Clinical trial NCT03985943: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Moderate-to-Severe Atopic Dermatitis
Keywords: CD14152
Nemolizumab
Atopic Dermatitis
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2019-06-14
Enrollment: 941
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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 a 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.

Eligibility criteria: 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 visit.
* 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, example, monoclonal antibody) or to any of the study drug excipients.
* Any clinically significant issue, based on investigator judgement.

Primary outcomes:
measure: Percentage of Participants With an Investigator's Global Assessment (IGA) Success (IGA of 0 or 1 and a More Than Equal to [>=] 2-point Reduction): Intent-To-Treat (ITT) Population
timeFrame: Week 16
measure: Percentage of Participants With an Investigator's Global Assessment (IGA) Success (IGA of 0 or 1 and a >= 2-point Reduction): Severe Pruritus Population
timeFrame: Week 16
measure: Percentage of Participants With >=75% Improvement in Eczema Area and Severity Index (EASI-75) at Week 16: ITT Population
timeFrame: Week 16
measure: Percentage of Participants With >=75% Improvement in Eczema Area and Severity Index (EASI-75) at 16: Severe Pruritus Population
timeFrame: Week 16
Secondary outcomes:
measure: Percentage of Participants With Improvement of >=4 Points in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 16: ITT Population
timeFrame: Week 16
measure: Percentage of Participants With Improvement of >=4 Points in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 16: Severe Pruritus Population
timeFrame: Week 16
measure: Percentage of Participants With <2 Points in Weekly Average PP NRS at Week 16: ITT Population
timeFrame: Week 16
measure: Percentage of Participants With <2 Points in Weekly Average PP NRS at Week 16: Severe Pruritus Population
timeFrame: Week 16
measure: Percentage of Participants With an Improvement of Sleep Disturbance Numeric Rating Scale (SD NRS) >=4 at Week 16: ITT Population
timeFrame: Week 16
measure: Percentage of Participants With an Improvement of Sleep Disturbance Numeric Rating Scale (SD NRS) >=4 at Week 16: Severe Pruritus Population
timeFrame: Week 16
measure: Percentage of Participants With Improvement of >=4 Points in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 4: ITT Population
timeFrame: Week 4
measure: Percentage of Participants With Improvement of >=4 Points in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 4: Severe Pruritus Population
timeFrame: Week 4
measure: Percentage of Participants With Peak Pruritus Numeric Rating Scale (PP NRS) <2 at Week 4: ITT Population
timeFrame: Week 4
measure: Percentage of Participants With Peak Pruritus Numeric Rating Scale (PP NRS) <2 at Week 4: Severe Pruritus Population
timeFrame: Week 4
measure: Percentage of Participants With Improvement of >=4 Points in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 2: ITT Population
timeFrame: Week 2
measure: Percentage of Participants With Improvement of >=4 Points in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 2: Severe Pruritus Population
timeFrame: Week 2
measure: Percentage of Participants With Improvement of >=4 Points in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 1: ITT Population
timeFrame: Week 1
measure: Percentage of Participants With Improvement of >=4 Points in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 1: Severe Pruritus Population
timeFrame: Week 1
Other outcomes:
Locations:
city: North Little Rock
country: United States
facility: Galderma Investigational Site 8880
state: Arkansas
city: Cerritos
country: United States
facility: Galderma Investigational Site 8578
state: California
city: Fountain Valley
country: United States
facility: Galderma Investigational Site 8636
state: California
city: Fullerton
country: United States
facility: Galderma Investigational Site 8888
state: California
city: Lomita
country: United States
facility: Galderma Investigational Site 8686
state: California
city: Los Angeles
country: United States
facility: Galderma Investigational Site 8674
state: California
city: San Francisco
country: United States
facility: Galderma Investigational Site 8125
state: California
city: Santa Ana
country: United States
facility: Galderma Investigational Site 8895
state: California
city: Santa Monica
country: United States
facility: Galderma Investigational Site 8608
state: California
city: Brandon
country: United States
facility: Galderma Investigational Site 8897
state: Florida
city: Cape Coral
country: United States
facility: Galderma Investigational Site 8805
