Long-term Safety and Efficacy of Nemolizumab With Moderate-to-severe Atopic Dermatitis

September 25, 2023 updated by: Galderma R&D

A Prospective, Multicenter, Long-Term Study to Assess the Safety and Efficacy of Nemolizumab (CD14152) in Subjects With Moderate-to-Severe Atopic Dermatitis

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

Study Overview

Status

Active, not recruiting

Conditions

Moderate-to-Severe Atopic Dermatitis

Intervention / Treatment

Drug: Nemolizumab

Detailed Description

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

Study Type

Interventional

Enrollment (Estimated)

1700

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Australia
- New South Wales
  - Darlinghurst, New South Wales, Australia, 2010
    - Galderma Investigational Site 5441
  - Kogarah, New South Wales, Australia, 2217
    - Galderma Investigational Site 5759
  - Westmead, New South Wales, Australia, 2145
    - Galderma Investigational Site 6152
- Queensland
  - Benowa, Queensland, Australia, 4217
    - Galderma Investigational Site 5638
  - Brisbane, Queensland, Australia, 4102
    - Galderma Investigational Site 6161
- South Australia
  - Woodville, South Australia, Australia, 5011
    - Galderma Investigational Site 6159
- Victoria
  - Carlton, Victoria, Australia, 3053
    - Galderma Investigational Site 6131
  - East Melbourne, Victoria, Australia, 3002
    - Galderma Investigational Site 5366
  - Parkville, Victoria, Australia, 3050
    - Galderma Investigational Site 5458
  - Parkville, Victoria, Australia, 3052
    - Galderma Investigational Site 6160
- Western Australia
  - Victoria Park, Western Australia, Australia, 6100
    - Galderma Investigational Site 6153
Austria
- - Vienna, Austria, 1090
    - Galderma Investigational Site 6194
  - Vienna, Austria, 1220
    - Galderma Investigational Site 6158
- Oberoesterreich
  - Linz, Oberoesterreich, Austria, 4020
    - Galderma Investigational Site 6156
- Styria
  - Graz, Styria, Austria, 8036
    - Galderma Investigational Site 6157
Belgium
- - Brussels, Belgium, 1200
    - Galderma Investigational Site 5448
  - Edegem, Belgium, 2650
    - Galderma Investigational Site 6163
  - Gent, Belgium, 9000
    - Galderma Investigational Site 6164
  - Liège, Belgium, 4000
    - Galderma Investigational Site 6162
- Vlaams-Brabant
  - Leuven, Vlaams-Brabant, Belgium, 3000
    - Galderma Investigational Site 6038
Bulgaria
- - Pleven, Bulgaria, 5800
    - Galderma Investigational Site 6029
  - Sofia, Bulgaria, 1407
    - Galderma Investigational Site 6051
  - Sofia, Bulgaria, 1408
    - Galderma Investigational Site 6078
  - Sofia, Bulgaria, 1431
    - Galderma Investigational Site 6102
  - Sofia, Bulgaria, 1431
    - Galderma Investigational Site 6165
  - Sofia, Bulgaria, 1528
    - Galderma Investigational Site 6216
  - Sofia, Bulgaria, 1606
    - Galderma Investigational Site 6046
  - Sofia, Bulgaria, 1606
    - Galderma Investigational Site 6080
  - Sofia, Bulgaria, 1612
    - Galderma Investigational Site 6101
  - Sofia, Bulgaria, 1618
    - Galderma Investigational Site 6079
  - Sofia, Bulgaria, 1784
    - Galderma Investigational Site 6250
  - Stara Zagora, Bulgaria, 6000
    - Galderma Investigational Site 6136
  - Stara Zagora, Bulgaria, 6000
    - Galderma Investigational Site 6251
Canada
- - Saint John, Canada, A1C 2H5
    - Galderma Investigational Site 8000
- Alberta
  - Calgary, Alberta, Canada, T2G 1B1
    - Galderma Investigational Site 8085
  - Calgary, Alberta, Canada, T2J 7E1
    - Galderma Investigational Site 8903
  - Calgary, Alberta, Canada, T3E 0B2
    - Galderma Investigational Site 8215
  - Edmonton, Alberta, Canada, T6G 1C3
    - Galderma Investigational Site 8824
  - Edmonton, Alberta, Canada, T6G 1C9
    - Galderma Investigational Site 8722
- British Columbia
  - Surrey, British Columbia, Canada, V3V 0C6
    - Galderma Investigational Site 8161
- Ontario
  - Barrie, Ontario, Canada, L4M 7G1
    - Galderma Investigational Site 8586
  - Guelph, Ontario, Canada, N1L 0B7
    - Galderma Investigational Site 8904
  - Niagara Falls, Ontario, Canada, L2H 1H5
    - Galderma Investigational Site 8780
  - Ottawa, Ontario, Canada, K1G 6C6
    - Galderma Investigational Site 8610
  - Ottawa, Ontario, Canada, K1H 7X3
    - Galderma Investigational Site 8901
  - Toronto, Ontario, Canada, M3H 5Y8
    - Galderma Investigational Site 8336
  - Toronto, Ontario, Canada, M4W 2N4
    - Galderma Investigational Site 8899
  - Waterloo, Ontario, Canada, N2J 1C4
    - Galderma Investigational Site 8731
Czechia
- - Brno, Czechia, 656 91
    - Galderma Investigational Site 6055
  - Náchod, Czechia, 547 01
    - Galderma Investigational Site 5225
  - Olomouc, Czechia, 779 00
    - Galderma Investigational Site 6030
  - Prague, Czechia, 100 00
    - Galderma Investigational Site 6024
  - Prague, Czechia, 120 00
    - Galderma Investigational Site 6240
  - Praha, Czechia, 110 00
    - Galderma Investigational Site 6021
  - Praha, Czechia, 110 00
    - Galderma Investigational Site 6054
  - Praha, Czechia, 150 06
    - Galderma Investigational Site 6025
Estonia
- - Tallinn, Estonia, 10134
    - Galderma Investigational Site 6068
  - Tallinn, Estonia, 10138
    - Galderma Investigational Site 6069
  - Tartu, Estonia, 50417
    - Galderma Investigational Site 6067
France
- - Le Mans, France, 72037
    - Galderma Investigational Site 6198
  - Lille, France, 59037
    - Galderma Investigational Site 5031
  - Martigues, France, 13500
    - Galderma Investigational Site 6170
  - Nantes, France, 44093
    - Galderma Investigational Site 6167
  - Nice, France, 06200
    - Galderma Investigational Site 5140
  - Paris, France, 75015
    - Galderma Investigational Site 6133
  - Paris, France, 75475
    - Galderma Investigational Site 6166
  - Pierre-Bénite, France, 69495
    - Galderma Investigational Site 5407
  - Quimper, France, 29107
    - Galderma Investigational Site 6135
  - Toulon, France, 83800
    - Galderma Investigational Site 6197
  - Toulouse, France, 31000
    - Galderma Investigational Site 6169
  - Valence, France, 26000
    - Galderma Investigational Site 6168
Georgia
- - Tbilisi, Georgia, 0159
    - Galderma Investigational Site 6224
  - Tbilisi, Georgia, 0159
    - Galderma Investigational Site 6228
  - Tbilisi, Georgia, 0159
    - Galderma Investigational Site 6235
  - Tbilisi, Georgia, 0159
    - Galderma Investigational Site 6238
  - Tbilisi, Georgia, 0186
    - Galderma Investigational Site 6227
  - Tbilisi, Georgia, 0186
    - Galderma Investigational Site 6230
  - Tbilisi, Georgia, 0186
    - Galderma Investigational Site 6234
  - Zugdidi, Georgia, 2100
    - Galderma Investigational Site 6236
Germany
- - Aachen, Germany, 52074
    - Galderma Investigational Site 5482
  - Augsburg, Germany, 86179
    - Galderma Investigational Site 5566
  - Bad Bentheim, Germany, 48455
    - Galderma Investigational Site 6022
  - Berlin, Germany, 13055
    - Galderma Investigational Site 6110
  - Bielefeld, Germany, 33647
    - Galderma Investigational Site 6061
  - Bonn, Germany, 53127
    - Galderma Investigational Site 6082
  - Buxtehude, Germany, 21614
    - Galderma Investigational Site 6062
  - Darmstadt, Germany, 64283
    - Galderma Investigational Site 5368
  - Dresden, Germany, 01097
    - Galderma Investigational Site 6132
  - Dülmen, Germany, 48249
    - Galderma Investigational Site 6028
  - Düsseldorf, Germany, 40225
    - Galderma Investigational Site 6031
  - Gera, Germany, 07548
    - Galderma Investigational Site 5442
  - Goettigen, Germany, 37075
    - Galderma Investigational Site 6081
  - Halle, Germany, 06120
    - Galderma Investigational Site 6062
  - Hamburg, Germany, 20251
    - Galderma Investigational Site 6041
  - Hamburg, Germany, 20537
    - Galderma Investigational Site 6150
  - Hamburg, Germany, 22391
    - Galderma Investigational Site 6040
  - Heidelberg, Germany, 69120
    - Galderma Investigational Site 5469
  - Kiel, Germany, 24148
    - Galderma Investigational Site 6086
  - Langenau, Germany, 89129
    - Galderma Investigational Site 6146
  - Mainz, Germany, 55131
    - Galderma Investigational Site 6084
  - Munich, Germany, 80337
    - Galderma Investigational Site 5382
  - Münster, Germany, 48149
    - Galderma Investigational Site 6039
  - Osnabrück, Germany, 49074
    - Galderma Investigational Site 5918
  - Stuttgart, Germany, 70499
    - Galderma Investigational Site 6109
  - Tuebingen, Germany, 72076
    - Galderma Investigational Site 6214
Hungary
- - Budapest, Hungary, 1036
    - Galderma Investigational Site 6147
  - Budapest, Hungary, 1085
    - Galderma Investigational Site 5513
  - Debrecen, Hungary, 4025
    - Galderma Investigational Site 5567
  - Debrecen, Hungary, 4032
    - Galderma Investigational Site 6026
  - Gyula, Hungary, 5700
    - Galderma Investigational Site 6254
  - Veszprem, Hungary, 8200
    - Galderma Investigational Site 6053
Italy
- - Bologna, Italy, 40138
    - Galderma Investigational Site 6145
  - L'Aquila, Italy, 67100
    - Galderma Investigational Site 6045
  - Roma, Italy, 00168
    - Galderma Investigational Site 6049
  - Rome, Italy, 00144
    - Galderma Investigational Site 6177
  - Rozzano, Italy, 20089
    - Galderma Investigational Site 6155
  - Vicenza, Italy, 36100
    - Galderma Investigational Site 6175
Korea, Republic of
- - Bucheon-Si, Korea, Republic of, 14584
    - Galderma Investigational Site 6095
  - Busan, Korea, Republic of, 49241
    - Galderma Investigational Site 6100
  - Gyeonggi-Do, Korea, Republic of, 18450
    - Galderma Investigational Site 6154
  - Gyeonggi-do, Korea, Republic of, 15355
    - Galderma Investigational Site 6098
  - Incheon, Korea, Republic of, 21431
    - Galderma Investigational Site 6138
  - Incheon, Korea, Republic of, 21565
    - Galderma Investigational Site 6120
  - Incheon, Korea, Republic of, 22332
    - Galderma Investigational Site 6093
  - Seoul, Korea, Republic of, 02841
    - Galderma Investigational Site 6105
  - Seoul, Korea, Republic of, 03080
    - Galderma Investigational Site 5659
  - Seoul, Korea, Republic of, 03722
    - Galderma Investigational Site 6116
  - Seoul, Korea, Republic of, 04763
    - Galderma Investigational Site 6129
  - Seoul, Korea, Republic of, 05030
    - Galderma Investigational Site 6103
  - Seoul, Korea, Republic of, 06591
    - Galderma Investigational Site 6056
  - Seoul, Korea, Republic of, 06973
    - Galderma Investigational Site 6094
  - Seoul, Korea, Republic of, 07441
    - Galderma Investigational Site 6099
Latvia
- - Liepaja, Latvia, LV-3401
    - Galderma Investigational Site 6113
  - Riga, Latvia, LV-1006
    - Galderma Investigational Site 6134
  - Riga, Latvia, LV-1009
    - Galderma Investigational Site 6059
  - Talsi, Latvia, LV-3201
    - Galderma Investigational Site 6060
Lithuania
- - Kaunas, Lithuania, LT-50161
    - Galderma Investigational Site 6111
  - Vilnius, Lithuania, LT-07195
    - Galderma Investigational Site 6073
  - Vilnius, Lithuania, LT-08411
    - Galderma Investigational Site 6112
Netherlands
- - Groningen, Netherlands, 9713
    - Galderma Investigational Site 6212
  - Rotterdam, Netherlands, 3015 GD
    - Galderma Investigational Site 6108
  - Utrecht, Netherlands, 3584 CX
    - Galderma Investigational Site 6027
New Zealand
- - Hamilton, New Zealand, 3204
    - Galderma Investigational Site 6119
  - Wellington, New Zealand, 6021
    - Galderma Investigational Site 6118
Poland
- - Białystok, Poland, 15-453
    - Galderma Investigational Site 5773
  - Chorzów, Poland, 41-500
    - Galderma Investigational Site 6097
  - Czestochowa, Poland, 42-202
    - Galderma Investigational Site 6255
  - Gdańsk, Poland, 80-214
    - Galderma Investigational Site 6075
  - Gdańsk, Poland, 80-382
    - Galderma Investigational Site 6243
  - Gdańsk, Poland, 80-803
    - Galderma Investigational Site 5138
  - Gdynia, Poland, 81-537
    - Galderma Investigational Site 6244
  - Katowice, Poland, 40-040
    - Galderma Investigational Site 6087
  - Katowice, Poland, 40-611
    - Galderma Investigational Site 5021
  - Kraków, Poland, 30-033
    - Galderma Investigational Site 5362
  - Kraków, Poland, 31-559
    - Galderma Investigational Site 6052
  - Lublin, Poland, 20-080
    - Galderma Investigational Site 5367
  - Lublin, Poland, 20-081
    - Galderma Investigational Site 6071
  - Nowa Sól, Poland, 67-100
    - Galderma Investigational Site 5377
  - Olsztyn, Poland, 10-229
    - Galderma Investigational Site 6063
  - Ostrowiec Świętokrzyski, Poland, 27-400
    - Galderma Investigational Site 6237
  - Poznań, Poland, 60-529
    - Galderma Investigational Site 6085
  - Poznań, Poland, 60-702
    - Galderma Investigational Site 6127
  - Rzeszów, Poland, 35-055
    - Galderma Investigational Site 5495
  - Rzeszów, Poland, 35-055
    - Galderma Investigational Site 6088
  - Szczecin, Poland, 70-332
    - Galderma Investigational Site 6223
  - Szczecin, Poland, 71-434
    - Galderma Investigational Site 6130
  - Tarnow, Poland, 33-100
    - Galderma Investigational Site 6048
  - Warsaw, Poland, 01-142
    - Galderma Investigational Site 6126
  - Warsaw, Poland, 01-817
    - Galderma Investigational Site 5707
  - Warszawa, Poland, 01-192
    - Galderma Investigational Site 6065
  - Warszawa, Poland, 02-507
    - Galderma Investigational Site 6122
  - Warszawa, Poland, 02-793
    - Galderma Investigational Site 6242
  - Warszawa, Poland, 02-953
    - Galderma Investigational Site 6064
  - Warszawa, Poland, 02-962
    - Galderma Investigational Site 6222
  - Wrocław, Poland, 50-381
    - Galderma Investigational Site 6047
  - Wrocław, Poland, 50-566
    - Galderma Investigational Site 6185
  - Wrocław, Poland, 51-318
    - Galderma Investigational Site 6096
  - Wrocław, Poland, 53-658
    - Galderma Investigational Site 5005
  - Łódź, Poland, 90-127
    - Galderma Investigational Site 6245
  - Łódź, Poland, 90-265
    - Galderma Investigational Site 5570
  - Łódź, Poland, 90-436
    - Galderma Investigational Site 5363
  - Łódź, Poland, 94-050
    - Galderma Investigational Site 6231
Singapore
- - Singapore, Singapore, 119228
    - Galderma Investigational Site 6124
  - Singapore, Singapore, 169608
    - Galderma Investigational Site 6077
  - Singapore, Singapore, 308205
    - Galderma Investigational Site 5499
Spain
- - Alicante, Spain, 03010
    - Galderma Investigational Site 6057
  - Barcelona, Spain, 08036
    - Galderma Investigational Site 6037
  - Barcelona, Spain, 08916
    - Galderma Investigational Site 6035
  - L'Hospitalet De Llobregat, Spain, 08907
    - Galderma Investigational Site 5580
  - Las Palmas De Gran Canaria, Spain, 35010
    - Galderma Investigational Site 6106
  - Madrid, Spain, 28006
    - Galderma Investigational Site 6058
  - Madrid, Spain, 28034
    - Galderma Investigational Site 5842
  - Madrid, Spain, 28046
    - Galderma Investigational Site 6190
  - Madrid, Spain, 28222
    - Galderma Investigational Site 6186
  - Madrid, Spain, 28223
    - Galderma Investigational Site 6036
  - Madrid, Spain, 28922
    - Galderma Investigational Site 5551
  - Pamplona, Spain, 31008
    - Galderma Investigational Site 6191
United Kingdom
- - Barnsley, United Kingdom, S75 3DL
    - Galderma Investigational Site 6202
  - Blackpool, United Kingdom, FY2 0JH
    - Galderma Investigational Site 6207
  - Cannock, United Kingdom, WS11 0BN
    - Galderma Investigational Site 6203
  - Dudley, United Kingdom, DY1 2HQ
    - Galderma Investigational Site 6090
  - Glasgow, United Kingdom, G3 8SJ
    - Galderma Investigational Site 6104
  - Liverpool, United Kingdom, L34 1BH
    - Galderma Investigational Site 6204
  - London, United Kingdom, SE1 9RT
    - Galderma Investigational Site 6121
  - Manchester, United Kingdom, M13 9NQ
    - Galderma Investigational Site 6205
  - Newcastle, United Kingdom, NE1 4LP
    - Galderma Investigational Site 6208
  - Stockton-on-Tees, United Kingdom, TS17 6EW
    - Galderma Investigational Site 6206
United States
- Alabama
  - Birmingham, Alabama, United States, 35244
    - Galderma Investigational Site 8749
  - Birmingham, Alabama, United States, 35244
    - Galderma Investigational Site 8893
  - Guntersville, Alabama, United States, 35976
    - Galderma Investigational Site 8866
- Arizona
  - Scottsdale, Arizona, United States, 85255
    - Galderma Investigational Site 8808
  - Scottsdale, Arizona, United States, 85260
    - Galderma Investigational Site 8873
- Arkansas
  - Fort Smith, Arkansas, United States, 72916
    - Galderma Investigational Site 8447
  - North Little Rock, Arkansas, United States, 72117
    - Galderma Investigational Site 8880
- California
  - Anaheim, California, United States, 92801
    - Galderma Investigational Site 8831
  - Bell Gardens, California, United States, 90201
    - Galderma Investigational Site 8906
  - Beverly Hills, California, United States, 90212
    - Galderma Investigational Site 8456
  - Cerritos, California, United States, 90703
    - Galderma Investigational Site 8578
  - Encinitas, California, United States, 92024
    - Galderma Investigational Site 8577
  - Fountain Valley, California, United States, 92708
    - Galderma Investigational Site 8636
  - Fremont, California, United States, 94538
    - Galderma Investigational Site 8224
  - Fresno, California, United States, 93720
    - Galderma Investigational Site 8791
  - Fullerton, California, United States, 92835
    - Galderma Investigational Site 8888
  - Huntington Beach, California, United States, 92647
    - Galderma Investigational Site 8845
  - Inglewood, California, United States, 90301
    - Galderma Investigational Site 8833
  - Lomita, California, United States, 90717
    - Galderma Investigational Site 8686
  - Los Angeles, California, United States, 90025
    - Galderma Investigational Site 8674
  - Los Angeles, California, United States, 90033
    - Galderma Investigational Site 8683
  - Los Angeles, California, United States, 90057
    - Galderma Investigational Site 8813
  - Newport Beach, California, United States, 92660
    - Galderma Investigational Site 8907
  - Ontario, California, United States, 91762
    - Galderma Investigational Site 8799
  - Pasadena, California, United States, 91105
    - Galderma Investigational Site 8745
  - San Diego, California, United States, 92108
    - Galderma Investigational Site 8671
  - San Diego, California, United States, 92121
    - Galderma Investigational Site 8692
  - San Diego, California, United States, 92123
    - Galderma Investigational Site 8658
  - San Francisco, California, United States, 94115
    - Galderma Investigational Site 8125
  - Santa Ana, California, United States, 92705
    - Galderma Investigational Site 8536
  - Santa Monica, California, United States, 90404
    - Galderma Investigational Site 8608
  - Westminster, California, United States, 92683
    - Galderma Investigational Site 8820
- Connecticut
  - Farmington, Connecticut, United States, 06606
    - Galderma Investigational Site 8637
- Florida
  - Boca Raton, Florida, United States, 33433
    - Galderma Investigational Site 8870
  - Cape Coral, Florida, United States, 33991
    - Galderma Investigational Site 8805
  - Clearwater, Florida, United States, 33765
    - Galderma Investigational Site 8786
  - Doral, Florida, United States, 33122
    - Galderma Investigational Site 8902
  - Hialeah, Florida, United States, 33016
    - Galderma Investigational Site 8391
  - Hialeah, Florida, United States, 33016
    - Galderma Investigational Site 8804
  - Jacksonville, Florida, United States, 32256
    - Galderma Investigational Site 8711
  - Jacksonville, Florida, United States, 32256
    - Galderma Investigational Site 8836
  - Largo, Florida, United States, 33770
    - Galderma Investigational Site 8523
  - Margate, Florida, United States, 33063
    - Galderma Investigational Site 8850
  - Miami, Florida, United States, 33125
    - Galderma Investigational Site 8719
  - Miami, Florida, United States, 33135
    - Galderma Investigational Site 8851
  - Miami, Florida, United States, 33137
    - Galderma Investigational Site 8656
  - Miami, Florida, United States, 33145
    - Galderma Investigational Site 8801
  - Miami, Florida, United States, 33155
    - Galderma Investigational Site 8704
  - Miami, Florida, United States, 33174
    - Galderma Investigational Site 8737
  - Miami, Florida, United States, 33175
    - Galderma Investigational Site 8706
  - Miami, Florida, United States, 33176
    - Galderma Investigational Site 8708
  - Miami Lakes, Florida, United States, 33014
    - Galderma Investigational Site 8806
  - Miami Lakes, Florida, United States, 33016
    - Galderma Investigational Site 8800
  - Ormond Beach, Florida, United States, 33174
    - Galderma Investigational Site 8856
  - Pembroke Pines, Florida, United States, 33028
    - Galderma Investigational Site 8734
  - Tampa, Florida, United States, 33607
    - Galderma Investigational Site 8203
  - Tampa, Florida, United States, 33613
    - Galderma Investigational Site 8816
  - Tampa, Florida, United States, 33613
    - Galderma Investigational Site 8889
  - Tampa, Florida, United States, 33615
    - Galderma Investigational Site 8839
  - West Palm Beach, Florida, United States, 33401
    - Galderma Investigational Site 8126
- Georgia
  - Columbus, Georgia, United States, 31904
    - Galderma Investigational Site 8667
  - Macon, Georgia, United States, 31217
    - Galderma Investigational Site 8744
  - Newnan, Georgia, United States, 30263
    - Galderma Investigational Site 8728
  - Stockbridge, Georgia, United States, 30281
    - Galderma Investigational Site 8707
- Idaho
  - Nampa, Idaho, United States, 83687
    - Galderma Investigational Site 8819
- Illinois
  - Chicago, Illinois, United States, 60611
    - Galderma Investigational Site 9916
  - Normal, Illinois, United States, 61761
    - Galderma Investigational Site 8739
  - Rolling Meadows, Illinois, United States, 60008
    - Galderma Investigational Site 8729
  - Skokie, Illinois, United States, 60076
    - Galderma Investigational Sites 8571
  - Skokie, Illinois, United States, 60077
    - Galderma Investigational Site 8712
- Indiana
  - Indianapolis, Indiana, United States, 46250
    - Galderma Investigational Site 8142
  - New Albany, Indiana, United States, 47150
    - Galderma Investigational Site 8724
- Kansas
  - Shawnee Mission, Kansas, United States, 66216
    - Galderma Investigational Site 9934
- Kentucky
  - Louisville, Kentucky, United States, 40241-6162
    - Galderma Investigational Site 8771
- Maine
  - Bangor, Maine, United States, 04401
    - Galderma Investigational Site 8882
- Michigan
  - Ann Arbor, Michigan, United States, 48109
    - Galderma Investigational Site 8743
  - Bay City, Michigan, United States, 48706
    - Galderma Investigational Site 8512
  - Detroit, Michigan, United States, 48202
    - Galderma Investigational Site 8554
  - Farmington Hills, Michigan, United States, 48334
    - Galderma Investigational Site 8617
  - Troy, Michigan, United States, 48084
    - Galderma Investigational Site 8155
  - Troy, Michigan, United States, 48084
    - Galderma Investigational Site 8849
  - Warren, Michigan, United States, 48088
    - Galderma Investigational Site 8226
  - Ypsilanti, Michigan, United States, 48197
    - Galderma Investigational Site 8748
- Missouri
  - Saint Joseph, Missouri, United States, 64506
    - Galderma Investigational Site 8521
- Montana
  - Missoula, Montana, United States, 59808
    - Galderma Investigational Site 8718
- Nebraska
  - Omaha, Nebraska, United States, 68144
    - Galderma Investigational Site 8810
- Nevada
  - Henderson, Nevada, United States, 89002
    - Galderma Investigational Site 8740
  - Las Vegas, Nevada, United States, 89106
    - Galderma Investigational Site 8825
  - Las Vegas, Nevada, United States, 89119
    - Galderma Investigational Site 8675
- New Hampshire
  - Lebanon, New Hampshire, United States, 03766
    - Galderma Investigational Site 8109
- New Jersey
  - Hackensack, New Jersey, United States, 07601
    - Galderma Investigational Site 8506
- New Mexico
  - Albuquerque, New Mexico, United States, 87106
    - Galderma Investigational Site 8826
- New York
  - Brooklyn, New York, United States, 11203
    - Galderma Investigational Site 8242
  - Buffalo, New York, United States, 14221
    - Galderma Investigational Site 8741
  - Cortland, New York, United States, 13045
    - Galderma Investigational Site 8723
  - Forest Hills, New York, United States, 11375
    - Galderma Investigational Site 8828
  - Glendale, New York, United States, 11385
    - Galderma Investigational Site 9925
  - New York, New York, United States, 10022
    - Galderma Investigational Site 8733
  - New York, New York, United States, 10023
    - Galderma Investigational Site 8620
  - New York, New York, United States, 10075
    - Galderma Investigational Site 8279
- North Carolina
  - Durham, North Carolina, United States, 27710
    - Galderma Investigational Site 8772
  - Shelby, North Carolina, United States, 28150
    - Galderma Investigational Site 8795
  - Wilmington, North Carolina, United States, 28405-3176
    - Galderma Investigational Site 8726
  - Wilmington, North Carolina, United States, 28405
    - Galderma Investigational Site 8648
- Ohio
  - Bexley, Ohio, United States, 43209
    - Galderma Investigational Site 8702
  - Cincinnati, Ohio, United States, 45219
    - Galderma Investigational Site 8747
  - Dublin, Ohio, United States, 43016
    - Galderma Investigational Site 8595
- Oklahoma
  - Norman, Oklahoma, United States, 73071
    - Galderma Investigational Site 8206
  - Oklahoma City, Oklahoma, United States, 73118
    - Galderma Investigational Site 8857
- Oregon
  - Portland, Oregon, United States, 97210
    - Galderma Investigational Site 8212
- Pennsylvania
  - Philadelphia, Pennsylvania, United States, 19103
    - Galderma Investigational Site 8255
  - Pittsburgh, Pennsylvania, United States, 15213
    - Galderma Investigational Site 8721
  - Plymouth Meeting, Pennsylvania, United States, 19462
    - Galderma Investigational Site 8802
- South Carolina
  - Charleston, South Carolina, United States, 29407
    - Galderma Investigational Site 8777
  - Charleston, South Carolina, United States, 29425
    - Galderma Investigational Site 8736
  - North Charleston, South Carolina, United States, 29420
    - Galderma Investigational Site 8713
- South Dakota
  - Rapid City, South Dakota, United States, 57702
    - Galderma Investigational Site 8818
- Texas
  - Arlington, Texas, United States, 76011
    - Galderma Investigational Site 8133
  - Austin, Texas, United States, 78723
    - Galderma Investigational Site 8298
  - Dallas, Texas, United States, 75230
    - Galderma Investigational Site 8238
  - Dallas, Texas, United States, 75231
    - Galderma Investigational Site 8245
  - Dripping Springs, Texas, United States, 78620
    - Galderma Investigational Site 8827
  - Frisco, Texas, United States, 75034
    - Galderma Investigational Site 8664
  - Houston, Texas, United States, 77029
    - Galderma Investigational Site 8807
  - Houston, Texas, United States, 77056
    - Galderma Investigational Site 8042
  - Houston, Texas, United States, 77401
    - Galderma Investigational Site 8670
  - Katy, Texas, United States, 77494
    - Galderma Investigational Site 8817
  - Plano, Texas, United States, 75093
    - Galderma Investigational Site 8787
  - San Antonio, Texas, United States, 78229
    - Galderma Investigational Site 8329
  - Waco, Texas, United States, 76710
    - Galderma Investigational Site 8618
  - Webster, Texas, United States, 77598
    - Galderma Investigational Site 8003
- Utah
  - Salt Lake City, Utah, United States, 84117
    - Galderma Investigational Site 8672
- Virginia
  - Burke, Virginia, United States, 22015
    - Galderma Investigational Site 8738
  - Fairfax, Virginia, United States, 22031
    - Galderma Investigational Site 8862
  - Richmond, Virginia, United States, 23219
    - Galderma Investigational Site 8896
- Washington
  - Seattle, Washington, United States, 98105
    - Galderma Investigational Site 8434

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Description

Key Inclusion Criteria:

Subjects who may benefit from study participation in the opinion of the investigator and had participated in a prior nemolizumab study for AD
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:

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.
Pregnant women, breastfeeding women, or women planning a pregnancy during the clinical study.
Body weight < 30 kg
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.
History of hypersensitivity (including anaphylaxis) to an immunoglobulin product (plasma-derived or recombinant, eg, monoclonal antibody)
Any clinically significant issue, based investigator judgement

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: N/A
Interventional Model: Single Group Assignment
Masking: None (Open Label)

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nemolizumab Nemolizumab administered via subcutaneous injection	Drug: Nemolizumab Nemolizumab Other Names: CD14152

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence and Severity of TEAEs Time Frame: Baseline to Week 200	Baseline to Week 200
Incidence of Serious TEAEs Time Frame: Baseline to Week 200	Baseline to Week 200
Incidence and Severity of Adverse Events of Special Interest (AESIs) Throughout the Study Time Frame: Baseline to Week 200	Baseline to Week 200

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Participants with IGA score = 0-1 at Each Visit Time Frame: Baseline to Week 200		Baseline to Week 200
Proportion of Participants with EASI-75 at Each Visit Time Frame: Baseline to Week 200		Baseline to Week 200
Change and Percent Change From Baseline in Overall Eczema Area and Severity Index (EASI) Score at Each Visit Time Frame: Baseline to Week 200	EASI assesses severity and extent of AD signs through a composite score of erythema, induration/population, excoriation, and lichenification. The severity will be assessed on a scale of 0 (absent) to 3 (severe) for each of the 4 body areas: head/neck, trunk, upper limbs, and lower limbs, with half points allowed. The EASI score can range from 0 to 72 with higher scores representing greater severity of atopic dermatitis.	Baseline to Week 200
Proportion of Participants with IGA ≤ 2 at Each Visit Time Frame: Baseline to Week 200		Baseline to Week 200
Change and Percent Change From Baseline in SCORAD Score at Each Visit Time Frame: Baseline to Week 200		Baseline to Week 200
Change and Percent Change From Baseline in Participant-Reported Pruritus Using 10-cm VAS (SCORAD Sub-Component) Time Frame: Baseline to Week 200		Baseline to Week 200
Change and Percent Change From Baseline in Participant-Reported Sleep Loss Using 10-cm VAS (SCORAD Sub-Component) Time Frame: Baseline to Week 200		Baseline to Week 200
Proportion of Participants Reporting Low Disease Activity State Based on PGAD at Each Visit Time Frame: Baseline to Week 200		Baseline to Week 200
Proportion of Participants Satisfied with Study Treatment Based on PGAT at each visit Time Frame: Baseline to Week 200		Baseline to Week 200
Change from Baseline in Dermatology Life Quality Index (DLQI) Time Frame: Baseline to Week 200		Baseline to Week 200
Change From Baseline in Children's Dermatology Life Quality Index (cDLQI) Total Score at Each Visit Through Week 200 Time Frame: Baseline to Week 200		Baseline to Week 200
Change From Baseline in Patient-Oriented Eczema Measure (POEM) Total Score at Each Visit Through Week 200 Time Frame: Baseline to Week 200		Baseline to Week 200
Change From Baseline in Hospital Anxiety and Depression Scale (HADS) for Each Subscale at Each Visit Through Week 200 Time Frame: Baseline to Week 200		Baseline to Week 200
Change From Baseline in Work Productivity and Activity Impairment: Atopic Dermatitis (WPAI:AD) for Each Subscale at Each Visit Through Week 200 Time Frame: Baseline to Week 200		Baseline to Week 200
Change From Baseline in EuroQoL 5-Dimension (EQ-5D) at Each Visit Through Week 200 Time Frame: Baseline to Week 200		Baseline to Week 200
Proportion of Participants Receiving Any Rescue Therapy by Rescue Treatment Type at Any Visit During the Treatment Period Time Frame: Baseline to Week 200		Baseline to Week 200
Time to First Relapse Time Frame: Baseline to Week 200		Baseline to Week 200
Duration of Remission Time Frame: Baseline to Week 200		Baseline to Week 200
Time to Permanent Study Drug Discontinuation Time Frame: Baseline to Week 200		Baseline to Week 200

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Galderma R&D

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 30, 2019

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

August 31, 2026

Study Registration Dates

First Submitted

June 14, 2019

First Submitted That Met QC Criteria

June 14, 2019

First Posted (Actual)

June 18, 2019

Study Record Updates

Last Update Posted (Actual)

September 26, 2023

Last Update Submitted That Met QC Criteria

September 25, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

RD.06.SPR.118163

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Study Overview

Status

Conditions

Intervention / Treatment

Detailed Description

Study Type

Enrollment (Estimated)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Estimated)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

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