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NCT06988605Recruiting

Real-world Experience Using Nemolizumab in the Treatment of Moderate-to-Severe Atopic Dermatitis in Adolescents & Adults

Galderma R&D

Start Date

7/14/2025

Completion Date

11/30/2027

Summary

The main aim of the study is to assess real-world effectiveness of nemolizumab in Atopic Dermatitis (AD) as measured by physician assessment and patient reported outcome (PRO) in clinical practice at Month 6.

Detailed Description

This prospective, multicenter, non-interventional study (NIS) seeks to evaluate treatment with nemolizumab of moderate-to-severe AD in adolescents and adults over an approximately 12-month period using physician assessments in routine clinical practice and PRO measures. Treatment with nemolizumab will be determined solely by the participant's physician prior to study enrollment. No additional visits, procedures, or laboratory tests are required outside of routine clinical practice. The visit structure is not defined by the study protocol but is determined by routine medical practice. The visit schedule is intended to facilitate a systematic data assessment according to clinical routine. A sub-study will be completed in Germany and the UK at selected sites in which participants will complete the Peak Pruritus (PP) Numerical Rating Scale (NRS), Average Pruritus (AP) NRS, Sleep Disturbance (SD) NRS, and Pain NRS on a daily basis from Day -1 to Day 14. Data collection will occur remotely, and no clinic visits will be required.

Eligibility Criteria

Age Range: 12 years to No maximum

Inclusion Criteria: * Participants who, according to the treating physician's decision and in line with the local package label, start treatment with nemolizumab (Nemluvio®). * Adolescent and adult participants aged \>=12 years with moderate-to-severe AD. * Participants who signed the written informed consent form (ICF) or had it signed by their legal representative. Exclusion Criteria: * Have contraindication(s) for the use of nemolizumab (Nemluvio®) according to the local package label. * Participants who received treatment with a drug under clinical development/investigation within 3 months prior to baseline. * Participants who received nemolizumab previously. * Participants who are mentally, physically, or linguistically unable to understand the content of the ICF and/or to complete the study questionnaires.