state: Florida
city: Doral
country: United States
facility: Galderma Investigational Site 8902
state: Florida
city: Hialeah
country: United States
facility: Galderma Investigational Site 8804
state: Florida
city: Jacksonville
country: United States
facility: Galderma Investigational Site 8711
state: Florida
city: Miami Lakes
country: United States
facility: Galderma Investigational Site 8806
state: Florida
city: Miami Lakes
country: United States
facility: Galderma Investigational Site 8800
state: Florida
city: Miami
country: United States
facility: Galderma Investigational Site 8710
state: Florida
city: Miami
country: United States
facility: Galderma Investigational Site 8801
state: Florida
city: Miami
country: United States
facility: Galderma Investigational Site 8737
state: Florida
city: Miami
country: United States
facility: Galderma Investigational Site 8708
state: Florida
city: Pembroke Pines
country: United States
facility: Galderma Investigational Site 8734
state: Florida
city: Macon
country: United States
facility: Galderma Investigational Site 8744
state: Georgia
city: Newnan
country: United States
facility: Galderma Investigational Site 8728
state: Georgia
city: Union City
country: United States
facility: Galderma Investigational Site 8887
state: Georgia
city: Blackfoot
country: United States
facility: Galderma Investigational Site 8890
state: Idaho
city: Nampa
country: United States
facility: Galderma Investigational Site 8819
state: Idaho
city: Skokie
country: United States
facility: Galderma Investigational Site 8571
state: Illinois
city: Skokie
country: United States
facility: Galderma Investigational Site 8712
state: Illinois
city: Indianapolis
country: United States
facility: Galderma Investigational Site 8142
state: Indiana
city: Louisville
country: United States
facility: Galderma Investigational Site 8771
state: Kentucky
city: Bangor
country: United States
facility: Galderma Investigational Site 8882
state: Maine
city: Ann Arbor
country: United States
facility: Galderma Investigational Site 8743
state: Michigan
city: Bay City
country: United States
facility: Galderma Investigational Site 8512
state: Michigan
city: Troy
country: United States
facility: Galderma Investigational Site 8155
state: Michigan
city: Ypsilanti
country: United States
facility: Galderma Investigational Site 8748
state: Michigan
city: Saint Joseph
country: United States
facility: Galderma Investigational Site 8521
state: Missouri
city: Missoula
country: United States
facility: Galderma Investigational Site 8718
state: Montana
city: Omaha
country: United States
facility: Galderma Investigational Site 8810
state: Nebraska
city: Henderson
country: United States
facility: Galderma Investigational Site 8740
state: Nevada
city: Brooklyn
country: United States
facility: Galderma Investigational Site 8242
state: New York
city: New York
country: United States
facility: Galderma Investigational Site 8620
state: New York
city: New York
country: United States
facility: Galderma Investigational Site 8279
state: New York
city: Wilmington
country: United States
facility: Galderma Investigational Site 8648
state: North Carolina
city: Bexley
country: United States
facility: Galderma Investigational Site 8702
state: Ohio
city: Dublin
country: United States
facility: Galderma Investigational Site 8595
state: Ohio
city: Norman
country: United States
facility: Galderma Investigational Site 8206
state: Oklahoma
city: Oklahoma City
country: United States
facility: Galderma Investigational Site 8857
state: Oklahoma
city: Philadelphia
country: United States
facility: Galderma Investigational Site 8255
state: Pennsylvania
city: Plymouth Meeting
country: United States
facility: Galderma Investigational Site 8802
state: Pennsylvania
city: Charleston
country: United States
facility: Galderma Investigational Site 8736
state: South Carolina
city: Rapid City
country: United States
facility: Galderma Investigational Site 8818
state: South Dakota
city: Arlington
country: United States
facility: Galderma Investigational Site 8133
state: Texas
city: Dallas
country: United States
facility: Galderma Investigational Site 8238
state: Texas
city: Dripping Springs
country: United States
facility: Galderma Investigational Site 8827
state: Texas
city: Frisco
country: United States
facility: Galderma Investigational Site 8664
state: Texas
city: Houston
country: United States
facility: Galderma Investigational Site 8042
state: Texas
city: Fairfax
country: United States
facility: Galderma Investigational Site 8862
state: Virginia
city: Darlinghurst
country: Australia
facility: Galderma Investigational Site 5441
state: New South Wales
city: Kogarah
country: Australia
facility: Galderma Investigational Site 5759
state: New South Wales
