AzTrials
AzTrials

Moderate-to-Severe Atopic DermatitisPhase 3NCT03989206

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

A Phase 3 study testing Nemolizumab in people with Moderate-to-Severe Atopic Dermatitis, run by Galderma R&D at 343 sites in 22 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Long-Term Safety and Efficacy of Nemolizumab in Subjects with Moderate-to-Severe Atopic Dermatitis Description Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
Moderate-to-Severe Atopic Dermatitis
What is being tested?
Nemolizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,935 participants
Where
343 sitesin 22 countries
Study dates
30 Dec 2019to 31 Aug 2026
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

343 sites in 22 countries.

343 sites in 22 countries

United States136 sites

  • Galderma Investigational Site 8826

    Albuquerque, New Mexico, 87106

  • Galderma Investigational Site 8831

    Anaheim, California, 92801

  • Galderma Investigational Site 8743

    Ann Arbor, Michigan, 48109

  • Galderma Investigational Site 8133

    Arlington, Texas, 76011

  • Galderma Investigational Site 8298

    Austin, Texas, 78723

  • Galderma Investigational Site 8882

    Bangor, Maine, 04401

  • Galderma Investigational Site 8512

    Bay City, Michigan, 48706

  • Galderma Investigational Site 8906

    Bell Gardens, California, 90201

  • Galderma Investigational Site 8456

    Beverly Hills, California, 90212

  • Galderma Investigational Site 8702

    Bexley, Ohio, 43209

  • Galderma Investigational Site 8749

    Birmingham, Alabama, 35244

  • Galderma Investigational Site 8893

    Birmingham, Alabama, 35244

  • Galderma Investigational Site 8870

    Boca Raton, Florida, 33433

  • Galderma Investigational Site 8242

    Brooklyn, New York, 11203

  • Galderma Investigational Site 8741

    Buffalo, New York, 14221

  • Galderma Investigational Site 8738

    Burke, Virginia, 22015

  • Galderma Investigational Site 8805

    Cape Coral, Florida, 33991

  • Galderma Investigational Site 8578

    Cerritos, California, 90703

  • Galderma Investigational Site 8777

    Charleston, South Carolina, 29407

  • Galderma Investigational Site 8736

    Charleston, South Carolina, 29425

  • Galderma Investigational Site 9916

    Chicago, Illinois, 60611

  • Galderma Investigational Site 8747

    Cincinnati, Ohio, 45219

  • Galderma Investigational Site 8786

    Clearwater, Florida, 33765

  • Galderma Investigational Site 8667

    Columbus, Georgia, 31904

  • Galderma Investigational Site 8723

    Cortland, New York, 13045

  • Galderma Investigational Site 8238

    Dallas, Texas, 75230

  • Galderma Investigational Site 8245

    Dallas, Texas, 75231

  • Galderma Investigational Site 8554

    Detroit, Michigan, 48202

  • Galderma Investigational Site 8902

    Doral, Florida, 33122

  • Galderma Investigational Site 8827

    Dripping Springs, Texas, 78620

  • Galderma Investigational Site 8595

    Dublin, Ohio, 43016

  • Galderma Investigational Site 8772

    Durham, North Carolina, 27710

  • Galderma Investigational Site 8577

    Encinitas, California, 92024

  • Galderma Investigational Site 8862

    Fairfax, Virginia, 22031

  • Galderma Investigational Site 8637

    Farmington, Connecticut, 06606

  • Galderma Investigational Site 8617

    Farmington Hills, Michigan, 48334

  • Galderma Investigational Site 8828

    Forest Hills, New York, 11375

  • Galderma Investigational Site 8447

    Fort Smith, Arkansas, 72916

  • Galderma Investigational Site 8636

    Fountain Valley, California, 92708

  • Galderma Investigational Site 8224

    Fremont, California, 94538

  • Galderma Investigational Site 8791

    Fresno, California, 93720

  • Galderma Investigational Site 8664

    Frisco, Texas, 75034

  • Galderma Investigational Site 8888

    Fullerton, California, 92835

  • Galderma Investigational Site 9925

    Glendale, New York, 11385

  • Galderma Investigational Site 8866

    Guntersville, Alabama, 35976

  • Galderma Investigational Site 8506

    Hackensack, New Jersey, 07601

  • Galderma Investigational Site 8740

    Henderson, Nevada, 89002

  • Galderma Investigational Site 8391

    Hialeah, Florida, 33016

  • Galderma Investigational Site 8804

    Hialeah, Florida, 33016

  • Galderma Investigational Site 8807

    Houston, Texas, 77029

  • Galderma Investigational Site 8042

    Houston, Texas, 77056

  • Galderma Investigational Site 8670

    Houston, Texas, 77401

  • Galderma Investigational Site 8845

    Huntington Beach, California, 92647

  • Galderma Investigational Site 8142

    Indianapolis, Indiana, 46250

  • Galderma Investigational Site 8833

    Inglewood, California, 90301

  • Galderma Investigational Site 8711

    Jacksonville, Florida, 32256

  • Galderma Investigational Site 8836

    Jacksonville, Florida, 32256

  • Galderma Investigational Site 8817

    Katy, Texas, 77494

  • Galderma Investigational Site 8523

    Largo, Florida, 33770

  • Galderma Investigational Site 8825

    Las Vegas, Nevada, 89106

  • Galderma Investigational Site 8675

    Las Vegas, Nevada, 89119

  • Galderma Investigational Site 8109

    Lebanon, New Hampshire, 03766

  • Galderma Investigational Site 8686

    Lomita, California, 90717

  • Galderma Investigational Site 8674

    Los Angeles, California, 90025

  • Galderma Investigational Site 8683

    Los Angeles, California, 90033

  • Galderma Investigational Site 8813

    Los Angeles, California, 90057

  • Galderma Investigational Site 8771

    Louisville, Kentucky, 40241-6162

  • Galderma Investigational Site 8744

    Macon, Georgia, 31217

  • Galderma Investigational Site 8850

    Margate, Florida, 33063

  • Galderma Investigational Site 8719

    Miami, Florida, 33125

  • Galderma Investigational Site 8851

    Miami, Florida, 33135

  • Galderma Investigational Site 8656

    Miami, Florida, 33137

  • Galderma Investigational Site 8801

    Miami, Florida, 33145

  • Galderma Investigational Site 8704

    Miami, Florida, 33155

  • Galderma Investigational Site 8737

    Miami, Florida, 33174

  • Galderma Investigational Site 8706

    Miami, Florida, 33175

  • Galderma Investigational Site 8708

    Miami, Florida, 33176

  • Galderma Investigational Site 8806

    Miami Lakes, Florida, 33014

  • Galderma Investigational Site 8800

    Miami Lakes, Florida, 33016

  • Galderma Investigational Site 8718

    Missoula, Montana, 59808

  • Galderma Investigational Site 8819

    Nampa, Idaho, 83687

  • Galderma Investigational Site 8724

    New Albany, Indiana, 47150

  • Galderma Investigational Site 8733

    New York, New York, 10022

  • Galderma Investigational Site 8620

    New York, New York, 10023

  • Galderma Investigational Site 8279

    New York, New York, 10075

  • Galderma Investigational Site 8728

    Newnan, Georgia, 30263

  • Galderma Investigational Site 8907

    Newport Beach, California, 92660

  • Galderma Investigational Site 8739

    Normal, Illinois, 61761

  • Galderma Investigational Site 8206

    Norman, Oklahoma, 73071

  • Galderma Investigational Site 8713

    North Charleston, South Carolina, 29420

  • Galderma Investigational Site 8880

    North Little Rock, Arkansas, 72117

  • Galderma Investigational Site 8857

    Oklahoma City, Oklahoma, 73118

  • Galderma Investigational Site 8810

    Omaha, Nebraska, 68144

  • Galderma Investigational Site 8799

    Ontario, California, 91762

  • Galderma Investigational Site 8856

    Ormond Beach, Florida, 33174

  • Galderma Investigational Site 8745

    Pasadena, California, 91105

  • Galderma Investigational Site 8734

    Pembroke Pines, Florida, 33028

  • Galderma Investigational Site 8255

    Philadelphia, Pennsylvania, 19103

  • Galderma Investigational Site 8721

    Pittsburgh, Pennsylvania, 15213

  • Galderma Investigational Site 8787

    Plano, Texas, 75093

  • Galderma Investigational Site 8802

    Plymouth Meeting, Pennsylvania, 19462

  • Galderma Investigational Site 8212

    Portland, Oregon, 97210

  • Galderma Investigational Site 8818

    Rapid City, South Dakota, 57702

  • Galderma Investigational Site 8896

    Richmond, Virginia, 23219

  • Galderma Investigational Site 8729

    Rolling Meadows, Illinois, 60008

  • Galderma Investigational Site 8521

    Saint Joseph, Missouri, 64506

  • Galderma Investigational Site 8672

    Salt Lake City, Utah, 84117

  • Galderma Investigational Site 8329

    San Antonio, Texas, 78229

  • Galderma Investigational Site 8671

    San Diego, California, 92108

  • Galderma Investigational Site 8692

    San Diego, California, 92121

  • Galderma Investigational Site 8658

    San Diego, California, 92123

  • Galderma Investigational Site 8125

    San Francisco, California, 94115

  • Galderma Investigational Site 8536

    Santa Ana, California, 92705

  • Galderma Investigational Site 8608

    Santa Monica, California, 90404

  • Galderma Investigational Site 8808

    Scottsdale, Arizona, 85255

  • Galderma Investigational Site 8873

    Scottsdale, Arizona, 85260

  • Galderma Investigational Site 8434

    Seattle, Washington, 98105

  • Galderma Investigational Site 9934

    Shawnee Mission, Kansas, 66216

  • Galderma Investigational Site 8795

    Shelby, North Carolina, 28150

  • Galderma Investigational Sites 8571

    Skokie, Illinois, 60076

  • Galderma Investigational Site 8712

    Skokie, Illinois, 60077

  • Galderma Investigational Site 8707

    Stockbridge, Georgia, 30281

  • Galderma Investigational Site 8203

    Tampa, Florida, 33607

  • Galderma Investigational Site 8816

    Tampa, Florida, 33613

  • Galderma Investigational Site 8889

    Tampa, Florida, 33613

  • Galderma Investigational Site 8839

    Tampa, Florida, 33615

  • Galderma Investigational Site 8155

    Troy, Michigan, 48084

  • Galderma Investigational Site 8849

    Troy, Michigan, 48084

  • Galderma Investigational Site 8618

    Waco, Texas, 76710

  • Galderma Investigational Site 8226

    Warren, Michigan, 48088

  • Galderma Investigational Site 8003

    Webster, Texas, 77598

  • Galderma Investigational Site 8126

    West Palm Beach, Florida, 33401

  • Galderma Investigational Site 8820

    Westminster, California, 92683

  • Galderma Investigational Site 8726

    Wilmington, North Carolina, 28405-3176

  • Galderma Investigational Site 8648

    Wilmington, North Carolina, 28405

  • Galderma Investigational Site 8748

    Ypsilanti, Michigan, 48197

Other trials in United States

Poland38 sites

  • Galderma Investigational Site 5773

    Bialystok, 15-453

  • Galderma Investigational Site 6097

