Clinical trial NCT01949311: Open-label Study of Dupilumab in Patients With Atopic Dermatitis
Official title: An Open-label Study of Dupilumab in Patients With Atopic Dermatitis Who Participated in Previous Dupilumab Clinical Trials
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Atopic Dermatitis
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Sanofi
First posted: 2013-09-24
Enrollment: 2733
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Treatment Emergent Adverse Events (TEAEs)
timeFrame: Up to 272 weeks
measure: OPTIONAL SUB-STUDY: Number of Adverse Events of Special Interest (AESIs) Through the Last Study Visit After Switching to the New Dupilumab Drug Product
timeFrame: Up to 24 Weeks
Secondary outcomes:
measure: Number of Serious Adverse Events (SAEs) of Special Interest
timeFrame: Up to 272 weeks
measure: Rate of AESIs
timeFrame: Up to 272 weeks
measure: Number of AESIs
timeFrame: Up to 272 weeks
measure: Percentage of Participants With Investigator's Global Assessment (IGA) Score = 0-1 at Each Visit
timeFrame: 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)
measure: 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
timeFrame: 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)"
measure: Percentage of Participants With Low Disease Activity State (eg, IGA ≤2) at Each Visit
timeFrame: 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)"
measure: Change From Baseline in EASI Score at Each Visit
timeFrame: 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)"
measure: Percent Change From Baseline in EASI Score at Each Visit
timeFrame: 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)"
measure: Percentage of Participants With EASI-50 (≥50% Reduction in EASI Scores From Baseline of the Parent Study) at Each Visit
timeFrame: 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)"
measure: Percentage of Participants With EASI-90 (≥90% Reduction in EASI Scores From Baseline of the Parent Study) at Each Visit
timeFrame: 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)"
measure: Change From Baseline in Pruritus Numerical Rating Scale (NRS) in Parent Study
timeFrame: 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)"
measure: Percent Change From Baseline in Pruritus NRS
timeFrame: 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)"
measure: Percentage of Participants With Improvement (Reduction) of Pruritus NRS ≥3 From Baseline
timeFrame: 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)"
measure: Percentage of Participants With Improvement (Reduction) of Pruritus NRS ≥4 From Baseline
timeFrame: 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)"
measure: Percentage of Participants Requiring Rescue Treatment: Overall
timeFrame: Up to 272 weeks
measure: Percentage of Participants Requiring Rescue Treatment: Systemic Treatment
timeFrame: Up to 272 weeks
measure: Percentage of Participants Requiring Rescue Treatment: Phototherapy
timeFrame: Up to 272 weeks
measure: Changes From Current Study Baseline to Prespecified Time Points Through the End of the Study: Dermatology Life Quality Index (DLQI)
timeFrame: Up to 272 weeks (End of Study), "Baseline, Weeks 12, 24, 36, 48, 76, 100, 124, 148, 272 (End of Study)"
measure: Changes From Current Study Baseline to Prespecified Time Points Through the End of the Study: Patient Oriented Eczema Measure (POEM)
timeFrame: Up to 272 weeks (End of Study), "Baseline, Weeks 12, 24, 36, 48, 76, 100, 124, 148, 272 (End of Study)"
measure: Changes From Parent Study Baseline to Prespecified Time Points Through the End of the Study: EuroQol-5D (EQ-5D)
timeFrame: Up to 272 weeks (End of Study), "Baseline, Weeks 12, 24, 36, 48, 76, 100, 124, 148, 272 (End of Study)"
measure: OPTIONAL SUB-STUDY: Ctrough of Functional Dupilumab in Serum Before and After Switching to the New Dupilumab Drug Product
timeFrame: Up to week 12
measure: OPTIONAL SUB-STUDY: Incidence of Treatment-emergent Anti-drug Antibody (ADA) Response in Patients Receiving the New Dupilumab Drug Product
timeFrame: Up to 24 Weeks
Other outcomes:
Locations:
city: Anniston
country: United States
facility: Regeneron Study Site
state: Alabama
city: Birmingham
country: United States
facility: Regeneron Study Site
state: Alabama
city: Birmingham
country: United States
facility: Regeneron Study Site 1
state: Alabama
city: Birmingham
country: United States
facility: Regeneron Study Site 2
state: Alabama
city: Phoenix
country: United States
facility: Regeneron Study Site 2
state: Arizona
city: Phoenix
country: United States
facility: Regeneron Study Site 3
state: Arizona
city: Phoenix
country: United States
facility: Regeneron Study Site 1
state: Arizona
city: Fort Smith
country: United States
facility: Regeneron Study Site
state: Arkansas
city: Rogers
country: United States
facility: Regeneron Study Site
state: Arkansas
city: Bakersfield
country: United States
facility: Regeneron Study Site
state: California
city: Clovis
country: United States
facility: Regeneron Study Site
state: California
city: Costa Mesa
country: United States
facility: Regeneron Study Site
state: California
city: Encinitas
country: United States
facility: Regeneron Study Site
state: California
city: Fremont
country: United States
facility: Regeneron Study Site
state: California
city: Lomita
country: United States
facility: Regeneron Study Site
state: California
city: Long Beach
country: United States
facility: Regeneron Study Site
state: California
city: Los Angeles
country: United States
facility: Regeneron Study Site 1
state: California
city: Los Angeles
country: United States
facility: Regeneron Study Site 2
state: California
city: Los Angeles
country: United States
facility: Regeneron Study Site
state: California
city: Oceanside
country: United States
facility: Regeneron Study Site
state: California
city: Orange
country: United States
facility: Regeneron Study Site
state: California
city: Rolling Hills Estates
country: United States
facility: Regeneron Study Site
state: California
city: San Diego
country: United States
facility: Regeneron Study Site
state: California
city: San Diego
country: United States
facility: Regeneron Study Site 1
state: California
city: San Diego
country: United States
facility: Regeneron Study Site 2
state: California
city: Santa Monica
country: United States
facility: Regeneron Study Site
state: California
city: Centennial
country: United States
facility: Regeneron Study Site
state: Colorado
city: Denver
country: United States
facility: Regeneron Study Site
state: Colorado
city: Denver
country: United States
facility: Regeneron Study Site
state: Colorado
city: Trumbull
country: United States
facility: Regeneron Study Site
state: Connecticut
city: Washington
country: United States
facility: Regeneron Study Site
state: District of Columbia
city: Boca Raton
country: United States
facility: Regeneron Study Site
state: Florida
city: Clearwater
country: United States
facility: Regeneron Study Site
state: Florida
city: Fort Lauderdale
country: United States
facility: Regeneron Study Site
state: Florida
city: Jacksonville
country: United States
facility: Regeneron Study Site 1
state: Florida
city: Jacksonville
country: United States
facility: Regeneron Study Site 2
state: Florida
city: Lake Worth
country: United States
facility: Regeneron Study Site
state: Florida
city: Miami Lakes
country: United States
facility: Regeneron Study Site
state: Florida
city: Miami
country: United States
facility: Regeneron Study Site
state: Florida
city: Miami
country: United States
facility: Regeneron Study Site
state: Florida
city: Orlando
country: United States
facility: Regeneron Study Site
state: Florida
city: Tampa
country: United States
facility: Regeneron Study Site
state: Florida
city: Tampa
country: United States
facility: Regeneron Study Site
state: Florida
city: Tampa
country: United States
facility: Regeneron Study Site
state: Florida
city: West Palm Beach
country: United States
facility: Regeneron Study Site
state: Florida
city: Alpharetta
country: United States
facility: Regeneron Study Site
state: Georgia
city: Atlanta
country: United States
facility: Regeneron Study Site
state: Georgia
city: Columbus
country: United States
facility: Regeneron Study Site
state: Georgia
city: Macon
country: United States
facility: Regeneron Study Site
state: Georgia
city: Newnan
country: United States
facility: Regeneron Study Site
state: Georgia
city: Sandy Springs
country: United States
facility: Regeneron Study Site
state: Georgia
city: Savannah
country: United States
facility: Regeneron Study Site
state: Georgia
city: Chicago
country: United States
facility: Regeneron Study Site
state: Illinois
city: Normal
country: United States
facility: Regeneron Study Site
state: Illinois
city: West Dundee
country: United States
facility: Regeneron Study Site
state: Illinois
city: Indianapolis
country: United States
facility: Regeneron Study Site
state: Indiana
city: Newburgh
country: United States
facility: Regeneron Study Site
state: Indiana
city: Plainfield
country: United States
facility: Regeneron Study Site
state: Indiana
city: Overland Park
country: United States
facility: Regeneron Study Site
state: Kansas
city: New Orleans
country: United States
facility: Regeneron Study Site
state: Louisiana
city: Rockville
country: United States
facility: Regeneron Study Site
state: Maryland
city: Boston
country: United States
facility: Regeneron Study Site
state: Massachusetts
city: Boston
country: United States
facility: Regeneron Study Site
state: Massachusetts
city: Boston
country: United States
facility: Regeneron Study Site
state: Massachusetts
city: Bay City
country: United States
facility: Regeneron Study Site
state: Michigan
city: Farmington Hills
country: United States
facility: Regeneron Study Site
state: Michigan
city: Troy
country: United States
facility: Regeneron Study Site
state: Michigan
city: Edina
country: United States
facility: Regeneron Study Site
state: Minnesota
city: Fridley
country: United States
facility: Regeneron Study Site
state: Minnesota
city: Minneapolis
country: United States
facility: Regeneron Study Site
state: Minnesota
city: Plymouth
country: United States
facility: Regeneron Study Site
state: Minnesota
city: Saint Joseph
country: United States
facility: Regeneron Study Site
state: Missouri
city: Saint Louis
