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

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 is 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.

Study Overview

• Status: Completed
• Conditions: Moderate-to-Severe Atopic Dermatitis
• Intervention / Treatment: Drug: Placebo; Drug: Nemolizumab

Detailed Description

This is 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 must have a documented history of inadequate response to topical AD medication(s). Approximately 750 subjects will be 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).

• Study Type: Interventional
• Enrollment (Actual): 941
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Darlinghurst, New South Wales, Australia, 2010
      • Galderma Investigational Site 5441
    • Kogarah, New South Wales, Australia, 2217
      • Galderma Investigational Site 5759
    • Westmead, New South Wales, Australia, 2145
      • Galderma Investigational Site 6152
  • Queensland
    • Benowa, Queensland, Australia, 4217
      • Galderma Investigational Site 5638
    • Brisbane, Queensland, Australia, 4102
      • Galderma Investigational Site 6161
  • South Australia
    • Woodville, South Australia, Australia, 5011
      • Galderma Investigational Site 6159
  • Victoria
    • Carlton, Victoria, Australia, 3053
      • Galderma Investigational Site 6131
    • East Melbourne, Victoria, Australia, 3002
      • Galderma Investigational Site 5366
    • Parkville, Victoria, Australia, 3050
      • Galderma Investigational Site 5458
    • Parkville, Victoria, Australia, 3052
      • Galderma Investigational Site 6160
  • Western Australia
    • Fremantle, Western Australia, Australia, 6160
      • Galderma Investigational Site 5453
    • Victoria Park, Western Australia, Australia, 6100
      • Galderma Investigational Site 6153
• Austria
  • Linz, Austria, 4020
    • Galderma Investigational Site 6156
  • Vienna, Austria, 1220
    • Galderma Investigational Site 6158
  • Styria
    • Graz, Styria, Austria, 8036
      • Galderma Investigational Sites 6157
  • Wien
    • Vienna, Wien, Austria, 1090
      • Galderma Investigational Site 6194
• Canada
  • Niagara Falls, Canada, L2H 1H5
    • Galderma Investigational Site 8780
  • Ottawa, Canada, K1G 6C6
    • Galderma Investigational Site 8610
  • Saint John, Canada, A1C2H5
    • Galderma Investigational Site 8000
  • Waterloo, Canada, N2J 1C4
    • Galderma Investigational Site 8731
  • Alberta
    • Calgary, Alberta, Canada, T2G 1B1
      • Galderma Investigational Site 8085
    • Calgary, Alberta, Canada, T2J 7E1
      • Galderma Investigational Site 8903
    • Calgary, Alberta, Canada, T3E 0B2
      • Galderma Investigational Site 8215
    • Edmonton, Alberta, Canada, T6G 1C3
      • Galderma Investigational Site 8824
    • Edmonton, Alberta, Canada, T6G 1C9
      • Galderma Investigational Site 8722
    • Edmonton, Alberta, Canada, T5J 3S9
      • Galderma Investigational Site 8088
  • British Columbia
    • Surrey, British Columbia, Canada, V3V 0C6
      • Galderma Investigational Site 8161
  • Ontario
    • Barrie, Ontario, Canada, L4M 7G1
      • Galderma Investigational Site 8586
    • Guelph, Ontario, Canada, N1L 0B7
      • Galderma Investigational Site 8904
    • Ottawa, Ontario, Canada, K1H7X3
      • Galderma Investigational Site 8901
    • Toronto, Ontario, Canada, M3H 5Y8
      • Galderma Investigational Site 8336
    • Toronto, Ontario, Canada, M4W 2N4
      • Galderma Investigational Site 8899
• Czechia
  • Brno, Czechia, 656 91
    • Galderma Investigational Site 6055
  • Náchod, Czechia, 547 01
    • Galderma Investigational Site 5225
  • Olomouc, Czechia, 779 00
    • Galderma Investigational Site 6030
  • Prague, Czechia, 100 00
    • Galderma Investigational Site 6024
  • Prague, Czechia, 120 00
    • Galderma Investigational Site 6240
  • Praha, Czechia, 110 00
    • Galderma Investigational Site 6054
  • Praha, Czechia, 150 06
    • Galderma Investigational Site 6025
  • Praha, Czechia, 11000
    • Galderma Investigational Site 6021
• Germany
  • Bad Bentheim, Germany, 48455
    • Galderma Investigational Site 6022
  • Berlin, Germany, 13055
    • Galderma Investigational Site 6110
  • Bielefeld, Germany, 33647
    • Galderma Investigational Site 6061
  • Buxtehude, Germany, 21614
    • Galderma Investigational Site 6066
  • Darmstadt, Germany, 64283
    • Galderma Investigational Site 5368
