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

Primary Purpose

Moderate-to-Severe Atopic Dermatitis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Placebo
Nemolizumab
Sponsored by
Galderma R&D
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Moderate-to-Severe Atopic Dermatitis focused on measuring CD14152, Nemolizumab, Atopic Dermatitis

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Galderma Investigational Site 8750
  • Galderma Investigational Site 8880
  • Galderma Investigational Site 8456
  • Galderma Investigational Site 8578
  • Galderma Investigational Site 8636
  • Galderma Investigational Site 8888
  • Galderma Investigational Site 8686
  • Galderma Investigational Site 8674
  • Galderma Investigational Site 8891
  • Galderma Investigational Site 8671
  • Galderma Investigational Site 8125
  • Galderma Investigational Site 8895
  • Galderma Investigational Site 8608
  • Galderma Investigational Site 8111
  • Galderma Investigational Site 8897
  • Galderma Investigational Site 8805
  • Galderma Investigational Site 8902
  • Galderma Investigational Site 8804
  • Galderma Investigational Site 8711
  • Galderma Investigational Site 8806
  • Galderma Investigational Site 8800
  • Galderma Investigational Site 8710
  • Galderma Investigational Site 8801
  • Galderma Investigational Site 8737
  • Galderma Investigational Site 8708
  • Galderma Investigational Site 8734
  • Galderma Investigational Site 8889
  • Galderma Investigational Site 8744
  • Galderma Investigational Site 8728
  • Galderma Investigational Site 8887
  • Galderma Investigational Site 8890
  • Galderma Investigational Site 8819
  • Galderma Investigational Site 8571
  • Galderma Investigational Site 8712
  • Galderma Investigational Site 8142
  • Galderma Investigational Site 8771
  • Galderma Investigational Site 8882
  • Galderma Investigational Site 8743
  • Galderma Investigational Site 8512
  • Galderma Investigational Site 8155
  • Galderma Investigational Site 8748
  • Galderma Investigational Site 8521
  • Galderma Investigational Site 8718
  • Galderma Investigational Site 8810
  • Galderma Investigational Site 8740
  • Galderma Investigational Site 8109
  • Galderma Investigational Site 8826
  • Galderma Investigational Site 8242
  • Galderma Investigational Site 8620
  • Galderma Investigational Site 8279
  • Galderma Investigational Site 8772
  • Galderma Investigational Site 8726
  • Galderma Investigational Site 8648
  • Galderma Investigational Site 8702
  • Galderma Investigational Site 8595
  • Galderma Investigational Site 8206
  • Galderma Investigational Site 8857
  • Galderma Investigational Site 8255
  • Galderma Investigational Site 8802
  • Galderma Investigational Site 8736
  • Galderma Investigational Site 8818
  • Galderma Investigational Site 8133
  • Galderma Investigational Site 8298
  • Galderma Investigational Site 8238
  • Galderma Investigational Site 8827
  • Galderma Investigational Site 8664
  • Galderma Investigational Site 8042
  • Galderma Investigational Site 8670
  • Galderma Investigational Site 8738
  • Galderma Investigational Site 8862
  • Galderma Investigational Site 5441
  • Galderma Investigational Site 5759
  • Galderma Investigational Site 6152
  • Galderma Investigational Site 5638
  • Galderma Investigational Site 6161
  • Galderma Investigational Site 6159
  • Galderma Investigational Site 6131
  • Galderma Investigational Site 5366
  • Galderma Investigational Site 5458
  • Galderma Investigational Site 6160
  • Galderma Investigational Site 5453
  • Galderma Investigational Site 6153
  • Galderma Investigational Sites 6157
  • Galderma Investigational Site 6194
  • Galderma Investigational Site 6156
  • Galderma Investigational Site 6158
  • Galderma Investigational Site 8085
  • Galderma Investigational Site 8903
  • Galderma Investigational Site 8215
  • Galderma Investigational Site 8088
  • Galderma Investigational Site 8824
  • Galderma Investigational Site 8722
  • Galderma Investigational Site 8161
  • Galderma Investigational Site 8586
  • Galderma Investigational Site 8904
  • Galderma Investigational Site 8901
  • Galderma Investigational Site 8336
  • Galderma Investigational Site 8899
  • Galderma Investigational Site 8780
  • Galderma Investigational Site 8610
  • Galderma Investigational Site 8000
  • Galderma Investigational Site 8731
  • Galderma Investigational Site 6055
  • Galderma Investigational Site 5225
  • Galderma Investigational Site 6030
  • Galderma Investigational Site 6024
  • Galderma Investigational Site 6240
  • Galderma Investigational Site 6054
  • Galderma Investigational Site 6021
  • Galderma Investigational Site 6025
  • Galderma Investigational Site 6146
  • Galderma Investigational Site 6214
  • Galderma Investigational Site 6172
  • Galderma Investigational Site 5437
  • Galderma Investigational Site 6022
  • Galderma Investigational Site 6110
  • Galderma Investigational Site 6061
  • Galderma Investigational Site 6066
  • Galderma Investigational Site 5368
  • Galderma Investigational Site 6028
  • Galderma Investigational Site 6033
  • Galderma Investigational Site 6039
  • Galderma Investigational Site 5918
  • Galderma Investigational Site 6109
  • Galderma Investigational Site 6095
  • Galderma Investigational Site 6100
  • Galderma Investigational Site 6098
  • Galderma Investigational Site 6154
  • Galderma Investigational Site 6138
  • Galderma Investigational Site 6120
  • Galderma Investigational Site 6093
  • Galderma Investigational Site 6105
  • Galderma Investigational Site 5659
  • Galderma Investigational Site 6166
  • Galderma Investigational Site 6129
  • Galderma Investigational Site 6103
  • Galderma Investigational Site 6056
  • Galderma Investigational Site 6094
  • Galderma Investigational Site 6099
  • Galderma Investigational Site 6113
  • Galderma Investigational Site 6134
  • Galderma Investigational Site 6059
  • Galderma Investigational Site 6060
  • Galderma Investigational Site 6111
  • Galderma Investigational Site 6072
  • Galderma Investigational Site 6073
  • Galderma Investigational Site 6112
  • Galderma Investigational Site 6212
  • Galderma Investigational Site 6108
  • Galderma Investigational Site 6027
  • Galderma Investigational Site 6119
  • Galderma Investigational Site 6118
  • Galderma Investigational Site 6255
  • Galderma Investigational Site 6075
  • Galderma Investigational Site 6243
  • Galderma Investigational Site 5138
  • Galderma Investigational Site 6244
  • Galderma Investigational Site 6087
  • Galderma Investigational Site 6071
  • Galderma Investigational Site 6237
  • Galderma Investigational Site 6127
  • Galderma Investigational Site 6088
  • Galderma Investigational Site 6223
  • Galderma Investigational Site 6065
  • Galderma Investigational Site 6122
  • Galderma Investigational Site 6242
  • Galderma Investigational Site 6064
  • Galderma Investigational Site 6222
  • Galderma Investigational Site 6047
  • Galderma Investigational Site 5005
  • Galderma Investigational Site 6245
  • Galderma Investigational Site 5570
  • Galderma Investigational Site 6231
  • Galderma Investigational Site 6057
  • Galderma Investigational Site 6037
  • Galderma Investigational Site 5550
  • Galderma Investigational Site 6035
  • Galderma Investigational Site 5580
  • Galderma Investigational Site 6106
  • Galderma Investigational Site 6058
  • Galderma Investigational Site 5842
  • Galderma Investigational Site 6190
  • Galderma Investigational Site 6036
  • Galderma Investigational Site 5551
  • Galderma Investigational Site 6186
  • Galderma Investigational Site 6193
  • Galderma Investigational Site 6191
  • Galderma Investigational Site 5970
  • Galderma Investigational Site 6202
  • Galderma Investigational Site 6207
  • Galderma Investigational Site 6203
  • Galderma Investigational Site 6246
  • Galderma Investigational Site 6248
  • Galderma Investigational Site 6090
  • Galderma Investigational Site
  • Galderma Investigational Site 6249
  • Galderma Investigational Site 6104
  • Galderma Investigational Site 6204
  • Galderma Investigational Site 6121
  • Galderma Investigational Site 6205
  • Galderma Investigational Site 6208
  • Galderma Investigational Site 6206

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Nemolizumab

Arm Description

Placebo

Nemolizumab Active

Outcomes

Primary Outcome Measures

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.
Proportion of subjects with EASI-75

Secondary Outcome Measures

Proportion of subjects with an improvement of PP NRS ≥ 4
Proportion of subjects with PP NRS < 2
Proportion of subjects with an improvement of sleep disturbance NRS (SD NRS) ≥ 4
Proportion of subjects with an improvement of PP NRS ≥ 4
Proportion of subjects with PP NRS < 2
Proportion of subjects with an improvement of PP NRS ≥ 4
Proportion of subjects with an improvement of PP NRS ≥ 4
Proportion of subjects with EASI-75 and improvement of PP NRS ≥ 4
Proportion of subjects with IGA success and improvement of PP NRS ≥ 4

Full Information

First Posted
June 11, 2019
Last Updated
September 19, 2023
Sponsor
Galderma R&D
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1. Study Identification

Unique Protocol Identification Number
NCT03985943
Brief Title
Efficacy and Safety of Nemolizumab in Subjects With Moderate-to-Severe Atopic Dermatitis
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
June 30, 2019 (Actual)
Primary Completion Date
August 11, 2022 (Actual)
Study Completion Date
August 11, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Galderma R&D

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Moderate-to-Severe Atopic Dermatitis
Keywords
CD14152, Nemolizumab, Atopic Dermatitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Treatment
Allocation
Randomized
Enrollment
941 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Arm Title
Nemolizumab
Arm Type
Experimental
Arm Description
Nemolizumab Active
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Nemolizumab
Other Intervention Name(s)
CD14152
Intervention Description
Nemolizumab
Primary Outcome Measure Information:
Title
Proportion of subjects with an IGA success (IGA of 0 or 1) and a ≥ 2-point reduction
Description
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.
Time Frame
Baseline to Week 16
Title
Proportion of subjects with EASI-75
Time Frame
Baseline to Week 16
Secondary Outcome Measure Information:
Title
Proportion of subjects with an improvement of PP NRS ≥ 4
Time Frame
Week 16
Title
Proportion of subjects with PP NRS < 2
Time Frame
Week 16
Title
Proportion of subjects with an improvement of sleep disturbance NRS (SD NRS) ≥ 4
Time Frame
Week 16
Title
Proportion of subjects with an improvement of PP NRS ≥ 4
Time Frame
Week 4
Title
Proportion of subjects with PP NRS < 2
Time Frame
Week 4
Title
Proportion of subjects with an improvement of PP NRS ≥ 4
Time Frame
Week 2
Title
Proportion of subjects with an improvement of PP NRS ≥ 4
Time Frame
Week 1
Title
Proportion of subjects with EASI-75 and improvement of PP NRS ≥ 4
Time Frame
Week 16
Title
Proportion of subjects with IGA success and improvement of PP NRS ≥ 4
Time Frame
Week 16

10. Eligibility

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

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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