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

NCT03985943 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: RD.06.SPR.118161
• Study Type: interventional
• Target: 941
• Locations: 13 countries
• Sites: 163

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 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.

  Week 16

• 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.

  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. 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.

  Week 16

• 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.

  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

Drug: Placebo

Nemolizumab

EXPERIMENTAL

Nemolizumab Active

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 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.

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, example, 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 (174)

Galderma Investigational Site 8880

North Little Rock, Arkansas, 72117, United States

Location

Galderma Investigational Site 8578

Cerritos, California, 90703, United States

Location

Galderma Investigational Site 8636

Fountain Valley, California, 92708, United States

Location

Galderma Investigational Site 8888

Fullerton, California, 92835, United States

Location

Galderma Investigational Site 8686

Lomita, California, 90717, United States

Location

Galderma Investigational Site 8674

Los Angeles, California, 90025, United States

Location

Galderma Investigational Site 8125

San Francisco, California, 94115, United States

Location

Galderma Investigational Site 8895

Santa Ana, California, 92703, United States

Location

Galderma Investigational Site 8608

Santa Monica, California, 90404, United States

Location

Galderma Investigational Site 8897

Brandon, Florida, 33511, United States

Location

Galderma Investigational Site 8805

Cape Coral, Florida, 33991, United States

Location

Galderma Investigational Site 8902

Doral, Florida, 33122, United States

Location

Galderma Investigational Site 8804

Hialeah, Florida, 33016, United States

Location

Galderma Investigational Site 8711

Jacksonville, Florida, 32256, United States

Location

Galderma Investigational Site 8710

Miami, Florida, 33126, United States

Location

Galderma Investigational Site 8801

Miami, Florida, 33145, United States

Location

Galderma Investigational Site 8737

Miami, Florida, 33174, United States

Location

Galderma Investigational Site 8708

Miami, Florida, 33176, United States

Location

Galderma Investigational Site 8806

Miami Lakes, Florida, 33014, United States

Location

Galderma Investigational Site 8800

Miami Lakes, Florida, 33016, United States

Location

Galderma Investigational Site 8734

Pembroke Pines, Florida, 33028, United States

Location

Galderma Investigational Site 8744

Macon, Georgia, 31217, United States

Location

Galderma Investigational Site 8728

Newnan, Georgia, 30263, United States

Location

Galderma Investigational Site 8887

Union City, Georgia, 30291, United States

Location

Galderma Investigational Site 8890

Blackfoot, Idaho, 83221, United States

Location

Galderma Investigational Site 8819

Nampa, Idaho, 83687, United States

Location

Galderma Investigational Site 8571

Skokie, Illinois, 60076, United States

Location

Galderma Investigational Site 8712

Skokie, Illinois, 60077, United States

Location

Galderma Investigational Site 8142

Indianapolis, Indiana, 46250, United States

Location

Galderma Investigational Site 8771

Louisville, Kentucky, 40241, United States

Location

Galderma Investigational Site 8882

Bangor, Maine, 04401, United States

Location

Galderma Investigational Site 8743

Ann Arbor, Michigan, 48109, United States

Location

Galderma Investigational Site 8512

Bay City, Michigan, 48706, United States

Location

Galderma Investigational Site 8155

Troy, Michigan, 48084, United States

Location

Galderma Investigational Site 8748

Ypsilanti, Michigan, 48197, United States

Location

Galderma Investigational Site 8521

Saint Joseph, Missouri, 64506, United States

Location

Galderma Investigational Site 8718

Missoula, Montana, 59808, United States

Location

Galderma Investigational Site 8810

Omaha, Nebraska, 68144, United States

Location

Galderma Investigational Site 8740

Henderson, Nevada, 89052, United States

Location

Galderma Investigational Site 8242

Brooklyn, New York, 11203, United States

Location

Galderma Investigational Site 8620

New York, New York, 10023, United States

Location

Galderma Investigational Site 8279

New York, New York, 10075, United States

Location

Galderma Investigational Site 8648

Wilmington, North Carolina, 28405, United States

Location

Galderma Investigational Site 8702

Bexley, Ohio, 43209, United States

Location

Galderma Investigational Site 8595

Dublin, Ohio, 43016, United States

Location

Galderma Investigational Site 8206

Norman, Oklahoma, 73071, United States

Location

Galderma Investigational Site 8857

Oklahoma City, Oklahoma, 73118, United States

Location

Galderma Investigational Site 8255

Philadelphia, Pennsylvania, 19103, United States

Location

Galderma Investigational Site 8802

Plymouth Meeting, Pennsylvania, 19462, United States

Location

Galderma Investigational Site 8736

Charleston, South Carolina, 29425, United States

Location

Galderma Investigational Site 8818

Rapid City, South Dakota, 57702, United States

Location

Galderma Investigational Site 8133

Arlington, Texas, 76011, United States

Location

Galderma Investigational Site 8238

Dallas, Texas, 75230, United States

Location

Galderma Investigational Site 8827

Dripping Springs, Texas, 78620, United States

Location

Galderma Investigational Site 8664

Frisco, Texas, 75034, United States

Location

Galderma Investigational Site 8042

Houston, Texas, 77056, United States

Location

Galderma Investigational Site 8862

Fairfax, Virginia, 22031, United States

Location

Galderma Investigational Site 5441

Darlinghurst, New South Wales, 2010, Australia

Location

Galderma Investigational Site 5759

Kogarah, New South Wales, 2217, Australia

Location

Galderma Investigational Site 6152

Westmead, New South Wales, 2145, Australia

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Galderma Investigational Site 5638

Benowa, Queensland, 4217, Australia

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Galderma Investigational Site 6161

Brisbane, Queensland, 4102, Australia

Location

Galderma Investigational Site 6159

Woodville, South Australia, 5011, Australia

Location

Galderma Investigational Site 6131

Carlton, Victoria, 3053, Australia

Location

Galderma Investigational Site 5366

East Melbourne, Victoria, 3002, Australia

Location

Galderma Investigational Site 5458

Parkville, Victoria, 3050, Australia

Location

Galderma Investigational Site 5453

Fremantle, Western Australia, 6160, Australia

Location

Galderma Investigational Site 6153

Victoria Park, Western Australia, 6100, Australia

Location

Galderma Investigational Sites 6157

Graz, Styria, 8036, Austria

Location

Galderma Investigational Site 6194

Vienna, Vienna, 1090, Austria

Location

Galderma Investigational Site 6158

Vienna, 1220, Austria

Location

Galderma Investigational Site 8085

Calgary, Alberta, T2G 1B1, Canada

Location

Galderma Investigational Site 8903

Calgary, Alberta, T2J 7E1, Canada

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Galderma Investigational Site 8215

Calgary, Alberta, T3E 0B2, Canada

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Galderma Investigational Site 8088

Edmonton, Alberta, T5J 3S9, Canada

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Galderma Investigational Site 8824

Edmonton, Alberta, T6G 1C3, Canada

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Galderma Investigational Site 8722

Edmonton, Alberta, T6G 1C9, Canada

Location

Galderma Investigational Site 8161

Surrey, British Columbia, V3V 0C6, Canada

Location

Galderma Investigational Site 8586

Barrie, Ontario, L4M 7G1, Canada

Location

Galderma Investigational Site 8904

Guelph, Ontario, N1L 0B7, Canada

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Galderma Investigational Site 8901

Ottawa, Ontario, K1H7X3, Canada

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Galderma Investigational Site 8336

Toronto, Ontario, M3H 5Y8, Canada

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Galderma Investigational Site 8899

