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

September 19, 2023 updated by: Galderma R&D

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

Intervention / Treatment

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)

788

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nemolizumab
Nemolizumab administered via subcutaneous injection
Nemolizumab
Other Names:
  • CD14152
Placebo Comparator: Placebo
Placebo administered via subcutaneous injection
Placebo

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
Time Frame: Baseline to Week 16
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
Time Frame: Baseline to Week 16
Baseline to Week 16

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 30, 2019

Primary Completion (Actual)

September 26, 2022

Study Completion (Actual)

September 26, 2022

Study Registration Dates

First Submitted

June 14, 2019

First Submitted That Met QC Criteria

June 14, 2019

First Posted (Actual)

June 18, 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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Moderate-to-Severe Atopic Dermatitis

Clinical Trials on Placebo

Subscribe