Efficacy and 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. |
NCT03985943 |
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 | Australia, Austria, Canada, Czechia, Germany, Korea, Republic of, Latvia, Lithuania, Netherlands, New Zealand, Poland, Spain, United Kingdom, 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
Experimental: Nemolizumab
Nemolizumab Active
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 8750
Little Rock, Arkansas, 72205
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Galderma Investigational Site 8880
North Little Rock, Arkansas, 72117
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Galderma Investigational Site 8456
Beverly Hills, California, 90212
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Galderma Investigational Site 8578
Cerritos, California, 90703
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Galderma Investigational Site 8636
Fountain Valley, California, 92708
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Galderma Investigational Site 8888
Fullerton, California, 92835
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Galderma Investigational Site 8686
Lomita, California, 90717
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Galderma Investigational Site 8674
Los Angeles, California, 90025
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Galderma Investigational Site 8891
North Hollywood, California, 91606
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Galderma Investigational Site 8671
San Diego, California, 92108
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Galderma Investigational Site 8125
San Francisco, California, 94115
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Galderma Investigational Site 8895
Santa Ana, California, 92703
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Galderma Investigational Site 8608
Santa Monica, California, 90404
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Galderma Investigational Site 8111
Washington, District of Columbia, 20037
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Galderma Investigational Site 8897
Brandon, Florida, 33511
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Galderma Investigational Site 8805
Cape Coral, Florida, 33991
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Galderma Investigational Site 8902
Doral, Florida, 33122
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Galderma Investigational Site 8804
Hialeah, Florida, 33016
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Galderma Investigational Site 8711
Jacksonville, Florida, 32256
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Galderma Investigational Site 8806
Miami Lakes, Florida, 33014
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Galderma Investigational Site 8800
Miami Lakes, Florida, 33016
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Galderma Investigational Site 8710
Miami, Florida, 33126
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Galderma Investigational Site 8801
Miami, Florida, 33145
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Galderma Investigational Site 8737
Miami, Florida, 33174
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Galderma Investigational Site 8708
Miami, Florida, 33176
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Galderma Investigational Site 8734
Pembroke Pines, Florida, 33028
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Galderma Investigational Site 8889
Tampa, Florida, 33511
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Galderma Investigational Site 8744
Macon, Georgia, 31217
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Galderma Investigational Site 8728
Newnan, Georgia, 30263
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Galderma Investigational Site 8887
Union City, Georgia, 30291
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Galderma Investigational Site 8890
Blackfoot, Idaho, 83221
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Galderma Investigational Site 8819
Nampa, Idaho, 83687
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Galderma Investigational Site 8571
Skokie, Illinois, 60076
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Galderma Investigational Site 8712
Skokie, Illinois, 60077
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Galderma Investigational Site 8142
Indianapolis, Indiana, 46250
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Galderma Investigational Site 8771
Louisville, Kentucky, 40241
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Galderma Investigational Site 8882
Bangor, Maine, 04401
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Galderma Investigational Site 8743
Ann Arbor, Michigan, 48109
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Galderma Investigational Site 8512
Bay City, Michigan, 48706
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Galderma Investigational Site 8155
Troy, Michigan, 48084
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Galderma Investigational Site 8748
Ypsilanti, Michigan, 48197
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Galderma Investigational Site 8521
Saint Joseph, Missouri, 64506
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Galderma Investigational Site 8718
Missoula, Montana, 59808
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Galderma Investigational Site 8810
Omaha, Nebraska, 68144
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Galderma Investigational Site 8740
Henderson, Nevada, 89052
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Galderma Investigational Site 8109
Lebanon, New Hampshire, 003766
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Galderma Investigational Site 8826
Albuquerque, New Mexico, 87106
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Galderma Investigational Site 8242
Brooklyn, New York, 11203
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Galderma Investigational Site 8620
New York, New York, 10023
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Galderma Investigational Site 8279
New York, New York, 10075
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Galderma Investigational Site 8772
Durham, North Carolina, 27710
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Galderma Investigational Site 8726
Wilmington, North Carolina, 28405-3176
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Galderma Investigational Site 8648
Wilmington, North Carolina, 28405
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Galderma Investigational Site 8702
Bexley, Ohio, 43209
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Galderma Investigational Site 8595
Dublin, Ohio, 43016
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Galderma Investigational Site 8206
Norman, Oklahoma, 73071
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Galderma Investigational Site 8857
Oklahoma City, Oklahoma, 73118
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Galderma Investigational Site 8255
Philadelphia, Pennsylvania, 19103
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Galderma Investigational Site 8802
Plymouth Meeting, Pennsylvania, 19462
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Galderma Investigational Site 8736
Charleston, South Carolina, 29425
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Galderma Investigational Site 8818
Rapid City, South Dakota, 57702
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Galderma Investigational Site 8133
Arlington, Texas, 76011
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Galderma Investigational Site 8298
