Clinical Trial Details for

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

NCT ID: NCT03989206

Last Updated: September 26, 2023

Official Title

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

Purpose

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

The Study at a Glance

Status: ACTIVE_NOT_RECRUITING

Phase: Phase 3

Gender: ALL

Condition: Moderate-to-Severe Atopic Dermatitis

Study Type: Interventional

Lead Sponsor: Galderma R&D

Eligibility

Sexes Eligible for Study: ALL

Accepts Healthy Volunteers: No

Key Inclusion Criteria: 1. Subjects who may benefit from study participation in the opinion of the investigator and had participated in a prior nemolizumab study for AD 2. Female subjects of childbearing potential (ie, fertile, following menarche and until becoming post-menopausal unless permanently sterile) must agree either to be strictly abstinent throughout the study and for 12 weeks after the last study drug injection, or to use an effective and approved method of contraception throughout the study and for 12 weeks after the last study drug injection. Key Exclusion Criteria: 1. Subjects who, during their participation in a prior nemolizumab study, experienced an AE which in the opinion of the investigator could indicate that continued treatment with nemolizumab may present an unreasonable risk for the subject. 2. Pregnant women, breastfeeding women, or women planning a pregnancy during the clinical study. 3. Body weight < 30 kg 4. Cutaneous infection within 1 week before the baseline visit, any infection requiring treatment with oral or parenteral antibiotics, antivirals, antiparasitics or antifungals within 2 weeks before the baseline visit, or any confirmed or suspected coronavirus disease (COVID)-19 infection within 2 weeks before the screening or baseline visit. Subjects may be rescreened once the infection has resolved. Resolution of COVID-19 infection can be confirmed by recovery assessment methods. 5. History of hypersensitivity (including anaphylaxis) to an immunoglobulin product (plasma-derived or recombinant, eg, monoclonal antibody) 6. Any clinically significant issue, based investigator judgement

Additional Information, Locations & Contacts

Collaborators: Not provided

Investigators: Not provided

Please refer to this study by its clinicaltrials.gov identifier: NCT03989206

Location
Galderma Investigational Site 8749 Birmingham, Alabama, United States
Galderma Investigational Site 8893 Birmingham, Alabama, United States
Galderma Investigational Site 8866 Guntersville, Alabama, United States
Galderma Investigational Site 8808 Scottsdale, Arizona, United States
Galderma Investigational Site 8873 Scottsdale, Arizona, United States
Galderma Investigational Site 8447 Fort Smith, Arkansas, United States
Galderma Investigational Site 8880 North Little Rock, Arkansas, United States
Galderma Investigational Site 8831 Anaheim, California, United States
Galderma Investigational Site 8906 Bell Gardens, California, United States
Galderma Investigational Site 8456 Beverly Hills, California, United States
Galderma Investigational Site 8578 Cerritos, California, United States
Galderma Investigational Site 8577 Encinitas, California, United States
Galderma Investigational Site 8636 Fountain Valley, California, United States
Galderma Investigational Site 8224 Fremont, California, United States
Galderma Investigational Site 8791 Fresno, California, United States
Galderma Investigational Site 8888 Fullerton, California, United States
Galderma Investigational Site 8845 Huntington Beach, California, United States
Galderma Investigational Site 8833 Inglewood, California, United States
Galderma Investigational Site 8686 Lomita, California, United States
Galderma Investigational Site 8674 Los Angeles, California, United States
Galderma Investigational Site 8683 Los Angeles, California, United States
Galderma Investigational Site 8813 Los Angeles, California, United States
Galderma Investigational Site 8907 Newport Beach, California, United States
Galderma Investigational Site 8799 Ontario, California, United States
Galderma Investigational Site 8745 Pasadena, California, United States
Galderma Investigational Site 8671 San Diego, California, United States
Galderma Investigational Site 8692 San Diego, California, United States
Galderma Investigational Site 8658 San Diego, California, United States
Galderma Investigational Site 8125 San Francisco, California, United States
Galderma Investigational Site 8536 Santa Ana, California, United States
Galderma Investigational Site 8608 Santa Monica, California, United States
Galderma Investigational Site 8820 Westminster, California, United States
Galderma Investigational Site 8637 Farmington, Connecticut, United States
Galderma Investigational Site 8870 Boca Raton, Florida, United States
Galderma Investigational Site 8805 Cape Coral, Florida, United States
Galderma Investigational Site 8786 Clearwater, Florida, United States
Galderma Investigational Site 8902 Doral, Florida, United States
Galderma Investigational Site 8391 Hialeah, Florida, United States
Galderma Investigational Site 8804 Hialeah, Florida, United States
Galderma Investigational Site 8711 Jacksonville, Florida, United States
Galderma Investigational Site 8836 Jacksonville, Florida, United States
Galderma Investigational Site 8523 Largo, Florida, United States
Galderma Investigational Site 8850 Margate, Florida, United States
Galderma Investigational Site 8806 Miami Lakes, Florida, United States
Galderma Investigational Site 8800 Miami Lakes, Florida, United States
Galderma Investigational Site 8719 Miami, Florida, United States
Galderma Investigational Site 8851 Miami, Florida, United States
Galderma Investigational Site 8656 Miami, Florida, United States
Galderma Investigational Site 8801 Miami, Florida, United States
Galderma Investigational Site 8704 Miami, Florida, United States
Galderma Investigational Site 8737 Miami, Florida, United States
Galderma Investigational Site 8706 Miami, Florida, United States
Galderma Investigational Site 8708 Miami, Florida, United States
Galderma Investigational Site 8856 Ormond Beach, Florida, United States
Galderma Investigational Site 8734 Pembroke Pines, Florida, United States
Galderma Investigational Site 8203 Tampa, Florida, United States
Galderma Investigational Site 8816 Tampa, Florida, United States
Galderma Investigational Site 8889 Tampa, Florida, United States
Galderma Investigational Site 8839 Tampa, Florida, United States
Galderma Investigational Site 8126 West Palm Beach, Florida, United States
Galderma Investigational Site 8667 Columbus, Georgia, United States
Galderma Investigational Site 8744 Macon, Georgia, United States
Galderma Investigational Site 8728 Newnan, Georgia, United States
Galderma Investigational Site 8707 Stockbridge, Georgia, United States
Galderma Investigational Site 8819 Nampa, Idaho, United States
Galderma Investigational Site 9916 Chicago, Illinois, United States
Galderma Investigational Site 8739 Normal, Illinois, United States
Galderma Investigational Site 8729 Rolling Meadows, Illinois, United States
Galderma Investigational Sites 8571 Skokie, Illinois, United States
Galderma Investigational Site 8712 Skokie, Illinois, United States
Galderma Investigational Site 8142 Indianapolis, Indiana, United States
Galderma Investigational Site 8724 New Albany, Indiana, United States
Galderma Investigational Site 9934 Shawnee Mission, Kansas, 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 8554 Detroit, Michigan, United States
Galderma Investigational Site 8617 Farmington Hills, Michigan, United States
Galderma Investigational Site 8155 Troy, Michigan, United States
Galderma Investigational Site 8849 Troy, Michigan, United States
Galderma Investigational Site 8226 Warren, 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 8825 Las Vegas, Nevada, United States
Galderma Investigational Site 8675 Las Vegas, Nevada, United States
Galderma Investigational Site 8109 Lebanon, New Hampshire, United States
Galderma Investigational Site 8506 Hackensack, New Jersey, United States
Galderma Investigational Site 8826 Albuquerque, New Mexico, United States
Galderma Investigational Site 8242 Brooklyn, New York, United States
Galderma Investigational Site 8741 Buffalo, New York, United States
Galderma Investigational Site 8723 Cortland, New York, United States
Galderma Investigational Site 8828 Forest Hills, New York, United States
Galderma Investigational Site 9925 Glendale, New York, United States
Galderma Investigational Site 8733 New York, 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 8795 Shelby, 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 8747 Cincinnati, 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 8212 Portland, Oregon, United States
Galderma Investigational Site 8255 Philadelphia, Pennsylvania, United States
Galderma Investigational Site 8721 Pittsburgh, Pennsylvania, United States
Galderma Investigational Site 8802 Plymouth Meeting, Pennsylvania, United States
Galderma Investigational Site 8777 Charleston, South Carolina, United States
Galderma Investigational Site 8736 Charleston, South Carolina, United States
Galderma Investigational Site 8713 North 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 8245 Dallas, Texas, United States
Galderma Investigational Site 8827 Dripping Springs, Texas, United States
Galderma Investigational Site 8664 Frisco, Texas, United States
Galderma Investigational Site 8807 Houston, Texas, United States
Galderma Investigational Site 8042 Houston, Texas, United States
Galderma Investigational Site 8670 Houston, Texas, United States
Galderma Investigational Site 8817 Katy, Texas, United States
Galderma Investigational Site 8787 Plano, Texas, United States
Galderma Investigational Site 8329 San Antonio, Texas, United States
Galderma Investigational Site 8618 Waco, Texas, United States
Galderma Investigational Site 8003 Webster, Texas, United States
Galderma Investigational Site 8672 Salt Lake City, Utah, United States
Galderma Investigational Site 8738 Burke, Virginia, United States
Galderma Investigational Site 8862 Fairfax, Virginia, United States
Galderma Investigational Site 8896 Richmond, Virginia, United States
Galderma Investigational Site 8434 Seattle, Washington, 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 6153 Victoria Park, Western Australia, Australia
Galderma Investigational Site 6156 Linz, Oberoesterreich, Austria
Galderma Investigational Site 6157 Graz, Styria, Austria
Galderma Investigational Site 6194 Vienna, Austria
Galderma Investigational Site 6158 Vienna, Austria
Galderma Investigational Site 6038 Leuven, Vlaams-Brabant, Belgium
Galderma Investigational Site 5448 Brussels, Belgium
Galderma Investigational Site 6163 Edegem, Belgium
Galderma Investigational Site 6164 Gent, Belgium
Galderma Investigational Site 6162 Liège, Belgium
Galderma Investigational Site 6029 Pleven, Bulgaria
Galderma Investigational Site 6051 Sofia, Bulgaria
Galderma Investigational Site 6078 Sofia, Bulgaria
Galderma Investigational Site 6102 Sofia, Bulgaria
Galderma Investigational Site 6165 Sofia, Bulgaria
Galderma Investigational Site 6216 Sofia, Bulgaria
Galderma Investigational Site 6046 Sofia, Bulgaria
Galderma Investigational Site 6080 Sofia, Bulgaria
Galderma Investigational Site 6101 Sofia, Bulgaria
Galderma Investigational Site 6079 Sofia, Bulgaria
Galderma Investigational Site 6250 Sofia, Bulgaria
Galderma Investigational Site 6136 Stara Zagora, Bulgaria
Galderma Investigational Site 6251 Stara Zagora, Bulgaria
Galderma Investigational Site 8085 Calgary, Alberta, Canada
Galderma Investigational Site 8903 Calgary, Alberta, Canada
Galderma Investigational Site 8215 Calgary, 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 8780 Niagara Falls, Ontario, Canada
Galderma Investigational Site 8610 Ottawa, 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 8731 Waterloo, Ontario, Canada
Galderma Investigational Site 8000 Saint John, 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 6021 Praha, Czechia
Galderma Investigational Site 6054 Praha, Czechia
Galderma Investigational Site 6025 Praha, Czechia
Galderma Investigational Site 6068 Tallinn, Estonia
Galderma Investigational Site 6069 Tallinn, Estonia
Galderma Investigational Site 6067 Tartu, Estonia
Galderma Investigational Site 6198 Le Mans, France
Galderma Investigational Site 5031 Lille, France
Galderma Investigational Site 6170 Martigues, France
Galderma Investigational Site 6167 Nantes, France
Galderma Investigational Site 5140 Nice, France
Galderma Investigational Site 6133 Paris, France
Galderma Investigational Site 6166 Paris, France
Galderma Investigational Site 5407 Pierre-Bénite, France
Galderma Investigational Site 6135 Quimper, France
Galderma Investigational Site 6197 Toulon, France
Galderma Investigational Site 6169 Toulouse, France
Galderma Investigational Site 6168 Valence, France
Galderma Investigational Site 6224 Tbilisi, Georgia
Galderma Investigational Site 6228 Tbilisi, Georgia
Galderma Investigational Site 6235 Tbilisi, Georgia
Galderma Investigational Site 6238 Tbilisi, Georgia
Galderma Investigational Site 6227 Tbilisi, Georgia
Galderma Investigational Site 6230 Tbilisi, Georgia
Galderma Investigational Site 6234 Tbilisi, Georgia
Galderma Investigational Site 6236 Zugdidi, Georgia
Galderma Investigational Site 5482 Aachen, Germany
Galderma Investigational Site 5566 Augsburg, Germany
Galderma Investigational Site 6022 Bad Bentheim, Germany
Galderma Investigational Site 6110 Berlin, Germany
Galderma Investigational Site 6061 Bielefeld, Germany
Galderma Investigational Site 6082 Bonn, Germany
Galderma Investigational Site 6062 Buxtehude, Germany
Galderma Investigational Site 5368 Darmstadt, Germany
Galderma Investigational Site 6132 Dresden, Germany
Galderma Investigational Site 6028 Dülmen, Germany
Galderma Investigational Site 6031 Düsseldorf, Germany
Galderma Investigational Site 5442 Gera, Germany
Galderma Investigational Site 6081 Goettigen, Germany
Galderma Investigational Site 6062 Halle, Germany
Galderma Investigational Site 6041 Hamburg, Germany
Galderma Investigational Site 6150 Hamburg, Germany
Galderma Investigational Site 6040 Hamburg, Germany
Galderma Investigational Site 5469 Heidelberg, Germany
Galderma Investigational Site 6086 Kiel, Germany
Galderma Investigational Site 6146 Langenau, Germany
Galderma Investigational Site 6084 Mainz, Germany
Galderma Investigational Site 5382 Munich, Germany
Galderma Investigational Site 6039 Münster, Germany
Galderma Investigational Site 5918 Osnabrück, Germany
Galderma Investigational Site 6109 Stuttgart, Germany
Galderma Investigational Site 6214 Tuebingen, Germany
Galderma Investigational Site 6147 Budapest, Hungary
Galderma Investigational Site 5513 Budapest, Hungary
Galderma Investigational Site 5567 Debrecen, Hungary
Galderma Investigational Site 6026 Debrecen, Hungary
Galderma Investigational Site 6254 Gyula, Hungary
Galderma Investigational Site 6053 Veszprem, Hungary
Galderma Investigational Site 6145 Bologna, Italy
Galderma Investigational Site 6045 L'Aquila, Italy
Galderma Investigational Site 6049 Roma, Italy
Galderma Investigational Site 6177 Rome, Italy
Galderma Investigational Site 6155 Rozzano, Italy
Galderma Investigational Site 6175 Vicenza, Italy
Galderma Investigational Site 6095 Bucheon-Si, 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 6116 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 Liepaja, 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 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 5773 Białystok, Poland
Galderma Investigational Site 6097 Chorzów, Poland
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 5021 Katowice, Poland
Galderma Investigational Site 5362 Kraków, Poland
Galderma Investigational Site 6052 Kraków, Poland
Galderma Investigational Site 5367 Lublin, Poland
Galderma Investigational Site 6071 Lublin, Poland
Galderma Investigational Site 5377 Nowa Sól, Poland
Galderma Investigational Site 6063 Olsztyn, Poland
Galderma Investigational Site 6237 Ostrowiec Świętokrzyski, Poland
Galderma Investigational Site 6085 Poznań, Poland
Galderma Investigational Site 6127 Poznań, Poland
Galderma Investigational Site 5495 Rzeszów, Poland
Galderma Investigational Site 6088 Rzeszów, Poland
Galderma Investigational Site 6223 Szczecin, Poland
Galderma Investigational Site 6130 Szczecin, Poland
Galderma Investigational Site 6048 Tarnow, Poland
Galderma Investigational Site 6126 Warsaw, Poland
Galderma Investigational Site 5707 Warsaw, 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 6185 Wrocław, Poland
Galderma Investigational Site 6096 Wrocław, Poland
Galderma Investigational Site 5005 Wrocław, Poland
Galderma Investigational Site 6245 Łódź, Poland
Galderma Investigational Site 5570 Łódź, Poland
Galderma Investigational Site 5363 Łódź, Poland
Galderma Investigational Site 6231 Łódź, Poland
Galderma Investigational Site 6124 Singapore, Singapore
Galderma Investigational Site 6077 Singapore, Singapore
Galderma Investigational Site 5499 Singapore, Singapore
Galderma Investigational Site 6057 Alicante, Spain
Galderma Investigational Site 6037 Barcelona, Spain
Galderma Investigational Site 6035 Barcelona, Spain
Galderma Investigational Site 5580 L'Hospitalet De Llobregat, 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 6186 Madrid, Spain
Galderma Investigational Site 6036 Madrid, Spain
Galderma Investigational Site 5551 Madrid, Spain
Galderma Investigational Site 6191 Pamplona, 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 6090 Dudley, 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