AzTrials
AzTrials

Moderate-to-Severe Atopic DermatitisPhase 3NCT03985943

Efficacy and 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 174 sites in 14 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
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
941 participants
Where
174 sitesin 14 countries
Study dates
27 Jun 2019to 11 Aug 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 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.

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

Trial locations and contacts

174 sites in 14 countries.

174 sites in 14 countries

United States57 sites

  • Galderma Investigational Site 8743

    Ann Arbor, Michigan, 48109

  • Galderma Investigational Site 8133

    Arlington, Texas, 76011

  • Galderma Investigational Site 8882

    Bangor, Maine, 04401

  • Galderma Investigational Site 8512

    Bay City, Michigan, 48706

  • Galderma Investigational Site 8702

    Bexley, Ohio, 43209

  • Galderma Investigational Site 8890

    Blackfoot, Idaho, 83221

  • Galderma Investigational Site 8897

    Brandon, Florida, 33511

  • Galderma Investigational Site 8242

    Brooklyn, New York, 11203

  • Galderma Investigational Site 8805

    Cape Coral, Florida, 33991

  • Galderma Investigational Site 8578

    Cerritos, California, 90703

  • Galderma Investigational Site 8736

    Charleston, South Carolina, 29425

  • Galderma Investigational Site 8238

    Dallas, Texas, 75230

  • Galderma Investigational Site 8902

    Doral, Florida, 33122

  • Galderma Investigational Site 8827

    Dripping Springs, Texas, 78620

  • Galderma Investigational Site 8595

    Dublin, Ohio, 43016

  • Galderma Investigational Site 8862

    Fairfax, Virginia, 22031

  • Galderma Investigational Site 8636

    Fountain Valley, California, 92708

  • Galderma Investigational Site 8664

    Frisco, Texas, 75034

  • Galderma Investigational Site 8888

    Fullerton, California, 92835

  • Galderma Investigational Site 8740

    Henderson, Nevada, 89052

  • Galderma Investigational Site 8804

    Hialeah, Florida, 33016

  • Galderma Investigational Site 8042

    Houston, Texas, 77056

  • Galderma Investigational Site 8142

    Indianapolis, Indiana, 46250

  • Galderma Investigational Site 8711

    Jacksonville, Florida, 32256

  • Galderma Investigational Site 8686

    Lomita, California, 90717

  • Galderma Investigational Site 8674

    Los Angeles, California, 90025

  • Galderma Investigational Site 8771

    Louisville, Kentucky, 40241

  • Galderma Investigational Site 8744

    Macon, Georgia, 31217

  • Galderma Investigational Site 8710

    Miami, Florida, 33126

  • Galderma Investigational Site 8801

    Miami, Florida, 33145

  • Galderma Investigational Site 8737

    Miami, Florida, 33174

  • Galderma Investigational Site 8708

    Miami, Florida, 33176

  • Galderma Investigational Site 8806

    Miami Lakes, Florida, 33014

  • Galderma Investigational Site 8800

    Miami Lakes, Florida, 33016

  • Galderma Investigational Site 8718

    Missoula, Montana, 59808

  • Galderma Investigational Site 8819

    Nampa, Idaho, 83687

  • Galderma Investigational Site 8620

    New York, New York, 10023

  • Galderma Investigational Site 8279

    New York, New York, 10075

  • Galderma Investigational Site 8728

    Newnan, Georgia, 30263

  • Galderma Investigational Site 8206

    Norman, Oklahoma, 73071

  • Galderma Investigational Site 8880

    North Little Rock, Arkansas, 72117

  • Galderma Investigational Site 8857

    Oklahoma City, Oklahoma, 73118

  • Galderma Investigational Site 8810

    Omaha, Nebraska, 68144

  • Galderma Investigational Site 8734

    Pembroke Pines, Florida, 33028

  • Galderma Investigational Site 8255

    Philadelphia, Pennsylvania, 19103

  • Galderma Investigational Site 8802

    Plymouth Meeting, Pennsylvania, 19462

  • Galderma Investigational Site 8818

    Rapid City, South Dakota, 57702

  • Galderma Investigational Site 8521

    Saint Joseph, Missouri, 64506

  • Galderma Investigational Site 8125

    San Francisco, California, 94115

  • Galderma Investigational Site 8895

    Santa Ana, California, 92703

  • Galderma Investigational Site 8608

    Santa Monica, California, 90404

  • Galderma Investigational Site 8571

    Skokie, Illinois, 60076

  • Galderma Investigational Site 8712

    Skokie, Illinois, 60077

  • Galderma Investigational Site 8155

    Troy, Michigan, 48084

  • Galderma Investigational Site 8887

    Union City, Georgia, 30291

  • Galderma Investigational Site 8648

    Wilmington, North Carolina, 28405

  • Galderma Investigational Site 8748

    Ypsilanti, Michigan, 48197

Other trials in United States

Poland20 sites

  • Galderma Investigational Site 6255

    Częstochowa, 42-202

  • Galderma Investigational Site 6075

    Gdansk, 80-214

  • Galderma Investigational Site 6243

    Gdansk, 80-382

  • Galderma Investigational Site 5138

    Gdansk, 80-462

  • Galderma Investigational Site 6244

    Gdynia, 81-537

  • Galderma Investigational Site 6087

    Katowice, 40-040

  • Galderma Investigational Site 6245

    Lodz, 90-127

  • Galderma Investigational Site 5570

    Lodz, 90-265

  • Galderma Investigational Site 6231

    Lodz, 94-050

  • Galderma Investigational Site 6071

    Lublin, 20-081

  • Galderma Investigational Site 6237

    Ostrowiec Świętokrzyski, 27-400

  • Galderma Investigational Site 6127

    Poznan, 60-702

  • Galderma Investigational Site 6223

    Szczecin, 70-332

  • Galderma Investigational Site 6065

    Warsaw, 01-192

  • Galderma Investigational Site 6122

    Warsaw, 02-507

  • Galderma Investigational Site 6242

    Warsaw, 02-793

  • Galderma Investigational Site 6064

    Warsaw, 02-953

  • Galderma Investigational Site 6222

    Warsaw, 02-962

  • Galderma Investigational Site 6047

    Wroclaw, 50-381

  • Galderma Investigational Site 5005

    Wroclaw, 53-658

Other trials in Poland

Canada16 sites

  • Galderma Investigational Site 8586

    Barrie, Ontario, L4M 7G1

  • Galderma Investigational Site 8085

    Calgary, Alberta, T2G 1B1

  • Galderma Investigational Site 8903

    Calgary, Alberta, T2J 7E1

  • Galderma Investigational Site 8215

    Calgary, Alberta, T3E 0B2

  • Galderma Investigational Site 8088

    Edmonton, Alberta, T5J 3S9

  • Galderma Investigational Site 8824

    Edmonton, Alberta, T6G 1C3

  • Galderma Investigational Site 8722

    Edmonton, Alberta, T6G 1C9

  • Galderma Investigational Site 8904

    Guelph, Ontario, N1L 0B7

  • Galderma Investigational Site 8780

    Niagara Falls, L2H 1H5

  • Galderma Investigational Site 8901

    Ottawa, Ontario, K1H7X3

  • Galderma Investigational Site 8610

    Ottawa, K1G 6C6

  • Galderma Investigational Site 8000

    Saint John, A1C2H5

  • Galderma Investigational Site 8161

    Surrey, British Columbia, V3V 0C6

  • Galderma Investigational Site 8336

    Toronto, Ontario, M3H 5Y8

  • Galderma Investigational Site 8899

    Toronto, Ontario, M4W 2N4

  • Galderma Investigational Site 8731

    Waterloo, N2J 1C4

Other trials in Canada

South Korea15 sites

  • Galderma Investigational Site 6095

    Bucheon-si, 14584

  • Galderma Investigational Site 6100

    Busan, 49241

  • Galderma Investigational Site 6098

    Gyeonggi-do, 15355

  • Galderma Investigational Site 6154

    Gyeonggi-do, 18450

  • Galderma Investigational Site 6138

    Incheon, 21431

  • Galderma Investigational Site 6120

    Incheon, 21565

  • Galderma Investigational Site 6093

    Incheon, 22332

  • Galderma Investigational Site 6105

    Seoul, 02841

  • Galderma Investigational Site 5659

    Seoul, 03080

  • Galderma Investigational Site 6116

    Seoul, 03722

  • Galderma Investigational Site 6129

    Seoul, 04763

  • Galderma Investigational Site 6103

    Seoul, 05030