  • Dülmen, Germany, 48249
    • Galderma Investigational Site 6028
  • Lubeck, Germany, 23538
    • Galderma Investigational Site 6033
  • Münster, Germany, 48149
    • Galderma Investigational Site 6039
  • Osnabrück, Germany, 49074
    • Galderma Investigational Site 5918
  • Stuttgart, Germany, 70499
    • Galderma Investigational Site 6109
  • Hesse
    • Langenau, Hesse, Germany, 89129
      • Galderma Investigational Site 6146
  • NRW
    • Berlin, NRW, Germany, 12203
      • Galderma Investigational Site 6172
  • Niedersachesen
    • Tuebingen, Niedersachesen, Germany, 72076
      • Galderma Investigational Site 6214
  • Schleswig-Holst
    • Kiel, Schleswig-Holst, Germany, 24105
      • Galderma Investigational Site 5437
• Korea, Republic of
  • Bucheon, Korea, Republic of, 14584
    • Galderma Investigational Site 6095
  • Busan, Korea, Republic of, 49241
    • Galderma Investigational Site 6100
  • Gyeonggi-do, Korea, Republic of, 15355
    • Galderma Investigational Site 6098
  • Gyeonggi-do, Korea, Republic of, 18450
    • Galderma Investigational Site 6154
  • Incheon, Korea, Republic of, 21431
    • Galderma Investigational Site 6138
  • Incheon, Korea, Republic of, 21565
    • Galderma Investigational Site 6120
  • Incheon, Korea, Republic of, 22332
    • Galderma Investigational Site 6093
  • Seoul, Korea, Republic of, 02841
    • Galderma Investigational Site 6105
  • Seoul, Korea, Republic of, 03080
    • Galderma Investigational Site 5659
  • Seoul, Korea, Republic of, 04763
    • Galderma Investigational Site 6129
  • Seoul, Korea, Republic of, 05030
    • Galderma Investigational Site 6103
  • Seoul, Korea, Republic of, 06591
    • Galderma Investigational Site 6056
  • Seoul, Korea, Republic of, 06973
    • Galderma Investigational Site 6094
  • Seoul, Korea, Republic of, 07441
    • Galderma Investigational Site 6099
  • Seoul, Korea, Republic of, 03722
    • Galderma Investigational Site 6166
• Latvia
  • Liepāja, Latvia, LV-3401
    • Galderma Investigational Site 6113
  • Riga, Latvia, LV-1006
    • Galderma Investigational Site 6134
  • Riga, Latvia, LV-1009
    • Galderma Investigational Site 6059
  • Talsi, Latvia, LV-3201
    • Galderma Investigational Site 6060
• Lithuania
  • Kaunas, Lithuania, LT-50161
    • Galderma Investigational Site 6111
  • Klaipėda, Lithuania, LT-92288
    • Galderma Investigational Site 6072
  • Vilnius, Lithuania, LT-07195
    • Galderma Investigational Site 6073
  • Vilnius, Lithuania, LT-08411
    • Galderma Investigational Site 6112
• Netherlands
  • Groningen, Netherlands, 9713
    • Galderma Investigational Site 6212
  • Rotterdam, Netherlands, 3015 GD
    • Galderma Investigational Site 6108
  • Utrecht, Netherlands, 3584 CX
    • Galderma Investigational Site 6027
• New Zealand
  • Hamilton, New Zealand, 3204
    • Galderma Investigational Site 6119
  • Wellington, New Zealand, 6021
    • Galderma Investigational Site 6118
• Poland
  • Czestochowa, Poland, 42-202
    • Galderma Investigational Site 6255
  • Gdańsk, Poland, 80-214
    • Galderma Investigational Site 6075
  • Gdańsk, Poland, 80-382
    • Galderma Investigational Site 6243
  • Gdańsk, Poland, 80-462
    • Galderma Investigational Site 5138
  • Gdynia, Poland, 81-537
    • Galderma Investigational Site 6244
  • Katowice, Poland, 40-040
    • Galderma Investigational Site 6087
  • Lublin, Poland, 20-081
    • Galderma Investigational Site 6071
  • Ostrowiec Świętokrzyski, Poland, 27-400
    • Galderma Investigational Site 6237
  • Poznań, Poland, 60-702
    • Galderma Investigational Site 6127
  • Rzeszów, Poland, 35-055
    • Galderma Investigational Site 6088
  • Szczecin, Poland, 70-332
    • Galderma Investigational Site 6223
  • Warszawa, Poland, 01-192
    • Galderma Investigational Site 6065
  • Warszawa, Poland, 02-507
    • Galderma Investigational Site 6122
  • Warszawa, Poland, 02-793
    • Galderma Investigational Site 6242
  • Warszawa, Poland, 02-953
    • Galderma Investigational Site 6064
  • Warszawa, Poland, 02-962
    • Galderma Investigational Site 6222
  • Wrocław, Poland, 50-381
    • Galderma Investigational Site 6047
  • Wrocław, Poland, 53-658
    • Galderma Investigational Site 5005
  • Łódź, Poland, 90-127
    • Galderma Investigational Site 6245
  • Łódź, Poland, 90-265
    • Galderma Investigational Site 5570
  • Łódź, Poland, 94-050
    • Galderma Investigational Site 6231
• Spain
  • Alicante, Spain, 03010
    • Galderma Investigational Site 6057
  • Barcelona, Spain, 08036
    • Galderma Investigational Site 6037
  • Barcelona, Spain, 08916
    • Galderma Investigational Site 6035
  • Barcelona, Spain, 08041
    • Galderma Investigational Site 5550
  • Barcelona, Spain, 8907
    • Galderma Investigational Site 5580
  • Las Palmas De Gran Canaria, Spain, 35010
    • Galderma Investigational Site 6106
  • Madrid, Spain, 28006
    • Galderma Investigational Site 6058
  • Madrid, Spain, 28034
    • Galderma Investigational Site 5842
  • Madrid, Spain, 28046
    • Galderma Investigational Site 6190
  • Madrid, Spain, 28223
    • Galderma Investigational Site 6036
  • Madrid, Spain, 28922
    • Galderma Investigational Site 5551
  • Majadahonda, Spain, 28222
    • Galderma Investigational Site 6186
  • Málaga, Spain, 29010
    • Galderma Investigational Site 6193
  • Pamplona, Spain, 31008
    • Galderma Investigational Site 6191
  • Valencia, Spain, 46026
    • Galderma Investigational Site 5970
• United Kingdom
  • Barnsley, United Kingdom, S75 3DL
    • Galderma Investigational Site 6202
  • Blackpool, United Kingdom, FY2 0JH
    • Galderma Investigational Site 6207
  • Cannock, United Kingdom, WS11 0BN
    • Galderma Investigational Site 6203
  • Cardiff, United Kingdom, CF15 9SS
    • Galderma Investigational Site 6246
  • Chorley, United Kingdom, PR7 7NA
    • Galderma Investigational Site 6248
  • Dudley, United Kingdom, DY1 2HQ
    • Galderma Investigational Site 6090
  • Dudley, United Kingdom, DY1 2HQ
    • Galderma Investigational Site
  • Edgbaston, United Kingdom, B15 2SQ
    • Galderma Investigational Site 6249
  • Glasgow, United Kingdom, G3 8SJ
    • Galderma Investigational Site 6104
  • Liverpool, United Kingdom, L34 1BH
    • Galderma Investigational Site 6204
  • London, United Kingdom, SE1 9RT
    • Galderma Investigational Site 6121
  • Manchester, United Kingdom, M13 9NQ
    • Galderma Investigational Site 6205
  • Newcastle, United Kingdom, NE1 4LP
    • Galderma Investigational Site 6208
  • Stockton-on-Tees, United Kingdom, TS17 6EW
    • Galderma Investigational Site 6206
• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Galderma Investigational Site 8750
    • North Little Rock, Arkansas, United States, 72117
      • Galderma Investigational Site 8880
  • California
    • Beverly Hills, California, United States, 90212
      • Galderma Investigational Site 8456
    • Cerritos, California, United States, 90703
      • Galderma Investigational Site 8578
    • Fountain Valley, California, United States, 92708
      • Galderma Investigational Site 8636
    • Fullerton, California, United States, 92835
      • Galderma Investigational Site 8888
    • Lomita, California, United States, 90717
      • Galderma Investigational Site 8686
    • Los Angeles, California, United States, 90025
      • Galderma Investigational Site 8674
    • North Hollywood, California, United States, 91606
      • Galderma Investigational Site 8891
    • San Diego, California, United States, 92108
      • Galderma Investigational Site 8671
    • San Francisco, California, United States, 94115
      • Galderma Investigational Site 8125
    • Santa Ana, California, United States, 92703
      • Galderma Investigational Site 8895
    • Santa Monica, California, United States, 90404
      • Galderma Investigational Site 8608
  • District of Columbia
    • Washington, District of Columbia, United States, 20037
      • Galderma Investigational Site 8111
  • Florida
    • Brandon, Florida, United States, 33511
      • Galderma Investigational Site 8897
    • Cape Coral, Florida, United States, 33991
      • Galderma Investigational Site 8805
    • Doral, Florida, United States, 33122
      • Galderma Investigational Site 8902
    • Hialeah, Florida, United States, 33016
      • Galderma Investigational Site 8804
    • Jacksonville, Florida, United States, 32256
      • Galderma Investigational Site 8711
    • Miami, Florida, United States, 33145
      • Galderma Investigational Site 8801
    • Miami, Florida, United States, 33174
      • Galderma Investigational Site 8737
    • Miami, Florida, United States, 33176
      • Galderma Investigational Site 8708
    • Miami, Florida, United States, 33126
      • Galderma Investigational Site 8710
    • Miami Lakes, Florida, United States, 33014
