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NCT03985943 Clinical Trial

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

Moderate-to-Severe Atopic Dermatitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03985943
Other study ID # RD.06.SPR.118161
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date June 30, 2019
Est. completion date August 11, 2022

Study information
Verified date January 2023
Source Galderma R&D
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility
Status Completed
Enrollment 941
Est. completion date August 11, 2022
Est. primary completion date August 11, 2022
Accepts healthy volunteers No
Gender All
Age group 12 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Placebo
Placebo
• Nemolizumab
Nemolizumab

Locations
Country Name City State
Australia Galderma Investigational Site 5638 Benowa Queensland
Australia Galderma Investigational Site 6161 Brisbane Queensland
Australia Galderma Investigational Site 6131 Carlton Victoria
Australia Galderma Investigational Site 5441 Darlinghurst New South Wales
Australia Galderma Investigational Site 5366 East Melbourne Victoria
Australia Galderma Investigational Site 5453 Fremantle Western Australia
Australia Galderma Investigational Site 5759 Kogarah New South Wales
Australia Galderma Investigational Site 5458 Parkville Victoria
Australia Galderma Investigational Site 6160 Parkville Victoria
Australia Galderma Investigational Site 6153 Victoria Park Western Australia
Australia Galderma Investigational Site 6152 Westmead New South Wales
Australia Galderma Investigational Site 6159 Woodville South Australia
Austria Galderma Investigational Sites 6157 Graz Styria
Austria Galderma Investigational Site 6156 Linz
Austria Galderma Investigational Site 6158 Vienna
Austria Galderma Investigational Site 6194 Vienna Wien
Canada Galderma Investigational Site 8586 Barrie Ontario
Canada Galderma Investigational Site 8085 Calgary Alberta
Canada Galderma Investigational Site 8215 Calgary Alberta
Canada Galderma Investigational Site 8903 Calgary Alberta
Canada Galderma Investigational Site 8088 Edmonton Alberta
Canada Galderma Investigational Site 8722 Edmonton Alberta
Canada Galderma Investigational Site 8824 Edmonton Alberta
Canada Galderma Investigational Site 8904 Guelph Ontario
Canada Galderma Investigational Site 8780 Niagara Falls
Canada Galderma Investigational Site 8610 Ottawa
Canada Galderma Investigational Site 8901 Ottawa Ontario
Canada Galderma Investigational Site 8000 Saint John
Canada Galderma Investigational Site 8161 Surrey British Columbia
Canada Galderma Investigational Site 8336 Toronto Ontario
Canada Galderma Investigational Site 8899 Toronto Ontario
Canada Galderma Investigational Site 8731 Waterloo
Czechia Galderma Investigational Site 6055 Brno
Czechia Galderma Investigational Site 5225 Náchod
Czechia Galderma Investigational Site 6030 Olomouc
Czechia Galderma Investigational Site 6024 Prague
Czechia Galderma Investigational Site 6240 Prague
Czechia Galderma Investigational Site 6021 Praha
Czechia Galderma Investigational Site 6025 Praha
Czechia Galderma Investigational Site 6054 Praha
Germany Galderma Investigational Site 6022 Bad Bentheim
Germany Galderma Investigational Site 6110 Berlin
Germany Galderma Investigational Site 6172 Berlin NRW
Germany Galderma Investigational Site 6061 Bielefeld
Germany Galderma Investigational Site 6066 Buxtehude
Germany Galderma Investigational Site 5368 Darmstadt
Germany Galderma Investigational Site 6028 Dülmen
Germany Galderma Investigational Site 5437 Kiel Schleswig-Holst
Germany Galderma Investigational Site 6146 Langenau Hesse
Germany Galderma Investigational Site 6033 Lubeck
Germany Galderma Investigational Site 6039 Münster
Germany Galderma Investigational Site 5918 Osnabrück
Germany Galderma Investigational Site 6109 Stuttgart
Germany Galderma Investigational Site 6214 Tuebingen Niedersachesen
Korea, Republic of Galderma Investigational Site 6095 Bucheon
Korea, Republic of Galderma Investigational Site 6100 Busan
Korea, Republic of Galderma Investigational Site 6098 Gyeonggi-do
Korea, Republic of Galderma Investigational Site 6154 Gyeonggi-do
Korea, Republic of Galderma Investigational Site 6093 Incheon
Korea, Republic of Galderma Investigational Site 6120 Incheon
Korea, Republic of Galderma Investigational Site 6138 Incheon
Korea, Republic of Galderma Investigational Site 5659 Seoul
Korea, Republic of Galderma Investigational Site 6056 Seoul
Korea, Republic of Galderma Investigational Site 6094 Seoul
Korea, Republic of Galderma Investigational Site 6099 Seoul
Korea, Republic of Galderma Investigational Site 6103 Seoul
Korea, Republic of Galderma Investigational Site 6105 Seoul
Korea, Republic of Galderma Investigational Site 6129 Seoul
Korea, Republic of Galderma Investigational Site 6166 Seoul
Latvia Galderma Investigational Site 6113 Liepaja
Latvia Galderma Investigational Site 6059 Riga
Latvia Galderma Investigational Site 6134 Riga
Latvia Galderma Investigational Site 6060 Talsi
Lithuania Galderma Investigational Site 6111 Kaunas
Lithuania Galderma Investigational Site 6072 Klaipeda
Lithuania Galderma Investigational Site 6073 Vilnius
Lithuania Galderma Investigational Site 6112 Vilnius
Netherlands Galderma Investigational Site 6212 Groningen
Netherlands Galderma Investigational Site 6108 Rotterdam
Netherlands Galderma Investigational Site 6027 Utrecht
New Zealand Galderma Investigational Site 6119 Hamilton
New Zealand Galderma Investigational Site 6118 Wellington
Poland Galderma Investigational Site 6255 Czestochowa
Poland Galderma Investigational Site 5138 Gdansk
Poland Galderma Investigational Site 6075 Gdansk
Poland Galderma Investigational Site 6243 Gdansk
Poland Galderma Investigational Site 6244 Gdynia
Poland Galderma Investigational Site 6087 Katowice
Poland Galderma Investigational Site 5570 Lódz
Poland Galderma Investigational Site 6231 Lódz
Poland Galderma Investigational Site 6245 Lódz
Poland Galderma Investigational Site 6071 Lublin
Poland Galderma Investigational Site 6237 Ostrowiec Swietokrzyski
Poland Galderma Investigational Site 6127 Poznan
Poland Galderma Investigational Site 6088 Rzeszów
Poland Galderma Investigational Site 6223 Szczecin
Poland Galderma Investigational Site 6064 Warszawa
Poland Galderma Investigational Site 6065 Warszawa
Poland Galderma Investigational Site 6122 Warszawa
Poland Galderma Investigational Site 6222 Warszawa
Poland Galderma Investigational Site 6242 Warszawa
Poland Galderma Investigational Site 5005 Wroclaw
Poland Galderma Investigational Site 6047 Wroclaw
Spain Galderma Investigational Site 6057 Alicante
Spain Galderma Investigational Site 5550 Barcelona
Spain Galderma Investigational Site 5580 Barcelona
Spain Galderma Investigational Site 6035 Barcelona
Spain Galderma Investigational Site 6037 Barcelona
Spain Galderma Investigational Site 6106 Las Palmas De Gran Canaria
Spain Galderma Investigational Site 5551 Madrid
Spain Galderma Investigational Site 5842 Madrid
Spain Galderma Investigational Site 6036 Madrid
Spain Galderma Investigational Site 6058 Madrid
Spain Galderma Investigational Site 6190 Madrid
Spain Galderma Investigational Site 6186 Majadahonda
Spain Galderma Investigational Site 6193 Málaga
Spain Galderma Investigational Site 6191 Pamplona
Spain Galderma Investigational Site 5970 Valencia
United Kingdom Galderma Investigational Site 6202 Barnsley
United Kingdom Galderma Investigational Site 6207 Blackpool
United Kingdom Galderma Investigational Site 6203 Cannock
United Kingdom Galderma Investigational Site 6246 Cardiff
United Kingdom Galderma Investigational Site 6248 Chorley
United Kingdom Galderma Investigational Site Dudley
United Kingdom Galderma Investigational Site 6090 Dudley
United Kingdom Galderma Investigational Site 6249 Edgbaston
United Kingdom Galderma Investigational Site 6104 Glasgow
United Kingdom Galderma Investigational Site 6204 Liverpool
United Kingdom Galderma Investigational Site 6121 London
United Kingdom Galderma Investigational Site 6205 Manchester
United Kingdom Galderma Investigational Site 6208 Newcastle
United Kingdom Galderma Investigational Site 6206 Stockton-on-Tees
United States Galderma Investigational Site 8826 Albuquerque New Mexico
United States Galderma Investigational Site 8743 Ann Arbor Michigan
United States Galderma Investigational Site 8133 Arlington Texas
United States Galderma Investigational Site 8298 Austin Texas
United States Galderma Investigational Site 8882 Bangor Maine
United States Galderma Investigational Site 8512 Bay City Michigan
United States Galderma Investigational Site 8456 Beverly Hills California
United States Galderma Investigational Site 8702 Bexley Ohio
United States Galderma Investigational Site 8890 Blackfoot Idaho
United States Galderma Investigational Site 8897 Brandon Florida
United States Galderma Investigational Site 8242 Brooklyn New York
United States Galderma Investigational Site 8738 Burke Virginia
United States Galderma Investigational Site 8805 Cape Coral Florida
United States Galderma Investigational Site 8578 Cerritos California
United States Galderma Investigational Site 8736 Charleston South Carolina
United States Galderma Investigational Site 8238 Dallas Texas
United States Galderma Investigational Site 8902 Doral Florida
United States Galderma Investigational Site 8827 Dripping Springs Texas
United States Galderma Investigational Site 8595 Dublin Ohio
United States Galderma Investigational Site 8772 Durham North Carolina
United States Galderma Investigational Site 8862 Fairfax Virginia
United States Galderma Investigational Site 8636 Fountain Valley California
United States Galderma Investigational Site 8664 Frisco Texas
United States Galderma Investigational Site 8888 Fullerton California
United States Galderma Investigational Site 8740 Henderson Nevada
United States Galderma Investigational Site 8804 Hialeah Florida
United States Galderma Investigational Site 8042 Houston Texas
United States Galderma Investigational Site 8670 Houston Texas
United States Galderma Investigational Site 8142 Indianapolis Indiana
United States Galderma Investigational Site 8711 Jacksonville Florida
United States Galderma Investigational Site 8109 Lebanon New Hampshire
United States Galderma Investigational Site 8750 Little Rock Arkansas
United States Galderma Investigational Site 8686 Lomita California
United States Galderma Investigational Site 8674 Los Angeles California
United States Galderma Investigational Site 8771 Louisville Kentucky
United States Galderma Investigational Site 8744 Macon Georgia
United States Galderma Investigational Site 8708 Miami Florida
United States Galderma Investigational Site 8710 Miami Florida
United States Galderma Investigational Site 8737 Miami Florida
United States Galderma Investigational Site 8801 Miami Florida
United States Galderma Investigational Site 8800 Miami Lakes Florida
United States Galderma Investigational Site 8806 Miami Lakes Florida
United States Galderma Investigational Site 8718 Missoula Montana
United States Galderma Investigational Site 8819 Nampa Idaho
United States Galderma Investigational Site 8279 New York New York
United States Galderma Investigational Site 8620 New York New York
United States Galderma Investigational Site 8728 Newnan Georgia
United States Galderma Investigational Site 8206 Norman Oklahoma
United States Galderma Investigational Site 8891 North Hollywood California
United States Galderma Investigational Site 8880 North Little Rock Arkansas
United States Galderma Investigational Site 8857 Oklahoma City Oklahoma
United States Galderma Investigational Site 8810 Omaha Nebraska
United States Galderma Investigational Site 8734 Pembroke Pines Florida
United States Galderma Investigational Site 8255 Philadelphia Pennsylvania
United States Galderma Investigational Site 8802 Plymouth Meeting Pennsylvania
United States Galderma Investigational Site 8818 Rapid City South Dakota
United States Galderma Investigational Site 8521 Saint Joseph Missouri
United States Galderma Investigational Site 8671 San Diego California
United States Galderma Investigational Site 8125 San Francisco California
United States Galderma Investigational Site 8895 Santa Ana California
United States Galderma Investigational Site 8608 Santa Monica California
United States Galderma Investigational Site 8571 Skokie Illinois
United States Galderma Investigational Site 8712 Skokie Illinois
United States Galderma Investigational Site 8889 Tampa Florida
United States Galderma Investigational Site 8155 Troy Michigan
United States Galderma Investigational Site 8887 Union City Georgia
United States Galderma Investigational Site 8111 Washington District of Columbia
United States Galderma Investigational Site 8648 Wilmington North Carolina
United States Galderma Investigational Site 8726 Wilmington North Carolina
United States Galderma Investigational Site 8748 Ypsilanti Michigan

Sponsors (1)
Lead Sponsor Collaborator
Galderma R&D

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Canada,  Czechia,  Germany,  Korea, Republic of,  Latvia,  Lithuania,  Netherlands,  New Zealand,  Poland,  Spain,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. Baseline to Week 16
Primary Proportion of subjects with EASI-75 Baseline to Week 16
Secondary Proportion of subjects with an improvement of PP NRS = 4 Week 16
Secondary Proportion of subjects with PP NRS < 2 Week 16
Secondary Proportion of subjects with an improvement of sleep disturbance NRS (SD NRS) = 4 Week 16
Secondary Proportion of subjects with an improvement of PP NRS = 4 Week 4
Secondary Proportion of subjects with PP NRS < 2 Week 4
Secondary Proportion of subjects with an improvement of PP NRS = 4 Week 2
Secondary Proportion of subjects with an improvement of PP NRS = 4 Week 1
Secondary Proportion of subjects with EASI-75 and improvement of PP NRS = 4 Week 16
Secondary Proportion of subjects with IGA success and improvement of PP NRS = 4 Week 16
See also
  Status Clinical Trial Phase
Completed NCT03054428 - Efficacy and Safety of Dupilumab in Participants ≥12 to <18 Years of Age, With Moderate-to-severe Atopic Dermatitis Phase 3
Active, not recruiting NCT05899816 - A Study Assessing Rocatinlimab on Vaccine Antibody Response in Moderate-to-severe Atopic Dermatitis (AD) (ROCKET - VOYAGER) Phase 3
Recruiting NCT04893707 - The Study of CM310 in Patients With Atopic Dermatitis Phase 2
Completed NCT03989349 - Efficacy & Safety of Nemolizumab in Subjects With Moderate-to-Severe Atopic Dermatitis Phase 3
Recruiting NCT04921345 - Pharmacokinetics, Safety and Efficacy of Nemolizumab in Participants With Moderate-to-Severe Atopic Dermatitis Phase 2
Completed NCT04893941 - Dose Escalation Trial of CM310 in Patients With Moderate-to-Severe Atopic Dermatitis (AD) Phase 1/Phase 2
Completed NCT04444752 - A Study to Assess the Efficacy and Safety of CBP-201 in Adult Subjects With Moderate to Severe Atopic Dermatitis Phase 2
Completed NCT05203380 - Neuropsychologic Assessments of Dupilumab-Treated Adolescent Participants With Moderate-to-Severe Atopic Dermatitis
Withdrawn NCT05056779 - Efficacy and Safety of Nemolizumab in Subjects With Moderate-to-Severe Atopic Dermatitis With Inadequate Response to or for Whom Cyclosporine A is Not Medically Advisable Phase 3
Active, not recruiting NCT05590585 - Dupilumab in Adolescent and Adult Skin of Color Participants: Open-label Moderate-to-severe Eczema Trial Phase 4
Completed NCT04805411 - Subcutaneously CM310/Placebo in Patients With Moderate-to-Severe Atopic Dermatitis (AD) Phase 2
Recruiting NCT05186922 - The Study of CM326 in Patients With Moderate-to-severe Atopic Dermatitis Phase 1/Phase 2
Recruiting NCT03057860 - TREATgermany: German National Clinical Registry for Patients With Moderate-to-severe Atopic Dermatitis
Active, not recruiting NCT03989206 - Long-term Safety and Efficacy of Nemolizumab With Moderate-to-severe Atopic Dermatitis Phase 3
Recruiting NCT05671432 - The Study of CM326 in Moderate-to-severe Atopic Dermatitis Phase 2
Not yet recruiting NCT06158490 - A Study to Evaluate JYP0061 Tablets in Patients With Moderate-to-severe Atopic Dermatitis Phase 2
Terminated NCT05984784 - A Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of IMG-007 in Adults With Atopic Dermatitis (AD) Phase 1/Phase 2
Completed NCT05017480 - A Study to Evaluate the Efficacy and Safety of CBP-201 in Moderate to Severe Atopic Dermatitis in China Phase 2