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

NCT06988605 | Recruiting

• 1 other identifier: SPR207806
• Study Type: observational
• Target: 1,000
• Locations: 3 countries
• Sites: 108

Brief 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.

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (2)

• Investigator Global Assessment (IGA) at Month 6

  The IGA is a 5-point scale ranging from 0 (clear) to 4 (severe) used by the investigator or trained designee to evaluate the global severity of AD and the clinical response to a treatment.

  At Month 6

• Peak Pruritus Numerical Rating Scale (PP NRS) at Month 6

  The PP NRS is a single question validated PRO assessment that participants will use to report the maximum intensity of their pruritus (itch). The PP NRS consists of the following question: "On a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable', how would you rate your itch at the worst moment during the previous 24 hours?". Here, a lower score indicates a better outcome.

  At Month 6

Secondary Outcomes (7)

• Eczema Area and Severity Index (EASI) up to Month 12

  Up to Month 12

• Scoring Atopic Dermatitis (SCORAD) up to Month 12

  Up to Month 12

• Investigator Global Assessment (IGA) up to Month 12

  Up to Month 12

• Peak Pruritus Numerical Rating Scale (PP NRS) up to Month 12

  Up to Month 12

• Average Pruritus Numerical Rating Scale (AP NRS) up to Month 12

  Up to Month 12

Study Arms (1)

Nemolizumab

Participants with moderate-to-severe AD who are receiving nemolizumab (Nemluvio®) in routine clinical practice will be observed for approximately 12 months.

Eligibility Criteria

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

Study Population

The clinical decision for treatment with nemolizumab has to be made by the physicians independently of the participation in this NIS and prior to the informed consent process. Participants greater than or equal to (\>=) 12 years of age will be eligible for the trial.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Galderma R&D: lead

Study Sites (108)

Galderma Investigational Site - 8893

Birmingham, Alabama, 35244, United States

ACTIVE NOT RECRUITING

Galdrma Investigational Site - 7077

Phoenix, Arizona, 85006-2754, United States

RECRUITING

Galderma Investigational Site 7060

Phoenix, Arizona, 85008-3884, United States

RECRUITING

Galderma Investigational Site - 8535

Phoenix, Arizona, 85032-2238, United States

RECRUITING

Galderma Investigational Site - 7067

Tucson, Arizona, 85718, United States

NOT YET RECRUITING

Galderma Investigational Site - 7074

Corona, California, 92882, United States

NOT YET RECRUITING

Galderma Investigational Site 8636

Fountain Valley, California, 92708-3701, United States

NOT YET RECRUITING

Galderma Investigational Site 8224

Fremont, California, 94538-1603, United States

RECRUITING

Galderma Investigational Site 7099

Los Angeles, California, 90024-2801, United States

NOT YET RECRUITING

Galderma Investigational Site 8553

Newport Beach, California, 92663-3606, United States

RECRUITING

Galderma Investigational Site 7064

Santa Monica, California, 90404-2216, United States

NOT YET RECRUITING

Galderma Investigational Site 7107

Thousand Oaks, California, 91360-7746, United States

NOT YET RECRUITING

Galderma Investigational Site 7061

Castle Rock, Colorado, 80109-8034, United States

NOT YET RECRUITING

Galderma Investigational Site 7059

Fairfield, Connecticut, 76824, United States

RECRUITING

Galderma Investigational Site 8597

Boca Raton, Florida, 33431-5133, United States

NOT YET RECRUITING

Galderma Investigational Site 7087

Coral Gables, Florida, 33134-2073, United States

NOT YET RECRUITING

Galderma Investigational Site 7063

Cutler Bay, Florida, 33157, United States

RECRUITING

Galderma Investigational Site 7134

Hollywood, Florida, 33021-6748, United States

RECRUITING

Galderma Investigational Site 7101

Jupiter, Florida, 33477, United States

NOT YET RECRUITING

Galderma Investigational Site 7078

Miami, Florida, 33173, United States

RECRUITING

Galderma Investigational Site 7070

North Miami Beach, Florida, 33162-4708, United States

NOT YET RECRUITING

Galderma Investigational Site 7112

Oakland Park, Florida, 33334, United States

NOT YET RECRUITING

Galderma Investigational Site 7090

St. Petersburg, Florida, 33713-8012, United States

RECRUITING

Galderma Investigational Site 7054

Tampa, Florida, 33609-2230, United States

RECRUITING

Galderma Investigational Site 7058

Chicago, Illinois, 60641, United States

RECRUITING

Galderma Investigational Site 8142

Indianapolis, Indiana, 46250-2041, United States

RECRUITING

Galderma Investigational Site 7083

West Lafayette, Indiana, 47906-1569, United States

NOT YET RECRUITING

Galderma Investigational Site 7098

Columbia, Maryland, 21045-2336, United States

RECRUITING

Galderma Investigational Site 8012

Glenn Dale, Maryland, 20769-9182, United States

RECRUITING

Galderma Investigational Site 7068

Rockville, Maryland, 20850-6243, United States

RECRUITING

Galderma Investigational Site 7065

Brighton, Massachusetts, 02135, United States

RECRUITING

Galderma Investigationa Site 7104

Milford, Massachusetts, 01757, United States

RECRUITING

Galderma Investigational Site 7066

Auburn Hills, Michigan, 48326-3396, United States

NOT YET RECRUITING

Galderma Investigational Site 7071

Caledonia, Michigan, 49316-7478, United States

RECRUITING

Galderma Investigational Site 7108

Grandville, Michigan, 49418, United States

NOT YET RECRUITING

Galderma Investigational Site 7072

Troy, Michigan, 48084-5260, United States

NOT YET RECRUITING

Galderma Investigational Site 7057

Lee's Summit, Missouri, 64064, United States

RECRUITING

Galderma Investigational Site 8848

Las Vegas, Nevada, 89144-0518, United States

RECRUITING

Galderma Investigational Site 7055

Portsmouth, New Hampshire, 03801-7156, United States

RECRUITING

Galderma Investigational Site - Site 7080

Auburn, New York, 13021, United States

RECRUITING

Galderma Investigational Site # 7052

East Syracuse, New York, 13057, United States

RECRUITING

Galderma Investigational Site - 8282

Mount Kisco, New York, 10549-3035, United States

NOT YET RECRUITING

Galderma Investigational Site - 7051

New York, New York, 10023, United States

RECRUITING

Galderma Investigational Site 7109

New York, New York, 10028, United States

RECRUITING

Galderma Investigational Site 8279

New York, New York, 10075-0337, United States

NOT YET RECRUITING

Galderma Investigational Site 7081

Dayton, Ohio, 45414-2799, United States

RECRUITING

Galderma Investigational Site 7073

Gresham, Oregon, 97030-2923, United States

RECRUITING

Galderma Investigational Site 8559

Philadelphia, Pennsylvania, 19103-4738, United States

NOT YET RECRUITING

Galderma Investigational Site 7103

Philadelphia, Pennsylvania, 19104, United States

NOT YET RECRUITING

Galderma Investigational Site 7106

Bluffton, South Carolina, 29910, United States

NOT YET RECRUITING

Galderma Investigational Site 7082

Cedar Park, Texas, 78613-7875, United States

RECRUITING

Galderma Investigational Site 8238

Dallas, Texas, 75230-5808, United States

RECRUITING

Galderma Investigational Site 7062

Edinburg, Texas, 78539-4660, United States

NOT YET RECRUITING

Galderma Investigational Site 7088

Grapevine, Texas, 76051, United States

RECRUITING

Galderma Investigational Site 7069

Sugar Land, Texas, 77478-3842, United States

RECRUITING

Galderma Investigational Site 8618

Waco, Texas, 76710-4023, United States

NOT YET RECRUITING

Galderma Investigational Site 7085

Bountiful, Utah, 84010-4801, United States

NOT YET RECRUITING

Galderma Investigational Site 7079

Vienna, Virginia, 22182, United States

NOT YET RECRUITING

Galderma Investigational Site 8725

Morgantown, West Virginia, 26505-1873, United States

RECRUITING

Galderma Investigational Site 6374

Karlsruhe, Baden-Wurttemberg, 76133, Germany

RECRUITING

Galderma Investigational Site 6412

Langenau, Baden-Wurttemberg, 89129, Germany

RECRUITING

Galderma Investigational Site 6416

Augsburg, Bavaria, 86179, Germany

RECRUITING

Galderma Investigational Site 6369

Erlangen, Bavaria, 91054, Germany

RECRUITING

Galderma Investigational Site 6417

Regensburg, Bavaria, 93053, Germany

RECRUITING

Galderma Investigational Site 6419

Remscheid, North Rhine-Westphalia, 42897, Germany

RECRUITING

Galderma Investigational Site 6387

Ahaus, 48683, Germany

RECRUITING

Galderma Investigational Site 6383

Augsburg, 86150, Germany

RECRUITING

Galderma Investigational Site 6385

Berlin, 10117, Germany

RECRUITING

Galderma Investigative Site 6172

Berlin, 12203, Germany

RECRUITING

Galderma Investigational Site 6366

Berlin, 13086, Germany

RECRUITING

Galderma Investigational Site 6398

Bernau bei Berlin, 16321, Germany

RECRUITING

Galderma Investigational Site 6386

Bielefeld, 33647, Germany

RECRUITING

Galderma Investigational Site 6066

Buxtehude, 21614, Germany

RECRUITING

Galderma Investigational Site 6414

Gladbeck, 45964, Germany

RECRUITING

Galderma Investigational Site 6418

Großenhain, 1558, Germany

RECRUITING

Galderma Investigational Site 6370

Haslach im Kinzigtal, 77716, Germany

RECRUITING

Galderma Investigational Site 6420

Hersbruck, 91217, Germany

RECRUITING

Galderma Investigational Site 6384

Koblenz, 56068, Germany

RECRUITING

Galderma Investigational Site 6013

Lübeck, 23562, Germany

RECRUITING

Galderma Investigational Site 6373

Mainz, 55128, Germany

RECRUITING

Galderma Investigational Site 6371

Oberursel, 61440, Germany

RECRUITING

Galderma Investigational Site 6411

Oranienburg, 16515, Germany

RECRUITING

Galderma Investigational Site 6390

Pforzheim, 75172, Germany

RECRUITING

Galderma Investigational Site 6372

Quedlinburg, 6484, Germany

RECRUITING

Galderma Investigational Site 5408

London, Hampshire, NW3 2QG, United Kingdom

RECRUITING

Galderma Investigational Site 6401

Southampton, Hampshire, SO16 6YD, United Kingdom

RECRUITING

Galderma Investigational Site 6399

Watford, Hertfordshire, WD18 0HB, United Kingdom

RECRUITING

Galderma Investigational Site 6400

Kings Lynn, Norfolk, PE30 4ET, United Kingdom

RECRUITING

Galderma Investigational Site 5131

Harrogate, North Yorkshire, HG2 7SX, United Kingdom

RECRUITING

Galderma Investigational Site 6389

Sheffield, South Yorkshire, S10 2TH, United Kingdom

RECRUITING

Galderma Investigational Site 6395

London, Surrey, SE5 9RS, United Kingdom

RECRUITING

Galderma Investigational Site 6392

Birmingham, West Midlands, B15 2GW, United Kingdom

RECRUITING

Galderma Investigational Site 6404

Leeds, West Yorkshire, LS9 7TF, United Kingdom

RECRUITING

Galderma Investigational Site 6397

York, Yorkshire, YO31 8HE, United Kingdom

RECRUITING

Galderma Investigational Site 6375

Bridgend, CF31 1RQ, United Kingdom

RECRUITING

Galderma Investigational Site 6388

Epsom, KT18 7EG, United Kingdom

RECRUITING

Galderma Investigational Site 6394

Harrow, HA3 7LT, United Kingdom

RECRUITING

Galderma Investigational Site 6393

Kingston upon Thames, KT2 7QB, United Kingdom

RECRUITING

Galderma Investigational Site 6666

Kirkcaldy, KY2 5AH, United Kingdom

NOT YET RECRUITING

Galderma Investigational Site 6415

Liverpool, L14 5AB, United Kingdom

RECRUITING

Galderma Investigational Site 5210

London, E11 1NR, United Kingdom

RECRUITING

Galderma Investigational Site 6368

London, SE1 9RT, United Kingdom

RECRUITING

Galderma Investigational Site 6396

Manchester, M23 2SY, United Kingdom

RECRUITING

Galderma Investigational Site 6402

Metropolitan Borough of Wirral, CH49 5PE, United Kingdom

RECRUITING

Galderma Investigational Site 5431

Redhill, RH1 5RH, United Kingdom

RECRUITING

Galderma Investigational Site 6403

Sandbach, CW11, United Kingdom

RECRUITING

Galderma Investigational Site 5989

Swansea, SA2 8QA, United Kingdom

RECRUITING

Galderma Investigational Site 5944

Wolverhampton, WV10 0QP, United Kingdom

RECRUITING

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Central Study Contacts

Galderma Research and Development

CONTACT

817-961-5000; clinical.studies@galderma.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2025
• First Posted: May 25, 2025
• Study Start: July 14, 2025
• Primary Completion (Estimated): November 6, 2026
• Study Completion (Estimated): November 30, 2027
• Last Updated: March 13, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (59); DE (25); GB (24)