Toronto, Ontario, M4W 2N4, Canada

Location

Galderma Investigational Site 8780

Niagara Falls, L2H 1H5, Canada

Location

Galderma Investigational Site 8610

Ottawa, K1G 6C6, Canada

Location

Galderma Investigational Site 8000

Saint John, A1C2H5, Canada

Location

Galderma Investigational Site 8731

Waterloo, N2J 1C4, Canada

Location

Galderma Investigational Site 6055

Brno, 656 91, Czechia

Location

Galderma Investigational Site 5225

Náchod, 547 01, Czechia

Location

Galderma Investigational Site 6030

Olomouc, 779 00, Czechia

Location

Galderma Investigational Site 6024

Prague, 100 00, Czechia

Location

Galderma Investigational Site 6054

Prague, 110 00, Czechia

Location

Galderma Investigational Site 6021

Prague, 11000, Czechia

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Galderma Investigational Site 6240

Prague, 120 00, Czechia

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Galderma Investigational Site 6025

Prague, 150 06, Czechia

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Galderma Investigational Site 6146

Langenau, Hesse, 89129, Germany

Location

Galderma Investigational Site 6214

Tübingen, Niedersachesen, 72076, Germany

Location

Galderma Investigational Site 6172

Berlin, North Rhine-Westphalia, 12203, Germany

Location

Galderma Investigational Site 5437

Kiel, Schleswig-Holst, 24105, Germany

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Galderma Investigational Site 6022

Bad Bentheim, 48455, Germany

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Galderma Investigational Site 6110

Berlin, 13055, Germany

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Galderma Investigational Site 6061

Bielefeld, 33647, Germany

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Galderma Investigational Site 6066

Buxtehude, 21614, Germany

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Galderma Investigational Site 5368

Darmstadt, 64283, Germany

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Galderma Investigational Site 6028

Dülmen, 48249, Germany

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Galderma Investigational Site 6039

