Trial Review

Technical difficulties have been reported by some users of the search function and is being investigated by technical staff. Thank you for your patience and apologies for any inconvenience caused.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03989206




Registration number
NCT03989206
Ethics application status
Date submitted
14/06/2019
Date registered
18/06/2019
Date last updated
18/06/2024

Titles & IDs
Public title
Long-term Safety and Efficacy of Nemolizumab With Moderate-to-severe Atopic Dermatitis
Scientific title
A Prospective, Multicenter, Long-Term Study to Assess the Safety and Efficacy of Nemolizumab (CD14152) in Subjects With Moderate-to-Severe Atopic Dermatitis
Secondary ID [1] 0 0
RD.06.SPR.118163
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Moderate-to-Severe Atopic Dermatitis 0 0
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Nemolizumab

Experimental: Nemolizumab - Nemolizumab administered via subcutaneous injection


Treatment: Drugs: Nemolizumab
Nemolizumab
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence and Severity of TEAEs
Timepoint [1] 0 0
Baseline to Week 200
Primary outcome [2] 0 0
Incidence of Serious TEAEs
Timepoint [2] 0 0
Baseline to Week 200
Primary outcome [3] 0 0
Incidence and Severity of Adverse Events of Special Interest (AESIs) Throughout the Study
Timepoint [3] 0 0
Baseline to Week 200
Secondary outcome [1] 0 0
Proportion of Participants with IGA score = 0-1 at Each Visit
Timepoint [1] 0 0
Baseline to Week 200
Secondary outcome [2] 0 0
Proportion of Participants with EASI-75 at Each Visit
Timepoint [2] 0 0
Baseline to Week 200
Secondary outcome [3] 0 0
Change and Percent Change From Baseline in Overall Eczema Area and Severity Index (EASI) Score at Each Visit
Timepoint [3] 0 0
Baseline to Week 200
Secondary outcome [4] 0 0
Proportion of Participants with IGA = 2 at Each Visit
Timepoint [4] 0 0
Baseline to Week 200
Secondary outcome [5] 0 0
Change and Percent Change From Baseline in SCORAD Score at Each Visit
Timepoint [5] 0 0
Baseline to Week 200
Secondary outcome [6] 0 0
Change and Percent Change From Baseline in Participant-Reported Pruritus Using 10-cm VAS (SCORAD Sub-Component)
Timepoint [6] 0 0
Baseline to Week 200
Secondary outcome [7] 0 0
Change and Percent Change From Baseline in Participant-Reported Sleep Loss Using 10-cm VAS (SCORAD Sub-Component)
Timepoint [7] 0 0
Baseline to Week 200
Secondary outcome [8] 0 0
Proportion of Participants Reporting Low Disease Activity State Based on PGAD at Each Visit
Timepoint [8] 0 0
Baseline to Week 200
Secondary outcome [9] 0 0
Proportion of Participants Satisfied with Study Treatment Based on PGAT at each visit
Timepoint [9] 0 0
Baseline to Week 200
Secondary outcome [10] 0 0
Change from Baseline in Dermatology Life Quality Index (DLQI)
Timepoint [10] 0 0
Baseline to Week 200
Secondary outcome [11] 0 0
Change From Baseline in Children's Dermatology Life Quality Index (cDLQI) Total Score at Each Visit Through Week 200
Timepoint [11] 0 0
Baseline to Week 200
Secondary outcome [12] 0 0
Change From Baseline in Patient-Oriented Eczema Measure (POEM) Total Score at Each Visit Through Week 200
Timepoint [12] 0 0
Baseline to Week 200
Secondary outcome [13] 0 0
Change From Baseline in Hospital Anxiety and Depression Scale (HADS) for Each Subscale at Each Visit Through Week 200
Timepoint [13] 0 0
Baseline to Week 200
Secondary outcome [14] 0 0
Change From Baseline in Work Productivity and Activity Impairment: Atopic Dermatitis (WPAI:AD) for Each Subscale at Each Visit Through Week 200
Timepoint [14] 0 0
Baseline to Week 200
Secondary outcome [15] 0 0
Change From Baseline in EuroQoL 5-Dimension (EQ-5D) at Each Visit Through Week 200
Timepoint [15] 0 0
Baseline to Week 200
Secondary outcome [16] 0 0
Proportion of Participants Receiving Any Rescue Therapy by Rescue Treatment Type at Any Visit During the Treatment Period
Timepoint [16] 0 0
Baseline to Week 200
Secondary outcome [17] 0 0
Time to First Relapse
Timepoint [17] 0 0
Baseline to Week 200
Secondary outcome [18] 0 0
Duration of Remission
Timepoint [18] 0 0
Baseline to Week 200
Secondary outcome [19] 0 0
Time to Permanent Study Drug Discontinuation
Timepoint [19] 0 0
Baseline to Week 200

Eligibility
Key inclusion criteria
Key

1. Subjects who may benefit from study participation in the opinion of the investigator and had participated in a prior nemolizumab study for AD
2. Female subjects of childbearing potential (ie, fertile, following menarche and until becoming post-menopausal 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 effective and approved method of contraception throughout the study and for 12 weeks after the last study drug injection.

Key
Minimum age
12 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Subjects who, during their participation in a prior nemolizumab study, experienced an AE which in the opinion of the investigator could indicate that continued treatment with nemolizumab may present an unreasonable risk for the subject.
2. Pregnant women, breastfeeding women, or women planning a pregnancy during the clinical study.
3. Body weight < 30 kg
4. 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. Subjects may be rescreened once the infection has resolved. Resolution of COVID-19 infection can be confirmed by recovery assessment methods.
5. History of hypersensitivity (including anaphylaxis) to an immunoglobulin product (plasma-derived or recombinant, eg, monoclonal antibody)
6. Any clinically significant issue, based investigator judgement

Study design
Purpose of the study
Treatment
Allocation to intervention
NA
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/12/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/08/2026
Actual
Sample size
Target
1700
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Galderma Investigational Site 5441 - Darlinghurst
Recruitment hospital [2] 0 0
Galderma Investigational Site 5759 - Kogarah
Recruitment hospital [3] 0 0
Galderma Investigational Site 6152 - Westmead
Recruitment hospital [4] 0 0
Galderma Investigational Site 5638 - Benowa
Recruitment hospital [5] 0 0
Galderma Investigational Site 6161 - Brisbane
Recruitment hospital [6] 0 0
Galderma Investigational Site 6159 - Woodville
Recruitment hospital [7] 0 0
Galderma Investigational Site 6131 - Carlton
Recruitment hospital [8] 0 0
Galderma Investigational Site 5366 - East Melbourne
Recruitment hospital [9] 0 0
Galderma Investigational Site 5458 - Parkville
Recruitment hospital [10] 0 0
Galderma Investigational Site 6160 - Parkville
Recruitment hospital [11] 0 0
Galderma Investigational Site 6153 - Victoria Park
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
2217 - Kogarah
Recruitment postcode(s) [3] 0 0
2145 - Westmead
Recruitment postcode(s) [4] 0 0
4217 - Benowa
Recruitment postcode(s) [5] 0 0
4102 - Brisbane
Recruitment postcode(s) [6] 0 0
5011 - Woodville
Recruitment postcode(s) [7] 0 0
3053 - Carlton
Recruitment postcode(s) [8] 0 0
3002 - East Melbourne
Recruitment postcode(s) [9] 0 0
3050 - Parkville
Recruitment postcode(s) [10] 0 0
3052 - Parkville
Recruitment postcode(s) [11] 0 0
6100 - Victoria Park
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Connecticut
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Georgia
Country [8] 0 0
United States of America
State/province [8] 0 0
Idaho
Country [9] 0 0
United States of America
State/province [9] 0 0
Illinois
Country [10] 0 0
United States of America
State/province [10] 0 0
Indiana
Country [11] 0 0
United States of America
State/province [11] 0 0
Kansas
Country [12] 0 0
United States of America
State/province [12] 0 0
Kentucky
Country [13] 0 0
United States of America
State/province [13] 0 0
Maine
Country [14] 0 0
United States of America
State/province [14] 0 0
Michigan
Country [15] 0 0
United States of America
State/province [15] 0 0
Missouri
Country [16] 0 0
United States of America
State/province [16] 0 0
Montana
Country [17] 0 0
United States of America
State/province [17] 0 0
Nebraska
Country [18] 0 0
United States of America
State/province [18] 0 0
Nevada
Country [19] 0 0
United States of America
State/province [19] 0 0
New Hampshire
Country [20] 0 0
United States of America
State/province [20] 0 0
New Jersey
Country [21] 0 0
United States of America
State/province [21] 0 0
New Mexico
Country [22] 0 0
United States of America
State/province [22] 0 0
New York
Country [23] 0 0
United States of America
State/province [23] 0 0
North Carolina
Country [24] 0 0
United States of America
State/province [24] 0 0
Ohio
Country [25] 0 0
United States of America
State/province [25] 0 0
Oklahoma
Country [26] 0 0
United States of America
State/province [26] 0 0
Oregon
Country [27] 0 0
United States of America
State/province [27] 0 0
Pennsylvania
Country [28] 0 0
United States of America
State/province [28] 0 0
South Carolina
Country [29] 0 0
United States of America
State/province [29] 0 0
South Dakota
Country [30] 0 0
United States of America
State/province [30] 0 0
Texas
Country [31] 0 0
United States of America
State/province [31] 0 0
Utah
Country [32] 0 0
United States of America
State/province [32] 0 0
Virginia
Country [33] 0 0
United States of America
State/province [33] 0 0
Washington
Country [34] 0 0
Austria
State/province [34] 0 0
Oberoesterreich
Country [35] 0 0
Austria
State/province [35] 0 0
Styria
Country [36] 0 0
Austria
State/province [36] 0 0
Vienna
Country [37] 0 0
Belgium
State/province [37] 0 0
Vlaams-Brabant
Country [38] 0 0
Belgium
State/province [38] 0 0
Brussels
Country [39] 0 0
Belgium
State/province [39] 0 0
Edegem
Country [40] 0 0
Belgium
State/province [40] 0 0
Gent
Country [41] 0 0
Belgium
State/province [41] 0 0
Liège
Country [42] 0 0
Bulgaria
State/province [42] 0 0
Pleven
Country [43] 0 0
Bulgaria
State/province [43] 0 0
Sofia
Country [44] 0 0
Bulgaria
State/province [44] 0 0
Stara Zagora
Country [45] 0 0
Canada
State/province [45] 0 0
Alberta
Country [46] 0 0
Canada
State/province [46] 0 0
British Columbia
Country [47] 0 0
Canada
State/province [47] 0 0
Ontario
Country [48] 0 0
Canada
State/province [48] 0 0
Saint John
Country [49] 0 0
Czechia
State/province [49] 0 0
Brno
Country [50] 0 0
Czechia
State/province [50] 0 0
Náchod
Country [51] 0 0
Czechia
State/province [51] 0 0
Olomouc
Country [52] 0 0
Czechia
State/province [52] 0 0
Prague
Country [53] 0 0
Czechia
State/province [53] 0 0
Praha
Country [54] 0 0
Estonia
State/province [54] 0 0
Tallinn
Country [55] 0 0
Estonia
State/province [55] 0 0
Tartu
Country [56] 0 0
France
State/province [56] 0 0
Le Mans
Country [57] 0 0
France
State/province [57] 0 0
Lille
Country [58] 0 0
France
State/province [58] 0 0
Martigues
Country [59] 0 0
France
State/province [59] 0 0
Nantes
Country [60] 0 0
France
State/province [60] 0 0
Nice
Country [61] 0 0
France
State/province [61] 0 0
Paris
Country [62] 0 0
France
State/province [62] 0 0
Pierre-Bénite
Country [63] 0 0
France
State/province [63] 0 0
Quimper
Country [64] 0 0
France
State/province [64] 0 0
Toulon
Country [65] 0 0
France
State/province [65] 0 0
Toulouse
Country [66] 0 0
France
State/province [66] 0 0
Valence
Country [67] 0 0
Georgia
State/province [67] 0 0
Tbilisi
Country [68] 0 0
Georgia
State/province [68] 0 0
Zugdidi
Country [69] 0 0
Germany
State/province [69] 0 0
Aachen
Country [70] 0 0
Germany
State/province [70] 0 0
Augsburg
Country [71] 0 0
Germany
State/province [71] 0 0
Bad Bentheim
Country [72] 0 0
Germany
State/province [72] 0 0
Berlin
Country [73] 0 0
Germany
State/province [73] 0 0
Bielefeld
Country [74] 0 0
Germany
State/province [74] 0 0
Bonn
Country [75] 0 0
Germany
State/province [75] 0 0
Buxtehude
Country [76] 0 0
Germany
State/province [76] 0 0
Darmstadt
Country [77] 0 0
Germany
State/province [77] 0 0
Dresden
Country [78] 0 0
Germany
State/province [78] 0 0
Dülmen
Country [79] 0 0
Germany
State/province [79] 0 0
Düsseldorf
Country [80] 0 0
Germany
State/province [80] 0 0
Gera
Country [81] 0 0
Germany
State/province [81] 0 0
Goettigen
Country [82] 0 0
Germany
State/province [82] 0 0
Halle
Country [83] 0 0
Germany
State/province [83] 0 0
Hamburg
Country [84] 0 0
Germany
State/province [84] 0 0
Heidelberg
Country [85] 0 0
Germany
State/province [85] 0 0
Kiel
Country [86] 0 0
Germany
State/province [86] 0 0
Langenau
Country [87] 0 0
Germany
State/province [87] 0 0
Mainz
Country [88] 0 0
Germany
State/province [88] 0 0
Munich
Country [89] 0 0
Germany
State/province [89] 0 0
Münster
Country [90] 0 0
Germany
State/province [90] 0 0
Osnabrück
Country [91] 0 0
Germany
State/province [91] 0 0
Stuttgart
Country [92] 0 0
Germany
State/province [92] 0 0
Tuebingen
Country [93] 0 0
Hungary
State/province [93] 0 0
Budapest
Country [94] 0 0
Hungary
State/province [94] 0 0
Debrecen
Country [95] 0 0
Hungary
State/province [95] 0 0
Gyula
Country [96] 0 0
Hungary
State/province [96] 0 0
Veszprem
Country [97] 0 0
Italy
State/province [97] 0 0
Bologna
Country [98] 0 0
Italy
State/province [98] 0 0
L'Aquila
Country [99] 0 0
Italy
State/province [99] 0 0
Roma
Country [100] 0 0
Italy
State/province [100] 0 0
Rome
Country [101] 0 0
Italy
State/province [101] 0 0
Rozzano
Country [102] 0 0
Italy
State/province [102] 0 0
Vicenza
Country [103] 0 0
Korea, Republic of
State/province [103] 0 0
Bucheon-Si
Country [104] 0 0
Korea, Republic of
State/province [104] 0 0
Busan
Country [105] 0 0
Korea, Republic of
State/province [105] 0 0
Gyeonggi-do
Country [106] 0 0
Korea, Republic of
State/province [106] 0 0
Gyeonggi-Do
Country [107] 0 0
Korea, Republic of
State/province [107] 0 0
Incheon
Country [108] 0 0
Korea, Republic of
State/province [108] 0 0
Seoul
Country [109] 0 0
Latvia
State/province [109] 0 0
Liepaja
Country [110] 0 0
Latvia
State/province [110] 0 0
Riga
Country [111] 0 0
Latvia
State/province [111] 0 0
Talsi
Country [112] 0 0
Lithuania
State/province [112] 0 0
Kaunas
Country [113] 0 0
Lithuania
State/province [113] 0 0
Vilnius
Country [114] 0 0
Netherlands
State/province [114] 0 0
Groningen
Country [115] 0 0
Netherlands
State/province [115] 0 0
Rotterdam
Country [116] 0 0
Netherlands
State/province [116] 0 0
Utrecht
Country [117] 0 0
New Zealand
State/province [117] 0 0
Hamilton
Country [118] 0 0
New Zealand
State/province [118] 0 0
Wellington
Country [119] 0 0
Poland
State/province [119] 0 0
Bialystok
Country [120] 0 0
Poland
State/province [120] 0 0
Chorzów
Country [121] 0 0
Poland
State/province [121] 0 0
Czestochowa
Country [122] 0 0
Poland
State/province [122] 0 0
Gdansk
Country [123] 0 0
Poland
State/province [123] 0 0
Gdynia
Country [124] 0 0
Poland
State/province [124] 0 0
Katowice
Country [125] 0 0
Poland
State/province [125] 0 0
Kraków
Country [126] 0 0
Poland
State/province [126] 0 0
Lublin
Country [127] 0 0
Poland
State/province [127] 0 0
Nowa Sól
Country [128] 0 0
Poland
State/province [128] 0 0
Olsztyn
Country [129] 0 0
Poland
State/province [129] 0 0
Ostrowiec Swietokrzyski
Country [130] 0 0
Poland
State/province [130] 0 0
Poznan
Country [131] 0 0
Poland
State/province [131] 0 0
Rzeszów
Country [132] 0 0
Poland
State/province [132] 0 0
Szczecin
Country [133] 0 0
Poland
State/province [133] 0 0
Tarnow
Country [134] 0 0
Poland
State/province [134] 0 0
Warsaw
Country [135] 0 0
Poland
State/province [135] 0 0
Warszawa
Country [136] 0 0
Poland
State/province [136] 0 0
Wroclaw
Country [137] 0 0
Poland
State/province [137] 0 0
Lódz
Country [138] 0 0
Singapore
State/province [138] 0 0
Singapore
Country [139] 0 0
Spain
State/province [139] 0 0
Alicante
Country [140] 0 0
Spain
State/province [140] 0 0
Barcelona
Country [141] 0 0
Spain
State/province [141] 0 0
L'Hospitalet De Llobregat
Country [142] 0 0
Spain
State/province [142] 0 0
Las Palmas De Gran Canaria
Country [143] 0 0
Spain
State/province [143] 0 0
Madrid
Country [144] 0 0
Spain
State/province [144] 0 0
Pamplona
Country [145] 0 0
United Kingdom
State/province [145] 0 0
Barnsley
Country [146] 0 0
United Kingdom
State/province [146] 0 0
Blackpool
Country [147] 0 0
United Kingdom
State/province [147] 0 0
Cannock
Country [148] 0 0
United Kingdom
State/province [148] 0 0
Dudley
Country [149] 0 0
United Kingdom
State/province [149] 0 0
Glasgow
Country [150] 0 0
United Kingdom
State/province [150] 0 0
Liverpool
Country [151] 0 0
United Kingdom
State/province [151] 0 0
London
Country [152] 0 0
United Kingdom
State/province [152] 0 0
Manchester
Country [153] 0 0
United Kingdom
State/province [153] 0 0
Newcastle
Country [154] 0 0
United Kingdom
State/province [154] 0 0
Stockton-on-Tees

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Galderma R&D
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Long-Term Safety and Efficacy of Nemolizumab in Subjects with Moderate-to-Severe Atopic Dermatitis Description
Trial website
https://clinicaltrials.gov/study/NCT03989206
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries