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Efficacy & 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 8749
  • Galderma Investigational Site 8893
  • Galderma Investigational Site 8866
  • Galderma Investigational Site 8808
  • Galderma Investigational Site 8906
  • Galderma Investigational Site 8905
  • Galderma Investigational Site 8577
  • Galderma Investigational Site 8224
  • Galderma Investigational Site 8673
  • Galderma Investigational Site 8683
  • Galderma Investigational Site 8907
  • Galderma Investigational Site 8799
  • Galderma Investigational Site 8745
  • Galderma Investigational Site 8692
  • Galderma Investigational Site 8658
  • Galderma Investigational Site 8536
  • Galderma Investigational Site 8820
  • Galderma Investigational Site 8637
  • Galderma Investigational Site 8875
  • Galderma Investigational Site 8391
  • Galderma Investigational Site 8727
  • Galderma Investigational Site 8523
  • Galderma Investigational Site 8719
  • Galderma Investigational Site 8656
  • Galderma Investigational Site 8704
  • Galderma Investigational Site 8706
  • Galderma Investigational Site 8203
  • Galderma Investigational Site 8839
  • Galderma Investigational Site 8126
  • Galderma Investigational Site 8667
  • Galderma Investigational Site 8729
  • Galderma Investigational Site 8724
  • Galderma Investigational Site 8554
  • Galderma Investigational Site 8617
  • Galderma Investigational Site 8226
  • Galderma Investigational Site 8825
  • Galderma Investigational Site 8675
  • Galderma Investigational Site 8506
  • Galderma Investigational Site 8741
  • Galderma Investigational Site 8723
  • Galderma Investigational Site 8821
  • Galderma Investigational Site 8733
  • Galderma Investigational Site 8823
  • Galderma Investigational Site 8030
  • Galderma Investigational Site 8747
  • Galderma Investigational Site 8212
  • Galderma Investigational Site 8721
  • Galderma Investigational Site 8713
  • Galderma Investigational Site 8705
  • Galderma Investigational Site 8807
  • Galderma Investigational Site 8618
  • Galderma Investigational Site 8003
  • Galderma Investigational Site 8672
  • Galderma Investigational Site 8896
  • Galderma Investigational Site 8434
  • Galderma Investigational Site 5448
  • Galderma Investigational Site 6163
  • Galderma Investigational Site 6164
  • Galderma Investigational Site 6038
  • Galderma Investigational Site 6162
  • Galderma Investigational Site 6029
  • Galderma Investigational Site 6034
  • Galderma Investigational Site 6051
  • Galderma Investigational Site 6078
  • Galderma Investigational Site 6102
  • Galderma Investigational Site 6165
  • Galderma Investigational Site 6216
  • Galderma Investigational Site 6046
  • Galderma Investigational Site 6080
  • Galderma Investigational Site 6101
  • Galderma Investigational Site 6079
  • Galderma Investigational Site 6250
  • Galderma Investigational Site 6136
  • Galderma Investigational Site 6251
  • Galderma Investigational Site 6069
  • Galderma Investigational Site 6068
  • Galderma Investigational Site 6067
  • Galderma Investigational Site 5104
  • Galderma Investigational Site 6198
  • Galderma Investigational Site 6171
  • Galderma Investigational Site 5031
  • Galderma Investigational Site 6170
  • Galderma Investigational Site 6167
  • Galderma Investigational Site 5140
  • Galderma Investigational Site 6133
  • Galderma Investigational Site 6166
  • Galderma Investigational Site 5407
  • Galderma Investigational Site 6135
  • Galderma Investigational Site 5137
  • Galderma Investigational Site 6197
  • Galderma Investigational Site 6169
  • Galderma Investigational Site 6168
  • Galderma Investigational Site 6238
  • Galderma Investigational Site 6227
  • Galderma Investigational Site 6230
  • Galderma Investigation Site 6228
  • Galderma Investigational Site 6224
  • Galderma Investigational Site 6235
  • Galderma Investigational Site 6234
  • Galderma Investigational Site 6236
  • Galderma Investigational Site 5482
  • Galderma Investigational Site 6114
  • Galderma Investigational Site 5566