    Chorzów, 41-500

  • Galderma Investigational Site 6255

    Częstochowa, 42-202

  • Galderma Investigational Site 6075

    Gdansk, 80-214

  • Galderma Investigational Site 6243

    Gdansk, 80-382

  • Galderma Investigational Site 5138

    Gdansk, 80-803

  • Galderma Investigational Site 6244

    Gdynia, 81-537

  • Galderma Investigational Site 6087

    Katowice, 40-040

  • Galderma Investigational Site 5021

    Katowice, 40-611

  • Galderma Investigational Site 5362

    Krakow, 30-033

  • Galderma Investigational Site 6052

    Krakow, 31-559

  • Galderma Investigational Site 6245

    Lodz, 90-127

  • Galderma Investigational Site 5570

    Lodz, 90-265

  • Galderma Investigational Site 5363

    Lodz, 90-436

  • Galderma Investigational Site 6231

    Lodz, 94-050

  • Galderma Investigational Site 5367

    Lublin, 20-080

  • Galderma Investigational Site 6071

    Lublin, 20-081

  • Galderma Investigational Site 5377

    Nowa Sól, 67-100

  • Galderma Investigational Site 6063

    Olsztyn, 10-229

  • Galderma Investigational Site 6237

    Ostrowiec Świętokrzyski, 27-400

  • Galderma Investigational Site 6085

    Poznan, 60-529

  • Galderma Investigational Site 6127

    Poznan, 60-702

  • Galderma Investigational Site 5495

    Rzeszów, 35-055

  • Galderma Investigational Site 6088

    Rzeszów, 35-055

  • Galderma Investigational Site 6223

    Szczecin, 70-332

  • Galderma Investigational Site 6130

    Szczecin, 71-434

  • Galderma Investigational Site 6048

    Tarnów, 33-100

  • Galderma Investigational Site 6126

    Warsaw, 01-142

  • Galderma Investigational Site 6065

    Warsaw, 01-192

  • Galderma Investigational Site 5707

    Warsaw, 01-817

  • Galderma Investigational Site 6122

    Warsaw, 02-507

  • Galderma Investigational Site 6242

    Warsaw, 02-793

  • Galderma Investigational Site 6064

    Warsaw, 02-953

  • Galderma Investigational Site 6222

    Warsaw, 02-962

  • Galderma Investigational Site 6047

    Wroclaw, 50-381

  • Galderma Investigational Site 6185

    Wroclaw, 50-566

  • Galderma Investigational Site 6096

    Wroclaw, 51-318

  • Galderma Investigational Site 5005

    Wroclaw, 53-658

Other trials in Poland

Germany26 sites

  • Galderma Investigational Site 5482

    Aachen, 52074

  • Galderma Investigational Site 5566

    Augsburg, 86179

  • Galderma Investigational Site 6022

    Bad Bentheim, 48455

  • Galderma Investigational Site 6110

    Berlin, 13055

  • Galderma Investigational Site 6061

    Bielefeld, 33647

  • Galderma Investigational Site 6082

    Bonn, 53127

  • Galderma Investigational Site 6062

    Buxtehude, 21614

  • Galderma Investigational Site 5368

    Darmstadt, 64283

  • Galderma Investigational Site 6132

    Dresden, 01097

  • Galderma Investigational Site 6028

    Dülmen, 48249

  • Galderma Investigational Site 6031

    Düsseldorf, 40225

  • Galderma Investigational Site 5442

    Gera, 07548

  • Galderma Investigational Site 6081

    Goettigen, 37075

  • Galderma Investigational Site 6062

    Halle, 06120

  • Galderma Investigational Site 6041

    Hamburg, 20251

  • Galderma Investigational Site 6150

    Hamburg, 20537

  • Galderma Investigational Site 6040

    Hamburg, 22391

  • Galderma Investigational Site 5469

    Heidelberg, 69120

  • Galderma Investigational Site 6086

    Kiel, 24148

  • Galderma Investigational Site 6146

    Langenau, 89129

  • Galderma Investigational Site 6084

    Mainz, 55131

  • Galderma Investigational Site 5382

    Munich, 80337

  • Galderma Investigational Site 6039

    Münster, 48149

  • Galderma Investigational Site 5918

    Osnabrück, 49074

  • Galderma Investigational Site 6109

    Stuttgart, 70499

  • Galderma Investigational Site 6214

    Tübingen, 72076

Other trials in Germany

Canada15 sites

  • Galderma Investigational Site 8586

    Barrie, Ontario, L4M 7G1

  • Galderma Investigational Site 8085

    Calgary, Alberta, T2G 1B1

  • Galderma Investigational Site 8903

    Calgary, Alberta, T2J 7E1

  • Galderma Investigational Site 8215

    Calgary, Alberta, T3E 0B2

  • Galderma Investigational Site 8824

    Edmonton, Alberta, T6G 1C3

  • Galderma Investigational Site 8722

    Edmonton, Alberta, T6G 1C9

  • Galderma Investigational Site 8904

    Guelph, Ontario, N1L 0B7

  • Galderma Investigational Site 8780

    Niagara Falls, Ontario, L2H 1H5

  • Galderma Investigational Site 8610

    Ottawa, Ontario, K1G 6C6

  • Galderma Investigational Site 8901

    Ottawa, Ontario, K1H 7X3

  • Galderma Investigational Site 8000

    Saint John, A1C 2H5

  • Galderma Investigational Site 8161

    Surrey, British Columbia, V3V 0C6

  • Galderma Investigational Site 8336

    Toronto, Ontario, M3H 5Y8

  • Galderma Investigational Site 8899

    Toronto, Ontario, M4W 2N4

  • Galderma Investigational Site 8731

    Waterloo, Ontario, N2J 1C4

Other trials in Canada

South Korea15 sites

  • Galderma Investigational Site 6095

    Bucheon-si, 14584

  • Galderma Investigational Site 6100

    Busan, 49241

  • Galderma Investigational Site 6098

    Gyeonggi-do, 15355

  • Galderma Investigational Site 6154

    Gyeonggi-do, 18450

  • Galderma Investigational Site 6138

    Incheon, 21431

  • Galderma Investigational Site 6120

    Incheon, 21565

  • Galderma Investigational Site 6093

    Incheon, 22332

  • Galderma Investigational Site 6105

    Seoul, 02841

  • Galderma Investigational Site 5659

    Seoul, 03080

  • Galderma Investigational Site 6116

    Seoul, 03722

  • Galderma Investigational Site 6129

    Seoul, 04763

  • Galderma Investigational Site 6103

    Seoul, 05030

  • Galderma Investigational Site 6056

    Seoul, 06591

  • Galderma Investigational Site 6094

    Seoul, 06973

  • Galderma Investigational Site 6099

    Seoul, 07441

Other trials in South Korea

Bulgaria13 sites

  • Galderma Investigational Site 6029

    Pleven, 5800

  • Galderma Investigational Site 6051

    Sofia, 1407

  • Galderma Investigational Site 6078

    Sofia, 1408

  • Galderma Investigational Site 6102

    Sofia, 1431

  • Galderma Investigational Site 6165

    Sofia, 1431

  • Galderma Investigational Site 6216

    Sofia, 1528

  • Galderma Investigational Site 6046

    Sofia, 1606

  • Galderma Investigational Site 6080

    Sofia, 1606

  • Galderma Investigational Site 6101

    Sofia, 1612

  • Galderma Investigational Site 6079

    Sofia, 1618

  • Galderma Investigational Site 6250

    Sofia, 1784

  • Galderma Investigational Site 6136

    Stara Zagora, 6000

  • Galderma Investigational Site 6251

    Stara Zagora, 6000

Other trials in Bulgaria

France12 sites

  • Galderma Investigational Site 6198

    Le Mans, 72037

  • Galderma Investigational Site 5031

    Lille, 59037

  • Galderma Investigational Site 6170

    Martigues, 13500

  • Galderma Investigational Site 6167

    Nantes, 44093

  • Galderma Investigational Site 5140

    Nice, 06200

  • Galderma Investigational Site 6133

    Paris, 75015

  • Galderma Investigational Site 6166

    Paris, 75475

  • Galderma Investigational Site 5407

    Pierre-Bénite, 69495

  • Galderma Investigational Site 6135

    Quimper, 29107

  • Galderma Investigational Site 6197

    Toulon, 83800

  • Galderma Investigational Site 6169

    Toulouse, 31000

  • Galderma Investigational Site 6168

    Valence, 26000

Other trials in France

Spain12 sites

  • Galderma Investigational Site 6057

    Alicante, 03010

  • Galderma Investigational Site 6037

    Barcelona, 08036

  • Galderma Investigational Site 6035

    Barcelona, 08916

  • Galderma Investigational Site 5580

    L'Hospitalet de Llobregat, 08907

  • Galderma Investigational Site 6106

    Las Palmas de Gran Canaria, 35010

  • Galderma Investigational Site 6058

    Madrid, 28006

  • Galderma Investigational Site 5842

    Madrid, 28034

  • Galderma Investigational Site 6190

    Madrid, 28046

  • Galderma Investigational Site 6186

    Madrid, 28222

  • Galderma Investigational Site 6036

    Madrid, 28223

  • Galderma Investigational Site 5551

    Madrid, 28922

  • Galderma Investigational Site 6191

    Pamplona, 31008

Other trials in Spain

Australia11 sites

  • Galderma Investigational Site 5638

    Benowa, Queensland, 4217

  • Galderma Investigational Site 6161

    Brisbane, Queensland, 4102

  • Galderma Investigational Site 6131

    Carlton, Victoria, 3053

  • Galderma Investigational Site 5441

    Darlinghurst, New South Wales, 2010

  • Galderma Investigational Site 5366

    East Melbourne, Victoria, 3002

  • Galderma Investigational Site 5759

    Kogarah, New South Wales, 2217

  • Galderma Investigational Site 5458

    Parkville, Victoria, 3050

  • Galderma Investigational Site 6160

    Parkville, Victoria, 3052

  • Galderma Investigational Site 6153

    Victoria Park, Western Australia, 6100

  • Galderma Investigational Site 6152

    Westmead, New South Wales, 2145

  • Galderma Investigational Site 6159

    Woodville, South Australia, 5011

Other trials in Australia

United Kingdom10 sites

  • Galderma Investigational Site 6202

    Barnsley, S75 3DL

  • Galderma Investigational Site 6207

    Blackpool, FY2 0JH

  • Galderma Investigational Site 6203

    Cannock, WS11 0BN

  • Galderma Investigational Site 6090

    Dudley, DY1 2HQ

  • Galderma Investigational Site 6104

    Glasgow, G3 8SJ

  • Galderma Investigational Site 6204

    Liverpool, L34 1BH

  • Galderma Investigational Site 6121

    London, SE1 9RT

  • Galderma Investigational Site 6205

    Manchester, M13 9NQ

  • Galderma Investigational Site 6208

    Newcastle, NE1 4LP

  • Galderma Investigational Site 6206

    Stockton-on-Tees, TS17 6EW

Other trials in United Kingdom

Czechia8 sites

  • Galderma Investigational Site 6055

    Brno, 656 91

  • Galderma Investigational Site 5225

    Náchod, 547 01

  • Galderma Investigational Site 6030

    Olomouc, 779 00

  • Galderma Investigational Site 6024

    Prague, 100 00

  • Galderma Investigational Site 6021

    Prague, 110 00

  • Galderma Investigational Site 6054

    Prague, 110 00

  • Galderma Investigational Site 6240

    Prague, 120 00

  • Galderma Investigational Site 6025

    Prague, 150 06

Other trials in Czechia

Georgia8 sites

  • Galderma Investigational Site 6224

    Tbilisi, 0159

  • Galderma Investigational Site 6228

    Tbilisi, 0159

  • Galderma Investigational Site 6235

    Tbilisi, 0159

  • Galderma Investigational Site 6238

    Tbilisi, 0159

  • Galderma Investigational Site 6227

    Tbilisi, 0186

  • Galderma Investigational Site 6230

    Tbilisi, 0186

  • Galderma Investigational Site 6234

    Tbilisi, 0186

  • Galderma Investigational Site 6236

    Zugdidi, 2100

Other trials in Georgia

Hungary6 sites

  • Galderma Investigational Site 6147

    Budapest, 1036

  • Galderma Investigational Site 5513

    Budapest, 1085

  • Galderma Investigational Site 5567

    Debrecen, 4025

  • Galderma Investigational Site 6026

    Debrecen, 4032

  • Galderma Investigational Site 6254

    Gyula, 5700

  • Galderma Investigational Site 6053

    Veszprém, 8200

Other trials in Hungary

Italy6 sites

  • Galderma Investigational Site 6145

    Bologna, 40138

  • Galderma Investigational Site 6045

    L’Aquila, 67100

  • Galderma Investigational Site 6049

    Roma, 00168

  • Galderma Investigational Site 6177

    Rome, 00144

  • Galderma Investigational Site 6155

    Rozzano, 20089

  • Galderma Investigational Site 6175

    Vicenza, 36100

Other trials in Italy

Belgium5 sites

  • Galderma Investigational Site 5448

    Brussels, 1200

  • Galderma Investigational Site 6163

    Edegem, 2650

  • Galderma Investigational Site 6164

    Ghent, 9000

  • Galderma Investigational Site 6038

    Leuven, Vlaams-Brabant, 3000

  • Galderma Investigational Site 6162

    Liège, Liège, 4000

Other trials in Belgium

Austria4 sites

  • Galderma Investigational Site 6157

    Graz, Styria, 8036

  • Galderma Investigational Site 6156

    Linz, Upper Austria, 4020

  • Galderma Investigational Site 6194

    Vienna, State of Vienna, 1090

  • Galderma Investigational Site 6158

    Vienna, State of Vienna, 1220

Other trials in Austria

Latvia4 sites

  • Galderma Investigational Site 6113

    Liepāja, LV-3401

  • Galderma Investigational Site 6134

    Riga, LV-1006

  • Galderma Investigational Site 6059

    Riga, LV-1009

  • Galderma Investigational Site 6060

    Talsi, LV-3201

Other trials in Latvia

Estonia3 sites

  • Galderma Investigational Site 6068

    Tallinn, 10134

  • Galderma Investigational Site 6069

    Tallinn, 10138

  • Galderma Investigational Site 6067

    Tartu, 50417

Other trials in Estonia

Lithuania3 sites

  • Galderma Investigational Site 6111

    Kaunas, LT-50161

  • Galderma Investigational Site 6073

    Vilnius, LT-07195

  • Galderma Investigational Site 6112

    Vilnius, LT-08411

Other trials in Lithuania

Netherlands3 sites

  • Galderma Investigational Site 6212

    Groningen, 9713

  • Galderma Investigational Site 6108

    Rotterdam, 3015 GD

  • Galderma Investigational Site 6027

    Utrecht, 3584 CX

Other trials in Netherlands

Singapore3 sites

  • Galderma Investigational Site 6124

    Singapore, 119228

  • Galderma Investigational Site 6077

    Singapore, 169608

  • Galderma Investigational Site 5499

    Singapore, 308205

Other trials in Singapore

New Zealand2 sites

  • Galderma Investigational Site 6119

    Hamilton, 3204

  • Galderma Investigational Site 6118

    Wellington, 6021

Other trials in New Zealand

About this study

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

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

Read the detailed description

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

Being tested
Nemolizumab

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NemolizumabDrug

    Also called CD14152

    Nemolizumab

Study groups in NCT03989206
Study groupRoleWhat they receive
NemolizumabExperimentalNemolizumab administered via subcutaneous injection
Receives: Drug: Nemolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence and Severity of TEAEs