country: United States
facility: Regeneron Study Site
state: Missouri
city: Saint Louis
country: United States
facility: Regeneron Study Site
state: Missouri
city: Henderson
country: United States
facility: Regeneron Study Site
state: Nevada
city: Las Vegas
country: United States
facility: Regeneron Study Site
state: Nevada
city: Portsmouth
country: United States
facility: Regeneron Study Site
state: New Hampshire
city: Berlin
country: United States
facility: Regeneron Study Site
state: New Jersey
city: East Windsor
country: United States
facility: Regeneron Study Site
state: New Jersey
city: Verona
country: United States
facility: Regeneron Study Site
state: New Jersey
city: Albuquerque
country: United States
facility: Regeneron Study Site 1
state: New Mexico
city: Albuquerque
country: United States
facility: Regeneron Study Site 2
state: New Mexico
city: Buffalo
country: United States
facility: Regeneron Study Site
state: New York
city: Corning
country: United States
facility: Regeneron Study Site
state: New York
city: Forest Hills
country: United States
facility: Regeneron Study Site
state: New York
city: New York
country: United States
facility: Regeneron Study Site
state: New York
city: New York
country: United States
facility: Regeneron Study Site
state: New York
city: New York
country: United States
facility: Regeneron Study Site
state: New York
city: New York
country: United States
facility: Regeneron Study Site
state: New York
city: Rochester
country: United States
facility: Regeneron Study Site
state: New York
city: Chapel Hill
country: United States
facility: Regeneron Study Site
state: North Carolina
city: High Point
country: United States
facility: Regeneron Study Site
state: North Carolina
city: Raleigh
country: United States
facility: Regeneron Study Site
state: North Carolina
city: Wilmington
country: United States
facility: Regeneron Study Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Regeneron Study Site
state: North Carolina
city: Cincinnati
country: United States
facility: Regeneron Study Site
state: Ohio
city: Cleveland
country: United States
facility: Regeneron Study Site
state: Ohio
city: Norman
country: United States
facility: Regeneron Study Site
state: Oklahoma
city: Tulsa
country: United States
facility: Regeneron Study Site
state: Oklahoma
city: Medford
country: United States
facility: Regeneron Study Site
state: Oregon
city: Portland
country: United States
facility: Regeneron Study Site
state: Oregon
city: Portland
country: United States
facility: Regeneron Study Site
state: Oregon
city: Bethlehem
country: United States
facility: Regeneron Study Site
state: Pennsylvania
city: Jenkintown
country: United States
facility: Regeneron Study Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Regeneron Study Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Regeneron Study Site
state: Pennsylvania
city: Charleston
country: United States
facility: Regeneron Study Site
state: South Carolina
city: Greer
country: United States
facility: Regeneron Study Site
state: South Carolina
city: Chattanooga
country: United States
facility: Regeneron Study Site
state: Tennessee
city: Nashville
country: United States
facility: Regeneron Study Site
state: Tennessee
city: Arlington
country: United States
facility: Regeneron Study Site
state: Texas
city: Austin
country: United States
facility: Regeneron Study Site
state: Texas
city: Bellaire
country: United States
facility: Regeneron Study Site
state: Texas
city: Dallas
country: United States
facility: Regeneron Study Site
state: Texas
city: Dallas
country: United States
facility: Regeneron Study Site
state: Texas
city: Dallas
country: United States
facility: Regeneron Study Site
state: Texas
city: Houston
country: United States
facility: Regeneron Study Site
state: Texas
city: San Antonio
country: United States
facility: Regeneron Study Site
state: Texas
city: San Antonio
country: United States
facility: Regeneron Study Site 1
state: Texas
city: San Antonio
country: United States
facility: Regeneron Study Site 2
state: Texas
city: San Antonio
country: United States
facility: Regeneron Study Site
state: Texas
city: Waco
country: United States
facility: Regeneron Study Site
state: Texas
city: Webster
country: United States
facility: Regeneron Study Site
state: Texas
city: Salt Lake City
country: United States
facility: Regeneron Study Site
state: Utah
city: South Burlington
country: United States
facility: Regeneron Study Site
state: Vermont
city: Newport News
country: United States
facility: Regeneron Study Site
state: Virginia
city: Norfolk
country: United States
facility: Regeneron Study Site
state: Virginia
city: Richmond
country: United States
facility: Regeneron Study Site
state: Virginia
city: Seattle
country: United States
facility: Regeneron Study Site
state: Washington
city: Phillip
country: Australia
facility: Regeneron Study Site
state: Australian Capital Territory
city: Kogarah
country: Australia
facility: Regeneron Study Site
state: New South Wales
city: Benowa
country: Australia
facility: Regeneron Study Site
state: Queensland
city: Woolloongabba
country: Australia
facility: Regeneron Study Site