  • Galderma Investigational Site 6082
  • Galderma Investigational Site 6132
  • Galderma Investigational Site 6031
  • Galderma Investigational Site 6083
  • Galderma Investigational Site 5442
  • Galderma Investigational Site 6081
  • Galderma Investigational Site 6062
  • Galderma Investigational Site 6041
  • Galderma Investigational Site 6150
  • Galderma Investigational Site 6040
  • Galderma Investigational Site 5469
  • Galderma Investigational Site 6086
  • Galderma Investigational Site 6084
  • Galderma Investigational Site 5382
  • Galderma Investigational Site 6147
  • Galderma Investigational Site 5513
  • Galderma Investigational Site 5567
  • Galderma Investigational Site 6026
  • Galderma Investigational Site 6254
  • Galderma Investigational Site 6043
  • Galderma Investigational Site 6053
  • Galderma Investigational Site 6179
  • Galderma Investigational Site 6145
  • Galderma Investigational Site 6181
  • Galderma Investigational Site 6141
  • Galderma Investigational Site 6115
  • Galderma Investigational Site 6176
  • Galderma Investigational Site 6045
  • Galderma Investigational Site 6144
  • Galderma Investigational Site 6178
  • Galderma Investigational Site 6151
  • Galderma Investigational Site 6180
  • Galderma Investigational Site 6182
  • Galderma Investigational Site 6143
  • Galderma Investigational Site 6044
  • Galderma Investigational Site 6049
  • Galderma Investigational Site 6177
  • Galderma Investigational Site 6155
  • Galderma Investigational Site 6142
  • Galderma Investigational Site 6175
  • Galderma Investigational Site 5773
  • Galderma Investigational Site 6097
  • Galderma Investigational Site 5362
  • Galderma Investigational Site 5021
  • Galderma Investigational Site 6052
  • Galderma Investigational Site 5367
  • Galderma Investigational Site 5377
  • Galderma Investigational Site 6063
  • Galderma Investigational Site 6085
  • Galderma Investigational Site 5495
  • Galderma Investigational Site 6130
  • Galderma Investigational Site 6048
  • Galderma Investigational Site 6126
  • Galderma Investigational Site 5707
  • Galderma Investigational Site 6185
  • Galderma Investigational Site 6096
  • Galderma Investigational Site 5363
  • Galderma Investigational Site 6124
  • Galderma Investigational Site 6077
  • Galderma Investigational Site 5499

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Nemolizumab

Arm Description

Placebo administered via subcutaneous injection

Nemolizumab administered via subcutaneous injection

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 14, 2019
Last Updated
September 19, 2023
Sponsor
Galderma R&D
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1. Study Identification

Unique Protocol Identification Number
NCT03989349
Brief Title
Efficacy & 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
September 26, 2022 (Actual)
Study Completion Date
September 26, 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
788 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo administered via subcutaneous injection
Arm Title
Nemolizumab
Arm Type
Experimental
Arm Description
Nemolizumab administered via subcutaneous injection
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 8749
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35244
Country
United States
Facility Name
Galderma Investigational Site 8893
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35244
Country
United States
Facility Name
Galderma Investigational Site 8866
City
Guntersville
State/Province
Alabama
ZIP/Postal Code
35976
Country
United States
Facility Name
Galderma Investigational Site 8808
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85255
Country
United States
Facility Name
Galderma Investigational Site 8906
City
Bell Gardens
State/Province
California
ZIP/Postal Code
90201
Country
United States
Facility Name
Galderma Investigational Site 8905
City
Canoga Park
State/Province
California
ZIP/Postal Code
91304
Country
United States
Facility Name
Galderma Investigational Site 8577
City
Encinitas
State/Province
California
ZIP/Postal Code
92024
Country
United States
Facility Name
Galderma Investigational Site 8224
City
Fremont
State/Province
California
ZIP/Postal Code
94538
Country
United States
Facility Name
Galderma Investigational Site 8673
City
Garden Grove
State/Province
California
ZIP/Postal Code
92840
Country
United States
Facility Name
Galderma Investigational Site 8683
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Galderma Investigational Site 8907
City
Newport Beach
State/Province
California
ZIP/Postal Code
92660
Country
United States
Facility Name
Galderma Investigational Site 8799
City
Ontario
State/Province
California
ZIP/Postal Code
91762
Country
United States
Facility Name
Galderma Investigational Site 8745
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
Facility Name
Galderma Investigational Site 8692
City
San Diego
State/Province
California
ZIP/Postal Code
92121
Country
United States
Facility Name
Galderma Investigational Site 8658
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Galderma Investigational Site 8536
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Facility Name
Galderma Investigational Site 8820
City
Westminster
State/Province
California
ZIP/Postal Code
92683
Country
United States
Facility Name
Galderma Investigational Site 8637
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06030
Country
United States
Facility Name
Galderma Investigational Site 8875
City
Delray Beach
State/Province
Florida
ZIP/Postal Code
33484
Country
United States
Facility Name
Galderma Investigational Site 8391
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33013
Country
United States
Facility Name
Galderma Investigational Site 8727
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
Galderma Investigational Site 8523
City
Largo
State/Province
Florida
ZIP/Postal Code
33770
Country
United States
Facility Name
Galderma Investigational Site 8719
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
Facility Name
Galderma Investigational Site 8656
City
Miami
State/Province
Florida
ZIP/Postal Code
33137
Country
United States
Facility Name
Galderma Investigational Site 8704
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Facility Name
Galderma Investigational Site 8706
City
Miami
State/Province
Florida
ZIP/Postal Code
33175
Country
United States
Facility Name
Galderma Investigational Site 8203
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Facility Name
Galderma Investigational Site 8839
City
Tampa
State/Province
Florida
ZIP/Postal Code
33615
Country
United States
Facility Name
Galderma Investigational Site 8126
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33401
Country
United States
Facility Name
Galderma Investigational Site 8667
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904
Country
United States
Facility Name
Galderma Investigational Site 8729
City
Rolling Meadows
State/Province
Illinois
ZIP/Postal Code
60008
Country
United States
Facility Name
Galderma Investigational Site 8724
City
New Albany
State/Province
Indiana
ZIP/Postal Code
47150
Country
United States
Facility Name
Galderma Investigational Site 8554
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Galderma Investigational Site 8617
City
Farmington Hills
State/Province
Michigan
ZIP/Postal Code
48334
Country
United States
Facility Name
Galderma Investigational Site 8226
City
Warren
State/Province
Michigan
ZIP/Postal Code
48088
Country
United States
Facility Name
Galderma Investigational Site 8825
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
Galderma Investigational Site 8675
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89119
Country
United States
Facility Name
Galderma Investigational Site 8506
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Galderma Investigational Site 8741
City
Buffalo
State/Province
New York
ZIP/Postal Code
14221
Country
United States
Facility Name
Galderma Investigational Site 8723
City
Cortland
State/Province
New York
ZIP/Postal Code
13045
Country
United States
Facility Name
Galderma Investigational Site 8821
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Galderma Investigational Site 8733
City
New York
State/Province
New York
ZIP/Postal Code
10022
Country
United States
Facility Name
Galderma Investigational Site 8823
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27408
Country
United States
Facility Name
Galderma Investigational Site 8030
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Galderma Investigational Site 8747
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Galderma Investigational Site 8212
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Galderma Investigational Site 8721
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Galderma Investigational Site 8713
City
North Charleston
State/Province
South Carolina
ZIP/Postal Code
29420
Country
United States
Facility Name
Galderma Investigational Site 8705
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37421
Country
United States
Facility Name
Galderma Investigational Site 8807
City
Houston
State/Province
Texas
ZIP/Postal Code
77029
Country
United States
Facility Name
Galderma Investigational Site 8618
City
Waco
State/Province
Texas
ZIP/Postal Code
76710
Country
United States
Facility Name
Galderma Investigational Site 8003
City
Webster
State/Province
Texas
ZIP/Postal Code
77598
Country
United States
Facility Name
Galderma Investigational Site 8672
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84117
Country
United States
Facility Name
Galderma Investigational Site 8896
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23219
Country
United States
Facility Name
Galderma Investigational Site 8434
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Facility Name
Galderma Investigational Site 5448
City
Brussel
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Galderma Investigational Site 6163
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Facility Name
Galderma Investigational Site 6164
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Galderma Investigational Site 6038
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Galderma Investigational Site 6162
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Galderma Investigational Site 6029
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Facility Name
Galderma Investigational Site 6034
City
Plovdiv
ZIP/Postal Code
4002
Country
Bulgaria
Facility Name
Galderma Investigational Site 6051
City
Sofia
ZIP/Postal Code
1407
Country
Bulgaria
Facility Name
Galderma Investigational Site 6078
City
Sofia
ZIP/Postal Code
1408
Country
Bulgaria
Facility Name
Galderma Investigational Site 6102
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
Galderma Investigational Site 6165
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
Galderma Investigational Site 6216
City
Sofia
ZIP/Postal Code
1528
Country
Bulgaria
Facility Name
Galderma Investigational Site 6046
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
Facility Name
Galderma Investigational Site 6080
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
Facility Name
Galderma Investigational Site 6101
City
Sofia
ZIP/Postal Code
1612
Country
Bulgaria
Facility Name
Galderma Investigational Site 6079
City
Sofia
ZIP/Postal Code
1618
Country
Bulgaria
Facility Name
Galderma Investigational Site 6250
City
Sofia
ZIP/Postal Code
1784
Country
Bulgaria
Facility Name
Galderma Investigational Site 6136
City
Stara Zagora
ZIP/Postal Code
6000
Country
Bulgaria
Facility Name
Galderma Investigational Site 6251
City
Stara Zagora
ZIP/Postal Code
6000
Country
Bulgaria
Facility Name
Galderma Investigational Site 6069
City
Tallinn
ZIP/Postal Code
10138
Country
Estonia
Facility Name
Galderma Investigational Site 6068
City
Tallin
ZIP/Postal Code
10134
Country
Estonia
Facility Name
Galderma Investigational Site 6067
City
Tartu
ZIP/Postal Code
50417
Country
Estonia
Facility Name
Galderma Investigational Site 5104
City
Brest
ZIP/Postal Code
29200
Country
France
Facility Name
Galderma Investigational Site 6198
City
Le Mans
ZIP/Postal Code
72037
Country
France
Facility Name
Galderma Investigational Site 6171
City
Lille
ZIP/Postal Code
59000
Country
France
Facility Name
Galderma Investigational Site 5031
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Galderma Investigational Site 6170
City
Martigues
ZIP/Postal Code
13500
Country
France
Facility Name
Galderma Investigational Site 6167
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
Galderma Investigational Site 5140
City
Nice
ZIP/Postal Code
6200
Country
France
Facility Name
Galderma Investigational Site 6133
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
Galderma Investigational Site 6166
City
Paris
ZIP/Postal Code
75475
Country
France
Facility Name
Galderma Investigational Site 5407
City
Pierre-Bénite
ZIP/Postal Code
69495
Country
France
Facility Name
Galderma Investigational Site 6135
City
Quimper
ZIP/Postal Code
29 107
Country
France
Facility Name
Galderma Investigational Site 5137
City
Saint-Priest-en-Jarez
ZIP/Postal Code
42270
Country
France
Facility Name
Galderma Investigational Site 6197
City
Toulon
ZIP/Postal Code
83800
Country
France
Facility Name
Galderma Investigational Site 6169
City
Toulouse
ZIP/Postal Code
31000
Country
France
Facility Name
Galderma Investigational Site 6168
City
Valence
ZIP/Postal Code
26000
Country
France
Facility Name
Galderma Investigational Site 6238
City
Tbilisi
ZIP/Postal Code
0159
Country
Georgia
Facility Name
Galderma Investigational Site 6227
City
Tbilisi
ZIP/Postal Code
0186
Country
Georgia
Facility Name
Galderma Investigational Site 6230
City
Tbilisi
ZIP/Postal Code
0186
Country
Georgia
Facility Name
Galderma Investigation Site 6228
City
Tbilisi
ZIP/Postal Code
159
Country
Georgia
Facility Name
Galderma Investigational Site 6224
City
Tbilisi
ZIP/Postal Code
159
Country
Georgia
Facility Name
Galderma Investigational Site 6235
City
Tbilisi
ZIP/Postal Code
159
Country
Georgia
Facility Name
Galderma Investigational Site 6234
City
Tbilisi
ZIP/Postal Code
186
Country
Georgia
Facility Name
Galderma Investigational Site 6236
City
Zugdidi
ZIP/Postal Code
2100
Country
Georgia
Facility Name
Galderma Investigational Site 5482
City
Aachen
ZIP/Postal Code
52074
Country
Germany
Facility Name
Galderma Investigational Site 6114
City
Augsburg
ZIP/Postal Code
86156
Country
Germany
Facility Name
Galderma Investigational Site 5566
City
Augsburg
ZIP/Postal Code
86179
Country
Germany
Facility Name
Galderma Investigational Site 6082
City
Bonn
ZIP/Postal Code
53127
Country
Germany
Facility Name
Galderma Investigational Site 6132
City
Dresden
ZIP/Postal Code
01097
Country
Germany
Facility Name
Galderma Investigational Site 6031
City
Duesseldorf
ZIP/Postal Code
40225
Country
Germany
Facility Name
Galderma Investigational Site 6083
City
Frankfurt
ZIP/Postal Code
60437
Country
Germany
Facility Name
Galderma Investigational Site 5442
City
Gera
ZIP/Postal Code
7548
Country
Germany
Facility Name
Galderma Investigational Site 6081
City
Goettigen
ZIP/Postal Code
37075
Country
Germany
Facility Name
Galderma Investigational Site 6062
City
Halle
ZIP/Postal Code
6120
Country
Germany
Facility Name
Galderma Investigational Site 6041
City
Hamburg
ZIP/Postal Code
20251
Country
Germany
Facility Name
Galderma Investigational Site 6150
City
Hamburg
ZIP/Postal Code
20537
Country
Germany
Facility Name
Galderma Investigational Site 6040
City
Hamburg
ZIP/Postal Code
22391
Country
Germany
Facility Name
Galderma Investigational Site 5469
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Galderma Investigational Site 6086
City
Kiel
ZIP/Postal Code
24148
Country
Germany
Facility Name
Galderma Investigational Site 6084
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Galderma Investigational Site 5382
City
Munich
ZIP/Postal Code
80337
Country
Germany
Facility Name
Galderma Investigational Site 6147
City
Budapest
ZIP/Postal Code
1036
Country
Hungary
Facility Name
Galderma Investigational Site 5513
City
Budapest
ZIP/Postal Code
1085
Country
Hungary
Facility Name
Galderma Investigational Site 5567
City
Debrecen
ZIP/Postal Code
4025
Country
Hungary
Facility Name
Galderma Investigational Site 6026
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Galderma Investigational Site 6254
City
Gyula
ZIP/Postal Code
5700
Country
Hungary
Facility Name
Galderma Investigational Site 6043
City
Szekszárd
ZIP/Postal Code
7100
Country
Hungary
Facility Name
Galderma Investigational Site 6053
City
Veszprém
ZIP/Postal Code
8200
Country
Hungary
Facility Name
Galderma Investigational Site 6179
City
Ancona
ZIP/Postal Code
60126
Country
Italy
Facility Name
Galderma Investigational Site 6145
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Galderma Investigational Site 6181
City
Catania
ZIP/Postal Code
95123
Country
Italy
Facility Name
Galderma Investigational Site 6141
City
Chieti
ZIP/Postal Code
66013
Country
Italy
Facility Name
Galderma Investigational Site 6115
City
Florence
ZIP/Postal Code
50125
Country
Italy
Facility Name
Galderma Investigational Site 6176
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
Galderma Investigational Site 6045
City
L'Aquila
ZIP/Postal Code
67100
Country
Italy
Facility Name
Galderma Investigational Site 6144
City
Modena
ZIP/Postal Code
41124
Country
Italy
Facility Name
Galderma Investigational Site 6178
City
Naples
ZIP/Postal Code
80131
Country
Italy
Facility Name
Galderma Investigational Site 6151
City
Parma
ZIP/Postal Code
43124
Country
Italy
Facility Name
Galderma Investigational Site 6180
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Galderma Investigational Site 6182
City
Perugia
ZIP/Postal Code
6123
Country
Italy
Facility Name
Galderma Investigational Site 6143
City
Pisa
ZIP/Postal Code
56126
Country
Italy
Facility Name
Galderma Investigational Site 6044
City
Roma
ZIP/Postal Code
00133
Country
Italy
Facility Name
Galderma Investigational Site 6049
City
Roma
ZIP/Postal Code
00168
Country
Italy
Facility Name
Galderma Investigational Site 6177
City
Rome
ZIP/Postal Code
00 144
Country
Italy
Facility Name
Galderma Investigational Site 6155
City
Rozzano
ZIP/Postal Code
20089
Country
Italy
Facility Name
Galderma Investigational Site 6142
City
Torino
ZIP/Postal Code
10126
Country
Italy
Facility Name
Galderma Investigational Site 6175
City
Vicenza
ZIP/Postal Code
36100
Country
Italy
Facility Name
Galderma Investigational Site 5773
City
Białystok
ZIP/Postal Code
15-453
Country
Poland
Facility Name
Galderma Investigational Site 6097
City
Chorzów
ZIP/Postal Code
41-500
Country
Poland
Facility Name
Galderma Investigational Site 5362
City
Cracovia
ZIP/Postal Code
30-033
Country
Poland
Facility Name
Galderma Investigational Site 5021
City
Katowice
ZIP/Postal Code
40-611
Country
Poland
Facility Name
Galderma Investigational Site 6052
City
Kraków
ZIP/Postal Code
31-559
Country
Poland
Facility Name
Galderma Investigational Site 5367
City
Lublin
ZIP/Postal Code
20-080
Country
Poland
Facility Name
Galderma Investigational Site 5377
City
Nowa Sól
ZIP/Postal Code
67-100
Country
Poland
Facility Name
Galderma Investigational Site 6063
City
Olsztyn
ZIP/Postal Code
10-229
Country
Poland
Facility Name
Galderma Investigational Site 6085
City
Poznań
ZIP/Postal Code
60-529
Country
Poland
Facility Name
Galderma Investigational Site 5495
City
Rzeszów
ZIP/Postal Code
35-055
Country
Poland
Facility Name
Galderma Investigational Site 6130
City
Szczecin
ZIP/Postal Code
71-434
Country
Poland
Facility Name
Galderma Investigational Site 6048
City
Tarnów
ZIP/Postal Code
33-100
Country
Poland
Facility Name
Galderma Investigational Site 6126
City
Warsaw
ZIP/Postal Code
01-142
Country
Poland
Facility Name
Galderma Investigational Site 5707
City
Warsaw
ZIP/Postal Code
01-817
Country
Poland
Facility Name
Galderma Investigational Site 6185
City
Wrocław
ZIP/Postal Code
50-566
Country
Poland
Facility Name
Galderma Investigational Site 6096
City
Wrocław
ZIP/Postal Code
51-318
Country
Poland
Facility Name
Galderma Investigational Site 5363
City
Łódź
ZIP/Postal Code
90-436
Country
Poland
Facility Name
Galderma Investigational Site 6124
City
Singapore
ZIP/Postal Code
119228
Country
Singapore
Facility Name
Galderma Investigational Site 6077
City
Singapore
ZIP/Postal Code
169608
Country
Singapore
Facility Name
Galderma Investigational Site 5499
City
Singapore
ZIP/Postal Code
308205
Country
Singapore

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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