Clinical Trial Details for

Efficacy and Safety of Nemolizumab in Subjects With Moderate-to-Severe Atopic Dermatitis

NCT ID: NCT03985943

Last Updated: February 14, 2022

Official Title

A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Nemolizumab in Subjects With Moderate-to-Severe Atopic Dermatitis

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.

The Study at a Glance

Status: Active, not recruiting

Phase: Phase 3

Gender: All

Age: 12 Years - N/A

Condition: Moderate-to-Severe Atopic Dermatitis

Study Type: Interventional

Lead Sponsor: Galderma R&D

Eligibility

Ages Eligible for Study: 12 Years to N/A

Sexes Eligible for Study: All

Accepts Healthy Volunteers: No

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 Key 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 - Any clinically significant issue, based on investigator judgement

Additional Information, Locations & Contacts

Collaborators: Not provided

Investigators: Not provided

Please refer to this study by its clinicaltrials.gov identifier: NCT03985943

Location
Galderma Investigational Site 8750 Little Rock, Arkansas, United States
Galderma Investigational Site 8880 North Little Rock, Arkansas, United States
Galderma Investigational Site 8456 Beverly Hills, California, United States
Galderma Investigational Site 8578 Cerritos, California, United States
Galderma Investigational Site 8636 Fountain Valley, California, United States
Galderma Investigational Site 8888 Fullerton, California, United States
Galderma Investigational Site 8686 Lomita, California, United States
Galderma Investigational Site 8674 Los Angeles, California, United States
Galderma Investigational Site 8891 North Hollywood, California, United States
Galderma Investigational Site 8671 San Diego, California, United States
Galderma Investigational Site 8125 San Francisco, California, United States
Galderma Investigational Site 8895 Santa Ana, California, United States
Galderma Investigational Site 8608 Santa Monica, California, United States
Galderma Investigational Site 8111 Washington, District of Columbia, United States
Galderma Investigational Site 8897 Brandon, Florida, United States
Galderma Investigational Site 8805 Cape Coral, Florida, United States
Galderma Investigational Site 8902 Doral, Florida, United States
Galderma Investigational Site 8804 Hialeah, Florida, United States
Galderma Investigational Site 8711 Jacksonville, Florida, United States
Galderma Investigational Site 8806 Miami Lakes, Florida, United States
Galderma Investigational Site 8800 Miami Lakes, Florida, United States
Galderma Investigational Site 8710 Miami, Florida, United States
Galderma Investigational Site 8801 Miami, Florida, United States
Galderma Investigational Site 8737 Miami, Florida, United States
Galderma Investigational Site 8708 Miami, Florida, United States
Galderma Investigational Site 8734 Pembroke Pines, Florida, United States
Galderma Investigational Site 8889 Tampa, Florida, United States
Galderma Investigational Site 8744 Macon, Georgia, United States
Galderma Investigational Site 8728 Newnan, Georgia, United States
Galderma Investigational Site 8887 Union City, Georgia, United States
Galderma Investigational Site 8890 Blackfoot, Idaho, United States
Galderma Investigational Site 8819 Nampa, Idaho, United States
Galderma Investigational Site 8571 Skokie, Illinois, United States
Galderma Investigational Site 8712 Skokie, Illinois, United States
Galderma Investigational Site 8142 Indianapolis, Indiana, United States
Galderma Investigational Site 8771 Louisville, Kentucky, United States
Galderma Investigational Site 8882 Bangor, Maine, United States
Galderma Investigational Site 8743 Ann Arbor, Michigan, United States
Galderma Investigational Site 8512 Bay City, Michigan, United States
Galderma Investigational Site 8155 Troy, Michigan, United States
Galderma Investigational Site 8748 Ypsilanti, Michigan, United States
Galderma Investigational Site 8521 Saint Joseph, Missouri, United States
Galderma Investigational Site 8718 Missoula, Montana, United States
Galderma Investigational Site 8810 Omaha, Nebraska, United States
Galderma Investigational Site 8740 Henderson, Nevada, United States
Galderma Investigational Site 8109 Lebanon, New Hampshire, United States
Galderma Investigational Site 8826 Albuquerque, New Mexico, United States
Galderma Investigational Site 8242 Brooklyn, New York, United States
Galderma Investigational Site 8620 New York, New York, United States
Galderma Investigational Site 8279 New York, New York, United States
Galderma Investigational Site 8772 Durham, North Carolina, United States
Galderma Investigational Site 8726 Wilmington, North Carolina, United States
Galderma Investigational Site 8648 Wilmington, North Carolina, United States
Galderma Investigational Site 8702 Bexley, Ohio, United States
Galderma Investigational Site 8595 Dublin, Ohio, United States
Galderma Investigational Site 8206 Norman, Oklahoma, United States
Galderma Investigational Site 8857 Oklahoma City, Oklahoma, United States
Galderma Investigational Site 8255 Philadelphia, Pennsylvania, United States
Galderma Investigational Site 8802 Plymouth Meeting, Pennsylvania, United States
Galderma Investigational Site 8736 Charleston, South Carolina, United States
Galderma Investigational Site 8818 Rapid City, South Dakota, United States
Galderma Investigational Site 8133 Arlington, Texas, United States
Galderma Investigational Site 8298 Austin, Texas, United States
Galderma Investigational Site 8238 Dallas, Texas, United States
Galderma Investigational Site 8827 Dripping Springs, Texas, United States
Galderma Investigational Site 8664 Frisco, Texas, United States
Galderma Investigational Site 8042 Houston, Texas, United States
Galderma Investigational Site 8670 Houston, Texas, United States
Galderma Investigational Site 8738 Burke, Virginia, United States
Galderma Investigational Site 8862 Fairfax, Virginia, United States
Galderma Investigational Site 5441 Darlinghurst, New South Wales, Australia
Galderma Investigational Site 5759 Kogarah, New South Wales, Australia
Galderma Investigational Site 6152 Westmead, New South Wales, Australia
Galderma Investigational Site 5638 Benowa, Queensland, Australia
Galderma Investigational Site 6161 Brisbane, Queensland, Australia
Galderma Investigational Site 6159 Woodville, South Australia, Australia
Galderma Investigational Site 6131 Carlton, Victoria, Australia
Galderma Investigational Site 5366 East Melbourne, Victoria, Australia
Galderma Investigational Site 5458 Parkville, Victoria, Australia
Galderma Investigational Site 6160 Parkville, Victoria, Australia
Galderma Investigational Site 5453 Fremantle, Western Australia, Australia
Galderma Investigational Site 6153 Victoria Park, Western Australia, Australia
Galderma Investigational Sites 6157 Graz, Styria, Austria
Galderma Investigational Site 6194 Vienna, Wien, Austria
Galderma Investigational Site 6156 Linz, Austria
Galderma Investigational Site 6158 Vienna, Austria
Galderma Investigational Site 8085 Calgary, Alberta, Canada
Galderma Investigational Site 8903 Calgary, Alberta, Canada
Galderma Investigational Site 8215 Calgary, Alberta, Canada
Galderma Investigational Site 8088 Edmonton, Alberta, Canada
Galderma Investigational Site 8824 Edmonton, Alberta, Canada
Galderma Investigational Site 8722 Edmonton, Alberta, Canada
Galderma Investigational Site 8161 Surrey, British Columbia, Canada
Galderma Investigational Site 8586 Barrie, Ontario, Canada
Galderma Investigational Site 8904 Guelph, Ontario, Canada
Galderma Investigational Site 8901 Ottawa, Ontario, Canada
Galderma Investigational Site 8336 Toronto, Ontario, Canada
Galderma Investigational Site 8899 Toronto, Ontario, Canada
Galderma Investigational Site 8780 Niagara Falls, Canada
Galderma Investigational Site 8610 Ottawa, Canada
Galderma Investigational Site 8000 Saint John, Canada
Galderma Investigational Site 8731 Waterloo, Canada
Galderma Investigational Site 6055 Brno, Czechia
Galderma Investigational Site 5225 Náchod, Czechia
Galderma Investigational Site 6030 Olomouc, Czechia
Galderma Investigational Site 6024 Prague, Czechia
Galderma Investigational Site 6240 Prague, Czechia
Galderma Investigational Site 6054 Praha, Czechia
Galderma Investigational Site 6021 Praha, Czechia
Galderma Investigational Site 6025 Praha, Czechia
Galderma Investigational Site 6146 Langenau, Hesse, Germany
Galderma Investigational Site 6214 Tuebingen, Niedersachesen, Germany
Galderma Investigational Site 6172 Berlin, NRW, Germany
Galderma Investigational Site 5437 Kiel, Schleswig-Holst, Germany
Galderma Investigational Site 6022 Bad Bentheim, Germany
Galderma Investigational Site 6110 Berlin, Germany
Galderma Investigational Site 6061 Bielefeld, Germany
Galderma Investigational Site 6066 Buxtehude, Germany
Galderma Investigational Site 5368 Darmstadt, Germany
Galderma Investigational Site 6028 Dülmen, Germany
Galderma Investigational Site 6033 Lubeck, Germany
Galderma Investigational Site 6039 Münster, Germany
Galderma Investigational Site 5918 Osnabrück, Germany
Galderma Investigational Site 6109 Stuttgart, Germany
Galderma Investigational Site 6095 Bucheon, Korea, Republic of
Galderma Investigational Site 6100 Busan, Korea, Republic of
Galderma Investigational Site 6098 Gyeonggi-do, Korea, Republic of
Galderma Investigational Site 6154 Gyeonggi-do, Korea, Republic of
Galderma Investigational Site 6138 Incheon, Korea, Republic of
Galderma Investigational Site 6120 Incheon, Korea, Republic of
Galderma Investigational Site 6093 Incheon, Korea, Republic of
Galderma Investigational Site 6105 Seoul, Korea, Republic of
Galderma Investigational Site 5659 Seoul, Korea, Republic of
Galderma Investigational Site 6166 Seoul, Korea, Republic of
Galderma Investigational Site 6129 Seoul, Korea, Republic of
Galderma Investigational Site 6103 Seoul, Korea, Republic of
Galderma Investigational Site 6056 Seoul, Korea, Republic of
Galderma Investigational Site 6094 Seoul, Korea, Republic of
Galderma Investigational Site 6099 Seoul, Korea, Republic of
Galderma Investigational Site 6113 Liepāja, Latvia
Galderma Investigational Site 6134 Riga, Latvia
Galderma Investigational Site 6059 Riga, Latvia
Galderma Investigational Site 6060 Talsi, Latvia
Galderma Investigational Site 6111 Kaunas, Lithuania
Galderma Investigational Site 6072 Klaipėda, Lithuania
Galderma Investigational Site 6073 Vilnius, Lithuania
Galderma Investigational Site 6112 Vilnius, Lithuania
Galderma Investigational Site 6212 Groningen, Netherlands
Galderma Investigational Site 6108 Rotterdam, Netherlands
Galderma Investigational Site 6027 Utrecht, Netherlands
Galderma Investigational Site 6119 Hamilton, New Zealand
Galderma Investigational Site 6118 Wellington, New Zealand
Galderma Investigational Site 6255 Czestochowa, Poland
Galderma Investigational Site 6075 Gdańsk, Poland
Galderma Investigational Site 6243 Gdańsk, Poland
Galderma Investigational Site 5138 Gdańsk, Poland
Galderma Investigational Site 6244 Gdynia, Poland
Galderma Investigational Site 6087 Katowice, Poland
Galderma Investigational Site 6071 Lublin, Poland
Galderma Investigational Site 6237 Ostrowiec Świętokrzyski, Poland
Galderma Investigational Site 6127 Poznań, Poland
Galderma Investigational Site 6088 Rzeszów, Poland
Galderma Investigational Site 6223 Szczecin, Poland
Galderma Investigational Site 6065 Warszawa, Poland
Galderma Investigational Site 6122 Warszawa, Poland
Galderma Investigational Site 6242 Warszawa, Poland
Galderma Investigational Site 6064 Warszawa, Poland
Galderma Investigational Site 6222 Warszawa, Poland
Galderma Investigational Site 6047 Wrocław, Poland
Galderma Investigational Site 5005 Wrocław, Poland
Galderma Investigational Site 6245 Łódź, Poland
Galderma Investigational Site 5570 Łódź, Poland
Galderma Investigational Site 6231 Łódź, Poland
Galderma Investigational Site 6057 Alicante, Spain
Galderma Investigational Site 6037 Barcelona, Spain
Galderma Investigational Site 5550 Barcelona, Spain
Galderma Investigational Site 6035 Barcelona, Spain
Galderma Investigational Site 5580 Barcelona, Spain
Galderma Investigational Site 6106 Las Palmas De Gran Canaria, Spain
Galderma Investigational Site 6058 Madrid, Spain
Galderma Investigational Site 5842 Madrid, Spain
Galderma Investigational Site 6190 Madrid, Spain
Galderma Investigational Site 6036 Madrid, Spain
Galderma Investigational Site 5551 Madrid, Spain
Galderma Investigational Site 6186 Majadahonda, Spain
Galderma Investigational Site 6193 Málaga, Spain
Galderma Investigational Site 6191 Pamplona, Spain
Galderma Investigational Site 5970 Valencia, Spain
Galderma Investigational Site 6202 Barnsley, United Kingdom
Galderma Investigational Site 6207 Blackpool, United Kingdom
Galderma Investigational Site 6203 Cannock, United Kingdom
Galderma Investigational Site 6246 Cardiff, United Kingdom
Galderma Investigational Site 6248 Chorley, United Kingdom
Galderma Investigational Site 6090 Dudley, United Kingdom
Galderma Investigational Site Dudley, United Kingdom
Galderma Investigational Site 6249 Edgbaston, United Kingdom
Galderma Investigational Site 6104 Glasgow, United Kingdom
Galderma Investigational Site 6204 Liverpool, United Kingdom
Galderma Investigational Site 6121 London, United Kingdom
Galderma Investigational Site 6205 Manchester, United Kingdom
Galderma Investigational Site 6208 Newcastle, United Kingdom
Galderma Investigational Site 6206 Stockton-on-Tees, United Kingdom