Open-label Study of Dupilumab in Patients With Atopic Dermatitis

Phase 3CompletedNCT01949311

Regeneron Pharmaceuticals2,733 enrolled

Overview

The primary objective is to assess the long-term safety of dupilumab administered in adult participants with atopic dermatitis (AD). The secondary objective of the study is to assess the immunogenicity of dupilumab in adult participants with AD, in the context of re-treatment, and to monitor efficacy parameters associated with long-term treatment. Optional Sub-Study: The primary objective of the sub-study is to assess the safety of the new dupilumab drug product in adult patients with AD after switching from the current dupilumab drug product. The secondary objectives of the sub-study are to evaluate systemic exposure and immunogenicity of the new dupilumab drug product in adult patients with AD.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

2,733

Conditions

Atopic Dermatitis

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Key Inclusion Criteria: 1. Participation in a prior clinical trial of dupilumab for AD and met one of the following: 1. Received study treatment and adequately completed the assessments required for both the treatment and follow-up periods of the parent studies (except studies listed in b) as defined in the parent protocols 2. Received study treatment in one the studies that have completed last patient, last visit irrespective of duration of participation, provided that patients completed with the instructions received during the study. 3. Underwent screening in R668-AD-1334 (Liberty AD SOLO 1) or R668-AD-1416 (Liberty AD SOLO 2) but could not be randomized due to randomization closure. 2. Willing and able to comply with all clinic visits and study-related procedures 3. Able to understand and complete study-related questionnaires 4. Provide signed informed consent Optional Sub-Study: 1. Provide separate informed consent 2. Continuing in the treatment period of the main OLE study 3. Demonstrated compliance with dupilumab therapy, as defined in the protocol Key Exclusion Criteria: 1. Patients who, during their participation in a previous dupilumab clinical trial, developed a serious adverse event (SAE) deemed related to dupilumab\*, which in the opinion of the investigator or of the medical monitor could indicate that continued treatment with dupilumab may present an unreasonable risk for the patient. 2. Patients who, during their participation in a previous dupilumab clinical trial, developed an AE that was deemed related to dupilumab\* and led to study treatment discontinuation, which in the opinion of the investigator or of the medical monitor could indicate that continued treatment with dupilumab may present an unreasonable risk for the patient. 3. Conditions in the previous dupilumab study consistent with protocol-defined criteria for permanent study drug discontinuation, if deemed related to dupilumab\* or led to investigator - or sponsor-initiated withdrawal of patient from the study (eg, non-compliance, inability to complete study assessments, etc.). \*Note for exclusion criteria # 1, 2, and 3: In studies that are still blinded, conditions deemed related to the study treatment will be considered related to dupilumab. 4. Treatment with an investigational drug, other than dupilumab, within 8 weeks or within 5 half-lives (if known), whichever is longer, before the baseline visit 5. Pregnant or breastfeeding women, or planning to become pregnant or breastfeed during the patient's participation in this study Optional Sub-Study: 1\. Patients who have already completed the end of treatment visit (ie, visit 44) for the main study R668-AD-1225 Note: Other Protocol Defined Inclusion / Exclusion Criteria Apply.

Locations (432)

Regeneron Study Site

Anniston, Alabama, United States

Regeneron Study Site

Birmingham, Alabama, United States

Regeneron Study Site 1

Birmingham, Alabama, United States

Regeneron Study Site 2

Birmingham, Alabama, United States

Regeneron Study Site 2

Phoenix, Arizona, United States

Regeneron Study Site 3

Outcomes

Primary Outcomes

Number of Treatment Emergent Adverse Events (TEAEs)

Time frame: Up to 272 weeks

OPTIONAL SUB-STUDY: Number of Adverse Events of Special Interest (AESIs) Through the Last Study Visit After Switching to the New Dupilumab Drug Product

Adverse events of special interest in this study include: Anaphylactic reactions, Systemic hypersensitivity reactions, Helminthic infections, Any severe type of conjunctivitis or blepharitis, Keratitis, Clinically symptomatic eosinophilia (or eosinophilia associated with clinical symptoms)

Time frame: Up to 24 Weeks

Secondary Outcomes

Number of Serious Adverse Events (SAEs) of Special Interest

Time frame: Up to 272 weeks

Rate of AESIs

Rate (events per patient-year) of AESIs Adverse events of special interest in this study include: Anaphylactic reactions, Systemic hypersensitivity reactions, Helminthic infections, Any severe type of conjunctivitis or blepharitis, Keratitis, Clinically symptomatic eosinophilia (or eosinophilia associated with clinical symptoms)

Time frame: Up to 272 weeks

Number of AESIs

Time frame: Up to 272 weeks

Percentage of Participants With Investigator's Global Assessment (IGA) Score = 0-1 at Each Visit

IGA is an assessment scale used to determine severity of hand and foot AD and clinical response to treatment on a 5-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema and papulation/infiltration.

Time frame: Up to 272 weeks (End of Study), "Baseline, Weeks 4, 16, 36, 52, 100, 124, 156, 172, 188, 204, 220, 236, 272 (End of Study)

Percentage of Participants With Eczema Area and Severity Index (EASI)-75 (≥75% Reduction in EASI Scores From Baseline of the Parent Study) at Each Visit

The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, induration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD.