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

NCT03989349 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: RD.06.SPR.118169
• Study Type: interventional
• Target: 787
• Locations: 11 countries
• Sites: 138

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.

Conditions

Moderate-to-Severe Atopic Dermatitis

Keywords

CD14152; Nemolizumab; Atopic Dermatitis

Outcome Measures

Primary Outcomes (4)

• Percentage of Participants With Investigator's Global Assessment (IGA) Success at Week 16: Intent-To-Treat (ITT) Population

  IGA success was defined as an IGA score of 0 (clear) or 1 (almost clear) and at least a 2-grade improvement from baseline to Week 16. 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 atopic dermatitis (AD) and the clinical response to treatment. If a participant received any rescue therapy, the data after receipt of rescue therapy was considered treatment failure. Participants with missing data at Week 16 were considered non-responders.

  Week 16

• Percentage of Participants With Investigator's Global Assessment (IGA) Success at Week 16: Severe Pruritus Population

  IGA success was defined as an IGA score of 0 (clear) or 1 (almost clear) and at least a 2-grade improvement from baseline to Week 16. 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 treatment. If a participant received any rescue therapy, the data after receipt of rescue therapy was considered a treatment failure. Participants with missing data at Week 16 were considered non-responders.

  Week 16

• Percentage of Participants With >=75% Improvement in Eczema Area and Severity Index (EASI-75) at Week 16: ITT Population

  EASI-75 was defined as \>=75 percent(%) improvement in EASI from baseline to Week 16. EASI evaluates severity of participants AD based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD(erythema, induration/papulation, excoriation and lichenification)scored separately for each of 4 body regions (head \& neck, upper limbs, trunk \& lower limbs on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI total score is composite score ranging from 0 to 72. Higher scores represent greater severity of AD. If a participant received any rescue therapy, the data after receipt of rescue therapy was considered a treatment failure. Participants with missing data at Week 16 were considered non-responders.

  Week 16

• Percentage of Participants With >=75% Improvement in Eczema Area and Severity Index (EASI-75) at Week 16: Severe Pruritus Population

  EASI-75 was defined as \>=75 percent(%) improvement in EASI from baseline to Week 16. EASI evaluates severity of participants AD based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD(erythema, induration/papulation, excoriation and lichenification)scored separately for each of 4 body regions (head \& neck, upper limbs, trunk \& lower limbs on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI total score is composite score ranging from 0 to 72. Higher scores represent greater severity of AD. If a participant received any rescue therapy, the data after receipt of rescue therapy was considered a treatment failure. Participants with missing data at Week 16 were considered non-responders.

  Week 16

Secondary Outcomes (14)

• Percentage of Participants With Improvement of >=4 Points in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 16: ITT Population

  Week 16

• Percentage of Participants With Improvement of >=4 Points in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 16: Severe Pruritus Population

  Week 16

• Percentage of Participants With <2 Points in Weekly Average PP NRS at Week 16: ITT Population

  Week 16

• Percentage of Participants With <2 Points in Weekly Average PP NRS at Week 16: Severe Pruritus Population

  Week 16

• Percentage of Participants With an Improvement of Sleep Disturbance Numeric Rating Scale (SD NRS) >=4 at Week 16: ITT Population

  Week 16

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo administered via subcutaneous injection

Drug: Placebo

Nemolizumab

EXPERIMENTAL

Nemolizumab administered via subcutaneous injection

Drug: Nemolizumab

Interventions

Placebo DRUG

Placebo

Placebo

Nemolizumab DRUG

Nemolizumab

Also known as: CD14152

Nemolizumab

Eligibility Criteria

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

You may qualify if:

• 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 visits.
• 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.

You may not qualify if:

• 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, e.g., monoclonal antibody) or to any of the study drug excipients.
• Any clinically significant issue, based on investigator judgement.

Sponsors & Collaborators

• Galderma R&D: lead

Study Sites (138)

Galderma Investigational Site 8749

Birmingham, Alabama, 35244, United States

Location

Galderma Investigational Site 8893

Birmingham, Alabama, 35244, United States

Location

Galderma Investigational Site 8866

Guntersville, Alabama, 35976, United States

Location

Galderma Investigational Site 8808

Scottsdale, Arizona, 85255, United States

Location

Galderma Investigational Site 8906

Bell Gardens, California, 90201, United States

Location

Galderma Investigational Site 8905

Canoga Park, California, 91304, United States

Location

Galderma Investigational Site 8577

Encinitas, California, 92024, United States

Location

Galderma Investigational Site 8673

Garden Grove, California, 92840, United States

Location

Galderma Investigational Site 8683

Los Angeles, California, 90033, United States

Location

Galderma Investigational Site 8907

Newport Beach, California, 92660, United States

Location

Galderma Investigational Site 8799

Ontario, California, 91762, United States

Location

Galderma Investigational Site 8745

Pasadena, California, 91105, United States

Location

Galderma Investigational Site 8658

San Diego, California, 92123, United States

Location

Galderma Investigational Site 8536

Santa Ana, California, 92705, United States

Location

Galderma Investigational Site 8820

Westminster, California, 92683, United States

Location

Galderma Investigational Site 8637

Farmington, Connecticut, 06030, United States

Location

Galderma Investigational Site 8875

Delray Beach, Florida, 33484, United States

Location

Galderma Investigational Site 8391

Hialeah, Florida, 33013, United States

Location

Galderma Investigational Site 8727

Hialeah, Florida, 33016, United States

Location

Galderma Investigational Site 8523

Largo, Florida, 33770, United States

Location

Galderma Investigational Site 8719

Miami, Florida, 33125, United States

Location

Galderma Investigational Site 8656

Miami, Florida, 33137, United States

Location

Galderma Investigational Site 8704

Miami, Florida, 33155, United States

Location

Galderma Investigational Site 8706

Miami, Florida, 33175, United States

Location

Galderma Investigational Site 8203

Tampa, Florida, 33607, United States

Location

Galderma Investigational Site 8839

Tampa, Florida, 33615, United States

Location

Galderma Investigational Site 8729

Rolling Meadows, Illinois, 60008, United States

Location

Galderma Investigational Site 8724

New Albany, Indiana, 47150, United States

Location

Galderma Investigational Site 8554

Detroit, Michigan, 48202, United States

Location

Galderma Investigational Site 8825

Las Vegas, Nevada, 89106, United States

Location

Galderma Investigational Site 8506

Hackensack, New Jersey, 07601, United States

Location

Galderma Investigational Site 8741

Buffalo, New York, 14221, United States

Location

Galderma Investigational Site 8723

Cortland, New York, 13045, United States

Location

Galderma Investigational Site 8733

New York, New York, 10022, United States

Location

Galderma Investigational Site 8823

Greensboro, North Carolina, 27408, United States

Location

Galderma Investigational Site 8030

Raleigh, North Carolina, 27612, United States

Location

Galderma Investigational Site 8747

Cincinnati, Ohio, 45219, United States

Location

Galderma Investigational Site 8212

Portland, Oregon, 97210, United States

Location

Galderma Investigational Site 8721

Pittsburgh, Pennsylvania, 15213, United States

Location

Galderma Investigational Site 8713

North Charleston, South Carolina, 29420, United States

Location

Galderma Investigational Site 8705

Chattanooga, Tennessee, 37421, United States

Location

Galderma Investigational Site 8807

Houston, Texas, 77029, United States

Location

Galderma Investigational Site 8618

Waco, Texas, 76710, United States

Location

Galderma Investigational Site 8003

Webster, Texas, 77598, United States

Location

Galderma Investigational Site 8672

Salt Lake City, Utah, 84117, United States

Location

Galderma Investigational Site 8896

Richmond, Virginia, 23219, United States

Location

Galderma Investigational Site 8434

Seattle, Washington, 98105, United States

Location

Galderma Investigational Site 5448

Brussels, 1200, Belgium

Location

Galderma Investigational Site 6164

Ghent, 9000, Belgium

Location

Galderma Investigational Site 6038

Leuven, 3000, Belgium

Location

Galderma Investigational Site 6162

Liège, 4000, Belgium

Location

Galderma Investigational Site 6029

Pleven, 5800, Bulgaria

Location

Galderma Investigational Site 6051

Sofia, 1407, Bulgaria

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Galderma Investigational Site 6078

Sofia, 1408, Bulgaria

Location

Galderma Investigational Site 6102

Sofia, 1431, Bulgaria

Location

Galderma Investigational Site 6165

Sofia, 1431, Bulgaria

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Galderma Investigational Site 6216

Sofia, 1528, Bulgaria

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Galderma Investigational Site 6046

Sofia, 1606, Bulgaria

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Galderma Investigational Site 6080

Sofia, 1606, Bulgaria

Location

Galderma Investigational Site 6079

Sofia, 1618, Bulgaria

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Galderma Investigational Site 6250

Sofia, 1784, Bulgaria

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Galderma Investigational Site 6251

Stara Zagora, 6000, Bulgaria

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Galderma Investigational Site 6068

Tallinn, 10134, Estonia

Location

Galderma Investigational Site 6069

Tallinn, 10138, Estonia

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Galderma Investigational Site 6067

Tartu, 50417, Estonia

Location

Galderma Investigational Site 6198

Le Mans, 72037, France

Location

Galderma Investigational Site 5031

Lille, 59037, France

Location

Galderma Investigational Site 6170

Martigues, 13500, France

Location

Galderma Investigational Site 6167

Nantes, 44093, France

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Galderma Investigational Site 5140

Nice, 6200, France

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Galderma Investigational Site 6133

Paris, 75015, France

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Galderma Investigational Site 6166

Paris, 75475, France

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Galderma Investigational Site 5407

Pierre-Bénite, 69495, France

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Galderma Investigational Site 6135

Quimper, 29 107, France

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Galderma Investigational Site 6197

Toulon, 83800, France

Location

Galderma Investigational Site 6169

Toulouse, 31000, France

Location

Galderma Investigational Site 6168

Valence, 26000, France

Location

Galderma Investigational Site 6238

Tbilisi, 0159, Georgia

Location

Galderma Investigational Site 6227

Tbilisi, 0186, Georgia

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Galderma Investigational Site 6230

Tbilisi, 0186, Georgia

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Galderma Investigation Site 6228

Tbilisi, 159, Georgia

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Galderma Investigational Site 6224

Tbilisi, 159, Georgia

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Galderma Investigational Site 6235

Tbilisi, 159, Georgia

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Galderma Investigational Site 6234

Tbilisi, 186, Georgia

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Galderma Investigational Site 6236

Zugdidi, 2100, Georgia

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Galderma Investigational Site 5482

Aachen, 52074, Germany

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Galderma Investigational Site 5566

Augsburg, 86179, Germany

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Galderma Investigational Site 6082

Bonn, 53127, Germany

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Galderma Investigational Site 6132

Dresden, 01097, Germany

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Galderma Investigational Site 6031

Düsseldorf, 40225, Germany

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Galderma Investigational Site 6083

Frankfurt, 60437, Germany

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Galderma Investigational Site 5442

Gera, 7548, Germany

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Galderma Investigational Site 6081

Goettigen, 37075, Germany

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Galderma Investigational Site 6062

Halle, 6120, Germany

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Galderma Investigational Site 6041

Hamburg, 20251, Germany

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Galderma Investigational Site 6150

Hamburg, 20537, Germany

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Galderma Investigational Site 6040

Hamburg, 22391, Germany

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Galderma Investigational Site 5469

Heidelberg, 69120, Germany

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Galderma Investigational Site 6086

Kiel, 24148, Germany

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Galderma Investigational Site 6084

Mainz, 55131, Germany

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Galderma Investigational Site 5382

Munich, 80337, Germany

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Galderma Investigational Site 6147

Budapest, 1036, Hungary

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Galderma Investigational Site 5513

Budapest, 1085, Hungary

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Galderma Investigational Site 5567

Debrecen, 4025, Hungary

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Galderma Investigational Site 6026

Debrecen, 4032, Hungary

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Galderma Investigational Site 6254

Gyula, 5700, Hungary

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Galderma Investigational Site 6053

Veszprém, 8200, Hungary

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Galderma Investigational Site 6145

Bologna, 40138, Italy

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Galderma Investigational Site 6141

Chieti, 66013, Italy

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Galderma Investigational Site 6045

L’Aquila, 67100, Italy

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Galderma Investigational Site 6151

Parma, 43124, Italy

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Galderma Investigational Site 6180

Pavia, 27100, Italy

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Galderma Investigational Site 6143

Pisa, 56126, Italy

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Galderma Investigational Site 6044

Roma, 00133, Italy

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Galderma Investigational Site 6049

Roma, 00168, Italy

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Galderma Investigational Site 6177

Rome, 00 144, Italy

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Galderma Investigational Site 6155

Rozzano, 20089, Italy

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Galderma Investigational Site 6175

Vicenza, 36100, Italy

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Galderma Investigational Site 5773

Bialystok, 15-453, Poland

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Galderma Investigational Site 6097

Chorzów, 41-500, Poland

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Galderma Investigational Site 5021

Katowice, 40-611, Poland

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Galderma Investigational Site 5362

Krakow, 30-033, Poland

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Galderma Investigational Site 6052

Krakow, 31-559, Poland

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Galderma Investigational Site 5363

Lodz, 90-436, Poland

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Galderma Investigational Site 5367

Lublin, 20-080, Poland

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Galderma Investigational Site 5377

Nowa Sól, 67-100, Poland

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Galderma Investigational Site 6063

Olsztyn, 10-229, Poland

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Galderma Investigational Site 6085

Poznan, 60-529, Poland

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Galderma Investigational Site 5495

Rzeszów, 35-055, Poland

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Galderma Investigational Site 6130

Szczecin, 71-434, Poland

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Galderma Investigational Site 6048

Tarnów, 33-100, Poland

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Galderma Investigational Site 6126

Warsaw, 01-142, Poland

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Galderma Investigational Site 5707

Warsaw, 01-817, Poland

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Galderma Investigational Site 6185

Wroclaw, 50-566, Poland

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Galderma Investigational Site 6096

Wroclaw, 51-318, Poland

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Galderma Investigational Site 6124

Singapore, 119228, Singapore

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Galderma Investigational Site 6077

Singapore, 169608, Singapore

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Galderma Investigational Site 5499

Singapore, 308205, Singapore

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Related Publications (3)

• 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.

  PMID: 40116983 DERIVED

• 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.

  PMID: 39067461 DERIVED

• 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.

  PMID: 39008191 DERIVED

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

nemolizumab

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

Results Point of Contact

• Title: Clinical Operations
• Organization: Galderma

Clinical.Studies@galderma.com

817 961 5000

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Treatment
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2019
• First Posted: June 18, 2019
• Study Start: June 30, 2019
• Primary Completion: February 23, 2022
• Study Completion: September 26, 2022
• Last Updated: August 14, 2024
• Results First Posted: August 14, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (12); GE (8); IT (11); HU (6); DE (16); BE (4); PL (17); SG (3); US (47); ES (3); BU (11)