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AzTrials

Moderate-to-Severe Atopic DermatitisPhase 3NCT03989349

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

A Phase 3 study testing Nemolizumab in people with Moderate-to-Severe Atopic Dermatitis, run by Galderma R&D at 138 sites in 11 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
Moderate-to-Severe Atopic Dermatitis
What is being tested?
Nemolizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
787 participants
Where
138 sitesin 11 countries
Study dates
30 Jun 2019to 26 Sep 2022
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

138 sites in 11 countries.

138 sites in 11 countries

United States47 sites

  • Galderma Investigational Site 8906

    Bell Gardens, California, 90201

  • Galderma Investigational Site 8749

    Birmingham, Alabama, 35244

  • Galderma Investigational Site 8893

    Birmingham, Alabama, 35244

  • Galderma Investigational Site 8741

    Buffalo, New York, 14221

  • Galderma Investigational Site 8905

    Canoga Park, California, 91304

  • Galderma Investigational Site 8705

    Chattanooga, Tennessee, 37421

  • Galderma Investigational Site 8747

    Cincinnati, Ohio, 45219

  • Galderma Investigational Site 8723

    Cortland, New York, 13045

  • Galderma Investigational Site 8875

    Delray Beach, Florida, 33484

  • Galderma Investigational Site 8554

    Detroit, Michigan, 48202

  • Galderma Investigational Site 8577

    Encinitas, California, 92024

  • Galderma Investigational Site 8637

    Farmington, Connecticut, 06030

  • Galderma Investigational Site 8673

    Garden Grove, California, 92840

  • Galderma Investigational Site 8823

    Greensboro, North Carolina, 27408

  • Galderma Investigational Site 8866

    Guntersville, Alabama, 35976

  • Galderma Investigational Site 8506

    Hackensack, New Jersey, 07601

  • Galderma Investigational Site 8391

    Hialeah, Florida, 33013

  • Galderma Investigational Site 8727

    Hialeah, Florida, 33016

  • Galderma Investigational Site 8807

    Houston, Texas, 77029

  • Galderma Investigational Site 8523

    Largo, Florida, 33770

  • Galderma Investigational Site 8825

    Las Vegas, Nevada, 89106

  • Galderma Investigational Site 8683

    Los Angeles, California, 90033

  • Galderma Investigational Site 8719

    Miami, Florida, 33125

  • Galderma Investigational Site 8656

    Miami, Florida, 33137

  • Galderma Investigational Site 8704

    Miami, Florida, 33155

  • Galderma Investigational Site 8706

    Miami, Florida, 33175

  • Galderma Investigational Site 8724

    New Albany, Indiana, 47150

  • Galderma Investigational Site 8733

    New York, New York, 10022

  • Galderma Investigational Site 8907

    Newport Beach, California, 92660

  • Galderma Investigational Site 8713

    North Charleston, South Carolina, 29420

  • Galderma Investigational Site 8799

    Ontario, California, 91762

  • Galderma Investigational Site 8745

    Pasadena, California, 91105

  • Galderma Investigational Site 8721

    Pittsburgh, Pennsylvania, 15213

  • Galderma Investigational Site 8212

    Portland, Oregon, 97210

  • Galderma Investigational Site 8030

    Raleigh, North Carolina, 27612

  • Galderma Investigational Site 8896

    Richmond, Virginia, 23219

  • Galderma Investigational Site 8729

    Rolling Meadows, Illinois, 60008

  • Galderma Investigational Site 8672

    Salt Lake City, Utah, 84117

  • Galderma Investigational Site 8658

    San Diego, California, 92123

  • Galderma Investigational Site 8536

    Santa Ana, California, 92705

  • Galderma Investigational Site 8808

    Scottsdale, Arizona, 85255

  • Galderma Investigational Site 8434

    Seattle, Washington, 98105

  • Galderma Investigational Site 8203

    Tampa, Florida, 33607

  • Galderma Investigational Site 8839

    Tampa, Florida, 33615

  • Galderma Investigational Site 8618

    Waco, Texas, 76710

  • Galderma Investigational Site 8003

    Webster, Texas, 77598

  • Galderma Investigational Site 8820

    Westminster, California, 92683

Other trials in United States

Poland17 sites

  • Galderma Investigational Site 5773

    Bialystok, 15-453

  • Galderma Investigational Site 6097

    Chorzów, 41-500

  • Galderma Investigational Site 5021

    Katowice, 40-611

  • Galderma Investigational Site 5362

    Krakow, 30-033

  • Galderma Investigational Site 6052

    Krakow, 31-559

  • Galderma Investigational Site 5363

    Lodz, 90-436

  • Galderma Investigational Site 5367

    Lublin, 20-080

  • Galderma Investigational Site 5377

    Nowa Sól, 67-100

  • Galderma Investigational Site 6063

    Olsztyn, 10-229

  • Galderma Investigational Site 6085

    Poznan, 60-529

  • Galderma Investigational Site 5495

    Rzeszów, 35-055

  • Galderma Investigational Site 6130

    Szczecin, 71-434

  • Galderma Investigational Site 6048

