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

NCT03989206 | Active Not Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: RD.06.SPR.118163
• Study Type: interventional
• Target: 1,700
• Locations: 20 countries
• Sites: 336

Brief Summary

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

Conditions

Moderate-to-Severe Atopic Dermatitis

Outcome Measures

Primary Outcomes (3)

• Incidence and Severity of TEAEs

  Baseline to Week 200

• Incidence of Serious TEAEs

  Baseline to Week 200

• Incidence and Severity of Adverse Events of Special Interest (AESIs) Throughout the Study

  Baseline to Week 200

Secondary Outcomes (19)

• Proportion of Participants with IGA score = 0-1 at Each Visit

  Baseline to Week 200

• Proportion of Participants with EASI-75 at Each Visit

  Baseline to Week 200

• Change and Percent Change From Baseline in Overall Eczema Area and Severity Index (EASI) Score at Each Visit

  Baseline to Week 200

• Proportion of Participants with IGA ≤ 2 at Each Visit

  Baseline to Week 200

• Change and Percent Change From Baseline in SCORAD Score at Each Visit

  Baseline to Week 200

Study Arms (1)

Nemolizumab

EXPERIMENTAL

Nemolizumab administered via subcutaneous injection

Drug: Nemolizumab

Interventions

Nemolizumab DRUG

Nemolizumab

Also known as: CD14152

Nemolizumab

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Galderma R&D: lead

Study Sites (343)

Galderma Investigational Site 8749

Birmingham, Alabama, 35244, United States

Location

Galderma Investigational Site 8893

Birmingham, Alabama, 35244, United States

Location

Galderma Investigational Site 8866

Guntersville, Alabama, 35976, United States

Location

Galderma Investigational Site 8808

Scottsdale, Arizona, 85255, United States

Location

Galderma Investigational Site 8873

Scottsdale, Arizona, 85260, United States

Location

Galderma Investigational Site 8447

Fort Smith, Arkansas, 72916, United States

Location

Galderma Investigational Site 8880

North Little Rock, Arkansas, 72117, United States

Location

Galderma Investigational Site 8831

Anaheim, California, 92801, United States

Location

Galderma Investigational Site 8906

Bell Gardens, California, 90201, United States

Location

Galderma Investigational Site 8456

Beverly Hills, California, 90212, United States

Location

Galderma Investigational Site 8578

Cerritos, California, 90703, United States

Location

Galderma Investigational Site 8577

Encinitas, California, 92024, United States

Location

Galderma Investigational Site 8636

Fountain Valley, California, 92708, United States

Location

Galderma Investigational Site 8224

Fremont, California, 94538, United States

Location

Galderma Investigational Site 8791

Fresno, California, 93720, United States

Location

Galderma Investigational Site 8888

Fullerton, California, 92835, United States

Location

Galderma Investigational Site 8845

Huntington Beach, California, 92647, United States

Location

Galderma Investigational Site 8833

Inglewood, California, 90301, United States

Location

Galderma Investigational Site 8686

Lomita, California, 90717, United States

Location

Galderma Investigational Site 8674

Los Angeles, California, 90025, United States

Location

Galderma Investigational Site 8683

Los Angeles, California, 90033, United States

Location

Galderma Investigational Site 8813

Los Angeles, California, 90057, United States

Location

Galderma Investigational Site 8907

Newport Beach, California, 92660, United States

Location

Galderma Investigational Site 8799

Ontario, California, 91762, United States

Location

Galderma Investigational Site 8745

Pasadena, California, 91105, United States

Location

Galderma Investigational Site 8671

San Diego, California, 92108, United States

Location

Galderma Investigational Site 8692

San Diego, California, 92121, United States

Location

Galderma Investigational Site 8658

San Diego, California, 92123, United States

Location

Galderma Investigational Site 8125

San Francisco, California, 94115, United States

Location

Galderma Investigational Site 8536

Santa Ana, California, 92705, United States

Location

Galderma Investigational Site 8608

Santa Monica, California, 90404, United States

Location

Galderma Investigational Site 8820

Westminster, California, 92683, United States

Location

Galderma Investigational Site 8637

Farmington, Connecticut, 06606, United States

Location

Galderma Investigational Site 8870

Boca Raton, Florida, 33433, United States

Location

Galderma Investigational Site 8805

Cape Coral, Florida, 33991, United States

Location

Galderma Investigational Site 8786

Clearwater, Florida, 33765, United States

Location

Galderma Investigational Site 8902

Doral, Florida, 33122, United States

Location

Galderma Investigational Site 8391

Hialeah, Florida, 33016, United States

Location

Galderma Investigational Site 8804

Hialeah, Florida, 33016, United States

Location

Galderma Investigational Site 8711

Jacksonville, Florida, 32256, United States

Location

Galderma Investigational Site 8836

Jacksonville, Florida, 32256, United States

Location

Galderma Investigational Site 8523

Largo, Florida, 33770, United States

Location

Galderma Investigational Site 8850

Margate, Florida, 33063, United States

Location

Galderma Investigational Site 8719

Miami, Florida, 33125, United States

Location

Galderma Investigational Site 8851

Miami, Florida, 33135, United States

Location

Galderma Investigational Site 8656

Miami, Florida, 33137, United States

Location

Galderma Investigational Site 8801

Miami, Florida, 33145, United States

Location

Galderma Investigational Site 8704

Miami, Florida, 33155, United States

Location

Galderma Investigational Site 8737

Miami, Florida, 33174, United States

Location

Galderma Investigational Site 8706

Miami, Florida, 33175, United States

Location

Galderma Investigational Site 8708

Miami, Florida, 33176, United States

Location

Galderma Investigational Site 8806

Miami Lakes, Florida, 33014, United States

Location

Galderma Investigational Site 8800

Miami Lakes, Florida, 33016, United States

Location

Galderma Investigational Site 8856

Ormond Beach, Florida, 33174, United States

Location

Galderma Investigational Site 8734

Pembroke Pines, Florida, 33028, United States

Location

Galderma Investigational Site 8203

Tampa, Florida, 33607, United States

Location

Galderma Investigational Site 8816

Tampa, Florida, 33613, United States

Location

Galderma Investigational Site 8889

Tampa, Florida, 33613, United States

Location

Galderma Investigational Site 8839

Tampa, Florida, 33615, United States

Location

Galderma Investigational Site 8126

West Palm Beach, Florida, 33401, United States

Location

Galderma Investigational Site 8667

Columbus, Georgia, 31904, United States

Location

Galderma Investigational Site 8744

Macon, Georgia, 31217, United States

Location

Galderma Investigational Site 8728

Newnan, Georgia, 30263, United States

Location

Galderma Investigational Site 8707

Stockbridge, Georgia, 30281, United States

Location

Galderma Investigational Site 8819

Nampa, Idaho, 83687, United States

Location

Galderma Investigational Site 9916

Chicago, Illinois, 60611, United States

Location

Galderma Investigational Site 8739

Normal, Illinois, 61761, United States

Location

Galderma Investigational Site 8729

Rolling Meadows, Illinois, 60008, United States

Location

Galderma Investigational Sites 8571

Skokie, Illinois, 60076, United States

Location

Galderma Investigational Site 8712

Skokie, Illinois, 60077, United States

Location

Galderma Investigational Site 8142

Indianapolis, Indiana, 46250, United States

Location

Galderma Investigational Site 8724

New Albany, Indiana, 47150, United States

Location

Galderma Investigational Site 9934

Shawnee Mission, Kansas, 66216, United States

Location

Galderma Investigational Site 8771

Louisville, Kentucky, 40241-6162, United States

Location

Galderma Investigational Site 8882

Bangor, Maine, 04401, United States

Location

Galderma Investigational Site 8743

Ann Arbor, Michigan, 48109, United States

Location

Galderma Investigational Site 8512

Bay City, Michigan, 48706, United States

Location

Galderma Investigational Site 8554

Detroit, Michigan, 48202, United States

Location

Galderma Investigational Site 8617

Farmington Hills, Michigan, 48334, United States

Location

Galderma Investigational Site 8155

Troy, Michigan, 48084, United States

Location

Galderma Investigational Site 8849

Troy, Michigan, 48084, United States

Location

Galderma Investigational Site 8226

Warren, Michigan, 48088, United States

Location

Galderma Investigational Site 8748

Ypsilanti, Michigan, 48197, United States

Location

Galderma Investigational Site 8521

Saint Joseph, Missouri, 64506, United States

Location

Galderma Investigational Site 8718

Missoula, Montana, 59808, United States

Location

Galderma Investigational Site 8810

Omaha, Nebraska, 68144, United States

Location

Galderma Investigational Site 8740

Henderson, Nevada, 89002, United States

Location

Galderma Investigational Site 8825

Las Vegas, Nevada, 89106, United States

Location

Galderma Investigational Site 8675

Las Vegas, Nevada, 89119, United States

Location

Galderma Investigational Site 8109

Lebanon, New Hampshire, 03766, United States

Location

Galderma Investigational Site 8506

Hackensack, New Jersey, 07601, United States

Location

Galderma Investigational Site 8826

Albuquerque, New Mexico, 87106, United States

Location

Galderma Investigational Site 8242

Brooklyn, New York, 11203, United States

Location

Galderma Investigational Site 8741

Buffalo, New York, 14221, United States

Location

Galderma Investigational Site 8723

Cortland, New York, 13045, United States

Location

Galderma Investigational Site 8828

Forest Hills, New York, 11375, United States

Location

Galderma Investigational Site 9925

Glendale, New York, 11385, United States

Location

Galderma Investigational Site 8733

New York, New York, 10022, United States

Location

Galderma Investigational Site 8620

New York, New York, 10023, United States

Location

Galderma Investigational Site 8279

New York, New York, 10075, United States

Location

Galderma Investigational Site 8772

Durham, North Carolina, 27710, United States

Location

Galderma Investigational Site 8795

Shelby, North Carolina, 28150, United States

Location

Galderma Investigational Site 8726

Wilmington, North Carolina, 28405-3176, United States

Location

Galderma Investigational Site 8648

Wilmington, North Carolina, 28405, United States

Location

Galderma Investigational Site 8702

Bexley, Ohio, 43209, United States

Location

Galderma Investigational Site 8747

Cincinnati, Ohio, 45219, United States

Location

Galderma Investigational Site 8595

Dublin, Ohio, 43016, United States

Location

Galderma Investigational Site 8206

Norman, Oklahoma, 73071, United States

Location

Galderma Investigational Site 8857

Oklahoma City, Oklahoma, 73118, United States

Location

Galderma Investigational Site 8212

Portland, Oregon, 97210, United States

Location

Galderma Investigational Site 8255

Philadelphia, Pennsylvania, 19103, United States

Location

Galderma Investigational Site 8721

Pittsburgh, Pennsylvania, 15213, United States

Location

Galderma Investigational Site 8802

Plymouth Meeting, Pennsylvania, 19462, United States

Location

Galderma Investigational Site 8777

Charleston, South Carolina, 29407, United States

Location

Galderma Investigational Site 8736

Charleston, South Carolina, 29425, United States

Location

Galderma Investigational Site 8713

North Charleston, South Carolina, 29420, United States

Location

Galderma Investigational Site 8818

Rapid City, South Dakota, 57702, United States

Location

Galderma Investigational Site 8133

Arlington, Texas, 76011, United States

Location

Galderma Investigational Site 8298

Austin, Texas, 78723, United States

Location

Galderma Investigational Site 8238

Dallas, Texas, 75230, United States

Location

Galderma Investigational Site 8245

Dallas, Texas, 75231, United States

Location

Galderma Investigational Site 8827

Dripping Springs, Texas, 78620, United States

Location

Galderma Investigational Site 8664

Frisco, Texas, 75034, United States

Location

Galderma Investigational Site 8807

Houston, Texas, 77029, United States

Location

Galderma Investigational Site 8042

Houston, Texas, 77056, United States

Location

Galderma Investigational Site 8670

Houston, Texas, 77401, United States

Location

Galderma Investigational Site 8817

Katy, Texas, 77494, United States

Location

Galderma Investigational Site 8787

Plano, Texas, 75093, United States

Location

Galderma Investigational Site 8329

San Antonio, Texas, 78229, United States

Location

Galderma Investigational Site 8618

Waco, Texas, 76710, United States

Location

Galderma Investigational Site 8003

Webster, Texas, 77598, United States

Location

Galderma Investigational Site 8672

Salt Lake City, Utah, 84117, United States

Location

Galderma Investigational Site 8738

Burke, Virginia, 22015, United States

Location

Galderma Investigational Site 8862

Fairfax, Virginia, 22031, United States

Location

Galderma Investigational Site 8896

Richmond, Virginia, 23219, United States

Location

Galderma Investigational Site 8434

Seattle, Washington, 98105, United States

Location

Galderma Investigational Site 5441

Darlinghurst, New South Wales, 2010, Australia

Location

Galderma Investigational Site 5759

Kogarah, New South Wales, 2217, Australia

Location

Galderma Investigational Site 6152

Westmead, New South Wales, 2145, Australia

Location

Galderma Investigational Site 5638

Benowa, Queensland, 4217, Australia

Location

Galderma Investigational Site 6161

Brisbane, Queensland, 4102, Australia

Location

Galderma Investigational Site 6159

Woodville, South Australia, 5011, Australia

Location

Galderma Investigational Site 6131

Carlton, Victoria, 3053, Australia

Location

Galderma Investigational Site 5366

East Melbourne, Victoria, 3002, Australia

Location

Galderma Investigational Site 5458

Parkville, Victoria, 3050, Australia

Location

Galderma Investigational Site 6160

Parkville, Victoria, 3052, Australia

Location

Galderma Investigational Site 6153

Victoria Park, Western Australia, 6100, Australia

Location

Galderma Investigational Site 6157

Graz, Styria, 8036, Austria

Location

Galderma Investigational Site 6156

Linz, Upper Austria, 4020, Austria

Location

Galderma Investigational Site 6194

Vienna, 1090, Austria

Location

Galderma Investigational Site 6158

Vienna, 1220, Austria

Location

Galderma Investigational Site 6038

Leuven, Vlaams-Brabant, 3000, Belgium

Location

Galderma Investigational Site 5448

Brussels, 1200, Belgium

Location

Galderma Investigational Site 6163

Edegem, 2650, Belgium

Location

Galderma Investigational Site 6164

Ghent, 9000, Belgium

Location

Galderma Investigational Site 6162

Liège, 4000, Belgium

Location

Galderma Investigational Site 6029

Pleven, 5800, Bulgaria

Location

Galderma Investigational Site 6051

Sofia, 1407, Bulgaria

Location

Galderma Investigational Site 6078

Sofia, 1408, Bulgaria

Location

Galderma Investigational Site 6102

Sofia, 1431, Bulgaria

Location

Galderma Investigational Site 6165

Sofia, 1431, Bulgaria

Location

Galderma Investigational Site 6216

Sofia, 1528, Bulgaria

Location

Galderma Investigational Site 6046

Sofia, 1606, Bulgaria

Location

Galderma Investigational Site 6080

Sofia, 1606, Bulgaria

Location

Galderma Investigational Site 6101

Sofia, 1612, Bulgaria

Location

Galderma Investigational Site 6079

Sofia, 1618, Bulgaria

Location

Galderma Investigational Site 6250

Sofia, 1784, Bulgaria

Location

Galderma Investigational Site 6136

Stara Zagora, 6000, Bulgaria

Location

Galderma Investigational Site 6251

Stara Zagora, 6000, Bulgaria

Location

Galderma Investigational Site 8085

Calgary, Alberta, T2G 1B1, Canada

Location

Galderma Investigational Site 8903

Calgary, Alberta, T2J 7E1, Canada

Location

Galderma Investigational Site 8215

Calgary, Alberta, T3E 0B2, Canada

Location

Galderma Investigational Site 8824

Edmonton, Alberta, T6G 1C3, Canada

Location

Galderma Investigational Site 8722

Edmonton, Alberta, T6G 1C9, Canada

Location

Galderma Investigational Site 8161

Surrey, British Columbia, V3V 0C6, Canada

Location

Galderma Investigational Site 8586

Barrie, Ontario, L4M 7G1, Canada

Location

Galderma Investigational Site 8904

Guelph, Ontario, N1L 0B7, Canada

Location

Galderma Investigational Site 8780

Niagara Falls, Ontario, L2H 1H5, Canada

Location

Galderma Investigational Site 8610

Ottawa, Ontario, K1G 6C6, Canada

Location

Galderma Investigational Site 8901

Ottawa, Ontario, K1H 7X3, Canada

Location

Galderma Investigational Site 8336

Toronto, Ontario, M3H 5Y8, Canada

Location

Galderma Investigational Site 8899

Toronto, Ontario, M4W 2N4, Canada

Location

Galderma Investigational Site 8731

Waterloo, Ontario, N2J 1C4, Canada

Location

Galderma Investigational Site 8000

Saint John, A1C 2H5, Canada

Location

Galderma Investigational Site 6055

Brno, 656 91, Czechia

Location

Galderma Investigational Site 5225

Náchod, 547 01, Czechia

Location

Galderma Investigational Site 6030

Olomouc, 779 00, Czechia

Location

Galderma Investigational Site 6024

Prague, 100 00, Czechia

Location

Galderma Investigational Site 6021

Prague, 110 00, Czechia

Location

Galderma Investigational Site 6054

Prague, 110 00, Czechia

Location

Galderma Investigational Site 6240

Prague, 120 00, Czechia

Location

Galderma Investigational Site 6025

Prague, 150 06, Czechia

Location

Galderma Investigational Site 6068

Tallinn, 10134, Estonia

Location

Galderma Investigational Site 6069

Tallinn, 10138, Estonia

Location

Galderma Investigational Site 6067

Tartu, 50417, Estonia

Location

Galderma Investigational Site 6198

Le Mans, 72037, France

Location

Galderma Investigational Site 5031

Lille, 59037, France

Location

Galderma Investigational Site 6170

Martigues, 13500, France

Location

Galderma Investigational Site 6167

Nantes, 44093, France

Location

Galderma Investigational Site 5140

Nice, 06200, France

Location

Galderma Investigational Site 6133

Paris, 75015, France

Location

Galderma Investigational Site 6166

Paris, 75475, France

Location

Galderma Investigational Site 5407

Pierre-Bénite, 69495, France

Location

Galderma Investigational Site 6135

Quimper, 29107, France

Location

Galderma Investigational Site 6197

Toulon, 83800, France

Location

Galderma Investigational Site 6169

Toulouse, 31000, France

Location

Galderma Investigational Site 6168

Valence, 26000, France

Location

Galderma Investigational Site 6224

Tbilisi, 0159, Georgia

Location

Galderma Investigational Site 6228

Tbilisi, 0159, Georgia

Location

Galderma Investigational Site 6235

Tbilisi, 0159, Georgia

Location

Galderma Investigational Site 6238

Tbilisi, 0159, Georgia

Location

Galderma Investigational Site 6227

Tbilisi, 0186, Georgia

Location

Galderma Investigational Site 6230

Tbilisi, 0186, Georgia

Location

Galderma Investigational Site 6234

Tbilisi, 0186, Georgia

Location

Galderma Investigational Site 6236

Zugdidi, 2100, Georgia

Location

Galderma Investigational Site 5482

Aachen, 52074, Germany

Location

Galderma Investigational Site 5566

Augsburg, 86179, Germany

Location

Galderma Investigational Site 6022

Bad Bentheim, 48455, Germany

Location

Galderma Investigational Site 6110

Berlin, 13055, Germany

Location

Galderma Investigational Site 6061

Bielefeld, 33647, Germany

Location

Galderma Investigational Site 6082

Bonn, 53127, Germany

Location

Galderma Investigational Site 6062

Buxtehude, 21614, Germany

Location

Galderma Investigational Site 5368

Darmstadt, 64283, Germany

Location

Galderma Investigational Site 6132

Dresden, 01097, Germany

Location

Galderma Investigational Site 6028

Dülmen, 48249, Germany

Location

Galderma Investigational Site 6031

Düsseldorf, 40225, Germany

Location

Galderma Investigational Site 5442

Gera, 07548, Germany

Location

Galderma Investigational Site 6081

Goettigen, 37075, Germany

Location

Galderma Investigational Site 6062

Halle, 06120, Germany

Location

Galderma Investigational Site 6041

Hamburg, 20251, Germany

Location

Galderma Investigational Site 6150

Hamburg, 20537, Germany

Location

Galderma Investigational Site 6040

Hamburg, 22391, Germany

Location

Galderma Investigational Site 5469

Heidelberg, 69120, Germany

Location

Galderma Investigational Site 6086

Kiel, 24148, Germany

Location

Galderma Investigational Site 6146

Langenau, 89129, Germany

Location

Galderma Investigational Site 6084

Mainz, 55131, Germany

Location

Galderma Investigational Site 5382

Munich, 80337, Germany

Location

Galderma Investigational Site 6039

Münster, 48149, Germany

Location

Galderma Investigational Site 5918

Osnabrück, 49074, Germany

Location

Galderma Investigational Site 6109

Stuttgart, 70499, Germany

Location

Galderma Investigational Site 6214

Tübingen, 72076, Germany

Location

Galderma Investigational Site 6147

Budapest, 1036, Hungary

Location

Galderma Investigational Site 5513

Budapest, 1085, Hungary

Location

Galderma Investigational Site 5567

Debrecen, 4025, Hungary

Location

Galderma Investigational Site 6026

Debrecen, 4032, Hungary

Location

Galderma Investigational Site 6254

Gyula, 5700, Hungary

Location

Galderma Investigational Site 6053

Veszprém, 8200, Hungary

Location

Galderma Investigational Site 6145

Bologna, 40138, Italy

Location

Galderma Investigational Site 6045

L’Aquila, 67100, Italy

Location

Galderma Investigational Site 6049

Roma, 00168, Italy

Location

Galderma Investigational Site 6177

Rome, 00144, Italy

Location

Galderma Investigational Site 6155

Rozzano, 20089, Italy

Location

Galderma Investigational Site 6175

Vicenza, 36100, Italy

Location

Galderma Investigational Site 6113

Liepāja, LV-3401, Latvia

Location

Galderma Investigational Site 6134

Riga, LV-1006, Latvia

Location

Galderma Investigational Site 6059

Riga, LV-1009, Latvia

Location

Galderma Investigational Site 6060

Talsi, LV-3201, Latvia

Location

Galderma Investigational Site 6111

Kaunas, LT-50161, Lithuania

Location

Galderma Investigational Site 6073

Vilnius, LT-07195, Lithuania

Location

Galderma Investigational Site 6112

Vilnius, LT-08411, Lithuania

Location

Galderma Investigational Site 6212

Groningen, 9713, Netherlands

Location

Galderma Investigational Site 6108

Rotterdam, 3015 GD, Netherlands

Location

Galderma Investigational Site 6027

Utrecht, 3584 CX, Netherlands

Location

Galderma Investigational Site 6119

Hamilton, 3204, New Zealand

Location

Galderma Investigational Site 6118

Wellington, 6021, New Zealand

Location

Galderma Investigational Site 5773

Bialystok, 15-453, Poland

Location

Galderma Investigational Site 6097

Chorzów, 41-500, Poland

Location

Galderma Investigational Site 6255

Częstochowa, 42-202, Poland

Location

Galderma Investigational Site 6075

Gdansk, 80-214, Poland

Location

Galderma Investigational Site 6243

Gdansk, 80-382, Poland

Location

Galderma Investigational Site 5138

Gdansk, 80-803, Poland

Location

Galderma Investigational Site 6244

Gdynia, 81-537, Poland

Location

Galderma Investigational Site 6087

Katowice, 40-040, Poland

Location

Galderma Investigational Site 5021

Katowice, 40-611, Poland

Location

Galderma Investigational Site 5362

Krakow, 30-033, Poland

Location

Galderma Investigational Site 6052

Krakow, 31-559, Poland

Location

Galderma Investigational Site 6245

Lodz, 90-127, Poland

Location

Galderma Investigational Site 5570

Lodz, 90-265, Poland

Location

Galderma Investigational Site 5363

Lodz, 90-436, Poland

Location

Galderma Investigational Site 6231

Lodz, 94-050, Poland

Location

Galderma Investigational Site 5367

Lublin, 20-080, Poland

Location

Galderma Investigational Site 6071

Lublin, 20-081, Poland

Location

Galderma Investigational Site 5377

Nowa Sól, 67-100, Poland

Location

Galderma Investigational Site 6063

Olsztyn, 10-229, Poland

Location

Galderma Investigational Site 6237

Ostrowiec Świętokrzyski, 27-400, Poland

Location

Galderma Investigational Site 6085

Poznan, 60-529, Poland

Location

Galderma Investigational Site 6127

Poznan, 60-702, Poland

Location

Galderma Investigational Site 5495

Rzeszów, 35-055, Poland

Location

Galderma Investigational Site 6088

Rzeszów, 35-055, Poland

Location

Galderma Investigational Site 6223

Szczecin, 70-332, Poland

Location

Galderma Investigational Site 6130

Szczecin, 71-434, Poland

Location

Galderma Investigational Site 6048

Tarnów, 33-100, Poland

Location

Galderma Investigational Site 6126

Warsaw, 01-142, Poland

Location

Galderma Investigational Site 6065

Warsaw, 01-192, Poland

Location

Galderma Investigational Site 5707

Warsaw, 01-817, Poland

Location

Galderma Investigational Site 6122

Warsaw, 02-507, Poland

Location

Galderma Investigational Site 6242

Warsaw, 02-793, Poland

Location

Galderma Investigational Site 6064

Warsaw, 02-953, Poland

Location

Galderma Investigational Site 6222

Warsaw, 02-962, Poland

Location

Galderma Investigational Site 6047

Wroclaw, 50-381, Poland

Location

Galderma Investigational Site 6185

Wroclaw, 50-566, Poland

Location

Galderma Investigational Site 6096

Wroclaw, 51-318, Poland

Location

Galderma Investigational Site 5005

Wroclaw, 53-658, Poland

Location

Galderma Investigational Site 6124

Singapore, 119228, Singapore

Location

Galderma Investigational Site 6077

Singapore, 169608, Singapore

Location

Galderma Investigational Site 5499

Singapore, 308205, Singapore

Location

Galderma Investigational Site 6095

Bucheon-si, 14584, South Korea

Location

Galderma Investigational Site 6100

Busan, 49241, South Korea

Location

Galderma Investigational Site 6098

Gyeonggi-do, 15355, South Korea

Location

Galderma Investigational Site 6154

Gyeonggi-do, 18450, South Korea

Location

Galderma Investigational Site 6138

Incheon, 21431, South Korea

Location

Galderma Investigational Site 6120

Incheon, 21565, South Korea

Location

Galderma Investigational Site 6093

Incheon, 22332, South Korea

Location

Galderma Investigational Site 6105

Seoul, 02841, South Korea

Location

Galderma Investigational Site 5659

Seoul, 03080, South Korea

Location

Galderma Investigational Site 6116

Seoul, 03722, South Korea

Location

Galderma Investigational Site 6129

Seoul, 04763, South Korea

Location

Galderma Investigational Site 6103

Seoul, 05030, South Korea

Location

Galderma Investigational Site 6056

Seoul, 06591, South Korea

Location

Galderma Investigational Site 6094

Seoul, 06973, South Korea

Location

Galderma Investigational Site 6099

Seoul, 07441, South Korea

Location

Galderma Investigational Site 6057

Alicante, 03010, Spain

Location

Galderma Investigational Site 6037

Barcelona, 08036, Spain

Location

Galderma Investigational Site 6035

Barcelona, 08916, Spain

Location

Galderma Investigational Site 5580

L'Hospitalet de Llobregat, 08907, Spain

Location

Galderma Investigational Site 6106

Las Palmas de Gran Canaria, 35010, Spain

Location

Galderma Investigational Site 6058

Madrid, 28006, Spain

Location

Galderma Investigational Site 5842

Madrid, 28034, Spain

Location

Galderma Investigational Site 6190

Madrid, 28046, Spain

Location

Galderma Investigational Site 6186

Madrid, 28222, Spain

Location

Galderma Investigational Site 6036

Madrid, 28223, Spain

Location

Galderma Investigational Site 5551

Madrid, 28922, Spain

Location

Galderma Investigational Site 6191

Pamplona, 31008, Spain

Location

Galderma Investigational Site 6202

Barnsley, S75 3DL, United Kingdom

Location

Galderma Investigational Site 6207

Blackpool, FY2 0JH, United Kingdom

Location

Galderma Investigational Site 6203

Cannock, WS11 0BN, United Kingdom

Location

Galderma Investigational Site 6090

Dudley, DY1 2HQ, United Kingdom

Location

Galderma Investigational Site 6104

Glasgow, G3 8SJ, United Kingdom

Location

Galderma Investigational Site 6204

Liverpool, L34 1BH, United Kingdom

Location

Galderma Investigational Site 6121

London, SE1 9RT, United Kingdom

Location

Galderma Investigational Site 6205

Manchester, M13 9NQ, United Kingdom

Location

Galderma Investigational Site 6208

Newcastle, NE1 4LP, United Kingdom

Location

Galderma Investigational Site 6206

Stockton-on-Tees, TS17 6EW, United Kingdom

Location

Related Publications (2)

• Augustin M, Tauber M, Sidbury R, Silverberg JI, Papp KA, Thaci D, De Bruin-Weller MS, Reich A, Peris K, Barber K, Galus R, Kaszuba A, Zirwas M, Nahm WK, Trullenque G, Maintz L, Alpizar S, Son SW, Laquer V, Gold LS, Cheong SY, Ryzhkova A, Drahos A, Ulianov L, Piketty C. Safety and efficacy of nemolizumab for atopic dermatitis up to 2 years in open-label extension study. J Eur Acad Dermatol Venereol. 2025 Oct 13. doi: 10.1111/jdv.70080. Online ahead of print.

  PMID: 41081535 DERIVED

• Brunner PM. A novel treatment approach for atopic dermatitis. Lancet. 2024 Aug 3;404(10451):407-409. doi: 10.1016/S0140-6736(24)01488-0. Epub 2024 Jul 25. No abstract available.

  PMID: 39068954 DERIVED

MeSH Terms

Interventions

nemolizumab

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2019
• First Posted: June 18, 2019
• Study Start: December 30, 2019
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: October 30, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (6); KR (15); GE (8); LI (3); FR (12); PL (38); NZ (2); BE (5); DE (26); HU (6); ES (12); US (136); NL (3); LA (4); GB (10); BU (13); AU (11); SG (3); CZ (8); CA (15)