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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06130566




Registration number
NCT06130566
Ethics application status
Date submitted
8/11/2023
Date registered
14/11/2023
Date last updated
4/11/2024

Titles & IDs
Public title
A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab Monotherapy Compared With Placebo in Participants Aged 12 Years and Older With Moderate-to-severe Atopic Dermatitis
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 Monotherapy by Subcutaneous Injection in Participants Aged 12 Years and Older With Moderate-to-severe Atopic Dermatitis
Secondary ID [1] 0 0
U1111-1275-9715
Secondary ID [2] 0 0
EFC17559
Universal Trial Number (UTN)
Trial acronym
COAST 1
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

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
Injection solution SC injection

Treatment: Drugs: Placebo
Injection solution SC injection
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 24
Timepoint [1] 0 0
Week 24
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 (EASI-75) at Week 24
Timepoint [2] 0 0
Week 24
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 24
Timepoint [3] 0 0
Week 24
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 24
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 24
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 24
Secondary outcome [4] 0 0
Proportion of participants reaching EASI-75
Timepoint [4] 0 0
Baseline to Week 20
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 20
Secondary outcome [6] 0 0
Proportion of participants reaching EASI-90
Timepoint [6] 0 0
Baseline to Week 24
Secondary outcome [7] 0 0
Proportion of participants reaching EASI-100
Timepoint [7] 0 0
Baseline to Week 24
Secondary outcome [8] 0 0
Proportion of participants with PP-NRS 0 or 1
Timepoint [8] 0 0
Baseline to Week 24
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 24
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 24
Secondary outcome [11] 0 0
Change in Children Dermatology Life Quality Index (CDLQI) from baseline in participants with age =12 to <16 years old
Timepoint [11] 0 0
Baseline to Week 24
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 24
Secondary outcome [13] 0 0
Change in Hospital Anxiety Depression Scale (HADS) from baseline
Timepoint [13] 0 0
Baseline to Week 24
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 24
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 24
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 24
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 24
Secondary outcome [18] 0 0
Percent change in weekly average of daily SP-NRS from baseline
Timepoint [18] 0 0
Baseline to Week 24
Secondary outcome [19] 0 0
Proportion of participants with vIGA-AD 0
Timepoint [19] 0 0
Week 24
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 24
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 24
Secondary outcome [22] 0 0
Percent change in weekly average of daily SD-NRS
Timepoint [22] 0 0
Baseline to Week 24
Secondary outcome [23] 0 0
Percent change in EASI score from baseline
Timepoint [23] 0 0
Baseline to Week 24
Secondary outcome [24] 0 0
Percent change in weekly average of daily PP-NRS from baseline
Timepoint [24] 0 0
Baseline to Week 24
Secondary outcome [25] 0 0
Absolute change in weekly average of daily PP-NRS from baseline
Timepoint [25] 0 0
Baseline to Week 24
Secondary outcome [26] 0 0
Proportion of participants reaching EASI-50
Timepoint [26] 0 0
Baseline to Week 24
Secondary outcome [27] 0 0
Proportion of participants with EASI =7
Timepoint [27] 0 0
Baseline to Week 24
Secondary outcome [28] 0 0
Change in percent Body Surface Area (BSA) affected by AD from baseline
Timepoint [28] 0 0
Baseline to Week 24
Secondary outcome [29] 0 0
Percent change in Scoring Atopic Dermatitis (SCORAD) index from baseline
Timepoint [29] 0 0
Baseline to Week 24
Secondary outcome [30] 0 0
Absolute change in SCORAD index from baseline
Timepoint [30] 0 0
Baseline to Week 24
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 24
Secondary outcome [32] 0 0
Change in Patient Oriented Eczema Measure (POEM) from baseline
Timepoint [32] 0 0
Baseline to Week 24
Secondary outcome [33] 0 0
Proportion of participants with a reduction in POEM =4 from baseline in participants with POEM Baseline =4
Timepoint [33] 0 0
Baseline to Week 24
Secondary outcome [34] 0 0
Proportion of participants with rescue medication use
Timepoint [34] 0 0
Baseline to Week 24
Secondary outcome [35] 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 [35] 0 0
Baseline to Week 40
Secondary outcome [36] 0 0
Serum amlitelimab concentrations
Timepoint [36] 0 0
Baseline to Week 40
Secondary outcome [37] 0 0
Incidence of antidrug antibodies (ADAs) of amlitelimab
Timepoint [37] 0 0
Baseline to Week 40

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 (within 6 months before screening) of either inadequate response or inadvisability to topical treatments, and/or inadequate response to systemic therapies (within 12 months before screening)
* 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
* 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 (1 week in the event of superficial skin infections)
* 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
8/11/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
14/11/2025
Actual
Sample size
Target
420
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Investigational Site Number : 0360010 - Westmead
Recruitment hospital [2] 0 0
Investigational Site Number : 0360007 - Woolloongabba
Recruitment hospital [3] 0 0
Investigational Site Number : 0360008 - Melbourne
Recruitment hospital [4] 0 0
Investigational Site Number : 0360006 - Melbourne
Recruitment hospital [5] 0 0
Investigational Site Number : 0361006 - Traralgon
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment postcode(s) [2] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [3] 0 0
3002 - Melbourne
Recruitment postcode(s) [4] 0 0
3004 - Melbourne
Recruitment postcode(s) [5] 0 0
3844 - Traralgon
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
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Kentucky
Country [6] 0 0
United States of America
State/province [6] 0 0
Louisiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Massachusetts
Country [8] 0 0
United States of America
State/province [8] 0 0
Michigan
Country [9] 0 0
United States of America
State/province [9] 0 0
Mississippi
Country [10] 0 0
United States of America
State/province [10] 0 0
Missouri
Country [11] 0 0
United States of America
State/province [11] 0 0
Nebraska
Country [12] 0 0
United States of America
State/province [12] 0 0
New York
Country [13] 0 0
United States of America
State/province [13] 0 0
North Carolina
Country [14] 0 0
United States of America
State/province [14] 0 0
Oregon
Country [15] 0 0
United States of America
State/province [15] 0 0
Pennsylvania
Country [16] 0 0
United States of America
State/province [16] 0 0
South Carolina
Country [17] 0 0
United States of America
State/province [17] 0 0
Texas
Country [18] 0 0
United States of America
State/province [18] 0 0
Utah
Country [19] 0 0
United States of America
State/province [19] 0 0
Virginia
Country [20] 0 0
Argentina
State/province [20] 0 0
Buenos Aires
Country [21] 0 0
Argentina
State/province [21] 0 0
Ciudad De Buenos Aires
Country [22] 0 0
Brazil
State/province [22] 0 0
Bahia
Country [23] 0 0
Brazil
State/province [23] 0 0
Maranhão
Country [24] 0 0
Brazil
State/province [24] 0 0
Paraná
Country [25] 0 0
Brazil
State/province [25] 0 0
Rio Grande Do Sul
Country [26] 0 0
Brazil
State/province [26] 0 0
São Paulo
Country [27] 0 0
Brazil
State/province [27] 0 0
Rio de Janeiro
Country [28] 0 0
Brazil
State/province [28] 0 0
Santo André
Country [29] 0 0
Canada
State/province [29] 0 0
Alberta
Country [30] 0 0
Canada
State/province [30] 0 0
British Columbia
Country [31] 0 0
Canada
State/province [31] 0 0
Ontario
Country [32] 0 0
Canada
State/province [32] 0 0
Quebec
Country [33] 0 0
Canada
State/province [33] 0 0
Saskatchewan
Country [34] 0 0
Chile
State/province [34] 0 0
Reg Metropolitana De Santiago
Country [35] 0 0
Chile
State/province [35] 0 0
Valparaíso
Country [36] 0 0
Chile
State/province [36] 0 0
Talcahuano
Country [37] 0 0
China
State/province [37] 0 0
Beijing
Country [38] 0 0
China
State/province [38] 0 0
Chengdu
Country [39] 0 0
China
State/province [39] 0 0
Chongqing
Country [40] 0 0
China
State/province [40] 0 0
Guangzhou
Country [41] 0 0
China
State/province [41] 0 0
Jinan
Country [42] 0 0
China
State/province [42] 0 0
Shenzhen
Country [43] 0 0
France
State/province [43] 0 0
Antony
Country [44] 0 0
France
State/province [44] 0 0
Nantes
Country [45] 0 0
France
State/province [45] 0 0
Paris
Country [46] 0 0
France
State/province [46] 0 0
Reims
Country [47] 0 0
France
State/province [47] 0 0
Romans-sur-isère
Country [48] 0 0
Germany
State/province [48] 0 0
Bad Bentheim
Country [49] 0 0
Germany
State/province [49] 0 0
Buxtehude
Country [50] 0 0
Germany
State/province [50] 0 0
Hamburg
Country [51] 0 0
Germany
State/province [51] 0 0
Kiel
Country [52] 0 0
Germany
State/province [52] 0 0
Magdeburg
Country [53] 0 0
Germany
State/province [53] 0 0
Mainz
Country [54] 0 0
Germany
State/province [54] 0 0
Münster
Country [55] 0 0
Greece
State/province [55] 0 0
Athens
Country [56] 0 0
Greece
State/province [56] 0 0
Thessaloniki
Country [57] 0 0
India
State/province [57] 0 0
Ahmedabad
Country [58] 0 0
India
State/province [58] 0 0
Belagavi
Country [59] 0 0
India
State/province [59] 0 0
Bengaluru
Country [60] 0 0
India
State/province [60] 0 0
Chandigarh
Country [61] 0 0
India
State/province [61] 0 0
Haryana
Country [62] 0 0
India
State/province [62] 0 0
Kolkata
Country [63] 0 0
India
State/province [63] 0 0
Nagpur
Country [64] 0 0
India
State/province [64] 0 0
Pune
Country [65] 0 0
Israel
State/province [65] 0 0
Afula
Country [66] 0 0
Israel
State/province [66] 0 0
Be'er Sheva
Country [67] 0 0
Israel
State/province [67] 0 0
Haifa
Country [68] 0 0
Israel
State/province [68] 0 0
Jerusalem
Country [69] 0 0
Israel
State/province [69] 0 0
Petah Tikva
Country [70] 0 0
Korea, Republic of
State/province [70] 0 0
Daegu-gwangyeoksi
Country [71] 0 0
Korea, Republic of
State/province [71] 0 0
Gyeonggi-do
Country [72] 0 0
Korea, Republic of
State/province [72] 0 0
Gyeongsangnam-do
Country [73] 0 0
Korea, Republic of
State/province [73] 0 0
Incheon-gwangyeoksi
Country [74] 0 0
Korea, Republic of
State/province [74] 0 0
Seoul-teukbyeolsi
Country [75] 0 0
Korea, Republic of
State/province [75] 0 0
Gwangju
Country [76] 0 0
Poland
State/province [76] 0 0
Slaskie
Country [77] 0 0
Poland
State/province [77] 0 0
Krakow
Country [78] 0 0
Poland
State/province [78] 0 0
Lodz
Country [79] 0 0
Poland
State/province [79] 0 0
Lublin
Country [80] 0 0
Poland
State/province [80] 0 0
Olsztyn
Country [81] 0 0
Poland
State/province [81] 0 0
Tarnow
Country [82] 0 0
Poland
State/province [82] 0 0
Warsaw
Country [83] 0 0
Taiwan
State/province [83] 0 0
Kaohsiung City
Country [84] 0 0
Taiwan
State/province [84] 0 0
Taichung
Country [85] 0 0
Taiwan
State/province [85] 0 0
Taipei City
Country [86] 0 0
Taiwan
State/province [86] 0 0
Taipei

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

Ethics approval
Ethics application status

Summary
Brief summary
This is a parallel group, Phase 3, multinational, multicenter, randomized, double blind, placebo-controlled, 3-arm monotherapy study for treatment of participants diagnosed with moderate to severe atopic dermatitis (AD), whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.

The purpose of this study is to measure the efficacy and safety of treatment with amlitelimab solution for SC injection compared with placebo in participants with moderate to severe AD aged 12 years and older.

Study details include:

At the end of the treatment period, participants will have an option to enter a separate study: the blinded extension study EFC17600 (ESTUARY).

For participants not entering the blinded extension Study EFC17600 (ESTUARY), the study duration will be up to 44 weeks including a 2 to 4-week screening, a 24-week randomized double-blind period, and a 16-week safety follow-up.

For participants entering the blinded extension Study EFC17600 (ESTUARY), the study duration will be up to 28 weeks including a 2 to 4-week screening and a 24-week randomized double-blind period.

The total treatment duration will be up to 24 weeks. The total number of visits will be up to 10 visits (or 9 visits for those entering the blinded extension study EFC17600\] (ESTUARY).
Trial website
https://clinicaltrials.gov/study/NCT06130566
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Sciences & Operations
Address 0 0
Sanofi
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
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06130566