Efficacy and Safety of Nemolizumab in Subjects With Moderate-to-Severe Atopic Dermatitis

NCT ID: NCT03985943

Last Updated: 2024-08-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 941 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-27
• Study Completion Date: 2022-08-11

Brief Summary

The main purpose of the study was to assess the efficacy and safety of nemolizumab after a 16-week treatment period in adult and adolescent subjects with moderate-to-severe atopic dermatitis (AD) not adequately controlled with topical treatments.

Detailed Description

This was a randomized, double-blind, placebo-controlled, multi-center, parallel-group study in adult and adolescent subjects of age 12 years and above with moderate-to-severe AD. Eligible subjects had a documented history of inadequate response to topical AD medication(s). Approximately 750 subjects were randomized in 2:1 to receive either nemolizumab or placebo, stratified by baseline disease severity (Investigator's Global Assessment (IGA) = 3, moderate; IGA = 4, severe) and peak pruritus numeric rating scale (PP NRS) severity (PP NRS >= 7; PP NRS < 7). A minimum of 250 subjects were randomized in each PP NRS strata. All nemolizumab-treated subjects who were clinical responders at Week 16 (i.e., the end of initial treatment [Initial Treatment Period]/beginning of Maintenance Period) were re-randomized (1:1:1) to different treatment regimens (nemolizumab injections Q4W or every 8 weeks (Q8W) [with placebo injections at Weeks 20, 28, 36, and 44 to maintain the blind] or placebo Q4W). A clinical responder was defined as a subject at Week 16 with an IGA of 0 (clear) or 1 (almost clear) or a >= 75% improvement in EASI from baseline (EASI-75). All placebo-treated subjects who responded to placebo during the Initial Treatment Period continued to receive placebo Q4W in the Maintenance Period.

Conditions

Moderate-to-Severe Atopic Dermatitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo

Nemolizumab

Nemolizumab Active

Group Type: EXPERIMENTAL

Nemolizumab

Intervention Type: DRUG

Nemolizumab

Interventions

Placebo

Placebo

Intervention Type: DRUG

Nemolizumab

Nemolizumab

Intervention Type: DRUG

Other Intervention Names

CD14152

Eligibility Criteria

Inclusion Criteria

• Male or female subjects aged greater than and equal to (>=) 12 years at the screening visit.
• Chronic atopic dermatitis (according to American Academy of Dermatology Consensus Criteria) that has been present for at least 2 years before the screening visit.
• Eczema Area and Severity Index (EASI) score >=16 at the screening and baseline visits.
• Investigator Global Assessment (IGA) score >= 3 (scale of 0 to 4) at the screening and baseline visits.
• AD involvement >= 10 percent (%) of body surface area (BSA) at screening and baseline visits.
• Peak Pruritus Numerical Rating Scale (PPNRS) score of at least 4.0 at the screening and baseline visit.
• Documented recent history of inadequate response to topical medications (topical corticosteroids [TCS] with or without Topical calcineurin inhibitors [TCI]).
• Female subjects of childbearing potential (that is, fertile, following menarche and until becoming postmenopausal 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 adequate and approved method of contraception throughout the study and for 12 weeks after the last study drug injection.

Exclusion Criteria

• Body weight (<) 30 kilograms (kg).
• Exacerbation of asthma requiring hospitalization in the preceding 12 months. Uncontrolled asthma in the preceding 3 months.
• 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.
• Pregnant women, breastfeeding women, or women planning a pregnancy during the clinical study.

Note: Subjects with chronic, stable use of prophylactic treatment for recurrent herpes viral infection can be included in this clinical study.

• History of hypersensitivity (including anaphylaxis) to an immunoglobulin product (plasma-derived or recombinant, example, monoclonal antibody) or to any of the study drug excipients.
• Any clinically significant issue, based on investigator judgement.