state: Queensland
city: Hectorville
country: Australia
facility: Regeneron Study Site
state: South Australia
city: Carlton
country: Australia
facility: Regeneron Study Site
state: Victoria
city: East Melbourne
country: Australia
facility: Regeneron Study Site
state: Victoria
city: Fremantle
country: Australia
facility: Regeneron Study Site
state: Western Australia
city: Wien
country: Austria
facility: Regeneron Study Site 1
city: Wien
country: Austria
facility: Regeneron Study Site 2
city: Bruxelles
country: Belgium
facility: Regeneron Study Site
state: Brussels Capital Region
city: Loverval
country: Belgium
facility: Regeneron Study Site
state: Hainaut
city: Leuven
country: Belgium
facility: Regeneron Study Site
state: Vlaams Brabant
city: Dupnitsa
country: Bulgaria
facility: Regeneron Study Site
state: Kjustendil
city: Sofia
country: Bulgaria
facility: Regeneron Study Site 1
state: Sofia-Grad
city: Sofia
country: Bulgaria
facility: Regeneron Study Site 2
state: Sofia-Grad
city: Calgary
country: Canada
facility: Regeneron Study Site 1
state: Alberta
city: Calgary
country: Canada
facility: Regeneron Study Site 2
state: Alberta
city: Edmonton
country: Canada
facility: Regeneron Study Site 1
state: Alberta
city: Edmonton
country: Canada
facility: Regeneron Study Site 2
state: Alberta
city: Surrey
country: Canada
facility: Regeneron Study Site 1
state: British Columbia
city: Surrey
country: Canada
facility: Regeneron Study Site 2
state: British Columbia
city: Vancouver
country: Canada
facility: Regeneron Study Site 1
state: British Columbia
city: Vancouver
country: Canada
facility: Regeneron Study Site 2
state: British Columbia
city: Vancouver
country: Canada
facility: Regeneron Study Site 3
state: British Columbia
city: Winnipeg
country: Canada
facility: Regeneron Study Site 1
state: Manitoba
city: Bathurst
country: Canada
facility: Regeneron Study Site
state: New Brunswick
city: St. John's
country: Canada
facility: Regeneron Study Site
state: Newfoundland and Labrador
city: Ajax
country: Canada
facility: Regeneron Study Site
state: Ontario
city: Barrie
country: Canada
facility: Regeneron Study Site 1
state: Ontario
city: Barrie
country: Canada
facility: Regeneron Study Site 2
state: Ontario
city: Etobicoke
country: Canada
facility: Regeneron Study Site
state: Ontario
city: Hamilton
country: Canada
facility: Regeneron Study Site 1
state: Ontario
city: Hamilton
country: Canada
facility: Regeneron Study Site 2
state: Ontario
city: Markham
country: Canada
facility: Regeneron Study Site
state: Ontario
city: Mississauga
country: Canada
facility: Regeneron Study Site
state: Ontario
city: Newmarket
country: Canada
facility: Regeneron Study Site
state: Ontario
city: North Bay
country: Canada
facility: Regeneron Study Site
state: Ontario
city: Oakville
country: Canada
facility: Regeneron Study Site
state: Ontario
city: Ottawa
country: Canada
facility: Regeneron Study Site 1
state: Ontario
city: Peterborough
country: Canada
facility: Regeneron Study Site
state: Ontario
city: Richmond Hill
country: Canada
facility: Regeneron Study Site 1
state: Ontario
city: Richmond Hill
country: Canada
facility: Regeneron Study Site 2
state: Ontario
city: Toronto
country: Canada
facility: Regeneron Study Site
state: Ontario
city: Waterloo
country: Canada
facility: Regeneron Study Site
state: Ontario
city: Windsor
country: Canada
facility: Regeneron Study Site 1
state: Ontario
city: Windsor
country: Canada
facility: Regeneron Study Site 2
state: Ontario
city: Drummondville
country: Canada
facility: Regeneron Study Site
state: Quebec
city: Montreal
country: Canada
facility: Regeneron Study Site
state: Quebec
city: Ste-Foy
country: Canada
facility: Regeneron Study Site 3
state: Quebec
city: Ste-Foy
country: Canada
facility: Regeneron Study Site
city: Winnipeg
country: Canada
facility: Regeneron Study Site
city: Hong Kong
country: China
facility: Regeneron Study Site
city: Hradec Kralove
country: Czechia
facility: Regeneron Study Site
city: Kutna Hora
country: Czechia
facility: Regeneron Study Site
city: Nachod
country: Czechia
facility: Regeneron Study Site
city: Praha 10
country: Czechia
facility: Regeneron Study Site
city: Praha 5
country: Czechia
facility: Regeneron Study Site
city: Praha 6
country: Czechia
facility: Regeneron Study Site
city: Svitavy
country: Czechia
facility: Regeneron Study Site
city: Usti nad Labem
country: Czechia
facility: Regeneron Study Site
city: Copenhagen
country: Denmark
facility: Regeneron Study Site
state: Capital
city: Hellerup
country: Denmark
facility: Regeneron Study Site
state: Capital
city: Aarhus
country: Denmark
facility: Regeneron Study Site
state: Central Jutland
city: Roskilde
country: Denmark
facility: Regeneron Study Site
state: Zeeland
city: Tallinn
country: Estonia
facility: Regeneron Study Site 1
state: Harjumaa
city: Tallinn
country: Estonia
facility: Regeneron Study Site 2
state: Harjumaa
city: Tallinn
country: Estonia
facility: Regeneron Study Site 3
state: Harjumaa
city: Tartu
country: Estonia
facility: Regeneron Study Site 1
state: Tartumaa
city: Tartu
country: Estonia
facility: Regeneron Study Site 2
state: Tartumaa
city: Helsinki
country: Finland
facility: Regeneron Study Site
state: Etelä-Suomen Iääni
city: Turku
country: Finland
facility: Regeneron Study Site
state: Etelä-Suomen Lääni
city: Tampere
country: Finland
facility: Regeneron Study Site
state: Länsi-Suomen Lääni
city: Nice Cedex 3
country: France
facility: Regeneron Study Site
state: Alpes-Maritimes
city: Marseille
country: France
facility: Regeneron Study Site
state: Bouches-du-Rhône
city: Reims
country: France
facility: Regeneron Study Site
state: Marne
city: Lille
country: France
facility: Regeneron Study Site
state: Nord
city: Pierre Benite
country: France
facility: Regeneron Study Site
state: Rhône-Alpes
city: Lille cedex
country: France
facility: Regeneron Study Site
city: Nantes
country: France
facility: Regeneron Study Site
city: Paris
country: France
facility: Regeneron Study Site
state: Île-de-France
city: Friedrichshafen
country: Germany
facility: Regeneron Study Site
state: Baden-Württemberg
city: Heidelberg
country: Germany
facility: Regeneron Study Site
state: Baden-Württemberg
city: Langenau
country: Germany
facility: Regeneron Study Site
state: Baden-Württemberg
city: Stuttgart
country: Germany
facility: Regeneron Study Site
state: Baden-Württemberg
city: Tuebingen
country: Germany
facility: Regeneron Study Site
state: Baden-Württemberg
city: Augsburg
country: Germany
facility: Regeneron Study Site
state: Bayern
city: Erlangen
country: Germany
facility: Regeneron Study Site
state: Bayern
city: Munchen
country: Germany
facility: Regeneron Study Site
state: Bayern
city: Munich
country: Germany
facility: Regeneron Study Site
state: Bayern
city: Mahlow
country: Germany
facility: Regeneron Study Site
state: Brandenburg
city: Hamburg
country: Germany
facility: Regeneron Study Site 2
state: Hamburgh
city: Frankfurt/Main
country: Germany
facility: Regeneron Study Site
state: Hessen
city: Schwerin
country: Germany
facility: Regeneron Study Site
state: Mecklenburg-Vorpommern
city: Hannover
country: Germany
facility: Regeneron Study Site
state: Niedersachsen
city: Bochum
country: Germany
facility: Regeneron Study Site 1
state: Nordrhein-Westfalen
city: Bochum
country: Germany
facility: Regeneron Study Site 2
state: Nordrhein-Westfalen
city: Dulmen
country: Germany
facility: Regeneron Study Site
state: Nordrhein-Westfalen
city: Ibbenbüren
country: Germany
facility: Regeneron Study Site
state: Nordrhein-Westfalen
city: Monchengladbach
country: Germany
facility: Regeneron Study Site
state: Nordrhein-Westfalen
city: Muenster
country: Germany
facility: Regeneron Study Site
state: Nordrhein-Westfalen
city: Mainz
country: Germany
facility: Regeneron Study Site
state: Rheinland-Pfalz
city: Selters
country: Germany
facility: Regeneron Study Site
state: Rheinland-Pfalz
city: Halle
country: Germany
facility: Regeneron Study Site
state: Sachsen-Anhalt
city: Magdeburg
country: Germany
facility: Regeneron Study Site
state: Sachsen-Anhalt
city: Dresden
country: Germany
facility: Regeneron Study Site 1
state: Sachsen
city: Dresden
country: Germany
facility: Regeneron Study Site 2
state: Sachsen
city: Dresden
country: Germany
facility: Regeneron Study Site 3
state: Sachsen
city: Leipzig
country: Germany
facility: Regeneron Study Site
state: Sachsen
city: Kiel
country: Germany
facility: Regeneron Study Site 1
state: Schleswig-Holstein
city: Kiel
country: Germany
facility: Regeneron Study Site 2
state: Schleswig-Holstein
city: Lubeck
country: Germany
facility: Regeneron Study Site
state: Schleswig-Holstein
city: Gera
country: Germany
facility: Regeneron Study Site
state: Thüringen
city: Berlin
country: Germany
facility: Regeneron Study Site 1
city: Berlin
country: Germany
facility: Regeneron Study Site 2
city: Berlin
country: Germany
facility: Regeneron Study Site 3
city: Berlin
country: Germany
facility: Regeneron Study Site 4
city: Berlin
country: Germany
facility: Regeneron Study Site 5
city: Berlin
country: Germany
facility: Regeneron Study Site 6
city: Berlin
country: Germany
facility: Regeneron Study Site 7
city: Bonn
country: Germany
facility: Regeneron Study Site
city: Darmstadt
country: Germany
facility: Regeneron Study Site
city: Hamburg
country: Germany
facility: Regeneron Study Site 1
city: Münster
country: Germany
facility: Regeneron Study Site
city: Osnabrück
country: Germany
facility: Regeneron Study Site
city: Sátoraljaújhely
country: Hungary
facility: Regeneron Study Site
state: Borsod-Abaúj-Zemplén
city: Oroshaza
country: Hungary
facility: Regeneron Study Site
state: Békés
city: Szeged
country: Hungary
facility: Regeneron Study Site
state: Csongrád
city: Szolnok
country: Hungary
facility: Regeneron Study Site
state: Jász-Nagykun-Szolnok
city: Kaposvár
country: Hungary
facility: Regeneron Study Site
state: Somogy
city: Budapest
country: Hungary
facility: Regeneron Study Site 1
city: Budapest
country: Hungary
facility: Regeneron Study Site 2
city: Budapest
country: Hungary
facility: Regeneron Study Site 3
city: Veszprem
country: Hungary
facility: Regeneron Study Site
city: Dublin
country: Ireland
facility: Regeneron Study Site
city: Bologna
country: Italy
facility: Regeneron Study Site
state: Balogna
city: Ancona
country: Italy
facility: Regeneron Study Site
city: Chieti
country: Italy
facility: Regeneron Study Site
city: Firenze
country: Italy
facility: Regeneron Study Site
city: L'Aquila
country: Italy
facility: Regeneron Study Site
city: Lucca
country: Italy
facility: Regeneron Study Site
city: Messina
country: Italy
facility: Regeneron Study Site
city: Milano
country: Italy
facility: Regeneron Study Site
city: Novara
country: Italy
facility: Regeneron Study Site
city: Pavia
country: Italy
facility: Regeneron Study Site
city: Perugia
country: Italy
facility: Regeneron Study Site
city: Pisa
country: Italy
facility: Regeneron Study Site
city: Roma
country: Italy
facility: Regeneron Study Site 1
city: Roma
country: Italy
facility: Regeneron Study Site 2
city: Nagakute
country: Japan
facility: Regeneron Study Site
state: Aichi
city: Kurume
country: Japan
facility: Regeneron Study Site
state: Fukuoka
city: Fukuyama
country: Japan
facility: Regeneron Study Site
state: Hiroshima
city: Sapporo
country: Japan
facility: Regeneron Study Site
state: Hokkaido
city: Fukuoka
country: Japan
facility: Regeneron Study Site 1
state: Hukuoka
city: Fukuoka
country: Japan
facility: Regeneron Study Site 2
state: Hukuoka
city: Kitakyushu
country: Japan
facility: Regeneron Study Site
state: Hukuoka
city: Amagasaki
country: Japan
facility: Regeneron Study Site 1
state: Hyôgo
city: Amagasaki
country: Japan
facility: Regeneron Study Site 2
state: Hyôgo
city: Inashiki-gun
country: Japan
facility: Regeneron Study Site
state: Ibaraki
city: Yokohama
country: Japan
facility: Regeneron Study Site 1
state: Kanagawa
city: Yokohama
country: Japan
facility: Regeneron Study Site 2
state: Kanagawa
city: Yokohama
country: Japan
facility: Regeneron Study Site 3
state: Kanagawa
city: Kamimashiki
country: Japan
facility: Regeneron Study Site
state: Kumamoto
city: Habikino
country: Japan
facility: Regeneron Study Site
state: Osaka
city: Neyagawa
country: Japan
facility: Regeneron Study Site
state: Osaka
city: Sakai
country: Japan
facility: Regeneron Study Site
state: Osaka
city: Takatsuki
country: Japan
facility: Regeneron Study Site
state: Osaka
city: Hamamatsu
country: Japan
facility: Regeneron Study Site
state: Shizuoka
city: Yaizu
country: Japan
facility: Regeneron Study Site
state: Shizuoka
city: Bunkyo-ku
country: Japan
facility: Regeneron Study Site 1
state: Tokyo
city: Bunkyo-ku
country: Japan
facility: Regeneron Study Site 2
state: Tokyo
city: Chiyoda-ku
country: Japan
facility: Regeneron Study Site 1
state: Tokyo
city: Chiyoda-ku
country: Japan
facility: Regeneron Study Site 2
state: Tokyo
city: Chuo-ku
country: Japan
facility: Regeneron Study Site
state: Tokyo
city: Koto-ku
country: Japan
facility: Regeneron Study Site
state: Tokyo
city: Nakano-ku
country: Japan
facility: Regeneron Study Site
state: Tokyo
city: Nerima
country: Japan
facility: Regeneron Study Site 1
state: Tokyo
city: Nerima
country: Japan
facility: Regeneron Study Site 2
state: Tokyo
city: Ota-ku
country: Japan
facility: Regeneron Study Site
state: Tokyo
city: Setagaya-ku
country: Japan
facility: Regeneron Study Site
state: Tokyo
city: Shibuya-ku
country: Japan
facility: Regeneron Study Site 1
state: Tokyo
city: Shibuya-ku
country: Japan
facility: Regeneron Study Site 2
state: Tokyo
city: Shibuya-ku
country: Japan
facility: Regeneron Study Site 3
state: Tokyo
city: Shinagawa-ku
country: Japan
facility: Regeneron Study Site 1
state: Tokyo
city: Shinagawa-ku
country: Japan
facility: Regeneron Study Site 2
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Regeneron Study Site 1
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Regeneron Study Site 2
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Regeneron Study Site 3
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Regeneron Study Site 4
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Regeneron Study Site 5
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Regeneron Study Site 6
state: Tokyo
city: Suginami
country: Japan
facility: Regeneron Study Site 1
state: Tokyo
city: Suginami
country: Japan
facility: Regeneron Study Site 2
state: Tokyo
city: Kofu
country: Japan
facility: Regeneron Study Site
state: Yamanashi
city: Chuo
country: Japan
facility: Regeneron Study Site
state: Yamanasi
city: Fukuyama
country: Japan
facility: Regeneron Study Site 2
city: Gifu
country: Japan
facility: Regeneron Study Site
city: Hiroshima
country: Japan
facility: Regeneron Study Site 1
city: Hiroshima
country: Japan
facility: Regeneron Study Site 2
city: Kyoto
country: Japan
facility: Regeneron Study Site 1
city: Kyoto
country: Japan
facility: Regeneron Study Site 2
city: Osaka
country: Japan
facility: Regeneron Study Site 1
city: Osaka
country: Japan
facility: Regeneron Study Site 2
city: Saitama
country: Japan
facility: Regeneron Study Site
city: Shinagawa-ku
country: Japan
facility: Regeneron Study Site 3
city: Suginome
country: Japan
facility: Regeneron Study Site
city: Wakayama
country: Japan
facility: Regeneron Study Site
city: Yokohama
country: Japan
facility: Regeneron Study Site 4
city: Busan
country: Korea, Republic of
facility: Regeneron Study Site
state: Busan Gwang'yeogsi
city: Bucheon-Si
country: Korea, Republic of
facility: Regeneron Study Site
state: Kyonggi-do
city: Hwaseong-si
country: Korea, Republic of
facility: Regeneron Study Site
state: Kyonggi-do
city: Suwon
country: Korea, Republic of
facility: Regeneron Study Site
state: Kyonggi-do
city: Uijeongbu-si
country: Korea, Republic of
facility: Regeneron Study Site
state: Kyonggi-do
city: Incheon
country: Korea, Republic of
facility: Regeneron Study Site 1
city: Incheon
country: Korea, Republic of
facility: Regeneron Study Site 2
city: Seoul
country: Korea, Republic of
facility: Regeneron Study Site 1
city: Seoul
country: Korea, Republic of
facility: Regeneron Study Site 2
city: Seoul
country: Korea, Republic of
facility: Regeneron Study Site 3
city: Seoul
country: Korea, Republic of
facility: Regeneron Study Site 4
city: Seoul
country: Korea, Republic of
facility: Regeneron Study Site 5
city: Seoul
country: Korea, Republic of
facility: Regeneron Study Site 6
city: Seoul
country: Korea, Republic of
facility: Regeneron Study Site 7
city: Seoul
country: Korea, Republic of
facility: Regeneron Study Site 8
city: Kaunas
country: Lithuania
facility: Regeneron Study Site
state: Kauno Apskritis
city: Vilnius
country: Lithuania
facility: Regeneron Study Site 1
state: Vilniaus Apskritis
city: Vilnius
country: Lithuania
facility: Regeneron Study Site 2
state: Vilniaus Apskritis
city: Klaipeda
country: Lithuania
facility: Regeneron Study Site 1
city: Klaipeda
country: Lithuania
facility: Regeneron Study Site 2
city: Breda
country: Netherlands
facility: Regeneron Study Site
state: Noord-Brabant
city: Amsterdam
country: Netherlands
facility: Regeneron Study Site
state: Noord-Holland
city: Rotterdam
country: Netherlands
facility: Regeneron Study Site
state: Zuid-Holland
city: Groningen
country: Netherlands
facility: Regeneron Study Site
city: Utrecht
country: Netherlands
facility: Regeneron Study Site
city: Dunedin
country: New Zealand
facility: Regeneron Study Site
state: South Island
city: Auckland
country: New Zealand
facility: Regeneron Study Site
city: Wroclaw
country: Poland
facility: Regeneron Study Site 1
state: Dolnośląskie
city: Wroclaw
country: Poland
facility: Regeneron Study Site 2
state: Dolnośląskie
city: Wroclaw
country: Poland
facility: Regeneron Study Site 3
state: Dolnośląskie
city: Torun
country: Poland
facility: Regeneron Study Site
state: Kujawsko-pomorskie
city: Lodz
country: Poland
facility: Regeneron Study Site 1
state: Lodzkie
city: Lodz
country: Poland
facility: Regeneron Study Site 2
state: Lodzkie
city: Lodz
country: Poland
facility: Regeneron Study Site 3
state: Lodzkie
city: Lublin
country: Poland
facility: Regeneron Study Site
state: Lubelskie
city: Krakow
country: Poland
facility: Regeneron Study Site 1
state: Malopolskie
city: Krakow
country: Poland
facility: Regeneron Study Site 2
state: Malopolskie
city: Krakow
country: Poland
facility: Regeneron Study Site 3
state: Malopolskie
city: Warszawa
country: Poland
facility: Regeneron Study Site 1
state: Mazowieckie
city: Warszawa
country: Poland
facility: Regeneron Study Site 2
state: Mazowieckie
city: Warszawa
country: Poland
facility: Regeneron Study Site 3
state: Mazowieckie
city: Warszawa
country: Poland
facility: Regeneron Study Site 4
state: Mazowieckie
city: Warszawa
country: Poland
facility: Regeneron Study Site 5
state: Mazowieckie
city: Warszawa
country: Poland
facility: Regeneron Study Site 6
state: Mazowieckie
city: Warszawa
country: Poland
facility: Regeneron Study Site 7
state: Mazowieckie
city: Strzelce Opolskie
country: Poland
facility: Regeneron Study Site
state: Opolskie
city: Iwonicz Zdroj
country: Poland
facility: Regeneron Study Site
state: Podkarpackie
city: Gdansk
country: Poland
facility: Regeneron Study Site 1
state: Pomorskie
city: Gdansk
country: Poland
facility: Regeneron Study Site 2
state: Pomorskie
city: Poznan
country: Poland
facility: Regeneron Study Site 1
state: Wielkopolskie
city: Poznan
country: Poland
facility: Regeneron Study Site 2
state: Wielkopolskie
city: Poznan
country: Poland
facility: Regeneron Study Site 3
state: Wielkopolskie
city: Szczecin
country: Poland
facility: Regeneron Study Site
state: Zachodniopomorskie
city: Bialystok
country: Poland
facility: Regeneron Study Site
city: Bydgoszcz
country: Poland
facility: Regeneron Study Site
city: Chorzow
country: Poland
facility: Regeneron Study Site
city: Elblag
country: Poland
facility: Regeneron Study Site
city: Katowice
country: Poland
facility: Regeneron Study Site 1
city: Katowice
country: Poland
facility: Regeneron Study Site 2
city: Katowice
country: Poland
facility: Regeneron Study Site 3
city: Ostrowiec Swietokrzyski
country: Poland
facility: Regeneron Study Site
city: Skarzysko-Kamienna
country: Poland
facility: Regeneron Study Site
city: Zgierz
country: Poland
facility: Regeneron Study Site
city: Brasov
country: Romania
facility: Regeneron Study Site
city: Moscow
country: Russian Federation
facility: Regeneron Study Site
state: Koskva
city: Ryazan
country: Russian Federation
facility: Regeneron Study Site
state: Ryazanskaya Oblast'
city: Saint Petersburg
country: Russian Federation
facility: Regeneron Study Site
state: Sankt-Peterburg
city: Kazan
country: Russian Federation
facility: Regeneron Study Site
state: Tatarstan Respublika
city: Chelyabinsk
country: Russian Federation
facility: Regeneron Study Site
city: Singapore
country: Singapore
facility: Regeneron Study Site 1
state: Central Singapore
city: Singapore
country: Singapore
facility: Regeneron Study Site 2
state: Central Singapore
city: Singapore
country: Singapore
facility: Regeneron Study Site
state: South West
city: Kosice
country: Slovakia
facility: Regeneron Study Site
city: Svidnik
country: Slovakia
facility: Regeneron Study Site
city: Elche
country: Spain
facility: Regeneron Study Site
state: Alicante
city: Badalona
country: Spain
facility: Regeneron Study Site
state: Barcelona
city: Las Palmas de Gran Canaria
country: Spain
facility: Regeneron Study Site
state: Canarias
city: Barcelona
country: Spain
facility: Regeneron Study Site 1
city: Barcelona
country: Spain
facility: Regeneron Study Site 2
city: Barcelona
country: Spain
facility: Regeneron Study Site 3
city: Barcelona
country: Spain
facility: Regeneron Study Site 4
city: Madrid
country: Spain
facility: Regeneron Study Site 1
city: Madrid
country: Spain
facility: Regeneron Study Site 2
city: Sevilla
country: Spain
facility: Regeneron Study Site
city: Dundee
country: United Kingdom
facility: Regeneron Study Site
state: Angus
city: Edgbaston
country: United Kingdom
facility: Regeneron Study Site
state: Birmingham
city: Plymouth
country: United Kingdom
facility: Regeneron Study Site
state: Devon
city: Portsmouth
country: United Kingdom
facility: Regeneron Study Site
state: Hampshire
city: Sidcup
country: United Kingdom
facility: Regeneron Study Site
state: Kent
city: Northwood
country: United Kingdom
facility: Regeneron Study Site
state: London
city: Oxford
country: United Kingdom
facility: Regeneron Study Site
state: Oxfordshire
city: Liverpool
country: United Kingdom
facility: Regeneron Study Site
city: London
country: United Kingdom
facility: Regeneron Study Site 1
city: London
country: United Kingdom
facility: Regeneron Study Site 2
city: Manchester
country: United Kingdom
facility: Regeneron Study Site
city: Salford
country: United Kingdom
facility: Regeneron Study Site
city: Sheffield
country: United Kingdom
facility: Regeneron Study Site
Study officials:
affiliation: Regeneron Pharmaceuticals
name: Clinical Trial Management
role: STUDY_DIRECTOR
References:
citation: Blauvelt A, Wollenberg A, Eichenfield LF, Zhang H, Sierka D, Khokhar FA, Vakil J, Shabbir A, Marco AR, Cyr SL. No Increased Risk of Overall Infection in Adults with Moderate-to-Severe Atopic Dermatitis Treated for up to 4 Years with Dupilumab. Adv Ther. 2023 Jan;40(1):367-380. doi: 10.1007/s12325-022-02322-y. Epub 2022 Nov 1.
citation: Wechsler ME, Klion AD, Paggiaro P, Nair P, Staumont-Salle D, Radwan A, Johnson RR, Kapoor U, Khokhar FA, Daizadeh N, Chen Z, Laws E, Ortiz B, Jacob-Nara JA, Mannent LP, Rowe PJ, Deniz Y. Effect of Dupilumab on Blood Eosinophil Counts in Patients With Asthma, Chronic Rhinosinusitis With Nasal Polyps, Atopic Dermatitis, or Eosinophilic Esophagitis. J Allergy Clin Immunol Pract. 2022 Oct;10(10):2695-2709. doi: 10.1016/j.jaip.2022.05.019. Epub 2022 May 28.
citation: Beck LA, Deleuran M, Bissonnette R, de Bruin-Weller M, Galus R, Nakahara T, Seo SJ, Khokhar FA, Vakil J, Xiao J, Marco AR, Levit NA, O'Malley JT, Shabbir A. Dupilumab Provides Acceptable Safety and Sustained Efficacy for up to 4 Years in an Open-Label Study of Adults with Moderate-to-Severe Atopic Dermatitis. Am J Clin Dermatol. 2022 May;23(3):393-408. doi: 10.1007/s40257-022-00685-0. Epub 2022 May 3.
citation: Armstrong A, Blauvelt A, Simpson EL, Smith CH, Herranz P, Kataoka Y, Seo SJ, Ferrucci SM, Chao J, Chen Z, Rossi AB, Shumel B, Tomondy P. Continued Treatment with Dupilumab is Associated with Improved Efficacy in Adults with Moderate-to-Severe Atopic Dermatitis Not Achieving Optimal Responses with Short-Term Treatment. Dermatol Ther (Heidelb). 2022 Jan;12(1):195-202. doi: 10.1007/s13555-021-00643-4. Epub 2021 Dec 13.
citation: Yosipovitch G, de Bruin-Weller M, Armstrong A, Wu JJ, Herranz P, Thaci D, Delevry D, Bagousse GB, Zhang R, Shumel B, Rossi AB, Chao J. Dupilumab Treatment Provides Sustained Improvements Over 2 Years in Symptoms and Quality of Life in Adults with Atopic Dermatitis. Dermatol Ther (Heidelb). 2021 Dec;11(6):2147-2157. doi: 10.1007/s13555-021-00630-9. Epub 2021 Oct 29.
citation: Beck LA, Thaci D, Deleuran M, de Bruin-Weller M, Chen Z, Khokhar FA, Zhang M, Ozturk ZE, Shumel B. Laboratory safety of dupilumab for up to 3 years in adults with moderate-to-severe atopic dermatitis: results from an open-label extension study. J Dermatolog Treat. 2022 May;33(3):1608-1616. doi: 10.1080/09546634.2020.1871463. Epub 2021 Feb 8.
citation: Beck LA, Thaci D, Deleuran M, Blauvelt A, Bissonnette R, de Bruin-Weller M, Hide M, Sher L, Hussain I, Chen Z, Khokhar FA, Beazley B, Ruddy M, Patel N, Graham NMH, Ardeleanu M, Shumel B. Dupilumab Provides Favorable Safety and Sustained Efficacy for up to 3 Years in an Open-Label Study of Adults with Moderate-to-Severe Atopic Dermatitis. Am J Clin Dermatol. 2020 Aug;21(4):567-577. doi: 10.1007/s40257-020-00527-x.