combination with topical corticosteroids in patients with moderate to severe AD.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Participants in this group will receive dupilumab according to dosing regimen 1.
dupilumab REGN668
(Experimental)
Participants in this group will receive dupilumab according to dosing regimen 2.
dupilumab REGN668
(Experimental)
Patients will receive SC matching placebo
placebo

Primary Outcomes

Measure
Proportion of patients with both an Investigator's Global Assessment (IGA) 0 to 1 (on a 5-point scale) at week 16 and a reduction from baseline of ≥2 points at week 16
time frame: At week 16

Secondary Outcomes

Measure
Proportion of patients with EASI-75 response (reduction of EASI score by ≥75% from baseline) at week 16
time frame: At week 16
Percent change from baseline to week 16 in in weekly average of peak daily Pruritus Numerical Rating Scale (NRS)
time frame: Baseline to week 16
Proportion of patients with improvement (reduction) in weekly average of peak daily Pruritus NRS ≥4 from baseline to week 16
time frame: Baseline to week 16
Proportion of patients with IGA 0 or 1 and a reduction from baseline of ≥2 points at week 52
time frame: At week 52
Proportion of patients with EASI-75 response at week 52
time frame: At week 52
Proportion of patients with improvement (reduction) in weekly average of peak daily Pruritus NRS ≥3 from baseline to week 16
time frame: Baseline to week 16
Percent change from baseline to week 52 in weekly average of peak daily Pruritus NRS
time frame: Baseline to week 52
Percent change in EASI score from baseline to week 16
time frame: Baseline to week 16
Change from baseline to week 16 in percent body surface area (BSA)
time frame: At week 16
Percent change in SCORing Atopic Dermatitis (SCORAD) from baseline to week 16
time frame: Baseline to week 16
Percent change from baseline to week 16 in global individual signs score (GISS) (erythema, infiltration/papulation, excoriations, lichenification)
time frame: Baseline to week 16
Change from baseline to week 16 in Dermatology Life Quality Index (DLQI)
time frame: Baseline to week 16
Change from baseline to week 16 in Patient Oriented Eczema Measure (POEM)
time frame: Baseline to week 16
Change from baseline to week 16 in Hospital Anxiety and Depression Scale (HADS)
time frame: Baseline to week 16
Reduction in topical AD medication use through week 16
time frame: Baseline to week 16
Proportion of patients with improvement (reduction) in weekly average of peak daily Pruritus NRS ≥3 from baseline to week 52
time frame: Baseline to week 52
Proportion of patients with improvement (reduction) in weekly average of peak daily Pruritus NRS ≥4 from baseline to week 52
time frame: Baseline to week 52
Percent change in EASI score from baseline to week 52
time frame: Baseline to week 52
Change from baseline to week 52 in percent BSA
time frame: Baseline to week 52
Percent change in SCORAD from baseline to week 52
time frame: Baseline to week 52
Percent change from baseline to week 52 in GISS (erythema, infiltration/papulation, excoriations, lichenification)
time frame: Baseline to week 52
Change from baseline to week 2 in weekly average of peak daily Pruritus NRS
time frame: Baseline to week 2
Change from baseline to week 52 in DLQI
time frame: Baseline to week 52
Change from baseline to week 52 in POEM
time frame: Baseline to week 52
Change from baseline to week 52 in HADS
time frame: Baseline to week 52
Number of flares through week 52
time frame: Baseline to week 52
Incidence of skin-infection TEAEs requiring systemic treatment from baseline through week 56
time frame: Baseline to week 56
Incidence of serious treatment-emergent adverse events (TEAEs) through week 56
time frame: Baseline to week 56
Incidence of TEAEs leading to study drug discontinuation from baseline through week 56
time frame: Baseline to week 56

Eligibility Criteria

Male or female participants at least 18 years old.

Key Inclusion Criteria: 1. Chronic atopic dermatitis (AD) that has been present for at least 3 years before the screening visit 2. Documented recent history (within 6 months before the screening visit) of inadequate response to a sufficient course of outpatient treatment with topical AD medication(s). Key Exclusion Criteria: 1. Participation in a prior dupilumab clinical trial 2. Important side effects of topical medication (eg, intolerance to treatment, hypersensitivity reactions, significant skin atrophy, systemic effects), as assessed by the investigator or treating physician 3. Having used any of the following treatments within 4 weeks before the baseline visit, or any condition that, in the opinion of the investigator, is likely to require such treatment(s) during the first 2 weeks of study treatment: 1. Immunosuppressive/immunomodulating drugs (eg, systemic steroids, cyclosporine, mycophenolate-mofetil, Janus kinase inhibitors, IFN-γ, azathioprine, methotrexate, etc) 2. Phototherapy for AD 4. Treatment with a live (attenuated) vaccine within 12 weeks before the baseline visit 5. History of human immunodeficiency virus (HIV) infection or positive HIV serology at screening 6. Positive hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), or hepatitis C antibody at the screening visit 7. Active or acute infection requiring systemic treatment within 2 weeks before baseline visit 8. Known or suspected history of immunosuppression 9. Pregnant or breastfeeding women, or planning to become pregnant or breastfeed during the patient's participation in this study Note: The eligibility criteria listed above is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial therefore not all inclusion/ exclusion criteria are listed.

Additional Information

Official title A Randomized, Double-Blind, Placebo-Controlled Study to Demonstrate the Efficacy and Long-Term Safety of Dupilumab in Adult Patients With Moderate-to-Severe Atopic Dermatitis
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Regeneron Pharmaceuticals.