    Measured: Baseline to Week 200

  2. Incidence of Serious TEAEs

    Measured: Baseline to Week 200

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

    Measured: Baseline to Week 200

Secondary outcomes (19)

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

    Measured: Baseline to Week 200

  2. Proportion of Participants with EASI-75 at Each Visit

    Measured: Baseline to Week 200

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

    EASI assesses severity and extent of AD signs through a composite score of erythema, induration/population, excoriation, and lichenification. The severity will be assessed on a scale of 0 (absent) to 3 (severe) for each of the 4 body areas: head/neck, trunk, upper limbs, and lower limbs, with half points allowed. The EASI score can range from 0 to 72 with higher scores representing greater severity of atopic dermatitis.

    Measured: Baseline to Week 200

  4. Proportion of Participants with IGA ≤ 2 at Each Visit

    Measured: Baseline to Week 200

  5. Change and Percent Change From Baseline in SCORAD Score at Each Visit

    Measured: Baseline to Week 200

  6. Change and Percent Change From Baseline in Participant-Reported Pruritus Using 10-cm VAS (SCORAD Sub-Component)

    Measured: Baseline to Week 200

  7. Change and Percent Change From Baseline in Participant-Reported Sleep Loss Using 10-cm VAS (SCORAD Sub-Component)

    Measured: Baseline to Week 200

  8. Proportion of Participants Reporting Low Disease Activity State Based on PGAD at Each Visit

    Measured: Baseline to Week 200

  9. Proportion of Participants Satisfied with Study Treatment Based on PGAT at each visit

    Measured: Baseline to Week 200

  10. Change from Baseline in Dermatology Life Quality Index (DLQI)

    Measured: Baseline to Week 200

  11. Change From Baseline in Children's Dermatology Life Quality Index (cDLQI) Total Score at Each Visit Through Week 200

    Measured: Baseline to Week 200

  12. Change From Baseline in Patient-Oriented Eczema Measure (POEM) Total Score at Each Visit Through Week 200

    Measured: Baseline to Week 200

  13. Change From Baseline in Hospital Anxiety and Depression Scale (HADS) for Each Subscale at Each Visit Through Week 200

    Measured: Baseline to Week 200

  14. Change From Baseline in Work Productivity and Activity Impairment: Atopic Dermatitis (WPAI:AD) for Each Subscale at Each Visit Through Week 200

    Measured: Baseline to Week 200

  15. Change From Baseline in EuroQoL 5-Dimension (EQ-5D) at Each Visit Through Week 200

    Measured: Baseline to Week 200

  16. Proportion of Participants Receiving Any Rescue Therapy by Rescue Treatment Type at Any Visit During the Treatment Period

    Measured: Baseline to Week 200

  17. Time to First Relapse

    Measured: Baseline to Week 200

  18. Duration of Remission

    Measured: Baseline to Week 200

  19. Time to Permanent Study Drug Discontinuation

    Measured: Baseline to Week 200

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jun 2019
  2. Study start30 Dec 2019
  3. Primary completion31 Aug 2026
  4. Study completion31 Aug 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
1,935 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03989206
Sponsor's protocol ID
RD.06.SPR.118163
Status last verified
Oct 2026
First submitted
14 Jun 2019
Last updated
20 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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. 2026 May;40(5):841-855. doi: 10.1111/jdv.70080. Epub 2025 Oct 13.

    PubMed 41081535

  • 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.

    PubMed 39068954

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Nemolizumab in people with Moderate-to-Severe Atopic Dermatitis, run by Galderma R&D at 343 sites in 22 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 343 sites in United States, Poland, Germany, Canada, South Korea and 17 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence and Severity of TEAEs (time frame: Baseline to Week 200). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03989206, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.

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