    Tarnów, 33-100

  • Galderma Investigational Site 6126

    Warsaw, 01-142

  • Galderma Investigational Site 5707

    Warsaw, 01-817

  • Galderma Investigational Site 6185

    Wroclaw, 50-566

  • Galderma Investigational Site 6096

    Wroclaw, 51-318

Other trials in Poland

Germany16 sites

  • Galderma Investigational Site 5482

    Aachen, 52074

  • Galderma Investigational Site 5566

    Augsburg, 86179

  • Galderma Investigational Site 6082

    Bonn, 53127

  • Galderma Investigational Site 6132

    Dresden, 01097

  • Galderma Investigational Site 6031

    Düsseldorf, 40225

  • Galderma Investigational Site 6083

    Frankfurt, 60437

  • Galderma Investigational Site 5442

    Gera, 7548

  • Galderma Investigational Site 6081

    Goettigen, 37075

  • Galderma Investigational Site 6062

    Halle, 6120

  • Galderma Investigational Site 6041

    Hamburg, 20251

  • Galderma Investigational Site 6150

    Hamburg, 20537

  • Galderma Investigational Site 6040

    Hamburg, 22391

  • Galderma Investigational Site 5469

    Heidelberg, 69120

  • Galderma Investigational Site 6086

    Kiel, 24148

  • Galderma Investigational Site 6084

    Mainz, 55131

  • Galderma Investigational Site 5382

    Munich, 80337

Other trials in Germany

France12 sites

  • Galderma Investigational Site 6198

    Le Mans, 72037

  • Galderma Investigational Site 5031

    Lille, 59037

  • Galderma Investigational Site 6170

    Martigues, 13500

  • Galderma Investigational Site 6167

    Nantes, 44093

  • Galderma Investigational Site 5140

    Nice, 6200

  • Galderma Investigational Site 6133

    Paris, 75015

  • Galderma Investigational Site 6166

    Paris, 75475

  • Galderma Investigational Site 5407

    Pierre-Bénite, 69495

  • Galderma Investigational Site 6135

    Quimper, 29 107

  • Galderma Investigational Site 6197

    Toulon, 83800

  • Galderma Investigational Site 6169

    Toulouse, 31000

  • Galderma Investigational Site 6168

    Valence, 26000

Other trials in France

Bulgaria11 sites

  • Galderma Investigational Site 6029

    Pleven, 5800

  • Galderma Investigational Site 6051

    Sofia, 1407

  • Galderma Investigational Site 6078

    Sofia, 1408

  • Galderma Investigational Site 6102

    Sofia, 1431

  • Galderma Investigational Site 6165

    Sofia, 1431

  • Galderma Investigational Site 6216

    Sofia, 1528

  • Galderma Investigational Site 6046

    Sofia, 1606

  • Galderma Investigational Site 6080

    Sofia, 1606

  • Galderma Investigational Site 6079

    Sofia, 1618

  • Galderma Investigational Site 6250

    Sofia, 1784

  • Galderma Investigational Site 6251

    Stara Zagora, 6000

Other trials in Bulgaria

Italy11 sites

  • Galderma Investigational Site 6145

    Bologna, 40138

  • Galderma Investigational Site 6141

    Chieti, 66013

  • Galderma Investigational Site 6045

    L’Aquila, 67100

  • Galderma Investigational Site 6151

    Parma, 43124

  • Galderma Investigational Site 6180

    Pavia, 27100

  • Galderma Investigational Site 6143

    Pisa, 56126

  • Galderma Investigational Site 6044

    Roma, 00133

  • Galderma Investigational Site 6049

    Roma, 00168

  • Galderma Investigational Site 6177

    Rome, 00 144

  • Galderma Investigational Site 6155

    Rozzano, 20089

  • Galderma Investigational Site 6175

    Vicenza, 36100

Other trials in Italy

Georgia8 sites

  • Galderma Investigational Site 6238

    Tbilisi, 0159

  • Galderma Investigational Site 6227

    Tbilisi, 0186

  • Galderma Investigational Site 6230

    Tbilisi, 0186

  • Galderma Investigation Site 6228

    Tbilisi, 159

  • Galderma Investigational Site 6224

    Tbilisi, 159

  • Galderma Investigational Site 6235

    Tbilisi, 159

  • Galderma Investigational Site 6234

    Tbilisi, 186

  • Galderma Investigational Site 6236

    Zugdidi, 2100

Other trials in Georgia

Hungary6 sites

  • Galderma Investigational Site 6147

    Budapest, 1036

  • Galderma Investigational Site 5513

    Budapest, 1085

  • Galderma Investigational Site 5567

    Debrecen, 4025

  • Galderma Investigational Site 6026

    Debrecen, 4032

  • Galderma Investigational Site 6254

    Gyula, 5700

  • Galderma Investigational Site 6053

    Veszprém, 8200

Other trials in Hungary

Belgium4 sites

  • Galderma Investigational Site 5448

    Brussels, 1200

  • Galderma Investigational Site 6164

    Ghent, 9000

  • Galderma Investigational Site 6038

    Leuven, 3000

  • Galderma Investigational Site 6162

    Liège, 4000

Other trials in Belgium

Estonia3 sites

  • Galderma Investigational Site 6068

    Tallinn, 10134

  • Galderma Investigational Site 6069

    Tallinn, 10138

  • Galderma Investigational Site 6067

    Tartu, 50417

Other trials in Estonia

Singapore3 sites

  • Galderma Investigational Site 6124

    Singapore, 119228

  • Galderma Investigational Site 6077

    Singapore, 169608

  • Galderma Investigational Site 5499

    Singapore, 308205

Other trials in Singapore

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Nemolizumab in Subjects With Moderate-to-Severe Atopic Dermatitis

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.

Read the 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.

Being tested
Placebo, Nemolizumab
Keywords
CD14152, Nemolizumab, Atopic Dermatitis
Medical subject headings
Dermatitis, Atopic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDrug

    Placebo

  • NemolizumabDrug

    Also called CD14152

    Nemolizumab

Study groups in NCT03989349
Study groupRoleWhat they receive
PlaceboPlacebo comparatorPlacebo administered via subcutaneous injection
Receives: Drug: Placebo
NemolizumabExperimentalNemolizumab administered via subcutaneous injection
Receives: Drug: Nemolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Week 16

  2. 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.

    Measured: Week 16

  3. 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.

    Measured: Week 16

  4. 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.

    Measured: Week 16

Secondary outcomes (14)

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

    The PP NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours on a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable'. Weekly average PP NRS score was calculated using 7 consecutive days diary data and set to missing if less than 4 days data available. If a participant received any rescue therapy, the data after receipt of rescue therapy was considered treatment failure.

    Measured: Week 16

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

    The PP NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours on a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable'. Weekly average PP NRS score was calculated using 7 consecutive days diary data and set to missing if less than 4 days data available. If a participant received any rescue therapy, the data after receipt of rescue therapy was considered treatment failure.

    Measured: Week 16

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

    The PP NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours on a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable'. Weekly average PP NRS score was calculated using 7 consecutive days diary data and set to missing if less than 4 days data available. If a participant received any rescue therapy, the data after receipt of rescue therapy was considered treatment failure. Participants with missing data were considered non-responders.

    Measured: Week 16

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

    The PP NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours on a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable'. Weekly average PP NRS score was calculated using 7 consecutive days diary data and set to missing if less than 4 days data available. If a participant received any rescue therapy, the data after receipt of rescue therapy was considered treatment failure. Participants with missing data were considered non-responders.

    Measured: Week 16

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

    The sleep disturbance NRS is a scale used by the participants to report the degree of their sleep loss related to AD. Participants were asked the following question in their local language: how would you rate your sleep last night? On a scale of 0 to 10, with 0 being 'no sleep loss related to signs/symptoms of AD' and 10 being 'I cannot sleep at all due to the signs/symptoms of AD'. Weekly average SD NRS score was calculated using 7 consecutive days diary data and set to missing if less than 4 days data available. If a participant received any rescue therapy, the data after receipt of rescue therapy was considered treatment failure. Participants with missing data were considered non-responders.

    Measured: Week 16

  6. Percentage of Participants With an Improvement of Sleep Disturbance Numeric Rating Scale (SD NRS) >=4 at Week 16: Severe Pruritus Population

    The sleep disturbance NRS is a scale used by the participants to report the degree of their sleep loss related to AD. Participants were asked the following question in their local language: how would you rate your sleep last night? On a scale of 0 to 10, with 0 being 'no sleep loss related to signs/symptoms of AD' and 10 being 'I cannot sleep at all due to the signs/symptoms of AD'. Weekly average SD NRS score was calculated using 7 consecutive days diary data and set to missing if less than 4 days data available. If a participant received any rescue therapy, the data after receipt of rescue therapy was considered treatment failure. Participants with missing data were considered non-responders.

    Measured: Week 16

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

    The PP NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours on a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable'. Weekly average PP NRS score was calculated using 7 consecutive days diary data and set to missing if less than 4 days data available. If a participant received any rescue therapy, the data after receipt of rescue therapy was considered treatment failure. Participants with missing data were considered non-responders.

    Measured: Week 4

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

    The PP NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours on a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable'. Weekly average PP NRS score was calculated using 7 consecutive days diary data and set to missing if less than 4 days data available. If a participant received any rescue therapy, the data after receipt of rescue therapy was considered treatment failure. Participants with missing data were considered non-responders.

    Measured: Week 4

  9. Percentage of Participants With Peak Pruritus Numeric Rating Scale (PP NRS) <2 at Week 4: ITT Population

    The PP NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours on a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable'. Weekly average PP NRS score was calculated using 7 consecutive days diary data and set to missing if less than 4 days data available. If a participant received any rescue therapy, the data after receipt of rescue therapy was considered treatment failure. Participants with missing data were considered non-responders.

    Measured: Week 4

  10. Percentage of Participants With Peak Pruritus Numeric Rating Scale (PP NRS) <2 at Week 4: Severe Pruritus Population

    The PP NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours on a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable'. Weekly average PP NRS score was calculated using 7 consecutive days diary data and set to missing if less than 4 days data available. If a participant received any rescue therapy, the data after receipt of rescue therapy was considered treatment failure. Participants with missing data were considered non-responders.

    Measured: Week 4

  11. Percentage of Participants With Improvement of >=4 Points in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 2: ITT Population

    The PP NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours on a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable'. Weekly average PP NRS score was calculated using 7 consecutive days diary data and set to missing if less than 4 days data available. If a participant received any rescue therapy, the data after receipt of rescue therapy was considered treatment failure. Participants with missing data were considered non-responders.

    Measured: Week 2

  12. Percentage of Participants With Improvement of >=4 Points in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 2: Severe Pruritus Population

    The PP NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours on a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable'. Weekly average PP NRS score was calculated using 7 consecutive days diary data and set to missing if less than 4 days data available. If a participant received any rescue therapy, the data after receipt of rescue therapy was considered treatment failure. Participants with missing data were considered non-responders.

    Measured: Week 2

  13. Percentage of Participants With Improvement of >=4 Points in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 1: ITT Population

    The PP NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours on a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable'. Weekly average PP NRS score was calculated using 7 consecutive days diary data and set to missing if less than 4 days data available. If a participant received any rescue therapy, the data after receipt of rescue therapy was considered treatment failure. Participants with missing data were considered non-responders.

    Measured: Week 1

  14. Percentage of Participants With Improvement of >=4 Points in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 1: Severe Pruritus Population

    The PP NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours on a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable'. Weekly average PP NRS score was calculated using 7 consecutive days diary data and set to missing if less than 4 days data available. If a participant received any rescue therapy, the data after receipt of rescue therapy was considered treatment failure. Participants with missing data were considered non-responders.

    Measured: Week 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jun 2019
  2. Study start30 Jun 2019
  3. Primary completion23 Feb 2022
  4. Study completion26 Sep 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
787 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03989349
Sponsor's protocol ID
RD.06.SPR.118169
Status last verified
Aug 2024
First submitted
14 Jun 2019
Last updated
14 Aug 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Liu D, Duca ED, Delaleu N, Lau M, Pulsinelli J, de Rosa JC, Bar J, Estrada Y, Gudjonsson J, Julia V, Guttman-Yassky E. Tape Strip Transcriptomics Reveal Nemolizumab Effects on Pruritus, Hyperplasia, Inflammation, and Extracellular Matrix Markers in Patients With Moderate-to-Severe Atopic Dermatitis. Allergy. 2026 Sep 4. doi: 10.1111/all.70505. Online ahead of print.

    PubMed 42693785

  • 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.

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  • 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.

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Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Nemolizumab in people with Moderate-to-Severe Atopic Dermatitis, run by Galderma R&D at 138 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 138 sites in United States, Poland, Germany, France, Bulgaria and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Investigator's Global Assessment (IGA) Success at Week 16: Intent-To-Treat (ITT) Population (time frame: Week 16). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03989349, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2024.

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