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

NCT ID: NCT06988605

Last Updated: 2025-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-07-14

Study Completion Date

2027-11-30

Brief Summary

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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

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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.

Conditions

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Atopic Dermatitis

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Nemolizumab

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

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Galderma R&D

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Galderma Investigational Site 6399

Watford, Hertfordshire, United Kingdom

Site Status RECRUITING

Galderma Investigational Site 6400

Kings Lynn, Norfolk, United Kingdom

Site Status RECRUITING

Galderma Investigational Site 5131

Harrogate, North Yorkshire, United Kingdom

Site Status RECRUITING

Galderma Investigational Site 6389

Sheffield, South Yorkshire, United Kingdom

Site Status RECRUITING

Galderma Investigational Site 6395

London, Surrey, United Kingdom

Site Status RECRUITING

Galderma Investigational Site 6392

Birmingham, West Midlands, United Kingdom

Site Status RECRUITING

Galderma Investigational Site 6404

Leeds, West Yorkshire, United Kingdom

Site Status RECRUITING

Galderma Investigational Site 6397

York, Yorkshire, United Kingdom

Site Status RECRUITING

Galderma Investigational Site 6375

Bridgend, , United Kingdom

Site Status RECRUITING

Galderma Investigational Site 6388

Epsom, , United Kingdom

Site Status RECRUITING

Galderma Investigational Site 6394

Harrow, , United Kingdom

Site Status RECRUITING

Galderma Investigational Site 6393

Kingston upon Thames, , United Kingdom

Site Status RECRUITING

Galderma Investigational Site 6415

Liverpool, , United Kingdom

Site Status RECRUITING

Galderma Investigational Site 5210

London, , United Kingdom

Site Status RECRUITING

Galderma Investigational Site 6368

London, , United Kingdom

Site Status RECRUITING

Galderma Investigational Site 6396

Manchester, , United Kingdom

Site Status RECRUITING

Galderma Investigational Site 6402

Metropolitan Borough of Wirral, , United Kingdom

Site Status RECRUITING

Galderma Investigational Site 5431

Redhill, , United Kingdom

Site Status RECRUITING

Galderma Investigational Site 6403

Sandbach, , United Kingdom

Site Status RECRUITING

Galderma Investigational Site 5989

Swansea, , United Kingdom

Site Status RECRUITING

Galderma Investigational Site 5944

Wolverhampton, , United Kingdom

Site Status RECRUITING

Galderma Investigational Site - 8893

Birmingham, Alabama, United States

Site Status RECRUITING

Galdrma Investigational Site - 7077

Phoenix, Arizona, United States

Site Status NOT_YET_RECRUITING

Galderma Investigational Site 7060

Phoenix, Arizona, United States

Site Status RECRUITING

Galderma Investigational Site - 8535

Phoenix, Arizona, United States

Site Status ACTIVE_NOT_RECRUITING

Galderma Investigational Site - 7067

Tucson, Arizona, United States

Site Status RECRUITING

Galderma Investigational Site - 7074

Corona, California, United States

Site Status RECRUITING

Galderma Investigational Site 6836

Fountain Valley, California, United States

Site Status RECRUITING

Galderma Investigational Site 8224

Fremont, California, United States

Site Status NOT_YET_RECRUITING

Galderma Investigational Site 7100

Irvine, California, United States

Site Status RECRUITING

Galderma Investigational Site 7099

Los Angeles, California, United States

Site Status RECRUITING

Galderma Investigational Site 8553

Newport Beach, California, United States

Site Status NOT_YET_RECRUITING

Galderma Investigational Site 6836

San Francisco, California, United States

Site Status RECRUITING

Galderma Investigational Site

Santa Monica, California, United States

Site Status RECRUITING

Galderma Investigational Site 7107

Thousand Oaks, California, United States

Site Status RECRUITING

Galderma Investigational Site 7061

Castle Rock, Colorado, United States

Site Status RECRUITING

Galderma Investigational Site 7059

Fairfield, Connecticut, United States

Site Status NOT_YET_RECRUITING

Galderma Investigational Site 7105

Coral Gables, Florida, United States

Site Status RECRUITING

Galderma Investigational Site 7063

Cutler Bay, Florida, United States

Site Status RECRUITING

Galderma Investigational Site 7101

Jupiter, Florida, United States

Site Status RECRUITING

Galderma Investigational Site 7021

Miami, Florida, United States

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Galderma Investigational Site 7084

Miami, Florida, United States

Site Status RECRUITING

Galderma Investigational Site 7078

Miami, Florida, United States

Site Status RECRUITING

Galderma Investigational Site 7070

North Miami Beach, Florida, United States

Site Status RECRUITING

Galderma Investigational Site 7090

St. Petersburg, Florida, United States

Site Status RECRUITING

Galderma Investigational Site 7054

Tampa, Florida, United States

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Galderma Investigational Site 7054

Tampa, Florida, United States

Site Status RECRUITING

Galderma Investigational Site 7091

Tampa, Florida, United States

Site Status RECRUITING

Galderma Investigational Site 7058

Chicago, Illinois, United States

Site Status RECRUITING

Galderma Investigational Site 8142

Indianapolis, Indiana, United States

Site Status RECRUITING

Galderma Investigational Site 7083

West Lafayette, Indiana, United States

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Galderma Investigational Site 7098

Columbia, Maryland, United States

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Galderma Investigational Site 8012

Glenn Dale, Maryland, United States

Site Status RECRUITING

Galderma Investigational Site 7068

Rockville, Maryland, United States

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Galderma Investigational Site 7065

Brighton, Massachusetts, United States

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Galderma Investigationa Site 7104

Milford, Massachusetts, United States

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Galderma Investigational Site 7066

Auburn Hills, Michigan, United States

Site Status RECRUITING

Galderma Investigational Site 7071

Caledonia, Michigan, United States

Site Status RECRUITING

Galderma Investigational Site 7108

Grandville, Michigan, United States

Site Status RECRUITING

Galderma Investigational Site 7072

Troy, Michigan, United States

Site Status NOT_YET_RECRUITING

Galderma Investigational Site 7057

Lee's Summit, Missouri, United States

Site Status NOT_YET_RECRUITING

Galderma Investigational Site 7076

St Louis, Missouri, United States

Site Status RECRUITING

Galderma Investigational Site 8848

Las Vegas, Nevada, United States

Site Status RECRUITING

Galderma Investigational Site 7055

Portsmouth, New Hampshire, United States

Site Status RECRUITING

Galderma Investigational Site - Site 7080

Auburn, New York, United States

Site Status RECRUITING

Galderma Investigational Site # 7052

East Syracuse, New York, United States

Site Status NOT_YET_RECRUITING

Galderma Investigational Site - 8282

Mount Kisco, New York, United States

Site Status NOT_YET_RECRUITING

Galderma Investigational Site - 7051

New York, New York, United States

Site Status RECRUITING

Galderma Investigational Site 7109

New York, New York, United States

Site Status RECRUITING

Galderma Investigational Site 8279

New York, New York, United States

Site Status RECRUITING

Galderma Investigational Site 7081

Dayton, Ohio, United States

Site Status RECRUITING

Galderma Investigational Site 7073

Gresham, Oregon, United States

Site Status RECRUITING

Galderma Investigational Site 8559

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Galderma Investigational Site 7103

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Galderma Investigational Site 7106

Bluffton, South Carolina, United States

Site Status RECRUITING

Galderma Investigational Site 7082

Cedar Park, Texas, United States

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Galderma Investigational Site 8238

Dallas, Texas, United States

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Galderma Investigational Site 7062

Edinburg, Texas, United States

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Galderma Investigational Site 7088

Grapevine, Texas, United States

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Galderma Investigational Site 7102

Houston, Texas, United States

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Galderma Investigational Site 7069

Sugar Land, Texas, United States

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Galderma Investigational Site 8618

Waco, Texas, United States

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Galderma Investigational Site 7085

Bountiful, Utah, United States

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Galderma Investigational Site 7079

Vienna, Virginia, United States

Site Status RECRUITING

Galderma Investigational Site 6374

Karlsruhe, Baden-Wurttemberg, Germany

Site Status RECRUITING

Galderma Investigational Site 6412

Langenau, Baden-Wurttemberg, Germany

Site Status RECRUITING

Galderma Investigational Site 6416

Augsburg, Bavaria, Germany

Site Status RECRUITING

Galderma Investigational Site 6369

Erlangen, Bavaria, Germany

Site Status RECRUITING

Galderma Investigational Site 6417

Regensburg, Bavaria, Germany

Site Status RECRUITING

Galderma Investigational Site 6419

Remscheid, North Rhine-Westphalia, Germany

Site Status RECRUITING

Galderma Investigational Site 6387

Ahaus, , Germany

Site Status RECRUITING

Galderma Investigational Site 6383

Augsburg, , Germany

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Galderma Investigational Site 6385

Berlin, , Germany

Site Status RECRUITING

Galderma Investigative Site 6172

Berlin, , Germany

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Galderma Investigational Site 6366

Berlin, , Germany

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Galderma Investigational Site 6398

Bernau bei Berlin, , Germany

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Galderma Investigational Site 6386

Bielefeld, , Germany

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Galderma Investigational Site 6066

Buxtehude, , Germany

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Galderma Investigational Site 6414

Gladbeck, , Germany

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Galderma Investigational Site 6418

Großenhain, , Germany

Site Status RECRUITING

Galderma Investigational Site 6370

Haslach im Kinzigtal, , Germany

Site Status RECRUITING

Galderma Investigational Site 6420

Hersbruck, , Germany

Site Status RECRUITING

Galderma Investigational Site 6384

Koblenz, , Germany

Site Status RECRUITING

Galderma Investigational Site 6013

Lübeck, , Germany

Site Status RECRUITING

Galderma Investigational Site 6373

Mainz, , Germany

Site Status RECRUITING

Galderma Investigational Site 6371

Oberursel, , Germany

Site Status RECRUITING

Galderma Investigational Site 6411

Oranienburg, , Germany

Site Status RECRUITING

Galderma Investigational Site 6390

Pforzheim, , Germany

Site Status RECRUITING

Galderma Investigational Site 6372

Quedlinburg, , Germany

Site Status RECRUITING

Galderma Investigational Site 5408

London, Hampshire, United Kingdom

Site Status RECRUITING

Galderma Investigational Site 6401

Southampton, Hampshire, United Kingdom

Site Status RECRUITING

Countries

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United States Germany United Kingdom

Central Contacts

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Galderma Research and Development

Role: CONTACT

817-961-5000

Facility Contacts

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Clinical Project Manager

Role: primary

Clinical Project Manager

Role: primary

Clinical Project Manager

Role: primary

Clinical Project Manager

Role: primary

Clinical Project Manager

Role: primary

Clinical Project Manager

Role: primary

Clinial Project Manager

Role: primary

Clinical Project Manager

Role: primary

Other Identifiers

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SPR207806

Identifier Type: -

Identifier Source: org_study_id

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