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Galderma R&D

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Galderma Investigational Site 8880

North Little Rock, Arkansas, United States

Galderma Investigational Site 8578

Cerritos, California, United States

Galderma Investigational Site 8636

Fountain Valley, California, United States

Galderma Investigational Site 8888

Fullerton, California, United States

Galderma Investigational Site 8686

Lomita, California, United States

Galderma Investigational Site 8674

Los Angeles, California, United States

Galderma Investigational Site 8125

San Francisco, California, United States

Galderma Investigational Site 8895

Santa Ana, California, United States

Galderma Investigational Site 8608

Santa Monica, California, United States

Galderma Investigational Site 8897

Brandon, Florida, United States

Galderma Investigational Site 8805

Cape Coral, Florida, United States

Galderma Investigational Site 8902

Doral, Florida, United States

Galderma Investigational Site 8804

Hialeah, Florida, United States

Galderma Investigational Site 8711

Jacksonville, Florida, United States

Galderma Investigational Site 8710

Miami, Florida, United States

Galderma Investigational Site 8801

Miami, Florida, United States

Galderma Investigational Site 8737

Miami, Florida, United States

Galderma Investigational Site 8708

Miami, Florida, United States

Galderma Investigational Site 8806

Miami Lakes, Florida, United States

Galderma Investigational Site 8800

Miami Lakes, Florida, United States

Galderma Investigational Site 8734

Pembroke Pines, Florida, United States

Galderma Investigational Site 8744

Macon, Georgia, United States

Galderma Investigational Site 8728

Newnan, Georgia, United States

Galderma Investigational Site 8887

Union City, Georgia, United States

Galderma Investigational Site 8890

Blackfoot, Idaho, United States

Galderma Investigational Site 8819

Nampa, Idaho, United States

Galderma Investigational Site 8571

Skokie, Illinois, United States

Galderma Investigational Site 8712

Skokie, Illinois, United States

Galderma Investigational Site 8142

Indianapolis, Indiana, United States

Galderma Investigational Site 8771

Louisville, Kentucky, United States

Galderma Investigational Site 8882

Bangor, Maine, United States

Galderma Investigational Site 8743

Ann Arbor, Michigan, United States

Galderma Investigational Site 8512

Bay City, Michigan, United States

Galderma Investigational Site 8155

Troy, Michigan, United States

Galderma Investigational Site 8748

Ypsilanti, Michigan, United States

Galderma Investigational Site 8521

Saint Joseph, Missouri, United States

Galderma Investigational Site 8718

Missoula, Montana, United States

Galderma Investigational Site 8810

Omaha, Nebraska, United States

Galderma Investigational Site 8740

Henderson, Nevada, United States

Galderma Investigational Site 8242

Brooklyn, New York, United States

Galderma Investigational Site 8620

New York, New York, United States

Galderma Investigational Site 8279

New York, New York, United States

Galderma Investigational Site 8648

Wilmington, North Carolina, United States

Galderma Investigational Site 8702

Bexley, Ohio, United States

Galderma Investigational Site 8595

Dublin, Ohio, United States

Galderma Investigational Site 8206

Norman, Oklahoma, United States

Galderma Investigational Site 8857

Oklahoma City, Oklahoma, United States

Galderma Investigational Site 8255

Philadelphia, Pennsylvania, United States

Galderma Investigational Site 8802

Plymouth Meeting, Pennsylvania, United States

Galderma Investigational Site 8736

Charleston, South Carolina, United States

Galderma Investigational Site 8818

Rapid City, South Dakota, United States

Galderma Investigational Site 8133

Arlington, Texas, United States

Galderma Investigational Site 8238

Dallas, Texas, United States

Galderma Investigational Site 8827

Dripping Springs, Texas, United States

Galderma Investigational Site 8664

Frisco, Texas, United States

Galderma Investigational Site 8042

Houston, Texas, United States

Galderma Investigational Site 8862

Fairfax, Virginia, United States

Galderma Investigational Site 5441

Darlinghurst, New South Wales, Australia

Galderma Investigational Site 5759

Kogarah, New South Wales, Australia

Galderma Investigational Site 6152

Westmead, New South Wales, Australia

Galderma Investigational Site 5638

Benowa, Queensland, Australia

Galderma Investigational Site 6161

Brisbane, Queensland, Australia

Galderma Investigational Site 6159

Woodville, South Australia, Australia

Galderma Investigational Site 6131

Carlton, Victoria, Australia

Galderma Investigational Site 5366

East Melbourne, Victoria, Australia

Galderma Investigational Site 5458

Parkville, Victoria, Australia

Galderma Investigational Site 5453

Fremantle, Western Australia, Australia

Galderma Investigational Site 6153

Victoria Park, Western Australia, Australia

Galderma Investigational Sites 6157

Graz, Styria, Austria

Galderma Investigational Site 6194

Vienna, Vienna, Austria

Galderma Investigational Site 6158

Vienna, , Austria

Galderma Investigational Site 8085

Calgary, Alberta, Canada

Galderma Investigational Site 8903

Calgary, Alberta, Canada

Galderma Investigational Site 8215

Calgary, Alberta, Canada

Galderma Investigational Site 8088

Edmonton, Alberta, Canada

Galderma Investigational Site 8824

Edmonton, Alberta, Canada

Galderma Investigational Site 8722

Edmonton, Alberta, Canada

Galderma Investigational Site 8161

Surrey, British Columbia, Canada

Galderma Investigational Site 8586

Barrie, Ontario, Canada

Galderma Investigational Site 8904

Guelph, Ontario, Canada

Galderma Investigational Site 8901

Ottawa, Ontario, Canada

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Toronto, Ontario, Canada

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Toronto, Ontario, Canada

Galderma Investigational Site 8780

Niagara Falls, , Canada

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Ottawa, , Canada

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Saint John, , Canada

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Waterloo, , Canada

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Brno, , Czechia

Galderma Investigational Site 5225

Náchod, , Czechia

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Olomouc, , Czechia

Galderma Investigational Site 6024

Prague, , Czechia

Galderma Investigational Site 6054

Prague, , Czechia

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Prague, , Czechia

Galderma Investigational Site 6240

Prague, , Czechia

Galderma Investigational Site 6025

Prague, , Czechia

Galderma Investigational Site 6146

Langenau, Hesse, Germany

Galderma Investigational Site 6214

Tübingen, Niedersachesen, Germany

Galderma Investigational Site 6172

Berlin, North Rhine-Westphalia, Germany

Galderma Investigational Site 5437

Kiel, Schleswig-Holst, Germany

Galderma Investigational Site 6022

Bad Bentheim, , Germany

Galderma Investigational Site 6110

Berlin, , Germany

Galderma Investigational Site 6061

Bielefeld, , Germany

Galderma Investigational Site 6066

Buxtehude, , Germany

Galderma Investigational Site 5368

Darmstadt, , Germany

Galderma Investigational Site 6028

Dülmen, , Germany

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Münster, , Germany

Galderma Investigational Site 5918

Osnabrück, , Germany

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Stuttgart, , Germany

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Liepāja, , Latvia

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Riga, , Latvia

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Riga, , Latvia

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Talsi, , Latvia

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Kaunas, , Lithuania

Galderma Investigational Site 6072

Klaipėda, , Lithuania

Galderma Investigational Site 6112

Vilnius, , Lithuania

Galderma Investigational Site 6212

Groningen, , Netherlands

Galderma Investigational Site 6108

Rotterdam, , Netherlands

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Utrecht, , Netherlands

Galderma Investigational Site 6119

Hamilton, , New Zealand

Galderma Investigational Site 6118

Wellington, , New Zealand

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Częstochowa, , Poland

Galderma Investigational Site 6075

Gdansk, , Poland

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Gdansk, , Poland

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Gdansk, , Poland

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Gdynia, , Poland

Galderma Investigational Site 6087

Katowice, , Poland

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Lodz, , Poland

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Lodz, , Poland

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Lodz, , Poland

Galderma Investigational Site 6071

Lublin, , Poland

Galderma Investigational Site 6237

Ostrowiec Świętokrzyski, , Poland

Galderma Investigational Site 6127

Poznan, , Poland

Galderma Investigational Site 6223

Szczecin, , Poland

Galderma Investigational Site 6065

Warsaw, , Poland

Galderma Investigational Site 6122

Warsaw, , Poland

Galderma Investigational Site 6242

Warsaw, , Poland

Galderma Investigational Site 6064

Warsaw, , Poland

Galderma Investigational Site 6222

Warsaw, , Poland

Galderma Investigational Site 6047

Wroclaw, , Poland

Galderma Investigational Site 5005

Wroclaw, , Poland

Galderma Investigational Site 6095

Bucheon-si, , South Korea

Galderma Investigational Site 6100

Busan, , South Korea

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Gyeonggi-do, , South Korea

Galderma Investigational Site 6154

Gyeonggi-do, , South Korea

Galderma Investigational Site 6138

Incheon, , South Korea

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Incheon, , South Korea

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Incheon, , South Korea

Galderma Investigational Site 6105

Seoul, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

Galderma Investigational Site 6099

Seoul, , South Korea

Galderma Investigational Site 6057

Alicante, , Spain

Galderma Investigational Site 6037

Barcelona, , Spain

Galderma Investigational Site 6035

Barcelona, , Spain

Galderma Investigational Site 5580

Barcelona, , Spain

Galderma Investigational Site 6106

Las Palmas de Gran Canaria, , Spain

Galderma Investigational Site 6058

Madrid, , Spain

Galderma Investigational Site 5842

Madrid, , Spain

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Madrid, , Spain

Galderma Investigational Site 6036

Madrid, , Spain

Galderma Investigational Site 5551

Madrid, , Spain

Galderma Investigational Site 6191

Pamplona, , Spain

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Barnsley, , United Kingdom

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Blackpool, , United Kingdom

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Cannock, , United Kingdom

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Glasgow, , United Kingdom

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Liverpool, , United Kingdom

Galderma Investigational Site 6121

London, , United Kingdom

Galderma Investigational Site 6205

Manchester, , United Kingdom

Galderma Investigational Site 6206

Stockton-on-Tees, , United Kingdom

Countries

United States; Australia; Austria; Canada; Czechia; Germany; Latvia; Lithuania; Netherlands; New Zealand; Poland; South Korea; Spain; United Kingdom

References

Silverberg JI, Filipenko D, Dias Barbosa C, Rodriguez D, Chambenoit O, Jack K, Piketty C, Subramanian R, Puelles J. Patients' Experiences of Atopic Dermatitis and Nemolizumab Treatment: An In-Trial Interview Study Embedded in a Phase 3 Clinical Trial (ARCADIA). Patient. 2025 Sep;18(5):511-521. doi: 10.1007/s40271-025-00741-x. Epub 2025 May 13.

Reference Type: DERIVED

PMID: 40360966 (View on PubMed)

Silverberg JI, Rodriguez DN, Dias-Barbosa C, Filipenko D, Ulianov L, Piketty C, Puelles J. Psychometric Validation of the Subject Sleep Diary in Patients with Moderate-to-Severe Atopic Dermatitis. Dermatol Ther (Heidelb). 2025 Apr;15(4):963-995. doi: 10.1007/s13555-025-01385-3. Epub 2025 Mar 21.

Reference Type: DERIVED

PMID: 40116983 (View on PubMed)

Silverberg JI, Wollenberg A, Reich A, Thaci D, Legat FJ, Papp KA, Stein Gold L, Bouaziz JD, Pink AE, Carrascosa JM, Rewerska B, Szepietowski JC, Krasowska D, Havlickova B, Kalowska M, Magnolo N, Pauser S, Nami N, Sauder MB, Jain V, Padlewska K, Cheong SY, Fleuranceau Morel P, Ulianov L, Piketty C; ARCADIA 1 and ARCADIA 2 Study Investigators. Nemolizumab with concomitant topical therapy in adolescents and adults with moderate-to-severe atopic dermatitis (ARCADIA 1 and ARCADIA 2): results from two replicate, double-blind, randomised controlled phase 3 trials. Lancet. 2024 Aug 3;404(10451):445-460. doi: 10.1016/S0140-6736(24)01203-0. Epub 2024 Jul 24.

Reference Type: DERIVED

PMID: 39067461 (View on PubMed)

Dias-Barbosa C, Silverberg JI, Stander S, Rodriguez D, Fofana F, Filipenko D, Ulianov L, Piketty C, Puelles J. Capturing patient-reported sleep disturbance in atopic dermatitis clinical trials. J Patient Rep Outcomes. 2024 Jul 15;8(1):73. doi: 10.1186/s41687-024-00751-7.

Reference Type: DERIVED

PMID: 39008191 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

RD.06.SPR.118161

Identifier Type: -

Identifier Source: org_study_id