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

A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Nemolizumab in Subjects With Moderate-to-Severe Atopic Dermatitis

The main purpose of the study was to assess the efficacy and safety of nemolizumab after a 16-week treatment period in adult and adolescent subjects with moderate-to-severe atopic dermatitis (AD) not adequately controlled with topical treatments.

Study Overview

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

Detailed Description

This was 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 had documented history of inadequate response to topical AD medication(s). Approximately 750 subjects were 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). A minimum of 250 subjects were randomized in each PP NRS strata. All nemolizumab-treated subjects who were clinical responders at Week 16 (i.e., the end of initial treatment [Initial Treatment Period]/beginning of Maintenance Period) were re-randomized (1:1:1) to different treatment regimens (nemolizumab injections Q4W or every 8 weeks (Q8W) [with placebo injections at Weeks 20, 28, 36, and 44 to maintain the blind] or placebo Q4W). A clinical responder was defined as a subject at Week 16 with an IGA of 0 (clear) or 1 (almost clear) or a >=75% improvement in EASI from baseline (EASI-75). All placebo-treated subjects who responded to placebo during the Initial Treatment Period continued to receive placebo Q4W in the Maintenance Period.

• Study Type: Interventional
• Enrollment (Actual): 787
• Phase: Phase 3

Contacts and Locations

Study Locations

• Belgium
  • Brussel, Belgium, 1200
    • Galderma Investigational Site 5448
  • Gent, Belgium, 9000
    • Galderma Investigational Site 6164
  • Leuven, Belgium, 3000
    • Galderma Investigational Site 6038
  • Liège, Belgium, 4000
    • Galderma Investigational Site 6162
• Bulgaria
  • Pleven, Bulgaria, 5800
    • Galderma Investigational Site 6029
  • 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, 1618
    • Galderma Investigational Site 6079
  • Sofia, Bulgaria, 1784
    • Galderma Investigational Site 6250
  • Stara Zagora, Bulgaria, 6000
    • Galderma Investigational Site 6251
• Estonia
  • Tallin, Estonia, 10134
    • Galderma Investigational Site 6068
  • Tallinn, Estonia, 10138
    • Galderma Investigational Site 6069
  • Tartu, Estonia, 50417
    • Galderma Investigational Site 6067
• France
  • Le Mans, France, 72037
    • Galderma Investigational Site 6198
  • Lille, France, 59037
    • Galderma Investigational Site 5031
  • 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
  • Toulon, France, 83800
    • Galderma Investigational Site 6197
  • Toulouse, France, 31000
    • Galderma Investigational Site 6169
  • Valence, France, 26000
    • Galderma Investigational Site 6168
• Georgia
  • 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
• Germany
  • Aachen, Germany, 52074
    • Galderma Investigational Site 5482
  • Augsburg, Germany, 86179
    • Galderma Investigational Site 5566
  • 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
• Hungary
  • 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
  • Veszprém, Hungary, 8200
    • Galderma Investigational Site 6053
• Italy
  • Bologna, Italy, 40138
    • Galderma Investigational Site 6145
  • Chieti, Italy, 66013
    • Galderma Investigational Site 6141
  • L'Aquila, Italy, 67100
    • Galderma Investigational Site 6045
  • Parma, Italy, 43124
    • Galderma Investigational Site 6151
  • Pavia, Italy, 27100
    • Galderma Investigational Site 6180
  • 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
  • Vicenza, Italy, 36100
    • Galderma Investigational Site 6175
• Poland
  • 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, Singapore, 119228
    • Galderma Investigational Site 6124
  • Singapore, Singapore, 169608
    • Galderma Investigational Site 6077
  • Singapore, Singapore, 308205
    • Galderma Investigational Site 5499
• United States
  • 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
    • 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, 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
  • 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
  • Nevada
    • Las Vegas, Nevada, United States, 89106
      • Galderma Investigational Site 8825
  • 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
  • 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

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 greater than and equal to (>=) 12 years at the screening visit.
• Chronic atopic dermatitis (according to American Academy of Dermatology Consensus Criteria) that has been present for at least 2 years before the screening visit.
• Eczema Area and Severity Index (EASI) score >=16 at the screening and baseline visits.
• Investigator Global Assessment (IGA) score >= 3 (scale of 0 to 4) at the screening and baseline visits.
• AD involvement >= 10 percent (%) of body surface area (BSA) at screening and baseline visits.
• Peak Pruritus Numerical Rating Scale (PPNRS) score of at least 4.0 at the screening and baseline visits.
• Documented recent history of inadequate response to topical medications (topical corticosteroids [TCS] with or without Topical calcineurin inhibitors [TCI]).
• Female subjects of childbearing potential (that is, fertile, following menarche and until becoming postmenopausal unless permanently sterile) must agree either to be strictly abstinent throughout the study and for 12 weeks after the last study drug injection or to use an adequate and approved method of contraception throughout the study and for 12 weeks after the last study drug injection.

Key Exclusion Criteria:

• Body weight (<) 30 kilograms (kg)
• Exacerbation of asthma requiring hospitalization in the preceding 12 months. Uncontrolled asthma in the preceding 3 months.
• Cutaneous infection within 1 week before the baseline visit, any infection requiring treatment with oral or parenteral antibiotics, antivirals, antiparasitics or antifungals within 2 weeks before the baseline visit, or any confirmed or suspected coronavirus disease (COVID)-19 infection within 2 weeks before the screening or baseline visit.
• Pregnant women, breastfeeding women, or women planning a pregnancy during the clinical study.

Note: Subjects with chronic,stable use of prophylactic treatment for recurrent herpes viral infection can be included in this clinical study.

• History of hypersensitivity (including anaphylaxis) to an immunoglobulin product (plasma-derived or recombinant, e.g., monoclonal antibody) or to any of the study drug excipients.
• Any clinically significant issue, based on investigator judgement.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Investigator's Global Assessment (IGA) Success at Week 16: Intent-To-Treat (ITT) Population	IGA success was defined as an IGA score of 0 (clear) or 1 (almost clear) and at least a 2-grade improvement from baseline to Week 16. The IGA is a 5-point scale ranging from 0 (clear) to 4 (severe) used by the Investigator or trained designee to evaluate the global severity of atopic dermatitis (AD) and the clinical response to treatment. If a participant received any rescue therapy, the data after receipt of rescue therapy was considered treatment failure. Participants with missing data at Week 16 were considered non-responders.	Week 16
Percentage of Participants With Investigator's Global Assessment (IGA) Success at Week 16: Severe Pruritus Population	IGA success was defined as an IGA score of 0 (clear) or 1 (almost clear) and at least a 2-grade improvement from baseline to Week 16. The IGA is a 5-point scale ranging from 0 (clear) to 4 (severe) used by the Investigator or trained designee to evaluate the global severity of AD and the clinical response to treatment. If a participant received any rescue therapy, the data after receipt of rescue therapy was considered a treatment failure. Participants with missing data at Week 16 were considered non-responders.	Week 16
Percentage of Participants With >=75% Improvement in Eczema Area and Severity Index (EASI-75) at Week 16: ITT Population	EASI-75 was defined as >=75 percent(%) improvement in EASI from baseline to Week 16. EASI evaluates severity of participants AD based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD(erythema, induration/papulation, excoriation and lichenification)scored separately for each of 4 body regions (head & neck, upper limbs, trunk & lower limbs on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI total score is composite score ranging from 0 to 72. Higher scores represent greater severity of AD. If a participant received any rescue therapy, the data after receipt of rescue therapy was considered a treatment failure. Participants with missing data at Week 16 were considered non-responders.	Week 16
Percentage of Participants With >=75% Improvement in Eczema Area and Severity Index (EASI-75) at Week 16: Severe Pruritus Population	EASI-75 was defined as >=75 percent(%) improvement in EASI from baseline to Week 16. EASI evaluates severity of participants AD based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD(erythema, induration/papulation, excoriation and lichenification)scored separately for each of 4 body regions (head & neck, upper limbs, trunk & lower limbs on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI total score is composite score ranging from 0 to 72. Higher scores represent greater severity of AD. If a participant received any rescue therapy, the data after receipt of rescue therapy was considered a treatment failure. Participants with missing data at Week 16 were considered non-responders.	Week 16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Improvement of >=4 Points in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 16: ITT Population	The PP NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours on a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable'. Weekly average PP NRS score was calculated using 7 consecutive days diary data and set to missing if less than 4 days data available. If a participant received any rescue therapy, the data after receipt of rescue therapy was considered treatment failure.	Week 16
Percentage of Participants With Improvement of >=4 Points in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 16: Severe Pruritus Population	The PP NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours on a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable'. Weekly average PP NRS score was calculated using 7 consecutive days diary data and set to missing if less than 4 days data available. If a participant received any rescue therapy, the data after receipt of rescue therapy was considered treatment failure.	Week 16
Percentage of Participants With <2 Points in Weekly Average PP NRS at Week 16: ITT Population	The PP NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours on a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable'. Weekly average PP NRS score was calculated using 7 consecutive days diary data and set to missing if less than 4 days data available. If a participant received any rescue therapy, the data after receipt of rescue therapy was considered treatment failure. Participants with missing data were considered non-responders.	Week 16
Percentage of Participants With <2 Points in Weekly Average PP NRS at Week 16: Severe Pruritus Population	The PP NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours on a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable'. Weekly average PP NRS score was calculated using 7 consecutive days diary data and set to missing if less than 4 days data available. If a participant received any rescue therapy, the data after receipt of rescue therapy was considered treatment failure. Participants with missing data were considered non-responders.	Week 16
Percentage of Participants With an Improvement of Sleep Disturbance Numeric Rating Scale (SD NRS) >=4 at Week 16: ITT Population	The sleep disturbance NRS is a scale used by the participants to report the degree of their sleep loss related to AD. Participants were asked the following question in their local language: how would you rate your sleep last night? On a scale of 0 to 10, with 0 being 'no sleep loss related to signs/symptoms of AD' and 10 being 'I cannot sleep at all due to the signs/symptoms of AD'. Weekly average SD NRS score was calculated using 7 consecutive days diary data and set to missing if less than 4 days data available. If a participant received any rescue therapy, the data after receipt of rescue therapy was considered treatment failure. Participants with missing data were considered non-responders.	Week 16
Percentage of Participants With an Improvement of Sleep Disturbance Numeric Rating Scale (SD NRS) >=4 at Week 16: Severe Pruritus Population	The sleep disturbance NRS is a scale used by the participants to report the degree of their sleep loss related to AD. Participants were asked the following question in their local language: how would you rate your sleep last night? On a scale of 0 to 10, with 0 being 'no sleep loss related to signs/symptoms of AD' and 10 being 'I cannot sleep at all due to the signs/symptoms of AD'. Weekly average SD NRS score was calculated using 7 consecutive days diary data and set to missing if less than 4 days data available. If a participant received any rescue therapy, the data after receipt of rescue therapy was considered treatment failure. Participants with missing data were considered non-responders.	Week 16
Percentage of Participants With Improvement of >=4 Points in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 4: ITT Population	The PP NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours on a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable'. Weekly average PP NRS score was calculated using 7 consecutive days diary data and set to missing if less than 4 days data available. If a participant received any rescue therapy, the data after receipt of rescue therapy was considered treatment failure. Participants with missing data were considered non-responders.	Week 4
Percentage of Participants With Improvement of >=4 Points in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 4: Severe Pruritus Population	The PP NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours on a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable'. Weekly average PP NRS score was calculated using 7 consecutive days diary data and set to missing if less than 4 days data available. If a participant received any rescue therapy, the data after receipt of rescue therapy was considered treatment failure. Participants with missing data were considered non-responders.	Week 4
Percentage of Participants With Peak Pruritus Numeric Rating Scale (PP NRS) <2 at Week 4: ITT Population	The PP NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours on a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable'. Weekly average PP NRS score was calculated using 7 consecutive days diary data and set to missing if less than 4 days data available. If a participant received any rescue therapy, the data after receipt of rescue therapy was considered treatment failure. Participants with missing data were considered non-responders.	Week 4
Percentage of Participants With Peak Pruritus Numeric Rating Scale (PP NRS) <2 at Week 4: Severe Pruritus Population	The PP NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours on a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable'. Weekly average PP NRS score was calculated using 7 consecutive days diary data and set to missing if less than 4 days data available. If a participant received any rescue therapy, the data after receipt of rescue therapy was considered treatment failure. Participants with missing data were considered non-responders.	Week 4
Percentage of Participants With Improvement of >=4 Points in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 2: ITT Population	The PP NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours on a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable'. Weekly average PP NRS score was calculated using 7 consecutive days diary data and set to missing if less than 4 days data available. If a participant received any rescue therapy, the data after receipt of rescue therapy was considered treatment failure. Participants with missing data were considered non-responders.	Week 2
Percentage of Participants With Improvement of >=4 Points in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 2: Severe Pruritus Population	The PP NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours on a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable'. Weekly average PP NRS score was calculated using 7 consecutive days diary data and set to missing if less than 4 days data available. If a participant received any rescue therapy, the data after receipt of rescue therapy was considered treatment failure. Participants with missing data were considered non-responders.	Week 2
Percentage of Participants With Improvement of >=4 Points in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 1: ITT Population	The PP NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours on a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable'. Weekly average PP NRS score was calculated using 7 consecutive days diary data and set to missing if less than 4 days data available. If a participant received any rescue therapy, the data after receipt of rescue therapy was considered treatment failure. Participants with missing data were considered non-responders.	Week 1
Percentage of Participants With Improvement of >=4 Points in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 1: Severe Pruritus Population	The PP NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours on a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable'. Weekly average PP NRS score was calculated using 7 consecutive days diary data and set to missing if less than 4 days data available. If a participant received any rescue therapy, the data after receipt of rescue therapy was considered treatment failure. Participants with missing data were considered non-responders.	Week 1

Collaborators and Investigators

• Sponsor: Galderma R&D

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2019
• Primary Completion (Actual): February 23, 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): August 14, 2024
• Last Update Submitted That Met QC Criteria: August 9, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Atopic Dermatitis; Nemolizumab; CD14152
• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic
• Other Study ID Numbers: RD.06.SPR.118169

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