  • Galderma Investigational Site 6056

    Seoul, 06591

  • Galderma Investigational Site 6094

    Seoul, 06973

  • Galderma Investigational Site 6099

    Seoul, 07441

Other trials in South Korea

Germany13 sites

  • Galderma Investigational Site 6022

    Bad Bentheim, 48455

  • Galderma Investigational Site 6172

    Berlin, North Rhine-Westphalia, 12203

  • Galderma Investigational Site 6110

    Berlin, 13055

  • Galderma Investigational Site 6061

    Bielefeld, 33647

  • Galderma Investigational Site 6066

    Buxtehude, 21614

  • Galderma Investigational Site 5368

    Darmstadt, 64283

  • Galderma Investigational Site 6028

    Dülmen, 48249

  • Galderma Investigational Site 5437

    Kiel, Schleswig-Holst, 24105

  • Galderma Investigational Site 6146

    Langenau, Hesse, 89129

  • Galderma Investigational Site 6039

    Münster, 48149

  • Galderma Investigational Site 5918

    Osnabrück, 49074

  • Galderma Investigational Site 6109

    Stuttgart, 70499

  • Galderma Investigational Site 6214

    Tübingen, Niedersachesen, 72076

Other trials in Germany

Australia11 sites

  • Galderma Investigational Site 5638

    Benowa, Queensland, 4217

  • Galderma Investigational Site 6161

    Brisbane, Queensland, 4102

  • Galderma Investigational Site 6131

    Carlton, Victoria, 3053

  • Galderma Investigational Site 5441

    Darlinghurst, New South Wales, 2010

  • Galderma Investigational Site 5366

    East Melbourne, Victoria, 3002

  • Galderma Investigational Site 5453

    Fremantle, Western Australia, 6160

  • Galderma Investigational Site 5759

    Kogarah, New South Wales, 2217

  • Galderma Investigational Site 5458

    Parkville, Victoria, 3050

  • Galderma Investigational Site 6153

    Victoria Park, Western Australia, 6100

  • Galderma Investigational Site 6152

    Westmead, New South Wales, 2145

  • Galderma Investigational Site 6159

    Woodville, South Australia, 5011

Other trials in Australia

Spain11 sites

  • Galderma Investigational Site 6057

    Alicante, 03010

  • Galderma Investigational Site 6037

    Barcelona, 08036

  • Galderma Investigational Site 6035

    Barcelona, 08916

  • Galderma Investigational Site 5580

    Barcelona, 8907

  • Galderma Investigational Site 6106

    Las Palmas de Gran Canaria, 35010

  • Galderma Investigational Site 6058

    Madrid, 28006

  • Galderma Investigational Site 5842

    Madrid, 28034

  • Galderma Investigational Site 6190

    Madrid, 28046

  • Galderma Investigational Site 6036

    Madrid, 28223

  • Galderma Investigational Site 5551

    Madrid, 28922

  • Galderma Investigational Site 6191

    Pamplona, 31008

Other trials in Spain

Czechia8 sites

  • Galderma Investigational Site 6055

    Brno, 656 91

  • Galderma Investigational Site 5225

    Náchod, 547 01

  • Galderma Investigational Site 6030

    Olomouc, 779 00

  • Galderma Investigational Site 6024

    Prague, 100 00

  • Galderma Investigational Site 6054

    Prague, 110 00

  • Galderma Investigational Site 6021

    Prague, 11000

  • Galderma Investigational Site 6240

    Prague, 120 00

  • Galderma Investigational Site 6025

    Prague, 150 06

Other trials in Czechia

United Kingdom8 sites

  • Galderma Investigational Site 6202

    Barnsley, S75 3DL

  • Galderma Investigational Site 6207

    Blackpool, FY2 0JH

  • Galderma Investigational Site 6203

    Cannock, WS11 0BN

  • Galderma Investigational Site 6104

    Glasgow, G3 8SJ

  • Galderma Investigational Site 6204

    Liverpool, L34 1BH

  • Galderma Investigational Site 6121

    London, SE1 9RT

  • Galderma Investigational Site 6205

    Manchester, M13 9NQ

  • Galderma Investigational Site 6206

    Stockton-on-Tees, TS17 6EW

Other trials in United Kingdom

Latvia4 sites

  • Galderma Investigational Site 6113

    Liepāja, LV-3401

  • Galderma Investigational Site 6134

    Riga, LV-1006

  • Galderma Investigational Site 6059