      • Galderma Investigational Site 8806
    • Miami Lakes, Florida, United States, 33016
      • Galderma Investigational Site 8800
    • Pembroke Pines, Florida, United States, 33028
      • Galderma Investigational Site 8734
    • Tampa, Florida, United States, 33511
      • Galderma Investigational Site 8889
  • Georgia
    • Macon, Georgia, United States, 31217
      • Galderma Investigational Site 8744
    • Newnan, Georgia, United States, 30263
      • Galderma Investigational Site 8728
    • Union City, Georgia, United States, 30291
      • Galderma Investigational Site 8887
  • Idaho
    • Blackfoot, Idaho, United States, 83221
      • Galderma Investigational Site 8890
    • Nampa, Idaho, United States, 83687
      • Galderma Investigational Site 8819
  • Illinois
    • Skokie, Illinois, United States, 60077
      • Galderma Investigational Site 8712
    • Skokie, Illinois, United States, 60076
      • Galderma Investigational Site 8571
  • Indiana
    • Indianapolis, Indiana, United States, 46250
      • Galderma Investigational Site 8142
  • Kentucky
    • Louisville, Kentucky, United States, 40241
      • Galderma Investigational Site 8771
  • Maine
    • Bangor, Maine, United States, 04401
      • Galderma Investigational Site 8882
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Galderma Investigational Site 8743
    • Bay City, Michigan, United States, 48706
      • Galderma Investigational Site 8512
    • Troy, Michigan, United States, 48084
      • Galderma Investigational Site 8155
    • Ypsilanti, Michigan, United States, 48197
      • Galderma Investigational Site 8748
  • Missouri
    • Saint Joseph, Missouri, United States, 64506
      • Galderma Investigational Site 8521
  • Montana
    • Missoula, Montana, United States, 59808
      • Galderma Investigational Site 8718
  • Nebraska
    • Omaha, Nebraska, United States, 68144
      • Galderma Investigational Site 8810
  • Nevada
    • Henderson, Nevada, United States, 89052
      • Galderma Investigational Site 8740
  • New Hampshire
    • Lebanon, New Hampshire, United States, 003766
      • Galderma Investigational Site 8109
  • New Mexico
    • Albuquerque, New Mexico, United States, 87106
      • Galderma Investigational Site 8826
  • New York
    • Brooklyn, New York, United States, 11203
      • Galderma Investigational Site 8242
    • New York, New York, United States, 10023
      • Galderma Investigational Site 8620
    • New York, New York, United States, 10075
      • Galderma Investigational Site 8279
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Galderma Investigational Site 8772
    • Wilmington, North Carolina, United States, 28405-3176
      • Galderma Investigational Site 8726
    • Wilmington, North Carolina, United States, 28405
      • Galderma Investigational Site 8648
  • Ohio
    • Bexley, Ohio, United States, 43209
      • Galderma Investigational Site 8702
    • Dublin, Ohio, United States, 43016
      • Galderma Investigational Site 8595
  • Oklahoma
    • Norman, Oklahoma, United States, 73071
      • Galderma Investigational Site 8206
    • Oklahoma City, Oklahoma, United States, 73118
      • Galderma Investigational Site 8857
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19103
      • Galderma Investigational Site 8255
    • Plymouth Meeting, Pennsylvania, United States, 19462
      • Galderma Investigational Site 8802
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Galderma Investigational Site 8736
  • South Dakota
    • Rapid City, South Dakota, United States, 57702
      • Galderma Investigational Site 8818
  • Texas
    • Arlington, Texas, United States, 76011
      • Galderma Investigational Site 8133
    • Austin, Texas, United States, 78723
      • Galderma Investigational Site 8298
    • Dallas, Texas, United States, 75230
      • Galderma Investigational Site 8238
    • Dripping Springs, Texas, United States, 78620
      • Galderma Investigational Site 8827
    • Frisco, Texas, United States, 75034
      • Galderma Investigational Site 8664
    • Houston, Texas, United States, 77056
      • Galderma Investigational Site 8042
    • Houston, Texas, United States, 77401
      • Galderma Investigational Site 8670
  • Virginia
    • Burke, Virginia, United States, 22015
      • Galderma Investigational Site 8738
    • Fairfax, Virginia, United States, 22031
      • Galderma Investigational Site 8862

