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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01949311




Registration number
NCT01949311
Ethics application status
Date submitted
20/09/2013
Date registered
24/09/2013
Date last updated
17/10/2023

Titles & IDs
Public title
Open-label Study of Dupilumab in Patients With Atopic Dermatitis
Scientific title
An Open-label Study of Dupilumab in Patients With Atopic Dermatitis Who Participated in Previous Dupilumab Clinical Trials
Secondary ID [1] 0 0
2013-001449-15
Secondary ID [2] 0 0
R668-AD-1225
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atopic Dermatitis 0 0
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Dupilumab

Experimental: Dupilumab - Participants will receive repeat doses of dupilumab


Treatment: Drugs: Dupilumab
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Treatment Emergent Adverse Events (TEAEs)
Timepoint [1] 0 0
Up to 272 weeks
Primary outcome [2] 0 0
OPTIONAL SUB-STUDY: Number of Adverse Events of Special Interest (AESIs) Through the Last Study Visit After Switching to the New Dupilumab Drug Product
Timepoint [2] 0 0
Up to 24 Weeks
Secondary outcome [1] 0 0
Number of Serious Adverse Events (SAEs) of Special Interest
Timepoint [1] 0 0
Up to 272 weeks
Secondary outcome [2] 0 0
Rate of AESIs
Timepoint [2] 0 0
Up to 272 weeks
Secondary outcome [3] 0 0
Number of AESIs
Timepoint [3] 0 0
Up to 272 weeks
Secondary outcome [4] 0 0
Percentage of Participants With Investigator's Global Assessment (IGA) Score = 0-1 at Each Visit
Timepoint [4] 0 0
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)
Secondary outcome [5] 0 0
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
Timepoint [5] 0 0
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)"
Secondary outcome [6] 0 0
Percentage of Participants With Low Disease Activity State (eg, IGA =2) at Each Visit
Timepoint [6] 0 0
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)"
Secondary outcome [7] 0 0
Change From Baseline in EASI Score at Each Visit
Timepoint [7] 0 0
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)"
Secondary outcome [8] 0 0
Percent Change From Baseline in EASI Score at Each Visit
Timepoint [8] 0 0
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)"
Secondary outcome [9] 0 0
Percentage of Participants With EASI-50 (=50% Reduction in EASI Scores From Baseline of the Parent Study) at Each Visit
Timepoint [9] 0 0
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)"
Secondary outcome [10] 0 0
Percentage of Participants With EASI-90 (=90% Reduction in EASI Scores From Baseline of the Parent Study) at Each Visit
Timepoint [10] 0 0
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)"
Secondary outcome [11] 0 0
Change From Baseline in Pruritus Numerical Rating Scale (NRS) in Parent Study
Timepoint [11] 0 0
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)"
Secondary outcome [12] 0 0
Percent Change From Baseline in Pruritus NRS
Timepoint [12] 0 0
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)"
Secondary outcome [13] 0 0
Percentage of Participants With Improvement (Reduction) of Pruritus NRS =3 From Baseline
Timepoint [13] 0 0
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)"
Secondary outcome [14] 0 0
Percentage of Participants With Improvement (Reduction) of Pruritus NRS =4 From Baseline
Timepoint [14] 0 0
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)"
Secondary outcome [15] 0 0
Percentage of Participants Requiring Rescue Treatment: Overall
Timepoint [15] 0 0
Up to 272 weeks
Secondary outcome [16] 0 0
Percentage of Participants Requiring Rescue Treatment: Systemic Treatment
Timepoint [16] 0 0
Up to 272 weeks
Secondary outcome [17] 0 0
Percentage of Participants Requiring Rescue Treatment: Phototherapy
Timepoint [17] 0 0
Up to 272 weeks
Secondary outcome [18] 0 0
Changes From Current Study Baseline to Prespecified Time Points Through the End of the Study: Dermatology Life Quality Index (DLQI)
Timepoint [18] 0 0
Up to 272 weeks (End of Study), "Baseline, Weeks 12, 24, 36, 48, 76, 100, 124, 148, 272 (End of Study)"
Secondary outcome [19] 0 0
Changes From Current Study Baseline to Prespecified Time Points Through the End of the Study: Patient Oriented Eczema Measure (POEM)
Timepoint [19] 0 0
Up to 272 weeks (End of Study), "Baseline, Weeks 12, 24, 36, 48, 76, 100, 124, 148, 272 (End of Study)"
Secondary outcome [20] 0 0
Changes From Parent Study Baseline to Prespecified Time Points Through the End of the Study: EuroQol-5D (EQ-5D)
Timepoint [20] 0 0
Up to 272 weeks (End of Study), "Baseline, Weeks 12, 24, 36, 48, 76, 100, 124, 148, 272 (End of Study)"
Secondary outcome [21] 0 0
OPTIONAL SUB-STUDY: Ctrough of Functional Dupilumab in Serum Before and After Switching to the New Dupilumab Drug Product
Timepoint [21] 0 0
Up to week 12
Secondary outcome [22] 0 0
OPTIONAL SUB-STUDY: Incidence of Treatment-emergent Anti-drug Antibody (ADA) Response in Patients Receiving the New Dupilumab Drug Product
Timepoint [22] 0 0
Up to 24 Weeks

Eligibility
Key inclusion criteria
Key

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
10/10/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
27/06/2022
Sample size
Target
Accrual to date
Final
2733
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Regeneron Study Site - Phillip
Recruitment hospital [2] 0 0
Regeneron Study Site - Kogarah
Recruitment hospital [3] 0 0
Regeneron Study Site - Benowa
Recruitment hospital [4] 0 0
Regeneron Study Site - Woolloongabba
Recruitment hospital [5] 0 0
Regeneron Study Site - Hectorville
Recruitment hospital [6] 0 0
Regeneron Study Site - Carlton
Recruitment hospital [7] 0 0
Regeneron Study Site - East Melbourne
Recruitment hospital [8] 0 0
Regeneron Study Site - Fremantle
Recruitment postcode(s) [1] 0 0
- Phillip
Recruitment postcode(s) [2] 0 0
- Kogarah
Recruitment postcode(s) [3] 0 0
- Benowa
Recruitment postcode(s) [4] 0 0
- Woolloongabba
Recruitment postcode(s) [5] 0 0
- Hectorville
Recruitment postcode(s) [6] 0 0
- Carlton
Recruitment postcode(s) [7] 0 0
- East Melbourne
Recruitment postcode(s) [8] 0 0
- Fremantle
Recruitment outside Australia
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United States of America
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Alabama
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Arizona
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Arkansas
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United States of America
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California
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Colorado
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Connecticut
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United States of America
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District of Columbia
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United States of America
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Florida
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United States of America
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Georgia
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United States of America
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Illinois
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Indiana
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Kansas
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Louisiana
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Massachusetts
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Michigan
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Missouri
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Nevada
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New Jersey
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Tennessee
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Svitavy
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Harjumaa
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Tartumaa
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Etelä-Suomen Iääni
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Etelä-Suomen Lääni
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Länsi-Suomen Lääni
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Alpes-Maritimes
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Nord
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Lille cedex
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Nantes
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Bayern
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Germany
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Brandenburg
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Germany
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Hamburgh
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Germany
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Hessen
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Germany
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Mecklenburg-Vorpommern
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Germany
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Germany
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Nordrhein-Westfalen
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Germany
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Rheinland-Pfalz
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Germany
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Sachsen-Anhalt
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Germany
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Sachsen
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Germany
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Schleswig-Holstein
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Germany
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Thüringen
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Germany
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Berlin
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Germany
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Bonn
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Germany
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Darmstadt
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Germany
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Hamburg
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Germany
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Münster
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Germany
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Osnabrück
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Hungary
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Borsod-Abaúj-Zemplén
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Hungary
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Békés
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Hungary
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Csongrád
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Hungary
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Jász-Nagykun-Szolnok
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Somogy
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Budapest
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Balogna
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Italy
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Ancona
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Italy
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Chieti
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Italy
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Firenze
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Italy
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L'Aquila
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Italy
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Lucca
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Italy
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Messina
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Italy
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Milano
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Italy
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Novara
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Italy
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Pavia
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Italy
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Perugia
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Italy
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Pisa
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Italy
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Roma
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Japan
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Aichi
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Japan
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Fukuoka
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Japan
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Hiroshima
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Japan
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Hokkaido
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Japan
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Hukuoka
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Japan
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Hyôgo
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Japan
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Ibaraki
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Japan
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Kanagawa
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Japan
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Kumamoto
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Japan
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Osaka
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Japan
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Shizuoka
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Japan
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Tokyo
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Japan
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Yamanashi
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Japan
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Yamanasi
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Japan
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Fukuyama
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Japan
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Gifu
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Japan
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Kyoto
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Japan
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Saitama
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Japan
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Shinagawa-ku
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Japan
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Suginome
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Japan
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Wakayama
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Japan
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Yokohama
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Korea, Republic of
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Busan Gwang'yeogsi
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Korea, Republic of
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Kyonggi-do
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Korea, Republic of
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Incheon
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Korea, Republic of
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Seoul
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Lithuania
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Kauno Apskritis
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Lithuania
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Vilniaus Apskritis
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Lithuania
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Klaipeda
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Netherlands
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Noord-Brabant
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Netherlands
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Noord-Holland
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Netherlands
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Zuid-Holland
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Netherlands
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Groningen
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Netherlands
State/province [149] 0 0
Utrecht
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New Zealand
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South Island
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New Zealand
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Auckland
Country [152] 0 0
Poland
State/province [152] 0 0
Dolnoslaskie
Country [153] 0 0
Poland
State/province [153] 0 0
Kujawsko-pomorskie
Country [154] 0 0
Poland
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Lodzkie
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Poland
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Lubelskie
Country [156] 0 0
Poland
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Malopolskie
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Poland
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Mazowieckie
Country [158] 0 0
Poland
State/province [158] 0 0
Opolskie
Country [159] 0 0
Poland
State/province [159] 0 0
Podkarpackie
Country [160] 0 0
Poland
State/province [160] 0 0
Pomorskie
Country [161] 0 0
Poland
State/province [161] 0 0
Wielkopolskie
Country [162] 0 0
Poland
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Zachodniopomorskie
Country [163] 0 0
Poland
State/province [163] 0 0
Bialystok
Country [164] 0 0
Poland
State/province [164] 0 0
Bydgoszcz
Country [165] 0 0
Poland
State/province [165] 0 0
Chorzow
Country [166] 0 0
Poland
State/province [166] 0 0
Elblag
Country [167] 0 0
Poland
State/province [167] 0 0
Katowice
Country [168] 0 0
Poland
State/province [168] 0 0
Ostrowiec Swietokrzyski
Country [169] 0 0
Poland
State/province [169] 0 0
Skarzysko-Kamienna
Country [170] 0 0
Poland
State/province [170] 0 0
Zgierz
Country [171] 0 0
Romania
State/province [171] 0 0
Brasov
Country [172] 0 0
Russian Federation
State/province [172] 0 0
Koskva
Country [173] 0 0
Russian Federation
State/province [173] 0 0
Ryazanskaya Oblast'
Country [174] 0 0
Russian Federation
State/province [174] 0 0
Sankt-Peterburg
Country [175] 0 0
Russian Federation
State/province [175] 0 0
Tatarstan Respublika
Country [176] 0 0
Russian Federation
State/province [176] 0 0
Chelyabinsk
Country [177] 0 0
Singapore
State/province [177] 0 0
Central Singapore
Country [178] 0 0
Singapore
State/province [178] 0 0
South West
Country [179] 0 0
Slovakia
State/province [179] 0 0
Kosice
Country [180] 0 0
Slovakia
State/province [180] 0 0
Svidnik
Country [181] 0 0
Spain
State/province [181] 0 0
Alicante
Country [182] 0 0
Spain
State/province [182] 0 0
Barcelona
Country [183] 0 0
Spain
State/province [183] 0 0
Canarias
Country [184] 0 0
Spain
State/province [184] 0 0
Madrid
Country [185] 0 0
Spain
State/province [185] 0 0
Sevilla
Country [186] 0 0
United Kingdom
State/province [186] 0 0
Angus
Country [187] 0 0
United Kingdom
State/province [187] 0 0
Birmingham
Country [188] 0 0
United Kingdom
State/province [188] 0 0
Devon
Country [189] 0 0
United Kingdom
State/province [189] 0 0
Hampshire
Country [190] 0 0
United Kingdom
State/province [190] 0 0
Kent
Country [191] 0 0
United Kingdom
State/province [191] 0 0
London
Country [192] 0 0
United Kingdom
State/province [192] 0 0
Oxfordshire
Country [193] 0 0
United Kingdom
State/province [193] 0 0
Liverpool
Country [194] 0 0
United Kingdom
State/province [194] 0 0
Manchester
Country [195] 0 0
United Kingdom
State/province [195] 0 0
Salford
Country [196] 0 0
United Kingdom
State/province [196] 0 0
Sheffield

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Regeneron Pharmaceuticals
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Sanofi
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01949311
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trial Management
Address 0 0
Regeneron Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01949311