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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06241118




Registration number
NCT06241118
Ethics application status
Date submitted
26/01/2024
Date registered
5/02/2024

Titles & IDs
Public title
A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab on Background Topical Corticosteroids Therapy in Participants Aged 12 Years and Older With Moderate-to-severe AD Who Have Had an Inadequate Response to Prior Biologic Therapy or an Oral JAK Inhibitor
Scientific title
A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, 3-arm, Multinational, Multicenter Study to Evaluate the Efficacy and Safety of Amlitelimab by Subcutaneous Injection in Participants Aged 12 Years and Older With Moderate-to-severe Atopic Dermatitis (AD) Who Are on Background Topical Corticosteroids and Have Had an Inadequate Response to Prior Biologic Therapy or Oral Janus Kinase (JAK) Inhibitor Treatment
Secondary ID [1] 0 0
2023-508099-12
Secondary ID [2] 0 0
EFC17599
Universal Trial Number (UTN)
Trial acronym
AQUA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dermatitis Atopic 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 - Amlitelimab
Treatment: Drugs - Placebo
Treatment: Drugs - Topical corticosteroids
Treatment: Drugs - Topical tacrolimus or pimecrolimus

Experimental: Amlitelimab dose 1 - Subcutaneous injection as per protocol

Experimental: Amlitelimab dose 2 - Subcutaneous injection as per protocol

Placebo comparator: Placebo - Subcutaneous injection as per protocol


Treatment: Drugs: Amlitelimab
Pharmaceutical form: Injection solution Route of administration: Subcutaneous

Treatment: Drugs: Placebo
Pharmaceutical form: Injection solution Route of administration: Subcutaneous

Treatment: Drugs: Topical corticosteroids
Pharmaceutical form: Various Topical formulation Route of administration: Topical

Treatment: Drugs: Topical tacrolimus or pimecrolimus
Pharmaceutical form: Various Topical formulation Route of administration: Topical
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
EU, EU reference countries, and Japan: Proportion of participants with Validated Investigator Global Assessment scale for Atopic Dermatitis (vIGA-AD) of 0 (clear) or 1 (almost clear) and a reduction from baseline of =2 points at Week 36
Timepoint [1] 0 0
Week 36
Primary outcome [2] 0 0
EU, EU reference countries, and Japan: Proportion of participants reaching 75% reduction from baseline in Eczema Area and Severity Index (EASI) score (EASI75) at Week 36
Timepoint [2] 0 0
Week 36
Primary outcome [3] 0 0
US and US reference countries: Proportion of participants with vIGA-AD of 0 (clear) or 1 (almost clear) and a reduction from baseline of =2 points at Week 36
Timepoint [3] 0 0
Week 36
Primary outcome [4] 0 0
Percent change in weekly average of daily SD-NRS
Timepoint [4] 0 0
Baseline to Week 36
Secondary outcome [1] 0 0
Proportion of participants reaching EASI-75 at Week 24 (for US and US reference countries only)
Timepoint [1] 0 0
Week 36
Secondary outcome [2] 0 0
Proportion of participants with vIGA-AD 0 (clear) or 1 (almost clear) with presence of only barely perceptible erythema (no induration/papulation, no lichenification, no oozing or crusting and a reduction from baseline of =2 points)
Timepoint [2] 0 0
Baseline to Week 36
Secondary outcome [3] 0 0
Proportion of participants with =4-point reduction in weekly average of daily Peak Pruritus-Numerical Rating Scale (PP-NRS) from baseline in participants with baseline weekly average of daily PP-NRS =4
Timepoint [3] 0 0
Baseline to Week 36
Secondary outcome [4] 0 0
Proportion of participants reaching EASI-75
Timepoint [4] 0 0
Baseline to Week 24
Secondary outcome [5] 0 0
Proportion of participants with vIGA-AD of 0 (clear) or 1 (almost clear) and a reduction from baseline of =2 points
Timepoint [5] 0 0
Baseline to Week 24
Secondary outcome [6] 0 0
Proportion of participants reaching EASI-90
Timepoint [6] 0 0
Baseline to Week 36
Secondary outcome [7] 0 0
Proportion of participants reaching EASI-100
Timepoint [7] 0 0
Baseline to Week 36
Secondary outcome [8] 0 0
Proportion of participants with PP-NRS 0 or 1
Timepoint [8] 0 0
Baseline to Week 36
Secondary outcome [9] 0 0
Change in Dermatology Life Quality Index (DLQI) from baseline in participants with age =16 years old
Timepoint [9] 0 0
Baseline to Week 36
Secondary outcome [10] 0 0
Proportion of participants with a reduction in DLQI =4 from baseline in participants with age =16 years old and with DLQI baseline =4
Timepoint [10] 0 0
Baseline to Week 36
Secondary outcome [11] 0 0
Change in Children Dermatology Life Quality Index (CDLQI) from baseline in participants with age =12 to <16 years
Timepoint [11] 0 0
Baseline to Week 36
Secondary outcome [12] 0 0
Proportion of participants with a reduction in CDLQI =6 from baseline in participants with age =12 to <16 years old and with CDLQI baseline =6
Timepoint [12] 0 0
Baseline to Week 36
Secondary outcome [13] 0 0
Change in Hospital Anxiety Depression Scale (HADS) from baseline
Timepoint [13] 0 0
Baseline to Week 36
Secondary outcome [14] 0 0
Proportion of participants with HADS subscale Anxiety (HADS-A) <8 in participants with baseline HADS-A =8
Timepoint [14] 0 0
Baseline to Week 36
Secondary outcome [15] 0 0
Proportion of participants with HADS subscale Depression (HADS-D) <8 in participants with HADS-D baseline =8
Timepoint [15] 0 0
Baseline to Week 36
Secondary outcome [16] 0 0
Absolute change in weekly average of daily Skin Pain-Numerical Rating Scale (SP-NRS) from baseline
Timepoint [16] 0 0
Baseline to Week 36
Secondary outcome [17] 0 0
Proportion of participants with a reduction in weekly average of daily SP-NRS =4 from baseline in participants with baseline weekly average of daily SP-NRS =4
Timepoint [17] 0 0
Baseline to Week 36
Secondary outcome [18] 0 0
Percent change in weekly average of daily SP-NRS from baseline
Timepoint [18] 0 0
Baseline to Week 36
Secondary outcome [19] 0 0
Proportion of participants with vIGA-AD 0 (clear)
Timepoint [19] 0 0
Baseline to Week 36
Secondary outcome [20] 0 0
Absolute change in weekly average of daily Sleep Disturbance-Numerical Rating Scale (SD-NRS) from baseline
Timepoint [20] 0 0
Baseline to Week 36
Secondary outcome [21] 0 0
Proportion of participants with a reduction in weekly average of daily SD-NRS =3 from baseline in participants with Baseline weekly average of daily SD-NRS =3
Timepoint [21] 0 0
Baseline to Week 36
Secondary outcome [22] 0 0
Percent change in weekly average of daily SD-NRS
Timepoint [22] 0 0
Baseline to Week 36
Secondary outcome [23] 0 0
Percent change in EASI score from baseline
Timepoint [23] 0 0
Baseline to Week 36
Secondary outcome [24] 0 0
Percent change in weekly average of daily PP-NRS from baseline
Timepoint [24] 0 0
Baseline to Week 36
Secondary outcome [25] 0 0
Absolute change in weekly average of daily PP-NRS from baseline
Timepoint [25] 0 0
Baseline to Week 36
Secondary outcome [26] 0 0
Proportion of participants reaching EASI-50
Timepoint [26] 0 0
Baseline to Week 36
Secondary outcome [27] 0 0
Proportion of participants with EASI =7
Timepoint [27] 0 0
Baseline to Week 36
Secondary outcome [28] 0 0
Change in percent Body Surface Area (BSA) affected by AD from baseline
Timepoint [28] 0 0
Baseline to Week 36
Secondary outcome [29] 0 0
Percent change in Scoring Atopic Dermatitis (SCORAD) index from baseline
Timepoint [29] 0 0
Baseline to Week 36
Secondary outcome [30] 0 0
Absolute change in SCORAD index from baseline
Timepoint [30] 0 0
Baseline to Week 36
Secondary outcome [31] 0 0
Proportion of participants with a reduction in SCORAD = 8.7 points from baseline in participants with baseline SCORAD score = 8.7
Timepoint [31] 0 0
Baseline to Week 36
Secondary outcome [32] 0 0
Proportion of participants with a reduction in Patient Oriented Eczema Measure (POEM) =4 from baseline in participants with POEM Baseline =4
Timepoint [32] 0 0
Baseline to Week 36
Secondary outcome [33] 0 0
Change in POEM from baseline
Timepoint [33] 0 0
Baseline to Week 36
Secondary outcome [34] 0 0
Proportion of participants with rescue medication use
Timepoint [34] 0 0
Baseline to Week 36
Secondary outcome [35] 0 0
Time to onset of effect on PP-NRS as measured by proportion of participants with an improvement (reduction) in PP-NRS by =4
Timepoint [35] 0 0
Baseline to Week 36
Secondary outcome [36] 0 0
Percentage of TCS/TCI free days
Timepoint [36] 0 0
Baseline to Week 36
Secondary outcome [37] 0 0
Percentage of participants who experienced Treatment-Emergent Adverse Events (TEAEs), experienced Treatment-Emergent Serious Adverse Events (TESAEs) and/or Treatment-Emergent Adverse Events of Special Interest (AESI)
Timepoint [37] 0 0
Baseline to Week 52
Secondary outcome [38] 0 0
Serum amlitelimab concentrations
Timepoint [38] 0 0
Baseline to Week 52
Secondary outcome [39] 0 0
Incidence of antidrug antibodies (ADAs) of amlitelimab
Timepoint [39] 0 0
Baseline to Week 52
Secondary outcome [40] 0 0
Time to onset of effect on vIGA-AD as measured by proportion of participants with vIGA-AD 0 (clear) or 1 (almost clear) and a reduction from baseline =2 during the 36-week treatment period
Timepoint [40] 0 0
Baseline to Week 36
Secondary outcome [41] 0 0
Time to onset of effect on EASI as measured by proportion of participants reaching a 75% reduction from baseline in EASI score during the 36-week treatment period
Timepoint [41] 0 0
Baseline to Week 36

Eligibility
Key inclusion criteria
* Participants must be 12 years of age (when signing informed consent form)
* Diagnosis of AD for at least 1 year (defined by the American Academy of Dermatology Consensus Criteria)
* Documented history prior to screening visit of inadequate response to a biologic AD medication or an oral JAKi therapy.
* v-IGA-AD of 3 or 4 at baseline visit
* EASI score of 16 or higher at baseline
* AD involvement of 10% or more of BSA at baseline
* Weekly average of daily PP-NRS of = 4 at baseline visit.
* Able and willing to comply with requested study visits and procedures
* Body weight =25 kg
Minimum age
12 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants are excluded from the study if any of the following criteria apply:

* Skin co-morbidity that would adversely affect the ability to undertake AD assessments
* Known history of or suspected significant current immunosuppression
* Any malignancies or history of malignancies prior to baseline (with the exception of non-melanoma skin cancer excised and cured >5 years prior to baseline)
* History of solid organ or stem cell transplant
* Any active or chronic infection including helminthic infection requiring systemic treatment within 4 weeks prior to baseline
* Positive for human immunodeficiency virus (HIV), Hepatitis B or hepatitis C at screening visit
* Having active tuberculosis (TB), latent TB, a history of incompletely treated TB, suspected extrapulmonary TB infection, or who are at high risk of contracting TB
* Having received any of the specified therapy within the specified timeframe(s) prior to the baseline visit
* In the Investigator's opinion, any clinically significant laboratory results or protocol specified laboratory abnormalities at screening
* History of hypersensitivity or allergy to any of the excipients or investigational medicinal product (IMP)

The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
29/02/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/06/2026
Actual
Sample size
Target
249
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Investigational Site Number : 0360008 - Melbourne
Recruitment postcode(s) [1] 0 0
3002 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Indiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Louisiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Nebraska
Country [10] 0 0
United States of America
State/province [10] 0 0
New Mexico
Country [11] 0 0
United States of America
State/province [11] 0 0
New York
Country [12] 0 0
United States of America
State/province [12] 0 0
Pennsylvania
Country [13] 0 0
United States of America
State/province [13] 0 0
Texas
Country [14] 0 0
United States of America
State/province [14] 0 0
Utah
Country [15] 0 0
United States of America
State/province [15] 0 0
Virginia
Country [16] 0 0
United States of America
State/province [16] 0 0
Washington
Country [17] 0 0
United States of America
State/province [17] 0 0
Wyoming
Country [18] 0 0
Argentina
State/province [18] 0 0
Santa Fe
Country [19] 0 0
Argentina
State/province [19] 0 0
Buenos Aires
Country [20] 0 0
Argentina
State/province [20] 0 0
Córdoba
Country [21] 0 0
Brazil
State/province [21] 0 0
Bahia
Country [22] 0 0
Brazil
State/province [22] 0 0
Rio Grande Do Sul
Country [23] 0 0
Brazil
State/province [23] 0 0
São Paulo
Country [24] 0 0
Canada
State/province [24] 0 0
Alberta
Country [25] 0 0
Canada
State/province [25] 0 0
Ontario
Country [26] 0 0
Canada
State/province [26] 0 0
Saskatchewan
Country [27] 0 0
Chile
State/province [27] 0 0
Reg Metropolitana De Santiago
Country [28] 0 0
China
State/province [28] 0 0
Changchun
Country [29] 0 0
China
State/province [29] 0 0
Guangzhou
Country [30] 0 0
China
State/province [30] 0 0
Hangzhou
Country [31] 0 0
China
State/province [31] 0 0
Nanyang
Country [32] 0 0
China
State/province [32] 0 0
Ningbo
Country [33] 0 0
China
State/province [33] 0 0
Shenyang
Country [34] 0 0
China
State/province [34] 0 0
Wuhan
Country [35] 0 0
China
State/province [35] 0 0
Xi An
Country [36] 0 0
France
State/province [36] 0 0
Bordeaux
Country [37] 0 0
France
State/province [37] 0 0
Clermont-ferrand
Country [38] 0 0
France
State/province [38] 0 0
Créteil
Country [39] 0 0
France
State/province [39] 0 0
Lille
Country [40] 0 0
France
State/province [40] 0 0
Rouen
Country [41] 0 0
Germany
State/province [41] 0 0
Berlin
Country [42] 0 0
Germany
State/province [42] 0 0
Blankenfelde-mahlow
Country [43] 0 0
Germany
State/province [43] 0 0
Dresden
Country [44] 0 0
Germany
State/province [44] 0 0
Lübeck
Country [45] 0 0
Greece
State/province [45] 0 0
Athens
Country [46] 0 0
Greece
State/province [46] 0 0
Thessaloniki
Country [47] 0 0
Israel
State/province [47] 0 0
Be'er Sheva
Country [48] 0 0
Israel
State/province [48] 0 0
Ramat Gan
Country [49] 0 0
Israel
State/province [49] 0 0
Tel Aviv
Country [50] 0 0
Italy
State/province [50] 0 0
Chieti
Country [51] 0 0
Italy
State/province [51] 0 0
Modena
Country [52] 0 0
Italy
State/province [52] 0 0
Napoli
Country [53] 0 0
Italy
State/province [53] 0 0
Perugia
Country [54] 0 0
Italy
State/province [54] 0 0
Torino
Country [55] 0 0
Japan
State/province [55] 0 0
Kanagawa
Country [56] 0 0
Japan
State/province [56] 0 0
Osaka
Country [57] 0 0
Japan
State/province [57] 0 0
Tochigi
Country [58] 0 0
Japan
State/province [58] 0 0
Tokyo
Country [59] 0 0
Japan
State/province [59] 0 0
Habikino
Country [60] 0 0
Japan
State/province [60] 0 0
Hiroshima
Country [61] 0 0
Japan
State/province [61] 0 0
Yokohama
Country [62] 0 0
Korea, Republic of
State/province [62] 0 0
Gyeonggi-do
Country [63] 0 0
Korea, Republic of
State/province [63] 0 0
Incheon-gwangyeoksi
Country [64] 0 0
Korea, Republic of
State/province [64] 0 0
Seoul-teukbyeolsi
Country [65] 0 0
Mexico
State/province [65] 0 0
Veracruz
Country [66] 0 0
Netherlands
State/province [66] 0 0
Rotterdam
Country [67] 0 0
Netherlands
State/province [67] 0 0
Utrecht
Country [68] 0 0
Poland
State/province [68] 0 0
Lubuskie
Country [69] 0 0
Poland
State/province [69] 0 0
Mazowieckie
Country [70] 0 0
Poland
State/province [70] 0 0
Pomorskie
Country [71] 0 0
Spain
State/province [71] 0 0
Catalunya [Cataluña]
Country [72] 0 0
Spain
State/province [72] 0 0
Madrid, Comunidad De
Country [73] 0 0
Spain
State/province [73] 0 0
Madrid
Country [74] 0 0
Spain
State/province [74] 0 0
Sevilla
Country [75] 0 0
Spain
State/province [75] 0 0
Alicante
Country [76] 0 0
Taiwan
State/province [76] 0 0
Kaohsiung City
Country [77] 0 0
Taiwan
State/province [77] 0 0
Taipei City
Country [78] 0 0
Turkey
State/province [78] 0 0
Gaziantep
Country [79] 0 0
Turkey
State/province [79] 0 0
Istanbul
Country [80] 0 0
United Arab Emirates
State/province [80] 0 0
Abu Dhabi
Country [81] 0 0
United Kingdom
State/province [81] 0 0
Devon
Country [82] 0 0
United Kingdom
State/province [82] 0 0
Hampshire
Country [83] 0 0
United Kingdom
State/province [83] 0 0
London, City Of
Country [84] 0 0
United Kingdom
State/province [84] 0 0
North Yorkshire
Country [85] 0 0
United Kingdom
State/province [85] 0 0
Nottinghamshire
Country [86] 0 0
United Kingdom
State/province [86] 0 0
Bradford
Country [87] 0 0
United Kingdom
State/province [87] 0 0
Bristol
Country [88] 0 0
United Kingdom
State/province [88] 0 0
Liverpool

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Sanofi
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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
Trial Transparency email recommended (Toll free for US & Canada)
Address 0 0
Country 0 0
Phone 0 0
800-633-1610
Fax 0 0
Email 0 0
Contact-US@sanofi.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06241118