Münster, 48149, Germany

Location

Galderma Investigational Site 5918

Osnabrück, 49074, Germany

Location

Galderma Investigational Site 6109

Stuttgart, 70499, Germany

Location

Galderma Investigational Site 6113

Liepāja, LV-3401, Latvia

Location

Galderma Investigational Site 6134

Riga, LV-1006, Latvia

Location

Galderma Investigational Site 6059

Riga, LV-1009, Latvia

Location

Galderma Investigational Site 6060

Talsi, LV-3201, Latvia

Location

Galderma Investigational Site 6111

Kaunas, LT-50161, Lithuania

Location

Galderma Investigational Site 6072

Klaipėda, LT-92288, Lithuania

Location

Galderma Investigational Site 6112

Vilnius, LT-08411, Lithuania

Location

Galderma Investigational Site 6212

Groningen, 9713, Netherlands

Location

Galderma Investigational Site 6108

Rotterdam, 3015 GD, Netherlands

Location

Galderma Investigational Site 6027

Utrecht, 3584 CX, Netherlands

Location

Galderma Investigational Site 6119

Hamilton, 3204, New Zealand

Location

Galderma Investigational Site 6118

Wellington, 6021, New Zealand

Location

Galderma Investigational Site 6255

Częstochowa, 42-202, Poland

Location

Galderma Investigational Site 6075

Gdansk, 80-214, Poland

Location

Galderma Investigational Site 6243

Gdansk, 80-382, Poland

Location

Galderma Investigational Site 5138

Gdansk, 80-462, Poland

Location

Galderma Investigational Site 6244

Gdynia, 81-537, Poland

Location

Galderma Investigational Site 6087

Katowice, 40-040, Poland

Location

Galderma Investigational Site 6245

Lodz, 90-127, Poland

Location

Galderma Investigational Site 5570

Lodz, 90-265, Poland

Location

Galderma Investigational Site 6231

Lodz, 94-050, Poland

Location

Galderma Investigational Site 6071

Lublin, 20-081, Poland

Location

Galderma Investigational Site 6237

Ostrowiec Świętokrzyski, 27-400, Poland

Location

Galderma Investigational Site 6127

Poznan, 60-702, Poland

Location

Galderma Investigational Site 6223

Szczecin, 70-332, Poland

Location

Galderma Investigational Site 6065

Warsaw, 01-192, Poland

Location

Galderma Investigational Site 6122

Warsaw, 02-507, Poland

Location

Galderma Investigational Site 6242

Warsaw, 02-793, Poland

Location

Galderma Investigational Site 6064

Warsaw, 02-953, Poland

Location

Galderma Investigational Site 6222

Warsaw, 02-962, Poland

Location

Galderma Investigational Site 6047

Wroclaw, 50-381, Poland

Location

Galderma Investigational Site 5005

Wroclaw, 53-658, Poland

Location

Galderma Investigational Site 6095

Bucheon-si, 14584, South Korea

Location

Galderma Investigational Site 6100

Busan, 49241, South Korea

Location

Galderma Investigational Site 6098

Gyeonggi-do, 15355, South Korea

Location

Galderma Investigational Site 6154

Gyeonggi-do, 18450, South Korea

Location

Galderma Investigational Site 6138

Incheon, 21431, South Korea

Location

Galderma Investigational Site 6120

Incheon, 21565, South Korea

Location

Galderma Investigational Site 6093

Incheon, 22332, South Korea

Location

Galderma Investigational Site 6105

Seoul, 02841, South Korea

Location

Galderma Investigational Site 5659

Seoul, 03080, South Korea

Location

Galderma Investigational Site 6116

Seoul, 03722, South Korea

Location

Galderma Investigational Site 6129

Seoul, 04763, South Korea

Location

Galderma Investigational Site 6103

Seoul, 05030, South Korea

Location

Galderma Investigational Site 6056

Seoul, 06591, South Korea

Location

Galderma Investigational Site 6094

Seoul, 06973, South Korea

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Galderma Investigational Site 6099

Seoul, 07441, South Korea

Location

Galderma Investigational Site 6057

Alicante, 03010, Spain

Location

Galderma Investigational Site 6037

Barcelona, 08036, Spain

Location

Galderma Investigational Site 6035

Barcelona, 08916, Spain

Location

Galderma Investigational Site 5580

Barcelona, 8907, Spain

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Galderma Investigational Site 6106

Las Palmas de Gran Canaria, 35010, Spain

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Galderma Investigational Site 6058

Madrid, 28006, Spain

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Galderma Investigational Site 5842

Madrid, 28034, Spain

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Galderma Investigational Site 6190

Madrid, 28046, Spain

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Galderma Investigational Site 6036

Madrid, 28223, Spain

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Galderma Investigational Site 5551

Madrid, 28922, Spain

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Galderma Investigational Site 6191

Pamplona, 31008, Spain

Location

Galderma Investigational Site 6202

Barnsley, S75 3DL, United Kingdom

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Galderma Investigational Site 6207

Blackpool, FY2 0JH, United Kingdom

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Galderma Investigational Site 6203

Cannock, WS11 0BN, United Kingdom

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Galderma Investigational Site 6104

Glasgow, G3 8SJ, United Kingdom

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Galderma Investigational Site 6204

Liverpool, L34 1BH, United Kingdom

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Galderma Investigational Site 6121

London, SE1 9RT, United Kingdom

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Galderma Investigational Site 6205

Manchester, M13 9NQ, United Kingdom

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Galderma Investigational Site 6206

Stockton-on-Tees, TS17 6EW, United Kingdom

Location

Related Publications (4)

• 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.

  PMID: 40360966 DERIVED

• 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
• 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 11, 2019
• First Posted: June 14, 2019
• Study Start: June 27, 2019
• Primary Completion: December 29, 2021
• Study Completion: August 11, 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

NL (3); LA (4); KR (15); LI (3); PL (20); CA (16); DE (13); ES (11); GB (8); AU (3); CZ (8); US (57); NZ (2)