Efficacy & Safety of Nemolizumab in Subjects With Moderate-to-Severe Atopic Dermatitis
Study Purpose
The main purpose of the study is to assess the efficacy and safety of nemolizumab after a 16-week treatment period in adult and adolescent subjects with moderate-to-severe atopic dermatitis (AD) not adequately controlled with topical treatments.
Recruitment Criteria
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
Eligible Ages | 12 Years and Over |
Gender | All |
Key
Inclusion Criteria:
- - Male or female subjects aged ≥ 12 years at the screening visit Note: Enrollment of subjects aged 12 to 17 years has been opened after the IDMC has assessed interim safety data from the phase 2 study (Protocol 116912) and provided recommendations to the sponsor, who then determined the eligibility of this age group for enrollment in the study.
- - Chronic AD that has been documented for at least 2 years.
- - EASI score ≥ 16.
- - IGA score ≥ 3.
- - AD involvement ≥ 10% of BSA.
- - PPNRS score of at least 4.0 at the screening and baseline visit.
- - Documented recent history of inadequate response to topical medications (TCS with or without TCI) - Female subjects of childbearing potential (that is, fertile, following menarche and until becoming postmenopausal 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 adequate and approved method of contraception throughout the study and for 12 weeks after the last study drug injection.
Exclusion Criteria:
- - Body weight < 30 kg.
- - Pregnant women, breastfeeding women, or women planning a pregnancy during the clinical study.
- - 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 Note: Subjects with chronic, stable use of prophylactic treatment for recurrent herpes viral infection can be included in this clinical study.
- - History of hypersensitivity (including anaphylaxis) to an immunoglobulin product (plasma-derived or recombinant, eg, monoclonal antibody) or to any of the study drug excipients.
Trial Details
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT03989349 |
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
Phase 3 |
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Galderma R&D |
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
N/A |
Principal Investigator Affiliation | N/A |
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Industry |
Overall Status | Active, not recruiting |
Countries | Belgium, Bulgaria, Estonia, France, Georgia, Germany, Hungary, Italy, Poland, Singapore, United States |
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Moderate-to-Severe Atopic Dermatitis |
This is a randomized, double-blind, placebo-controlled, multi-center, parallel-group study in adult and adolescent subjects of age 12 years and above with moderate-to-severe AD. Eligible subjects must have a documented history of inadequate response to topical AD medication(s). Approximately 750 subjects will be randomized in 2:1 to receive either nemolizumab or placebo, stratified by baseline disease severity (Investigator's Global Assessment (IGA) = 3, moderate; IGA = 4, severe) and peak pruritus numeric rating scale (PP NRS) severity (PP NRS = 7; PP NRS < 7).
Arms
Placebo Comparator: Placebo
Placebo administered via subcutaneous injection
Experimental: Nemolizumab
Nemolizumab administered via subcutaneous injection
Interventions
Drug: - Placebo
Placebo
Drug: - Nemolizumab
Nemolizumab
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Status
Address
Galderma Investigational Site 8749
Birmingham, Alabama, 35244
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Galderma Investigational Site 8893
Birmingham, Alabama, 35244
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Galderma Investigational Site 8866
Guntersville, Alabama, 35976
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Galderma Investigational Site 8808
Scottsdale, Arizona, 85255
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Galderma Investigational Site 8906
Bell Gardens, California, 90201
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Galderma Investigational Site 8905
Canoga Park, California, 91304
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Galderma Investigational Site 8577
Encinitas, California, 92024
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Galderma Investigational Site 8224
Fremont, California, 94538
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Galderma Investigational Site 8673
Garden Grove, California, 92840
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Galderma Investigational Site 8683
Los Angeles, California, 90033
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Galderma Investigational Site 8907
Newport Beach, California, 92660
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Galderma Investigational Site 8799
Ontario, California, 91762
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Galderma Investigational Site 8745
Pasadena, California, 91105
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Galderma Investigational Site 8692
San Diego, California, 92121
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Galderma Investigational Site 8658
San Diego, California, 92123
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Galderma Investigational Site 8536
Santa Ana, California, 92705
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Galderma Investigational Site 8820
Westminster, California, 92683
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Galderma Investigational Site 8637
Farmington, Connecticut, 06030
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Galderma Investigational Site 8875
Delray Beach, Florida, 33484
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Galderma Investigational Site 8391
Hialeah, Florida, 33013
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Galderma Investigational Site 8727
Hialeah, Florida, 33016
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Galderma Investigational Site 8523
Largo, Florida, 33770
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Galderma Investigational Site 8719
Miami, Florida, 33125
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Galderma Investigational Site 8656
Miami, Florida, 33137
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Galderma Investigational Site 8704
Miami, Florida, 33155
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Galderma Investigational Site 8706
Miami, Florida, 33175
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Galderma Investigational Site 8203
Tampa, Florida, 33607
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Galderma Investigational Site 8839
Tampa, Florida, 33615
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Galderma Investigational Site 8126
West Palm Beach, Florida, 33401
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Galderma Investigational Site 8667
Columbus, Georgia, 31904
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Galderma Investigational Site 8729
Rolling Meadows, Illinois, 60008
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Galderma Investigational Site 8724
New Albany, Indiana, 47150
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Galderma Investigational Site 8554
Detroit, Michigan, 48202
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Galderma Investigational Site 8617
Farmington Hills, Michigan, 48334
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Galderma Investigational Site 8226
Warren, Michigan, 48088
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Galderma Investigational Site 8825
Las Vegas, Nevada, 89106
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Galderma Investigational Site 8675
Las Vegas, Nevada, 89119
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Galderma Investigational Site 8506
Hackensack, New Jersey, 07601
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Galderma Investigational Site 8741
Buffalo, New York, 14221
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Galderma Investigational Site 8723
Cortland, New York, 13045
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Galderma Investigational Site 8821
New York, New York, 10016
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Galderma Investigational Site 8733
New York, New York, 10022
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Galderma Investigational Site 8823
Greensboro, North Carolina, 27408
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Galderma Investigational Site 8030
Raleigh, North Carolina, 27612
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Galderma Investigational Site 8747
Cincinnati, Ohio, 45219
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Galderma Investigational Site 8212
Portland, Oregon, 97210
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Galderma Investigational Site 8721
Pittsburgh, Pennsylvania, 15213
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Galderma Investigational Site 8713
North Charleston, South Carolina, 29420
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Galderma Investigational Site 8705
Chattanooga, Tennessee, 37421
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Galderma Investigational Site 8807
Houston, Texas, 77029
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Galderma Investigational Site 8618
Waco, Texas, 76710
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Galderma Investigational Site 8003
Webster, Texas, 77598
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Galderma Investigational Site 8672
Salt Lake City, Utah, 84117
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Galderma Investigational Site 8896
Richmond, Virginia, 23219
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Galderma Investigational Site 8434
Seattle, Washington, 98105
International Sites
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Galderma Investigational Site 5448
Brussel, , 1200
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Galderma Investigational Site 6163
Edegem, , 2650
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Gent, , 9000
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Leuven, , 3000
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Liège, , 4000
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Pleven, , 5800
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Plovdiv, , 4002
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Sofia, , 1407
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Galderma Investigational Site 6078
Sofia, , 1408
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Galderma Investigational Site 6102
Sofia, , 1431
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Galderma Investigational Site 6165
Sofia, , 1431
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Galderma Investigational Site 6216
Sofia, , 1528
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Galderma Investigational Site 6046
Sofia, , 1606
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Galderma Investigational Site 6080
Sofia, , 1606
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Galderma Investigational Site 6101
Sofia, , 1612
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Galderma Investigational Site 6079
Sofia, , 1618
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Galderma Investigational Site 6250
Sofia, , 1784
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Stara Zagora, , 6000
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Galderma Investigational Site 6251
Stara Zagora, , 6000
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Tallinn, , 10138
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Tallin, , 10134
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Tartu, , 50417
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Brest, , 29200
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Le Mans, , 72037
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Lille, , 59000
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Lille, , 59037
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Martigues, , 13500
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Nantes, , 44093
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Nice, , 6200
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Galderma Investigational Site 6133
Paris, , 75015
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Galderma Investigational Site 6166
Paris, , 75475
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Galderma Investigational Site 5407
Pierre-Bénite, , 69495
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Quimper, , 29 107
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Saint-Priest-en-Jarez, , 42270
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Toulon, , 83800
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Toulouse, , 31000
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Valence, , 26000
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Tbilisi, , 0159
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Tbilisi, , 0186
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Galderma Investigational Site 6230
Tbilisi, , 0186
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Tbilisi, , 159
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Tbilisi, , 159
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Tbilisi, , 159
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Tbilisi, , 186
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Zugdidi, , 2100
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Galderma Investigational Site 5482
Aachen, , 52074
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Galderma Investigational Site 6114
Augsburg, , 86156
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Galderma Investigational Site 5566
Augsburg, , 86179
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Galderma Investigational Site 6082
Bonn, , 53127
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Galderma Investigational Site 6132
Dresden, , 01097
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Galderma Investigational Site 6031
Duesseldorf, , 40225
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Galderma Investigational Site 6083
Frankfurt, , 60437
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Galderma Investigational Site 5442
Gera, , 7548
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Galderma Investigational Site 6081
Goettigen, , 37075
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Galderma Investigational Site 6062
Halle, , 6120
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Galderma Investigational Site 6041
Hamburg, , 20251
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Galderma Investigational Site 6150
Hamburg, , 20537
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Galderma Investigational Site 6040
Hamburg, , 22391
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Galderma Investigational Site 5469
Heidelberg, , 69120
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Galderma Investigational Site 6086
Kiel, , 24148
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Galderma Investigational Site 6084
Mainz, , 55131
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Galderma Investigational Site 5382
Munich, , 80337
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Galderma Investigational Site 6147
Budapest, , 1036
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Galderma Investigational Site 5513
Budapest, , 1085
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Galderma Investigational Site 5567
Debrecen, , 4025
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Galderma Investigational Site 6026
Debrecen, , 4032
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Galderma Investigational Site 6254
Gyula, , 5700
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Szekszárd, , 7100
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Galderma Investigational Site 6053
Veszprém, , 8200
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Ancona, , 60126
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Bologna, , 40138
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Catania, , 95123
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Chieti, , 66013
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Galderma Investigational Site 6115
Florence, , 50125
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Genova, , 16132
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Galderma Investigational Site 6045
L'Aquila, , 67100
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Modena, , 41124
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Naples, , 80131
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Parma, , 43124
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Pavia, , 27100
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Perugia, , 6123
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Pisa, , 56126
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Roma, , 00133
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Roma, , 00168
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Rome, , 00 144
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Galderma Investigational Site 6155
Rozzano, , 20089
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Galderma Investigational Site 6142
Torino, , 10126
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Galderma Investigational Site 6175
Vicenza, , 36100
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Galderma Investigational Site 5773
Białystok, , 15-453
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Galderma Investigational Site 6097
Chorzów, , 41-500
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Cracovia, , 30-033
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Katowice, , 40-611
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Galderma Investigational Site 6052
Kraków, , 31-559
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Lublin, , 20-080
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Galderma Investigational Site 5377
Nowa Sól, , 67-100
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Galderma Investigational Site 6063
Olsztyn, , 10-229
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Galderma Investigational Site 6085
Poznań, , 60-529
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Galderma Investigational Site 5495
Rzeszów, , 35-055
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Galderma Investigational Site 6130
Szczecin, , 71-434
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Tarnów, , 33-100
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Warsaw, , 01-142
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Galderma Investigational Site 5707
Warsaw, , 01-817
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Galderma Investigational Site 6185
Wrocław, , 50-566
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Galderma Investigational Site 6096
Wrocław, , 51-318
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Galderma Investigational Site 5363
Łódź, , 90-436
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Galderma Investigational Site 6124
Singapore, , 119228
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Galderma Investigational Site 6077
Singapore, , 169608
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Galderma Investigational Site 5499
Singapore, , 308205