Austin, Texas, 78723
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Galderma Investigational Site 8238
Dallas, Texas, 75230
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Galderma Investigational Site 8827
Dripping Springs, Texas, 78620
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Galderma Investigational Site 8664
Frisco, Texas, 75034
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Galderma Investigational Site 8042
Houston, Texas, 77056
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Galderma Investigational Site 8670
Houston, Texas, 77401
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Galderma Investigational Site 8738
Burke, Virginia, 22015
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Galderma Investigational Site 8862
Fairfax, Virginia, 22031
International Sites
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Galderma Investigational Site 5441
Darlinghurst, New South Wales, 2010
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Galderma Investigational Site 5759
Kogarah, New South Wales, 2217
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Galderma Investigational Site 6152
Westmead, New South Wales, 2145
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Galderma Investigational Site 5638
Benowa, Queensland, 4217
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Galderma Investigational Site 6161
Brisbane, Queensland, 4102
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Galderma Investigational Site 6159
Woodville, South Australia, 5011
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Galderma Investigational Site 6131
Carlton, Victoria, 3053
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Galderma Investigational Site 5366
East Melbourne, Victoria, 3002
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Galderma Investigational Site 5458
Parkville, Victoria, 3050
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Galderma Investigational Site 6160
Parkville, Victoria, 3052
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Galderma Investigational Site 5453
Fremantle, Western Australia, 6160
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Galderma Investigational Site 6153
Victoria Park, Western Australia, 6100
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Galderma Investigational Sites 6157
Graz, Styria, 8036
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Galderma Investigational Site 6194
Vienna, Wien, 1090
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Galderma Investigational Site 6156
Linz, , 4020
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Galderma Investigational Site 6158
Vienna, , 1220
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Galderma Investigational Site 8085
Calgary, Alberta, T2G 1B1
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Galderma Investigational Site 8903
Calgary, Alberta, T2J 7E1
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Galderma Investigational Site 8215
Calgary, Alberta, T3E 0B2
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Galderma Investigational Site 8088
Edmonton, Alberta, T5J 3S9
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Galderma Investigational Site 8824
Edmonton, Alberta, T6G 1C3
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Galderma Investigational Site 8722
Edmonton, Alberta, T6G 1C9
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Galderma Investigational Site 8161
Surrey, British Columbia, V3V 0C6
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Galderma Investigational Site 8586
Barrie, Ontario, L4M 7G1
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Galderma Investigational Site 8904
Guelph, Ontario, N1L 0B7
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Galderma Investigational Site 8901
Ottawa, Ontario, K1H7X3
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Galderma Investigational Site 8336
Toronto, Ontario, M3H 5Y8
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Galderma Investigational Site 8899
Toronto, Ontario, M4W 2N4
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Galderma Investigational Site 8780
Niagara Falls, , L2H 1H5
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Galderma Investigational Site 8610
Ottawa, , K1G 6C6
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Galderma Investigational Site 8000
Saint John, , A1C2H5
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Galderma Investigational Site 8731
Waterloo, , N2J 1C4
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Galderma Investigational Site 6055
Brno, , 656 91
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Galderma Investigational Site 5225
Náchod, , 547 01
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Galderma Investigational Site 6030
Olomouc, , 779 00
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Galderma Investigational Site 6024
Prague, , 100 00
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Galderma Investigational Site 6240
Prague, , 120 00
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Galderma Investigational Site 6054
Praha, , 110 00
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Galderma Investigational Site 6021
Praha, , 11000
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Galderma Investigational Site 6025
Praha, , 150 06
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Galderma Investigational Site 6146
Langenau, Hesse, 89129
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Galderma Investigational Site 6214
Tuebingen, Niedersachesen, 72076
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Galderma Investigational Site 6172
Berlin, NRW, 12203
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Galderma Investigational Site 5437
Kiel, Schleswig-Holst, 24105
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Galderma Investigational Site 6022
Bad Bentheim, , 48455
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Galderma Investigational Site 6110
Berlin, , 13055
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Galderma Investigational Site 6061
Bielefeld, , 33647
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Galderma Investigational Site 6066
Buxtehude, , 21614
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Galderma Investigational Site 5368
Darmstadt, , 64283
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Galderma Investigational Site 6028
Dülmen, , 48249
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Galderma Investigational Site 6033
Lubeck, , 23538
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Galderma Investigational Site 6039
Münster, , 48149
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Galderma Investigational Site 5918
Osnabrück, , 49074
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Galderma Investigational Site 6109
Stuttgart, , 70499
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Galderma Investigational Site 6095
Bucheon, , 14584
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Galderma Investigational Site 6100
Busan, , 49241
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Galderma Investigational Site 6098
Gyeonggi-do, , 15355
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Galderma Investigational Site 6154
Gyeonggi-do, , 18450
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Galderma Investigational Site 6138
Incheon, , 21431
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Galderma Investigational Site 6120
Incheon, , 21565
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Galderma Investigational Site 6093
Incheon, , 22332
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Galderma Investigational Site 6105
Seoul, , 02841
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Galderma Investigational Site 5659
Seoul, , 03080
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Galderma Investigational Site 6166
Seoul, , 03722
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Galderma Investigational Site 6129
Seoul, , 04763
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Galderma Investigational Site 6103
Seoul, , 05030
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Galderma Investigational Site 6056
Seoul, , 06591
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Galderma Investigational Site 6094
Seoul, , 06973
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Galderma Investigational Site 6099
Seoul, , 07441
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Galderma Investigational Site 6113
Liepāja, , LV-3401
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Galderma Investigational Site 6134
Riga, , LV-1006
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Galderma Investigational Site 6059
Riga, , LV-1009
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Galderma Investigational Site 6060
Talsi, , LV-3201
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Galderma Investigational Site 6111
Kaunas, , LT-50161
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Galderma Investigational Site 6072
Klaipėda, , LT-92288
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Galderma Investigational Site 6073
Vilnius, , LT-07195
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Galderma Investigational Site 6112
Vilnius, , LT-08411
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Galderma Investigational Site 6212
Groningen, , 9713
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Galderma Investigational Site 6108
Rotterdam, , 3015 GD
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Galderma Investigational Site 6027
Utrecht, , 3584 CX
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Galderma Investigational Site 6119
Hamilton, , 3204
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Galderma Investigational Site 6118
Wellington, , 6021
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Galderma Investigational Site 6255
Czestochowa, , 42-202
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Galderma Investigational Site 6075
Gdańsk, , 80-214
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Galderma Investigational Site 6243
Gdańsk, , 80-382
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Galderma Investigational Site 5138
Gdańsk, , 80-462
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Galderma Investigational Site 6244
Gdynia, , 81-537
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Galderma Investigational Site 6087
Katowice, , 40-040
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Galderma Investigational Site 6071
Lublin, , 20-081
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Galderma Investigational Site 6237
Ostrowiec Świętokrzyski, , 27-400
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Galderma Investigational Site 6127
Poznań, , 60-702
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Galderma Investigational Site 6088
Rzeszów, , 35-055
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Galderma Investigational Site 6223
Szczecin, , 70-332
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Galderma Investigational Site 6065
Warszawa, , 01-192
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Galderma Investigational Site 6122
Warszawa, , 02-507
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Galderma Investigational Site 6242
Warszawa, , 02-793
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Galderma Investigational Site 6064
Warszawa, , 02-953
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Galderma Investigational Site 6222
Warszawa, , 02-962
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Galderma Investigational Site 6047
Wrocław, , 50-381
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Galderma Investigational Site 5005
Wrocław, , 53-658
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Galderma Investigational Site 6245
Łódź, , 90-127
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Galderma Investigational Site 5570
Łódź, , 90-265
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Galderma Investigational Site 6231
Łódź, , 94-050
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Galderma Investigational Site 6057
Alicante, , 03010
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Galderma Investigational Site 6037
Barcelona, , 08036
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Galderma Investigational Site 5550
Barcelona, , 08041
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Galderma Investigational Site 6035
Barcelona, , 08916
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Galderma Investigational Site 5580
Barcelona, , 8907
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Galderma Investigational Site 6106
Las Palmas De Gran Canaria, , 35010
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Galderma Investigational Site 6058
Madrid, , 28006
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Galderma Investigational Site 5842
Madrid, , 28034
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Galderma Investigational Site 6190
Madrid, , 28046
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Galderma Investigational Site 6036
Madrid, , 28223
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Galderma Investigational Site 5551
Madrid, , 28922
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Galderma Investigational Site 6186
Majadahonda, , 28222
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Galderma Investigational Site 6193
Málaga, , 29010
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Galderma Investigational Site 6191
Pamplona, , 31008
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Galderma Investigational Site 5970
Valencia, , 46026
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Galderma Investigational Site 6202
Barnsley, , S75 3DL
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Galderma Investigational Site 6207
Blackpool, , FY2 0JH
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Galderma Investigational Site 6203
Cannock, , WS11 0BN
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Galderma Investigational Site 6246
Cardiff, , CF15 9SS
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Galderma Investigational Site 6248
Chorley, , PR7 7NA
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Galderma Investigational Site 6090
Dudley, , DY1 2HQ
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Galderma Investigational Site
Dudley, , DY1 2HQ
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Galderma Investigational Site 6249
Edgbaston, , B15 2SQ
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Galderma Investigational Site 6104
Glasgow, , G3 8SJ
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Galderma Investigational Site 6204
Liverpool, , L34 1BH
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Galderma Investigational Site 6121
London, , SE1 9RT
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Galderma Investigational Site 6205
Manchester, , M13 9NQ
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Galderma Investigational Site 6208
Newcastle, , NE1 4LP
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Galderma Investigational Site 6206
Stockton-on-Tees, , TS17 6EW