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

NCT ID: NCT03989349

Last Updated: 2024-08-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 787 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-30
• Study Completion Date: 2022-09-26

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 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 administered via subcutaneous injection

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo

Nemolizumab

Nemolizumab administered via subcutaneous injection

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 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.

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, e.g., 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 8749

Birmingham, Alabama, United States

Galderma Investigational Site 8893

Birmingham, Alabama, United States

Galderma Investigational Site 8866

Guntersville, Alabama, United States

Galderma Investigational Site 8808

Scottsdale, Arizona, United States

Galderma Investigational Site 8906

Bell Gardens, California, United States

Galderma Investigational Site 8905

Canoga Park, California, United States

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Encinitas, California, United States

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Garden Grove, California, United States

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Los Angeles, California, United States

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Newport Beach, California, United States

Galderma Investigational Site 8799

Ontario, California, United States

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Pasadena, California, United States

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San Diego, California, United States

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Santa Ana, California, United States

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Westminster, California, United States

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Farmington, Connecticut, United States

Galderma Investigational Site 8875

Delray Beach, Florida, United States

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Hialeah, Florida, United States

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Hialeah, Florida, United States

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Largo, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Tampa, Florida, United States

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Tampa, Florida, United States

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Rolling Meadows, Illinois, United States

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New Albany, Indiana, United States

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Detroit, Michigan, United States

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Las Vegas, Nevada, United States

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Hackensack, New Jersey, United States

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Buffalo, New York, United States

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Cortland, New York, United States

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New York, New York, United States

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Greensboro, North Carolina, United States

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Raleigh, North Carolina, United States

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Cincinnati, Ohio, United States

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Portland, Oregon, United States

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Pittsburgh, Pennsylvania, United States

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North Charleston, South Carolina, United States

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Chattanooga, Tennessee, United States

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Houston, Texas, United States

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Waco, Texas, United States

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Webster, Texas, United States

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Salt Lake City, Utah, United States

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Richmond, Virginia, United States

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Seattle, Washington, United States

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Brussels, , Belgium

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Ghent, , Belgium

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Leuven, , Belgium

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Liège, , Belgium

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Pleven, , Bulgaria

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Sofia, , Bulgaria

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Sofia, , Bulgaria

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Sofia, , Bulgaria

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Sofia, , Bulgaria

Galderma Investigational Site 6216

Sofia, , Bulgaria

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Sofia, , Bulgaria

Galderma Investigational Site 6080

Sofia, , Bulgaria

Galderma Investigational Site 6079

Sofia, , Bulgaria

Galderma Investigational Site 6250

Sofia, , Bulgaria

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Stara Zagora, , Bulgaria

Galderma Investigational Site 6068

Tallinn, , Estonia

Galderma Investigational Site 6069

Tallinn, , Estonia

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Tartu, , Estonia

Galderma Investigational Site 6198

Le Mans, , France

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Lille, , France

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Martigues, , France

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Nantes, , France

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Nice, , France

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Paris, , France

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Paris, , France

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Pierre-Bénite, , France

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Quimper, , France

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Toulon, , France

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Toulouse, , France

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Valence, , France

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Tbilisi, , Georgia

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Tbilisi, , Georgia

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Tbilisi, , Georgia

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Tbilisi, , Georgia

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Tbilisi, , Georgia

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Tbilisi, , Georgia

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Tbilisi, , Georgia

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Zugdidi, , Georgia

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Aachen, , Germany

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Augsburg, , Germany

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Bonn, , Germany

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Dresden, , Germany

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Düsseldorf, , Germany

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Frankfurt, , Germany

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Gera, , Germany

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Goettigen, , Germany

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Halle, , Germany

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Hamburg, , Germany

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Hamburg, , Germany

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Hamburg, , Germany

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Heidelberg, , Germany

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Kiel, , Germany

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Mainz, , Germany

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Munich, , Germany

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Budapest, , Hungary

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Budapest, , Hungary

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Debrecen, , Hungary

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Debrecen, , Hungary

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Gyula, , Hungary

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Veszprém, , Hungary

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Bologna, , Italy

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Chieti, , Italy

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L’Aquila, , Italy

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Parma, , Italy

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Pavia, , Italy

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Pisa, , Italy

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Roma, , Italy

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Rome, , Italy

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Rozzano, , Italy

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Vicenza, , Italy

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Bialystok, , Poland

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Chorzów, , Poland

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Katowice, , Poland

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Krakow, , Poland

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Krakow, , Poland

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Lodz, , Poland

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Lublin, , Poland

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Nowa Sól, , Poland

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Olsztyn, , Poland

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Poznan, , Poland

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Rzeszów, , Poland

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Szczecin, , Poland

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Tarnów, , Poland

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Warsaw, , Poland

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Warsaw, , Poland

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Wroclaw, , Poland

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Wroclaw, , Poland

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Singapore, , Singapore

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Singapore, , Singapore

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Countries

United States; Belgium; Bulgaria; Estonia; France; Georgia; Germany; Hungary; Italy; Poland; Singapore

References

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.118169

Identifier Type: -

Identifier Source: org_study_id