    Riga, LV-1009

  • Galderma Investigational Site 6060

    Talsi, LV-3201

Other trials in Latvia

Austria3 sites

  • Galderma Investigational Sites 6157

    Graz, Styria, 8036

  • Galderma Investigational Site 6194

    Vienna, State of Vienna, 1090

  • Galderma Investigational Site 6158

    Vienna, 1220

Other trials in Austria

Lithuania3 sites

  • Galderma Investigational Site 6111

    Kaunas, LT-50161

  • Galderma Investigational Site 6072

    Klaipėda, LT-92288

  • Galderma Investigational Site 6112

    Vilnius, LT-08411

Other trials in Lithuania

Netherlands3 sites

  • Galderma Investigational Site 6212

    Groningen, 9713

  • Galderma Investigational Site 6108

    Rotterdam, 3015 GD

  • Galderma Investigational Site 6027

    Utrecht, 3584 CX

Other trials in Netherlands

New Zealand2 sites

  • Galderma Investigational Site 6119

    Hamilton, 3204

  • Galderma Investigational Site 6118

    Wellington, 6021

Other trials in New Zealand

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 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.

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 NCT03985943
Study groupRoleWhat they receive
PlaceboPlacebo comparatorPlacebo
Receives: Drug: Placebo
NemolizumabExperimentalNemolizumab Active
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 an Investigator's Global Assessment (IGA) Success (IGA of 0 or 1 and a More Than Equal to [>=] 2-point Reduction): 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 an Investigator's Global Assessment (IGA) Success (IGA of 0 or 1 and a >= 2-point Reduction): 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. 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. EASI total score is composite score ranging from 0 to 72. Higher scores represent greater severity of AD.

    Measured: Week 16

  4. Percentage of Participants With >=75% Improvement in Eczema Area and Severity Index (EASI-75) at 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. 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. EASI total score is composite score ranging from 0 to 72. Higher scores represent greater severity of AD.

    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 posted14 Jun 2019
  2. Study start27 Jun 2019
  3. Primary completion29 Dec 2021
  4. Study completion11 Aug 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
941 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03985943
Sponsor's protocol ID
RD.06.SPR.118161
Status last verified
Aug 2024
First submitted
11 Jun 2019
Last updated
14 Aug 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Silverberg JI, Daniele P, Rodriguez D, Mulnick S, Yosipovitch G, Eichenfield LF, Gooderham M, Warren R, Subramanian R, Jack K, Ulianov L, Piketty C, Rout R, Puelles J. Development of a Conceptual Disease Model of Atopic Dermatitis Using Data from the Phase 3 ARCADIA 1 Trial. Dermatol Ther (Heidelb). 2026 Sep 22. doi: 10.1007/s13555-026-01905-9. Online ahead of print.

    PubMed 42771135

  • 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, 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.

    PubMed 40360966

  • 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.

    PubMed 40116983

  • 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.

    PubMed 39067461

  • 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.

    PubMed 39008191

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 174 sites in 14 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 174 sites in United States, Poland, Canada, South Korea, Germany and 9 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 an Investigator's Global Assessment (IGA) Success (IGA of 0 or 1 and a More Than Equal to [>=] 2-point Reduction): 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 NCT03985943, which also lists 6 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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