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Key Inclusion Criteria:

• Male or female subjects aged ≥ 12 years at the screening visit Note: Enrollment of subjects aged 12 to 17 years has been opened after the IDMC has assessed interim safety data from the phase 2 study (Protocol 116912) and provided recommendations to the sponsor, who then determined the eligibility of this age group for enrollment in the study
• Chronic AD that has been documented for at least 2 years
• EASI score ≥ 16
• IGA score ≥ 3
• AD involvement ≥ 10% of BSA
• PPNRS score of at least 4.0 at the screening and baseline visit
• Documented recent history of inadequate response to topical medications (TCS with or without 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

Key Exclusion Criteria:

• Body weight < 30 kg
• Pregnant women, breastfeeding women, or women planning a pregnancy during the clinical study
• 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 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, eg, monoclonal antibody) or to any of the study drug excipients
• Any clinically significant issue, based on investigator judgement

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Placebo
Experimental: Nemolizumab; Nemolizumab Active	Drug: Nemolizumab; Nemolizumab; Other Names: CD14152

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of subjects with an IGA success (IGA of 0 or 1) and a ≥ 2-point reduction	IGA success rate defined as the proportion of subjects who achieve an IGA score of 1 (Almost Clear) or 0 (Clear) and at least a 2-grade improvement from Baseline to Week 16.	Baseline to Week 16
Proportion of subjects with EASI-75		Baseline to Week 16

Secondary Outcome Measures

Outcome Measure	Time Frame
Proportion of subjects with an improvement of PP NRS ≥ 4	Week 16
Proportion of subjects with PP NRS < 2	Week 16
Proportion of subjects with an improvement of sleep disturbance NRS (SD NRS) ≥ 4	Week 16
Proportion of subjects with an improvement of PP NRS ≥ 4	Week 4
Proportion of subjects with PP NRS < 2	Week 4
Proportion of subjects with an improvement of PP NRS ≥ 4	Week 2
Proportion of subjects with an improvement of PP NRS ≥ 4	Week 1
Proportion of subjects with EASI-75 and improvement of PP NRS ≥ 4	Week 16
Proportion of subjects with IGA success and improvement of PP NRS ≥ 4	Week 16

Collaborators and Investigators

• Sponsor: Galderma R&D

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2019
• Primary Completion (Actual): August 11, 2022
• Study Completion (Actual): August 11, 2022

Study Registration Dates

• First Submitted: June 11, 2019
• First Submitted That Met QC Criteria: June 11, 2019
• First Posted (Actual): June 14, 2019

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: September 19, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Atopic Dermatitis; Nemolizumab; CD14152
• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic
• Other Study ID Numbers: RD.06.SPR.118161

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No