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Conditions

Atopic Dermatitis

Locations

Galderma Investigational Site - 8893

Birmingham, Alabama 35244

United States

Galdrma Investigational Site - 7077

Phoenix, Arizona 85006-2754

United States

Galderma Investigational Site 7060

Phoenix, Arizona 85008-3884

United States

Galderma Investigational Site - 8535

Phoenix, Arizona 85032-2238

United States

Galderma Investigational Site - 7067

Tucson, Arizona 85718

United States

Galderma Investigational Site - 7074

Corona, California 92882

United States

Galderma Investigational Site 8636

Fountain Valley, California 92708-3701

United States

Galderma Investigational Site 8224

Fremont, California 94538-1603

United States

Galderma Investigational Site 7099

Los Angeles, California 90024-2801

United States

Galderma Investigational Site 8553

Newport Beach, California 92663-3606

United States

Galderma Investigational Site 7064

Santa Monica, California 90404-2216

United States

Galderma Investigational Site 7107

Thousand Oaks, California 91360-7746

United States

Galderma Investigational Site 7061

Castle Rock, Colorado 80109-8034

United States

Galderma Investigational Site 7059

Fairfield, Connecticut 76824

United States

Galderma Investigational Site 8597

Boca Raton, Florida 33431-5133

United States

Galderma Investigational Site 7087

Coral Gables, Florida 33134-2073

United States

Galderma Investigational Site 7063

Cutler Bay, Florida 33157

United States

Galderma Investigational Site 7134

Hollywood, Florida 33021-6748

United States

Galderma Investigational Site 7101

Jupiter, Florida 33477

United States

Galderma Investigational Site 7078

Miami, Florida 33173

United States

Galderma Investigational Site 7070

North Miami Beach, Florida 33162-4708

United States

Galderma Investigational Site 7112

Oakland Park, Florida 33334

United States

Galderma Investigational Site 7090

St. Petersburg, Florida 33713-8012

United States

Galderma Investigational Site 7054

Tampa, Florida 33609-2230

United States

Galderma Investigational Site 7058

Chicago, Illinois 60641

United States

Galderma Investigational Site 8142

Indianapolis, Indiana 46250-2041

United States

Galderma Investigational Site 7083

West Lafayette, Indiana 47906-1569

United States

Galderma Investigational Site 7098

Columbia, Maryland 21045-2336

United States

Galderma Investigational Site 8012

Glenn Dale, Maryland 20769-9182

United States

Galderma Investigational Site 7068

Rockville, Maryland 20850-6243

United States

Galderma Investigational Site 7065

Brighton, Massachusetts 02135

United States

Galderma Investigationa Site 7104

Milford, Massachusetts 01757

United States

Galderma Investigational Site 7066

Auburn Hills, Michigan 48326-3396

United States

Galderma Investigational Site 7071

Caledonia, Michigan 49316-7478

United States

Galderma Investigational Site 7108

Grandville, Michigan 49418

United States

Galderma Investigational Site 7072

Troy, Michigan 48084-5260

United States

Galderma Investigational Site 7057

Lee's Summit, Missouri 64064

United States

Galderma Investigational Site 8848

Las Vegas, Nevada 89144-0518

United States

Galderma Investigational Site 7055

Portsmouth, New Hampshire 03801-7156

United States

Galderma Investigational Site - Site 7080

Auburn, New York 13021

United States

Galderma Investigational Site # 7052

East Syracuse, New York 13057

United States

Galderma Investigational Site - 8282

Mount Kisco, New York 10549-3035

United States

Galderma Investigational Site - 7051

New York, New York 10023

United States

Galderma Investigational Site 7109

New York, New York 10028

United States

Galderma Investigational Site 8279

New York, New York 10075-0337

United States

Galderma Investigational Site 7081

Dayton, Ohio 45414-2799

United States

Galderma Investigational Site 7073

Gresham, Oregon 97030-2923

United States

Galderma Investigational Site 8559

Philadelphia, Pennsylvania 19103-4738

United States

Galderma Investigational Site 7103

Philadelphia, Pennsylvania 19104

United States

Galderma Investigational Site 7106

Bluffton, South Carolina 29910

United States

Galderma Investigational Site 7082

Cedar Park, Texas 78613-7875

United States

Galderma Investigational Site 8238

Dallas, Texas 75230-5808

United States

Galderma Investigational Site 7062

Edinburg, Texas 78539-4660

United States

Galderma Investigational Site 7088

Grapevine, Texas 76051

United States

Galderma Investigational Site 7069

Sugar Land, Texas 77478-3842

United States

Galderma Investigational Site 8618

Waco, Texas 76710-4023

United States

Galderma Investigational Site 7085

Bountiful, Utah 84010-4801

United States

Galderma Investigational Site 7079

Vienna, Virginia 22182

United States

Galderma Investigational Site 8725

Morgantown, West Virginia 26505-1873

United States

Galderma Investigational Site 6374

Karlsruhe, Baden-Wurttemberg 76133

Germany

Galderma Investigational Site 6412

Langenau, Baden-Wurttemberg 89129

Germany

Galderma Investigational Site 6416

Augsburg, Bavaria 86179

Germany

Galderma Investigational Site 6369

Erlangen, Bavaria 91054

Germany

Galderma Investigational Site 6417

Regensburg, Bavaria 93053

Germany

Galderma Investigational Site 6419

Remscheid, North Rhine-Westphalia 42897

Germany

Galderma Investigational Site 6387

Ahaus, 48683

Germany

Galderma Investigational Site 6383

Augsburg, 86150

Germany

Galderma Investigational Site 6385

Berlin, 10117

Germany

Galderma Investigative Site 6172

Berlin, 12203

Germany

Galderma Investigational Site 6366

Berlin, 13086

Germany

Galderma Investigational Site 6398

Bernau bei Berlin, 16321

Germany

Galderma Investigational Site 6386

Bielefeld, 33647

Germany

Galderma Investigational Site 6066

Buxtehude, 21614

Germany

Galderma Investigational Site 6414

Gladbeck, 45964

Germany

Galderma Investigational Site 6418

Großenhain, 1558

Germany

Galderma Investigational Site 6370

Haslach im Kinzigtal, 77716

Germany

Galderma Investigational Site 6420

Hersbruck, 91217

Germany

Galderma Investigational Site 6384

Koblenz, 56068

Germany

Galderma Investigational Site 6013

Lübeck, 23562

Germany

Galderma Investigational Site 6373

Mainz, 55128

Germany

Galderma Investigational Site 6371

Oberursel, 61440

Germany

Galderma Investigational Site 6411

Oranienburg, 16515

Germany

Galderma Investigational Site 6390

Pforzheim, 75172

Germany

Galderma Investigational Site 6372

Quedlinburg, 6484

Germany

Galderma Investigational Site 5408

London, Hampshire NW3 2QG

United Kingdom

Galderma Investigational Site 6401

Southampton, Hampshire SO16 6YD

United Kingdom

Galderma Investigational Site 6399

Watford, Hertfordshire WD18 0HB

United Kingdom

Galderma Investigational Site 6400

Kings Lynn, Norfolk PE30 4ET

United Kingdom

Galderma Investigational Site 5131

Harrogate, North Yorkshire HG2 7SX

United Kingdom

Galderma Investigational Site 6389

Sheffield, South Yorkshire S10 2TH

United Kingdom

Galderma Investigational Site 6395

London, Surrey SE5 9RS

United Kingdom

Galderma Investigational Site 6392

Birmingham, West Midlands B15 2GW

United Kingdom

Galderma Investigational Site 6404

Leeds, West Yorkshire LS9 7TF

United Kingdom

Galderma Investigational Site 6397

York, Yorkshire YO31 8HE

United Kingdom

Galderma Investigational Site 6375

Bridgend, CF31 1RQ

United Kingdom

Galderma Investigational Site 6388

Epsom, KT18 7EG

United Kingdom

Galderma Investigational Site 6394

Harrow, HA3 7LT

United Kingdom

Galderma Investigational Site 6393

Kingston upon Thames, KT2 7QB

United Kingdom

Galderma Investigational Site 6666

Kirkcaldy, KY2 5AH

United Kingdom

Galderma Investigational Site 6415

Liverpool, L14 5AB

United Kingdom

Galderma Investigational Site 5210

London, E11 1NR

United Kingdom

Galderma Investigational Site 6368

London, SE1 9RT

United Kingdom

Galderma Investigational Site 6396

Manchester, M23 2SY

United Kingdom

Galderma Investigational Site 6402

Metropolitan Borough of Wirral, CH49 5PE

United Kingdom

Galderma Investigational Site 5431

Redhill, RH1 5RH

United Kingdom

Galderma Investigational Site 6403

Sandbach, CW11

United Kingdom

Galderma Investigational Site 5989

Swansea, SA2 8QA

United Kingdom

Galderma Investigational Site 5944

Wolverhampton, WV10 0QP

United Kingdom