city: Westmead
country: Australia
facility: Galderma Investigational Site 6152
state: New South Wales
city: Benowa
country: Australia
facility: Galderma Investigational Site 5638
state: Queensland
city: Brisbane
country: Australia
facility: Galderma Investigational Site 6161
state: Queensland
city: Woodville
country: Australia
facility: Galderma Investigational Site 6159
state: South Australia
city: Carlton
country: Australia
facility: Galderma Investigational Site 6131
state: Victoria
city: East Melbourne
country: Australia
facility: Galderma Investigational Site 5366
state: Victoria
city: Parkville
country: Australia
facility: Galderma Investigational Site 5458
state: Victoria
city: Fremantle
country: Australia
facility: Galderma Investigational Site 5453
state: Western Australia
city: Victoria Park
country: Australia
facility: Galderma Investigational Site 6153
state: Western Australia
city: Graz
country: Austria
facility: Galderma Investigational Sites 6157
state: Styria
city: Vienna
country: Austria
facility: Galderma Investigational Site 6194
state: Wien
city: Vienna
country: Austria
facility: Galderma Investigational Site 6158
city: Calgary
country: Canada
facility: Galderma Investigational Site 8085
state: Alberta
city: Calgary
country: Canada
facility: Galderma Investigational Site 8903
state: Alberta
city: Calgary
country: Canada
facility: Galderma Investigational Site 8215
state: Alberta
city: Edmonton
country: Canada
facility: Galderma Investigational Site 8088
state: Alberta
city: Edmonton
country: Canada
facility: Galderma Investigational Site 8824
state: Alberta
city: Edmonton
country: Canada
facility: Galderma Investigational Site 8722
state: Alberta
city: Surrey
country: Canada
facility: Galderma Investigational Site 8161
state: British Columbia
city: Barrie
country: Canada
facility: Galderma Investigational Site 8586
state: Ontario
city: Guelph
country: Canada
facility: Galderma Investigational Site 8904
state: Ontario
city: Ottawa
country: Canada
facility: Galderma Investigational Site 8901
state: Ontario
city: Toronto
country: Canada
facility: Galderma Investigational Site 8336
state: Ontario
city: Toronto
country: Canada
facility: Galderma Investigational Site 8899
state: Ontario
city: Niagara Falls
country: Canada
facility: Galderma Investigational Site 8780
city: Ottawa
country: Canada
facility: Galderma Investigational Site 8610
city: Saint John
country: Canada
facility: Galderma Investigational Site 8000
city: Waterloo
country: Canada
facility: Galderma Investigational Site 8731
city: Brno
country: Czechia
facility: Galderma Investigational Site 6055
city: Náchod
country: Czechia
facility: Galderma Investigational Site 5225
city: Olomouc
country: Czechia
facility: Galderma Investigational Site 6030
city: Prague
country: Czechia
facility: Galderma Investigational Site 6024
city: Prague
country: Czechia
facility: Galderma Investigational Site 6240
city: Praha
country: Czechia
facility: Galderma Investigational Site 6054
city: Praha
country: Czechia
facility: Galderma Investigational Site 6021
city: Praha
country: Czechia
facility: Galderma Investigational Site 6025
city: Langenau
country: Germany
facility: Galderma Investigational Site 6146
state: Hesse
city: Tuebingen
country: Germany
facility: Galderma Investigational Site 6214
state: Niedersachesen
city: Berlin
country: Germany
facility: Galderma Investigational Site 6172
state: NRW
city: Kiel
country: Germany
facility: Galderma Investigational Site 5437
state: Schleswig-Holst
city: Bad Bentheim
country: Germany
facility: Galderma Investigational Site 6022
city: Berlin
country: Germany
facility: Galderma Investigational Site 6110
city: Bielefeld
country: Germany
facility: Galderma Investigational Site 6061
city: Buxtehude
country: Germany
facility: Galderma Investigational Site 6066
city: Darmstadt
country: Germany
facility: Galderma Investigational Site 5368
city: Dülmen
country: Germany
facility: Galderma Investigational Site 6028
city: Münster
country: Germany
facility: Galderma Investigational Site 6039
city: Osnabrück
country: Germany
facility: Galderma Investigational Site 5918
city: Stuttgart
country: Germany
facility: Galderma Investigational Site 6109
city: Bucheon
country: Korea, Republic of
facility: Galderma Investigational Site 6095
city: Busan
country: Korea, Republic of
facility: Galderma Investigational Site 6100
city: Gyeonggi-do
country: Korea, Republic of
facility: Galderma Investigational Site 6098
city: Gyeonggi-do
country: Korea, Republic of
facility: Galderma Investigational Site 6154
city: Incheon
country: Korea, Republic of
facility: Galderma Investigational Site 6138
city: Incheon
country: Korea, Republic of
facility: Galderma Investigational Site 6120
city: Incheon
country: Korea, Republic of
facility: Galderma Investigational Site 6093
city: Seoul
country: Korea, Republic of
facility: Galderma Investigational Site 6105
city: Seoul
country: Korea, Republic of
facility: Galderma Investigational Site 5659
city: Seoul
country: Korea, Republic of
facility: Galderma Investigational Site 6116
city: Seoul
country: Korea, Republic of
facility: Galderma Investigational Site 6129
city: Seoul
country: Korea, Republic of
facility: Galderma Investigational Site 6103
city: Seoul
country: Korea, Republic of
facility: Galderma Investigational Site 6056
city: Seoul
country: Korea, Republic of
facility: Galderma Investigational Site 6094
city: Seoul
country: Korea, Republic of
facility: Galderma Investigational Site 6099
city: Liepāja
country: Latvia
facility: Galderma Investigational Site 6113
city: Riga
country: Latvia
facility: Galderma Investigational Site 6134
city: Riga
country: Latvia
facility: Galderma Investigational Site 6059
city: Talsi
country: Latvia
facility: Galderma Investigational Site 6060
city: Kaunas
country: Lithuania
facility: Galderma Investigational Site 6111
city: Klaipėda
country: Lithuania
facility: Galderma Investigational Site 6072
city: Vilnius
country: Lithuania
facility: Galderma Investigational Site 6112
city: Groningen
country: Netherlands
facility: Galderma Investigational Site 6212
city: Rotterdam
country: Netherlands
facility: Galderma Investigational Site 6108
city: Utrecht
country: Netherlands
facility: Galderma Investigational Site 6027
city: Hamilton
country: New Zealand
facility: Galderma Investigational Site 6119
city: Wellington
country: New Zealand
facility: Galderma Investigational Site 6118
city: Czestochowa
country: Poland
facility: Galderma Investigational Site 6255
city: Gdańsk
country: Poland
facility: Galderma Investigational Site 6075
city: Gdańsk
country: Poland
facility: Galderma Investigational Site 6243
city: Gdańsk
country: Poland
facility: Galderma Investigational Site 5138
city: Gdynia
country: Poland
facility: Galderma Investigational Site 6244
city: Katowice
country: Poland
facility: Galderma Investigational Site 6087
city: Lublin
country: Poland
facility: Galderma Investigational Site 6071
city: Ostrowiec Świętokrzyski
country: Poland
facility: Galderma Investigational Site 6237
city: Poznań
country: Poland
facility: Galderma Investigational Site 6127
city: Szczecin
country: Poland
facility: Galderma Investigational Site 6223
city: Warszawa
country: Poland
facility: Galderma Investigational Site 6065
city: Warszawa
country: Poland
facility: Galderma Investigational Site 6122
city: Warszawa
country: Poland
facility: Galderma Investigational Site 6242
city: Warszawa
country: Poland
facility: Galderma Investigational Site 6064
city: Warszawa
country: Poland
facility: Galderma Investigational Site 6222
city: Wrocław
country: Poland
facility: Galderma Investigational Site 6047
city: Wrocław
country: Poland
facility: Galderma Investigational Site 5005
city: Łódź
country: Poland
facility: Galderma Investigational Site 6245
city: Łódź
country: Poland
facility: Galderma Investigational Site 5570
city: Łódź
country: Poland
facility: Galderma Investigational Site 6231
city: Alicante
country: Spain
facility: Galderma Investigational Site 6057
city: Barcelona
country: Spain
facility: Galderma Investigational Site 6037
city: Barcelona
country: Spain
facility: Galderma Investigational Site 6035
city: Barcelona
country: Spain
facility: Galderma Investigational Site 5580
city: Las Palmas De Gran Canaria
country: Spain
facility: Galderma Investigational Site 6106
city: Madrid
country: Spain
facility: Galderma Investigational Site 6058
city: Madrid
country: Spain
facility: Galderma Investigational Site 5842
city: Madrid
country: Spain
facility: Galderma Investigational Site 6190
city: Madrid
country: Spain
facility: Galderma Investigational Site 6036
city: Madrid
country: Spain
facility: Galderma Investigational Site 5551
city: Pamplona
country: Spain
facility: Galderma Investigational Site 6191
city: Barnsley
country: United Kingdom
facility: Galderma Investigational Site 6202
city: Blackpool
country: United Kingdom
facility: Galderma Investigational Site 6207
city: Cannock
country: United Kingdom
facility: Galderma Investigational Site 6203
city: Glasgow
country: United Kingdom
facility: Galderma Investigational Site 6104
city: Liverpool
country: United Kingdom
facility: Galderma Investigational Site 6204
city: London
country: United Kingdom
facility: Galderma Investigational Site 6121
city: Manchester
country: United Kingdom
facility: Galderma Investigational Site 6205
city: Stockton-on-Tees
country: United Kingdom
facility: Galderma Investigational Site 6206
Study officials:
References: