An Open-label Study of Dupilumab in Patients With Atopic Dermatitis Who Participated in Previous Dupilumab Clinical Trials

Regeneron Pharmaceuticals9 sites in 4 countries2,733 target enrollmentOctober 10, 2013

ConditionsAtopic Dermatitis

InterventionsDupilumab

DrugsDupilumab

Overview

Phase: Phase 3
Intervention: Dupilumab
Conditions: Atopic Dermatitis
Sponsor: Regeneron Pharmaceuticals
Enrollment: 2733
Locations: 9
Primary Endpoint: Number of Treatment Emergent Adverse Events (TEAEs)
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

October 10, 2013

End Date

June 27, 2022

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Regeneron Pharmaceuticals

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Participation in a prior clinical trial of dupilumab for AD and met one of the following:
•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
•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.
•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.
•Willing and able to comply with all clinic visits and study-related procedures
•Able to understand and complete study-related questionnaires
•Provide signed informed consent
•Optional Sub-Study:
•Provide separate informed consent
•Continuing in the treatment period of the main OLE study

Exclusion Criteria

•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.
•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.
•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.
•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
•Pregnant or breastfeeding women, or planning to become pregnant or breastfeed during the patient's participation in this study
•Optional Sub-Study:
•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.

Arms & Interventions

Dupilumab

Participants will receive repeat doses of dupilumab

Intervention: Dupilumab

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

Time Frame: Up to 24 Weeks

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)

Secondary Outcomes

Percentage of Participants With Improvement (Reduction) of Pruritus NRS ≥4 From Baseline(Up to 272 weeks (End of Study), "Baseline, Weeks 1, 4, 16, 36, 52, 100, 124, 156, 172, 188, 204, 220, 236, 252, 272 (End of Study)")
Rate of AESIs(Up to 272 weeks)
Change From Baseline in Pruritus Numerical Rating Scale (NRS) in Parent Study(Up to 272 weeks (End of Study), "Baseline, Weeks 1, 4, 16, 36, 52, 100, 124, 156, 172, 188, 204, 220, 236, 252, 272 (End of Study)")
Percentage of Participants With Improvement (Reduction) of Pruritus NRS ≥3 From Baseline(Up to 272 weeks (End of Study), "Baseline, Weeks 1, 4, 16, 36, 52, 100, 124, 156, 172, 188, 204, 220, 236, 252, 272 (End of Study)")
Number of Serious Adverse Events (SAEs) of Special Interest(Up to 272 weeks)
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(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 Low Disease Activity State (eg, IGA ≤2) at Each Visit(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)")
Number of AESIs(Up to 272 weeks)
Percentage of Participants With Investigator's Global Assessment (IGA) Score = 0-1 at Each Visit(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 EASI-50 (≥50% Reduction in EASI Scores From Baseline of the Parent Study) at Each Visit(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 Requiring Rescue Treatment: Systemic Treatment(Up to 272 weeks)
Percentage of Participants Requiring Rescue Treatment: Phototherapy(Up to 272 weeks)
Percent Change From Baseline in EASI Score at Each Visit(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)")
OPTIONAL SUB-STUDY: Incidence of Treatment-emergent Anti-drug Antibody (ADA) Response in Patients Receiving the New Dupilumab Drug Product(Up to 24 Weeks)
Change From Baseline in EASI Score at Each Visit(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 EASI-90 (≥90% Reduction in EASI Scores From Baseline of the Parent Study) at Each Visit(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)")
Percent Change From Baseline in Pruritus NRS(Up to 272 weeks (End of Study), "Baseline, Weeks 1, 4, 16, 36, 52, 100, 124, 156, 172, 188, 204, 220, 236, 252, 272 (End of Study)")
Percentage of Participants Requiring Rescue Treatment: Overall(Up to 272 weeks)
Changes From Parent Study Baseline to Prespecified Time Points Through the End of the Study: EuroQol-5D (EQ-5D)(Up to 272 weeks (End of Study), "Baseline, Weeks 12, 24, 36, 48, 76, 100, 124, 148, 272 (End of Study)")
OPTIONAL SUB-STUDY: Ctrough of Functional Dupilumab in Serum Before and After Switching to the New Dupilumab Drug Product(Up to week 12)
Changes From Current Study Baseline to Prespecified Time Points Through the End of the Study: Dermatology Life Quality Index (DLQI)(Up to 272 weeks (End of Study), "Baseline, Weeks 12, 24, 36, 48, 76, 100, 124, 148, 272 (End of Study)")
Changes From Current Study Baseline to Prespecified Time Points Through the End of the Study: Patient Oriented Eczema Measure (POEM)(Up to 272 weeks (End of Study), "Baseline, Weeks 12, 24, 36, 48, 76, 100, 124, 148, 272 (End of Study)")