Clinical trial NCT03989206: Long-term Safety and Efficacy of Nemolizumab With Moderate-to-severe Atopic Dermatitis
Official title: A Prospective, Multicenter, Long-Term Study to Assess the Safety and Efficacy of Nemolizumab (CD14152) in Subjects With Moderate-to-Severe Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Moderate-to-Severe Atopic Dermatitis
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2019-06-18
Enrollment: 1700
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Long-Term Safety and Efficacy of Nemolizumab in Subjects with Moderate-to-Severe Atopic Dermatitis Description

Detailed description: Long-term study to assess the safety and efficacy of nemolizumab in subjects with moderate-to-severe AD

Eligibility criteria: Key Inclusion Criteria:

1. Subjects who may benefit from study participation in the opinion of the investigator and had participated in a prior nemolizumab study for AD
2. Female subjects of childbearing potential (ie, fertile, following menarche and until becoming post-menopausal unless permanently sterile) must agree either to be strictly abstinent throughout the study and for 12 weeks after the last study drug injection, or to use an effective and approved method of contraception throughout the study and for 12 weeks after the last study drug injection.

Key Exclusion Criteria:

1. Subjects who, during their participation in a prior nemolizumab study, experienced an AE which in the opinion of the investigator could indicate that continued treatment with nemolizumab may present an unreasonable risk for the subject.
2. Pregnant women, breastfeeding women, or women planning a pregnancy during the clinical study.
3. Body weight \< 30 kg
4. Cutaneous infection within 1 week before the baseline visit, any infection requiring treatment with oral or parenteral antibiotics, antivirals, antiparasitics or antifungals within 2 weeks before the baseline visit, or any confirmed or suspected coronavirus disease (COVID)-19 infection within 2 weeks before the screening or baseline visit. Subjects may be rescreened once the infection has resolved. Resolution of COVID-19 infection can be confirmed by recovery assessment methods.
5. History of hypersensitivity (including anaphylaxis) to an immunoglobulin product (plasma-derived or recombinant, eg, monoclonal antibody)
6. Any clinically significant issue, based investigator judgement

Primary outcomes:
measure: Incidence and Severity of TEAEs
timeFrame: Baseline to Week 200
measure: Incidence of Serious TEAEs
timeFrame: Baseline to Week 200
measure: Incidence and Severity of Adverse Events of Special Interest (AESIs) Throughout the Study
timeFrame: Baseline to Week 200
Secondary outcomes:
measure: Proportion of Participants with IGA score = 0-1 at Each Visit
timeFrame: Baseline to Week 200
measure: Proportion of Participants with EASI-75 at Each Visit
timeFrame: Baseline to Week 200
measure: Change and Percent Change From Baseline in Overall Eczema Area and Severity Index (EASI) Score at Each Visit
timeFrame: Baseline to Week 200
measure: Proportion of Participants with IGA ≤ 2 at Each Visit
timeFrame: Baseline to Week 200
measure: Change and Percent Change From Baseline in SCORAD Score at Each Visit
timeFrame: Baseline to Week 200
measure: Change and Percent Change From Baseline in Participant-Reported Pruritus Using 10-cm VAS (SCORAD Sub-Component)
timeFrame: Baseline to Week 200
measure: Change and Percent Change From Baseline in Participant-Reported Sleep Loss Using 10-cm VAS (SCORAD Sub-Component)
timeFrame: Baseline to Week 200
measure: Proportion of Participants Reporting Low Disease Activity State Based on PGAD at Each Visit
timeFrame: Baseline to Week 200
measure: Proportion of Participants Satisfied with Study Treatment Based on PGAT at each visit
timeFrame: Baseline to Week 200
measure: Change from Baseline in Dermatology Life Quality Index (DLQI)
timeFrame: Baseline to Week 200
measure: Change From Baseline in Children's Dermatology Life Quality Index (cDLQI) Total Score at Each Visit Through Week 200
timeFrame: Baseline to Week 200
measure: Change From Baseline in Patient-Oriented Eczema Measure (POEM) Total Score at Each Visit Through Week 200
timeFrame: Baseline to Week 200
measure: Change From Baseline in Hospital Anxiety and Depression Scale (HADS) for Each Subscale at Each Visit Through Week 200
timeFrame: Baseline to Week 200
measure: Change From Baseline in Work Productivity and Activity Impairment: Atopic Dermatitis (WPAI:AD) for Each Subscale at Each Visit Through Week 200
timeFrame: Baseline to Week 200
measure: Change From Baseline in EuroQoL 5-Dimension (EQ-5D) at Each Visit Through Week 200
timeFrame: Baseline to Week 200
measure: Proportion of Participants Receiving Any Rescue Therapy by Rescue Treatment Type at Any Visit During the Treatment Period
timeFrame: Baseline to Week 200
measure: Time to First Relapse
timeFrame: Baseline to Week 200
measure: Duration of Remission
timeFrame: Baseline to Week 200
measure: Time to Permanent Study Drug Discontinuation
timeFrame: Baseline to Week 200
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Galderma Investigational Site 8749
state: Alabama
city: Birmingham
country: United States
facility: Galderma Investigational Site 8893
state: Alabama
city: Guntersville
country: United States
facility: Galderma Investigational Site 8866
state: Alabama
city: Scottsdale
country: United States
facility: Galderma Investigational Site 8808
state: Arizona
city: Scottsdale
country: United States
facility: Galderma Investigational Site 8873
state: Arizona
city: Fort Smith
country: United States
facility: Galderma Investigational Site 8447
state: Arkansas
city: North Little Rock
country: United States
facility: Galderma Investigational Site 8880
state: Arkansas
city: Anaheim
country: United States
facility: Galderma Investigational Site 8831
state: California
city: Bell Gardens
country: United States
facility: Galderma Investigational Site 8906
state: California
city: Beverly Hills
country: United States
facility: Galderma Investigational Site 8456
state: California
city: Cerritos
country: United States
facility: Galderma Investigational Site 8578
state: California
city: Encinitas
country: United States
facility: Galderma Investigational Site 8577
state: California
city: Fountain Valley
country: United States
facility: Galderma Investigational Site 8636
state: California
city: Fremont
country: United States
facility: Galderma Investigational Site 8224
state: California
city: Fresno
country: United States
facility: Galderma Investigational Site 8791
state: California
city: Fullerton
country: United States
facility: Galderma Investigational Site 8888
state: California
city: Huntington Beach
country: United States
facility: Galderma Investigational Site 8845
state: California
city: Inglewood
country: United States
facility: Galderma Investigational Site 8833
state: California
city: Lomita
country: United States
facility: Galderma Investigational Site 8686
state: California
city: Los Angeles
country: United States
facility: Galderma Investigational Site 8674
state: California
city: Los Angeles
country: United States
facility: Galderma Investigational Site 8683
state: California
city: Los Angeles
country: United States
facility: Galderma Investigational Site 8813
state: California
city: Newport Beach
country: United States
facility: Galderma Investigational Site 8907
state: California
city: Ontario
country: United States
facility: Galderma Investigational Site 8799
state: California
city: Pasadena
country: United States
facility: Galderma Investigational Site 8745
state: California
city: San Diego
country: United States
facility: Galderma Investigational Site 8671
state: California
city: San Diego
country: United States
facility: Galderma Investigational Site 8692
state: California
city: San Diego
country: United States
facility: Galderma Investigational Site 8658
state: California
city: San Francisco
country: United States
facility: Galderma Investigational Site 8125
state: California
city: Santa Ana
country: United States
facility: Galderma Investigational Site 8536
state: California
city: Santa Monica
country: United States
facility: Galderma Investigational Site 8608
state: California
city: Westminster
country: United States
facility: Galderma Investigational Site 8820
state: California
city: Farmington
country: United States
facility: Galderma Investigational Site 8637
state: Connecticut
city: Boca Raton
country: United States
facility: Galderma Investigational Site 8870
state: Florida
city: Cape Coral
country: United States
facility: Galderma Investigational Site 8805
state: Florida
city: Clearwater
country: United States
facility: Galderma Investigational Site 8786
state: Florida
city: Doral
country: United States
facility: Galderma Investigational Site 8902
state: Florida
city: Hialeah
country: United States
facility: Galderma Investigational Site 8391
state: Florida
city: Hialeah
country: United States
facility: Galderma Investigational Site 8804
state: Florida
city: Jacksonville
country: United States
facility: Galderma Investigational Site 8711
state: Florida
city: Jacksonville
country: United States
facility: Galderma Investigational Site 8836
state: Florida
city: Largo
country: United States
facility: Galderma Investigational Site 8523
state: Florida
city: Margate
country: United States
facility: Galderma Investigational Site 8850
state: Florida
city: Miami Lakes
country: United States
facility: Galderma Investigational Site 8806
state: Florida
city: Miami Lakes
country: United States
facility: Galderma Investigational Site 8800
state: Florida
city: Miami
country: United States
facility: Galderma Investigational Site 8719
state: Florida
city: Miami
country: United States
facility: Galderma Investigational Site 8851
state: Florida
city: Miami
country: United States
facility: Galderma Investigational Site 8656
state: Florida
city: Miami
country: United States
facility: Galderma Investigational Site 8801
state: Florida
city: Miami
country: United States
facility: Galderma Investigational Site 8704
state: Florida
city: Miami
country: United States
facility: Galderma Investigational Site 8737
state: Florida
city: Miami
country: United States
facility: Galderma Investigational Site 8706
state: Florida
city: Miami
country: United States
facility: Galderma Investigational Site 8708
state: Florida
city: Ormond Beach
country: United States
facility: Galderma Investigational Site 8856
state: Florida
city: Pembroke Pines
country: United States
facility: Galderma Investigational Site 8734
state: Florida
city: Tampa
country: United States
facility: Galderma Investigational Site 8203
state: Florida
city: Tampa
country: United States
facility: Galderma Investigational Site 8816
state: Florida
city: Tampa
country: United States
facility: Galderma Investigational Site 8889
state: Florida
city: Tampa
country: United States
facility: Galderma Investigational Site 8839
state: Florida
city: West Palm Beach
country: United States
facility: Galderma Investigational Site 8126
state: Florida
city: Columbus
country: United States
facility: Galderma Investigational Site 8667
state: Georgia
city: Macon
country: United States
facility: Galderma Investigational Site 8744
state: Georgia
city: Newnan
country: United States
facility: Galderma Investigational Site 8728
state: Georgia
city: Stockbridge
country: United States
facility: Galderma Investigational Site 8707
state: Georgia
city: Nampa
country: United States
facility: Galderma Investigational Site 8819
state: Idaho
city: Chicago
country: United States
facility: Galderma Investigational Site 9916
state: Illinois
city: Normal
country: United States
facility: Galderma Investigational Site 8739
state: Illinois
city: Rolling Meadows
country: United States
facility: Galderma Investigational Site 8729
state: Illinois
city: Skokie
country: United States
facility: Galderma Investigational Sites 8571
state: Illinois
city: Skokie
country: United States
facility: Galderma Investigational Site 8712
state: Illinois
city: Indianapolis
country: United States
facility: Galderma Investigational Site 8142
state: Indiana
city: New Albany
country: United States
facility: Galderma Investigational Site 8724
state: Indiana
city: Shawnee Mission
country: United States
facility: Galderma Investigational Site 9934
state: Kansas
city: Louisville
country: United States
facility: Galderma Investigational Site 8771
state: Kentucky
city: Bangor
country: United States
facility: Galderma Investigational Site 8882
state: Maine
city: Ann Arbor
country: United States
facility: Galderma Investigational Site 8743
state: Michigan
city: Bay City
country: United States
facility: Galderma Investigational Site 8512
state: Michigan
city: Detroit
country: United States
facility: Galderma Investigational Site 8554
state: Michigan
city: Farmington Hills
country: United States
facility: Galderma Investigational Site 8617
state: Michigan
city: Troy
country: United States
facility: Galderma Investigational Site 8155
state: Michigan
city: Troy
country: United States
facility: Galderma Investigational Site 8849
state: Michigan
city: Warren
country: United States
facility: Galderma Investigational Site 8226
state: Michigan
city: Ypsilanti
country: United States
facility: Galderma Investigational Site 8748
state: Michigan
city: Saint Joseph
country: United States
facility: Galderma Investigational Site 8521
state: Missouri
city: Missoula
country: United States
facility: Galderma Investigational Site 8718
state: Montana
city: Omaha
country: United States
facility: Galderma Investigational Site 8810
state: Nebraska
city: Henderson
country: United States
facility: Galderma Investigational Site 8740
state: Nevada
city: Las Vegas
country: United States
facility: Galderma Investigational Site 8825
state: Nevada
city: Las Vegas
country: United States
facility: Galderma Investigational Site 8675
state: Nevada
city: Lebanon
country: United States
facility: Galderma Investigational Site 8109
state: New Hampshire
city: Hackensack
country: United States
facility: Galderma Investigational Site 8506
state: New Jersey
city: Albuquerque
country: United States
facility: Galderma Investigational Site 8826
state: New Mexico
city: Brooklyn
country: United States
facility: Galderma Investigational Site 8242
state: New York
city: Buffalo
country: United States
facility: Galderma Investigational Site 8741
state: New York
city: Cortland
country: United States
facility: Galderma Investigational Site 8723
state: New York
city: Forest Hills
country: United States
facility: Galderma Investigational Site 8828
state: New York
city: Glendale
country: United States
facility: Galderma Investigational Site 9925
state: New York
city: New York
country: United States
facility: Galderma Investigational Site 8733
state: New York
city: New York
country: United States
facility: Galderma Investigational Site 8620
state: New York
city: New York
country: United States
facility: Galderma Investigational Site 8279
state: New York
city: Durham
country: United States
facility: Galderma Investigational Site 8772
state: North Carolina
city: Shelby
country: United States
facility: Galderma Investigational Site 8795
state: North Carolina
city: Wilmington
country: United States
facility: Galderma Investigational Site 8726
state: North Carolina
city: Wilmington
country: United States
facility: Galderma Investigational Site 8648
state: North Carolina
city: Bexley
country: United States
facility: Galderma Investigational Site 8702
state: Ohio
city: Cincinnati
country: United States
facility: Galderma Investigational Site 8747
state: Ohio
city: Dublin
country: United States
facility: Galderma Investigational Site 8595
state: Ohio
city: Norman
country: United States
facility: Galderma Investigational Site 8206
state: Oklahoma
city: Oklahoma City
country: United States
facility: Galderma Investigational Site 8857
state: Oklahoma
city: Portland
country: United States
facility: Galderma Investigational Site 8212
state: Oregon
city: Philadelphia
country: United States
facility: Galderma Investigational Site 8255
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Galderma Investigational Site 8721
state: Pennsylvania
city: Plymouth Meeting
country: United States
facility: Galderma Investigational Site 8802
state: Pennsylvania
city: Charleston
country: United States
facility: Galderma Investigational Site 8777
state: South Carolina
city: Charleston
country: United States
facility: Galderma Investigational Site 8736
state: South Carolina
city: North Charleston
country: United States
facility: Galderma Investigational Site 8713
state: South Carolina
city: Rapid City
country: United States
facility: Galderma Investigational Site 8818
state: South Dakota
city: Arlington
country: United States
facility: Galderma Investigational Site 8133
state: Texas
city: Austin
country: United States
facility: Galderma Investigational Site 8298
state: Texas
city: Dallas
country: United States
facility: Galderma Investigational Site 8238
state: Texas
city: Dallas
country: United States
facility: Galderma Investigational Site 8245
state: Texas
city: Dripping Springs
country: United States
facility: Galderma Investigational Site 8827
state: Texas
city: Frisco
country: United States
facility: Galderma Investigational Site 8664
state: Texas
city: Houston
country: United States
facility: Galderma Investigational Site 8807
state: Texas
city: Houston
country: United States
facility: Galderma Investigational Site 8042
state: Texas
city: Houston
country: United States
facility: Galderma Investigational Site 8670
state: Texas
city: Katy
country: United States
facility: Galderma Investigational Site 8817
state: Texas
city: Plano
country: United States
facility: Galderma Investigational Site 8787
state: Texas
city: San Antonio
country: United States
facility: Galderma Investigational Site 8329
state: Texas
city: Waco
country: United States
facility: Galderma Investigational Site 8618
state: Texas
city: Webster
country: United States
facility: Galderma Investigational Site 8003
state: Texas
city: Salt Lake City
country: United States
facility: Galderma Investigational Site 8672
state: Utah
city: Burke
country: United States
facility: Galderma Investigational Site 8738
state: Virginia
city: Fairfax
country: United States
facility: Galderma Investigational Site 8862
state: Virginia
city: Richmond
country: United States
facility: Galderma Investigational Site 8896
state: Virginia
city: Seattle
country: United States
facility: Galderma Investigational Site 8434
state: Washington
city: Darlinghurst
country: Australia
facility: Galderma Investigational Site 5441
state: New South Wales
city: Kogarah
country: Australia
facility: Galderma Investigational Site 5759
state: New South Wales
city: Westmead
country: Australia
facility: Galderma Investigational Site 6152
state: New South Wales
city: Benowa
country: Australia
facility: Galderma Investigational Site 5638
state: Queensland
city: Brisbane
country: Australia
facility: Galderma Investigational Site 6161
state: Queensland
city: Woodville
country: Australia
facility: Galderma Investigational Site 6159
state: South Australia
city: Carlton
country: Australia
facility: Galderma Investigational Site 6131
state: Victoria
city: East Melbourne
country: Australia
facility: Galderma Investigational Site 5366
state: Victoria
city: Parkville
country: Australia
facility: Galderma Investigational Site 5458
state: Victoria
city: Parkville
country: Australia
facility: Galderma Investigational Site 6160
state: Victoria
city: Victoria Park
country: Australia
facility: Galderma Investigational Site 6153
state: Western Australia
city: Linz
country: Austria
facility: Galderma Investigational Site 6156
state: Oberoesterreich
city: Graz
country: Austria
facility: Galderma Investigational Site 6157
state: Styria
city: Vienna
country: Austria
facility: Galderma Investigational Site 6194
city: Vienna
country: Austria
facility: Galderma Investigational Site 6158
city: Leuven
country: Belgium
facility: Galderma Investigational Site 6038
state: Vlaams-Brabant
city: Brussels
country: Belgium
facility: Galderma Investigational Site 5448
city: Edegem
country: Belgium
facility: Galderma Investigational Site 6163
city: Gent
country: Belgium
facility: Galderma Investigational Site 6164
city: Liège
country: Belgium
facility: Galderma Investigational Site 6162
city: Pleven
country: Bulgaria
facility: Galderma Investigational Site 6029
city: Sofia
country: Bulgaria
facility: Galderma Investigational Site 6051
city: Sofia
country: Bulgaria
facility: Galderma Investigational Site 6078
city: Sofia
country: Bulgaria
facility: Galderma Investigational Site 6102
city: Sofia
country: Bulgaria
facility: Galderma Investigational Site 6165
city: Sofia
country: Bulgaria
facility: Galderma Investigational Site 6216
city: Sofia
country: Bulgaria
facility: Galderma Investigational Site 6046
city: Sofia
country: Bulgaria
facility: Galderma Investigational Site 6080
city: Sofia
country: Bulgaria
facility: Galderma Investigational Site 6101
city: Sofia
country: Bulgaria
facility: Galderma Investigational Site 6079
city: Sofia
country: Bulgaria
facility: Galderma Investigational Site 6250
city: Stara Zagora
country: Bulgaria
facility: Galderma Investigational Site 6136
city: Stara Zagora
country: Bulgaria
facility: Galderma Investigational Site 6251
city: Calgary
country: Canada
facility: Galderma Investigational Site 8085
state: Alberta
city: Calgary
country: Canada
facility: Galderma Investigational Site 8903
state: Alberta
city: Calgary
country: Canada
facility: Galderma Investigational Site 8215
state: Alberta
city: Edmonton
country: Canada
facility: Galderma Investigational Site 8824
state: Alberta
city: Edmonton
country: Canada
facility: Galderma Investigational Site 8722
state: Alberta
city: Surrey
country: Canada
facility: Galderma Investigational Site 8161
state: British Columbia
city: Barrie
country: Canada
facility: Galderma Investigational Site 8586
state: Ontario
city: Guelph
country: Canada
facility: Galderma Investigational Site 8904
state: Ontario
city: Niagara Falls
country: Canada
facility: Galderma Investigational Site 8780
state: Ontario
city: Ottawa
country: Canada
facility: Galderma Investigational Site 8610
state: Ontario
city: Ottawa
country: Canada
facility: Galderma Investigational Site 8901
state: Ontario
city: Toronto
country: Canada
facility: Galderma Investigational Site 8336
state: Ontario
city: Toronto
country: Canada
facility: Galderma Investigational Site 8899
state: Ontario
city: Waterloo
country: Canada
facility: Galderma Investigational Site 8731
state: Ontario
city: Saint John
country: Canada
facility: Galderma Investigational Site 8000
city: Brno
country: Czechia
facility: Galderma Investigational Site 6055
city: Náchod
country: Czechia
facility: Galderma Investigational Site 5225
city: Olomouc
country: Czechia
facility: Galderma Investigational Site 6030
city: Prague
country: Czechia
facility: Galderma Investigational Site 6024
city: Prague
country: Czechia
facility: Galderma Investigational Site 6240
city: Praha
country: Czechia
facility: Galderma Investigational Site 6021
city: Praha
country: Czechia
facility: Galderma Investigational Site 6054
city: Praha
country: Czechia
facility: Galderma Investigational Site 6025
city: Tallinn
country: Estonia
facility: Galderma Investigational Site 6068
city: Tallinn
country: Estonia
facility: Galderma Investigational Site 6069
city: Tartu
country: Estonia
facility: Galderma Investigational Site 6067
city: Le Mans
country: France
facility: Galderma Investigational Site 6198
city: Lille
country: France
facility: Galderma Investigational Site 5031
city: Martigues
country: France
facility: Galderma Investigational Site 6170
city: Nantes
country: France
facility: Galderma Investigational Site 6167
city: Nice
country: France
facility: Galderma Investigational Site 5140
city: Paris
country: France
facility: Galderma Investigational Site 6133
city: Paris
country: France
facility: Galderma Investigational Site 6166
city: Pierre-Bénite
country: France
facility: Galderma Investigational Site 5407
city: Quimper
country: France
facility: Galderma Investigational Site 6135
city: Toulon
country: France
facility: Galderma Investigational Site 6197
city: Toulouse
country: France
facility: Galderma Investigational Site 6169
city: Valence
country: France
facility: Galderma Investigational Site 6168
city: Tbilisi
country: Georgia
facility: Galderma Investigational Site 6224
city: Tbilisi
country: Georgia
facility: Galderma Investigational Site 6228
city: Tbilisi
country: Georgia
facility: Galderma Investigational Site 6235
city: Tbilisi
country: Georgia
facility: Galderma Investigational Site 6238
city: Tbilisi
country: Georgia
facility: Galderma Investigational Site 6227
city: Tbilisi
country: Georgia
facility: Galderma Investigational Site 6230
city: Tbilisi
country: Georgia
facility: Galderma Investigational Site 6234
city: Zugdidi
country: Georgia
facility: Galderma Investigational Site 6236
city: Aachen
country: Germany
facility: Galderma Investigational Site 5482
city: Augsburg
country: Germany
facility: Galderma Investigational Site 5566
city: Bad Bentheim
country: Germany
facility: Galderma Investigational Site 6022
city: Berlin
country: Germany
facility: Galderma Investigational Site 6110
city: Bielefeld
country: Germany
facility: Galderma Investigational Site 6061
city: Bonn
country: Germany
facility: Galderma Investigational Site 6082
city: Buxtehude
country: Germany
facility: Galderma Investigational Site 6062
city: Darmstadt
country: Germany
facility: Galderma Investigational Site 5368
city: Dresden
country: Germany
facility: Galderma Investigational Site 6132
city: Dülmen
country: Germany
facility: Galderma Investigational Site 6028
city: Düsseldorf
country: Germany
facility: Galderma Investigational Site 6031
city: Gera
country: Germany
facility: Galderma Investigational Site 5442
city: Goettigen
country: Germany
facility: Galderma Investigational Site 6081
city: Halle
country: Germany
facility: Galderma Investigational Site 6062
city: Hamburg
country: Germany
facility: Galderma Investigational Site 6041
city: Hamburg
country: Germany
facility: Galderma Investigational Site 6150
city: Hamburg
country: Germany
facility: Galderma Investigational Site 6040
city: Heidelberg
country: Germany
facility: Galderma Investigational Site 5469
city: Kiel
country: Germany
facility: Galderma Investigational Site 6086
city: Langenau
country: Germany
facility: Galderma Investigational Site 6146
city: Mainz
country: Germany
facility: Galderma Investigational Site 6084
city: Munich
country: Germany
facility: Galderma Investigational Site 5382
city: Münster
country: Germany
facility: Galderma Investigational Site 6039
city: Osnabrück
country: Germany
facility: Galderma Investigational Site 5918
city: Stuttgart
country: Germany
facility: Galderma Investigational Site 6109
city: Tuebingen
country: Germany
facility: Galderma Investigational Site 6214
city: Budapest
country: Hungary
facility: Galderma Investigational Site 6147
city: Budapest
country: Hungary
facility: Galderma Investigational Site 5513
city: Debrecen
country: Hungary
facility: Galderma Investigational Site 5567
city: Debrecen
country: Hungary
facility: Galderma Investigational Site 6026
city: Gyula
country: Hungary
facility: Galderma Investigational Site 6254
city: Veszprem
country: Hungary
facility: Galderma Investigational Site 6053
city: Bologna
country: Italy
facility: Galderma Investigational Site 6145
city: L'Aquila
country: Italy
facility: Galderma Investigational Site 6045
city: Roma
country: Italy
facility: Galderma Investigational Site 6049
city: Rome
country: Italy
facility: Galderma Investigational Site 6177
city: Rozzano
country: Italy
facility: Galderma Investigational Site 6155
city: Vicenza
country: Italy
facility: Galderma Investigational Site 6175
city: Bucheon-Si
country: Korea, Republic of
facility: Galderma Investigational Site 6095
city: Busan
country: Korea, Republic of
facility: Galderma Investigational Site 6100
city: Gyeonggi-do
country: Korea, Republic of
facility: Galderma Investigational Site 6098
city: Gyeonggi-Do
country: Korea, Republic of
facility: Galderma Investigational Site 6154
city: Incheon
country: Korea, Republic of
facility: Galderma Investigational Site 6138
city: Incheon
country: Korea, Republic of
facility: Galderma Investigational Site 6120
city: Incheon
country: Korea, Republic of
facility: Galderma Investigational Site 6093
city: Seoul
country: Korea, Republic of
facility: Galderma Investigational Site 6105
city: Seoul
country: Korea, Republic of
facility: Galderma Investigational Site 5659
city: Seoul
country: Korea, Republic of
facility: Galderma Investigational Site 6116
city: Seoul
country: Korea, Republic of
facility: Galderma Investigational Site 6129
city: Seoul
country: Korea, Republic of
facility: Galderma Investigational Site 6103
city: Seoul
country: Korea, Republic of
facility: Galderma Investigational Site 6056
city: Seoul
country: Korea, Republic of
facility: Galderma Investigational Site 6094
city: Seoul
country: Korea, Republic of
facility: Galderma Investigational Site 6099
city: Liepaja
country: Latvia
facility: Galderma Investigational Site 6113
city: Riga
country: Latvia
facility: Galderma Investigational Site 6134
city: Riga
country: Latvia
facility: Galderma Investigational Site 6059
city: Talsi
country: Latvia
facility: Galderma Investigational Site 6060
city: Kaunas
country: Lithuania
facility: Galderma Investigational Site 6111
city: Vilnius
country: Lithuania
facility: Galderma Investigational Site 6073
city: Vilnius
country: Lithuania
facility: Galderma Investigational Site 6112
city: Groningen
country: Netherlands
facility: Galderma Investigational Site 6212
city: Rotterdam
country: Netherlands
facility: Galderma Investigational Site 6108
city: Utrecht
country: Netherlands
facility: Galderma Investigational Site 6027
city: Hamilton
country: New Zealand
facility: Galderma Investigational Site 6119
city: Wellington
country: New Zealand
facility: Galderma Investigational Site 6118
city: Białystok
country: Poland
facility: Galderma Investigational Site 5773
city: Chorzów
country: Poland
facility: Galderma Investigational Site 6097
city: Czestochowa
country: Poland
facility: Galderma Investigational Site 6255
city: Gdańsk
country: Poland
facility: Galderma Investigational Site 6075
city: Gdańsk
country: Poland
facility: Galderma Investigational Site 6243
city: Gdańsk
country: Poland
facility: Galderma Investigational Site 5138
city: Gdynia
country: Poland
facility: Galderma Investigational Site 6244
city: Katowice
country: Poland
facility: Galderma Investigational Site 6087
city: Katowice
country: Poland
facility: Galderma Investigational Site 5021
city: Kraków
country: Poland
facility: Galderma Investigational Site 5362
city: Kraków
country: Poland
facility: Galderma Investigational Site 6052
city: Lublin
country: Poland
facility: Galderma Investigational Site 5367
city: Lublin
country: Poland
facility: Galderma Investigational Site 6071
city: Nowa Sól
country: Poland
facility: Galderma Investigational Site 5377
city: Olsztyn
country: Poland
facility: Galderma Investigational Site 6063
city: Ostrowiec Świętokrzyski
country: Poland
facility: Galderma Investigational Site 6237
city: Poznań
country: Poland
facility: Galderma Investigational Site 6085
city: Poznań
country: Poland
facility: Galderma Investigational Site 6127
city: Rzeszów
country: Poland
facility: Galderma Investigational Site 5495
city: Rzeszów
country: Poland
facility: Galderma Investigational Site 6088
city: Szczecin
country: Poland
facility: Galderma Investigational Site 6223
city: Szczecin
country: Poland
facility: Galderma Investigational Site 6130
city: Tarnow
country: Poland
facility: Galderma Investigational Site 6048
city: Warsaw
country: Poland
facility: Galderma Investigational Site 6126
city: Warsaw
country: Poland
facility: Galderma Investigational Site 5707
city: Warszawa
country: Poland
facility: Galderma Investigational Site 6065
city: Warszawa
country: Poland
facility: Galderma Investigational Site 6122
city: Warszawa
country: Poland
facility: Galderma Investigational Site 6242
city: Warszawa
country: Poland
facility: Galderma Investigational Site 6064
city: Warszawa
country: Poland
facility: Galderma Investigational Site 6222
city: Wrocław
country: Poland
facility: Galderma Investigational Site 6047
city: Wrocław
country: Poland
facility: Galderma Investigational Site 6185
city: Wrocław
country: Poland
facility: Galderma Investigational Site 6096
city: Wrocław
country: Poland
facility: Galderma Investigational Site 5005
city: Łódź
country: Poland
facility: Galderma Investigational Site 6245
city: Łódź
country: Poland
facility: Galderma Investigational Site 5570
city: Łódź
country: Poland
facility: Galderma Investigational Site 5363
city: Łódź
country: Poland
facility: Galderma Investigational Site 6231
city: Singapore
country: Singapore
facility: Galderma Investigational Site 6124
city: Singapore
country: Singapore
facility: Galderma Investigational Site 6077
city: Singapore
country: Singapore
facility: Galderma Investigational Site 5499
city: Alicante
country: Spain
facility: Galderma Investigational Site 6057
city: Barcelona
country: Spain
facility: Galderma Investigational Site 6037
city: Barcelona
country: Spain
facility: Galderma Investigational Site 6035
city: L'Hospitalet De Llobregat
country: Spain
facility: Galderma Investigational Site 5580
city: Las Palmas De Gran Canaria
country: Spain
facility: Galderma Investigational Site 6106
city: Madrid
country: Spain
facility: Galderma Investigational Site 6058
city: Madrid
country: Spain
facility: Galderma Investigational Site 5842
city: Madrid
country: Spain
facility: Galderma Investigational Site 6190
city: Madrid
country: Spain
facility: Galderma Investigational Site 6186
city: Madrid
country: Spain
facility: Galderma Investigational Site 6036
city: Madrid
country: Spain
facility: Galderma Investigational Site 5551
city: Pamplona
country: Spain
facility: Galderma Investigational Site 6191
city: Barnsley
country: United Kingdom
facility: Galderma Investigational Site 6202
city: Blackpool
country: United Kingdom
facility: Galderma Investigational Site 6207
city: Cannock
country: United Kingdom
facility: Galderma Investigational Site 6203
city: Dudley
country: United Kingdom
facility: Galderma Investigational Site 6090
city: Glasgow
country: United Kingdom
facility: Galderma Investigational Site 6104
city: Liverpool
country: United Kingdom
facility: Galderma Investigational Site 6204
city: London
country: United Kingdom
facility: Galderma Investigational Site 6121
city: Manchester
country: United Kingdom
facility: Galderma Investigational Site 6205
city: Newcastle
country: United Kingdom
facility: Galderma Investigational Site 6208
city: Stockton-on-Tees
country: United Kingdom
facility: Galderma Investigational Site 6206
Study officials:
References: