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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

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
Assessment method [1] 0 0
The vIGA-AD is an Investigator-completed assessment scale used to determine severity of AD and clinical response to treatment. It is based on a 5-point scale, ranging from 0 (clear) to 4 (severe).
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
Assessment method [2] 0 0
The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD.
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
Assessment method [3] 0 0
The vIGA-AD is an Investigator-completed assessment scale used to determine severity of AD and clinical response to treatment. It is based on a 5-point scale, ranging from 0 (clear) to 4 (severe).
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)
Assessment method [1] 0 0
The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD. EASI-75 is 75% reduction from baseline in EASI score.
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
Assessment method [2] 0 0
The vIGA-AD is an Investigator-completed assessment scale used to determine severity of AD and clinical response to treatment. It is based on a 5-point scale, ranging from 0 (clear) to 4 (severe).
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
Assessment method [3] 0 0
The PP-NRS is a validated single item 0-10 numeric rating scale assessing peak pruritus (itch) associated with AD with 0 = no itch and 10 = worst itch imaginable.
Timepoint [3] 0 0
Baseline to Week 24
Secondary outcome [4] 0 0
Proportion of participants reaching EASI-75
Assessment method [4] 0 0
The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD. EASI-75 is 75% reduction from baseline in EASI score.
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
Assessment method [5] 0 0
The vIGA-AD is an Investigator-completed assessment scale used to determine severity of AD and clinical response to treatment. It is based on a 5-point scale, ranging from 0 (clear) to 4 (severe).
Timepoint [5] 0 0
Baseline to Week 20
Secondary outcome [6] 0 0
Proportion of participants reaching EASI-90
Assessment method [6] 0 0
The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD. EASI-90 is 90% reduction from baseline in EASI score.
Timepoint [6] 0 0
Baseline to Week 24
Secondary outcome [7] 0 0
Proportion of participants reaching EASI-100
Assessment method [7] 0 0
The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD. EASI-100 is 100% reduction from baseline in EASI score.
Timepoint [7] 0 0
Baseline to Week 24
Secondary outcome [8] 0 0
Proportion of participants with PP-NRS 0 or 1
Assessment method [8] 0 0
The PP-NRS is a validated single item 0-10 numeric rating scale assessing peak pruritus (itch) associated with AD with 0 = no itch and 10 = worst itch imaginable.
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
Assessment method [9] 0 0
The DLQI is a validated 10-item questionnaire to measure dermatology-specific quality of life (QoL) in adult patients. Overall scoring ranges from 0 to 30, with a higher score indicating a poorer QoL.
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
Assessment method [10] 0 0
The DLQI is a validated 10-item questionnaire to measure dermatology-specific quality of life (QoL) in adult patients. Overall scoring ranges from 0 to 30, with a higher score indicating a poorer QoL.
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
Assessment method [11] 0 0
The CDLQI is a validated 10-item questionnaire to measure dermatology-specific quality of life (QoL) in children aged 4-\<16 years. Overall scoring ranges from 0 to 30, with a higher score indicating a poorer QoL.
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
Assessment method [12] 0 0
The CDLQI is a validated 10-item questionnaire to measure dermatology-specific quality of life (QoL) in children aged 4-\<16 years. Overall scoring ranges from 0 to 30, with a higher score indicating a poorer QoL.
Timepoint [12] 0 0
Baseline to Week 24
Secondary outcome [13] 0 0
Change in Hospital Anxiety Depression Scale (HADS) from baseline
Assessment method [13] 0 0
The HADS is 14-item questionnaire with two subscales: anxiety \& depression. Each subscale (anxiety \& depression) ranges 0-21. The total HADS score ranges 0-42 with higher score indicating a poorer state.
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
Assessment method [14] 0 0
HADS-A score ranges 0-21 with higher score indicating a poorer state.
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
Assessment method [15] 0 0
HADS-D score ranges 0-21 with higher score indicating a poorer state.
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
Assessment method [16] 0 0
The SP-NRS is a single item 0-10 numeric rating scale assessing skin pain associated with AD with 0 = no pain and 10 = worst possible pain imaginable.
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
Assessment method [17] 0 0
The SP-NRS is a single item 0-10 numeric rating scale assessing skin pain associated with AD with 0 = no pain and 10 = worst possible pain imaginable.
Timepoint [17] 0 0
Baseline to Week 24
Secondary outcome [18] 0 0
Percent change in weekly average of daily SP-NRS from baseline
Assessment method [18] 0 0
The SP-NRS is a single item 0-10 numeric rating scale assessing skin pain associated with AD with 0 = no pain and 10 = worst possible pain imaginable.
Timepoint [18] 0 0
Baseline to Week 24
Secondary outcome [19] 0 0
Proportion of participants with vIGA-AD 0
Assessment method [19] 0 0
The vIGA-AD is an Investigator-completed assessment scale used to determine severity of AD and clinical response to treatment. It is based on a 5-point scale, ranging from 0 (clear) to 4 (severe).
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
Assessment method [20] 0 0
The SD-NRS is a single item 0-10 numeric rating scale assessing sleep disturbance associated with AD with 0 = no sleep loss and 10 = did not sleep at all.
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
Assessment method [21] 0 0
The SD-NRS is a single item 0-10 numeric rating scale assessing sleep disturbance associated with AD with 0 = no sleep loss and 10 = did not sleep at all.
Timepoint [21] 0 0
Baseline to Week 24
Secondary outcome [22] 0 0
Percent change in weekly average of daily SD-NRS
Assessment method [22] 0 0
The SD-NRS is a single item 0-10 numeric rating scale assessing sleep disturbance associated with AD with 0 = no sleep loss and 10 = did not sleep at all.
Timepoint [22] 0 0
Baseline to Week 24
Secondary outcome [23] 0 0
Percent change in EASI score from baseline
Assessment method [23] 0 0
The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD.
Timepoint [23] 0 0
Baseline to Week 24
Secondary outcome [24] 0 0
Percent change in weekly average of daily PP-NRS from baseline
Assessment method [24] 0 0
The PP-NRS is a validated single item 0-10 numeric rating scale assessing peak pruritus (itch) associated with AD with 0 = no itch and 10 = worst itch imaginable.
Timepoint [24] 0 0
Baseline to Week 24
Secondary outcome [25] 0 0
Absolute change in weekly average of daily PP-NRS from baseline
Assessment method [25] 0 0
The PP-NRS is a validated single item 0-10 numeric rating scale assessing peak pruritus (itch) associated with AD with 0 = no itch and 10 = worst itch imaginable.
Timepoint [25] 0 0
Baseline to Week 24
Secondary outcome [26] 0 0
Proportion of participants reaching EASI-50
Assessment method [26] 0 0
The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD. EASI-50 is 50% reduction from baseline in EASI score.
Timepoint [26] 0 0
Baseline to Week 24
Secondary outcome [27] 0 0
Proportion of participants with EASI =7
Assessment method [27] 0 0
The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD.
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
Assessment method [28] 0 0
Timepoint [28] 0 0
Baseline to Week 24
Secondary outcome [29] 0 0
Percent change in Scoring Atopic Dermatitis (SCORAD) index from baseline
Assessment method [29] 0 0
The SCORAD index is a clinical tool to evaluate the extent and severity of AD. Total score ranges from 0 (absent disease) to 103 (severe disease).
Timepoint [29] 0 0
Baseline to Week 24
Secondary outcome [30] 0 0
Absolute change in SCORAD index from baseline
Assessment method [30] 0 0
The SCORAD index is a clinical tool to evaluate the extent and severity of AD. Total score ranges from 0 (absent disease) to 103 (severe disease).
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
Assessment method [31] 0 0
The SCORAD index is a clinical tool to evaluate the extent and severity of AD. Total score ranges from 0 (absent disease) to 103 (severe disease).
Timepoint [31] 0 0
Baseline to Week 24
Secondary outcome [32] 0 0
Change in Patient Oriented Eczema Measure (POEM) from baseline
Assessment method [32] 0 0
The POEM is a 7-item self-assessment questionnaire that assesses disease symptoms on a 5-point scale; 0 (no days) to 4 (every day in the last week). The sum of the 7 items gives the total POEM score of 0 (absent disease) to 28 (very severe). Higher scores indicated more severe disease and poor quality of life.
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
Assessment method [33] 0 0
The POEM is a 7-item self-assessment questionnaire that assesses disease symptoms on a 5-point scale; 0 (no days) to 4 (every day in the last week). The sum of the 7 items gives the total POEM score of 0 (absent disease) to 28 (very severe). Higher scores indicated more severe disease and poor quality of life.
Timepoint [33] 0 0
Baseline to Week 24
Secondary outcome [34] 0 0
Proportion of participants with rescue medication use
Assessment method [34] 0 0
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)
Assessment method [35] 0 0
Timepoint [35] 0 0
Baseline to Week 40
Secondary outcome [36] 0 0
Serum amlitelimab concentrations
Assessment method [36] 0 0
Timepoint [36] 0 0
Baseline to Week 40
Secondary outcome [37] 0 0
Incidence of antidrug antibodies (ADAs) of amlitelimab
Assessment method [37] 0 0
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
Ciudad De Buenos Aires
Country [21] 0 0
Argentina
State/province [21] 0 0
Tucumán
Country [22] 0 0
Argentina
State/province [22] 0 0
Buenos Aires
Country [23] 0 0
Brazil
State/province [23] 0 0
Bahia
Country [24] 0 0
Brazil
State/province [24] 0 0
Maranhão
Country [25] 0 0
Brazil
State/province [25] 0 0
Paraná
Country [26] 0 0
Brazil
State/province [26] 0 0
Rio Grande Do Sul
Country [27] 0 0
Brazil
State/province [27] 0 0
São Paulo
Country [28] 0 0
Brazil
State/province [28] 0 0
Rio de Janeiro
Country [29] 0 0
Brazil
State/province [29] 0 0
Santo André
Country [30] 0 0
Canada
State/province [30] 0 0
Alberta
Country [31] 0 0
Canada
State/province [31] 0 0
British Columbia
Country [32] 0 0
Canada
State/province [32] 0 0
Ontario
Country [33] 0 0
Canada
State/province [33] 0 0
Quebec
Country [34] 0 0
Canada
State/province [34] 0 0
Saskatchewan
Country [35] 0 0
Chile
State/province [35] 0 0
Reg Metropolitana De Santiago
Country [36] 0 0
Chile
State/province [36] 0 0
Valparaíso
Country [37] 0 0
Chile
State/province [37] 0 0
Talcahuano
Country [38] 0 0
China
State/province [38] 0 0
Beijing
Country [39] 0 0
China
State/province [39] 0 0
Chengdu
Country [40] 0 0
China
State/province [40] 0 0
Chongqing
Country [41] 0 0
China
State/province [41] 0 0
Guangzhou
Country [42] 0 0
China
State/province [42] 0 0
Jinan
Country [43] 0 0
China
State/province [43] 0 0
Shenzhen
Country [44] 0 0
France
State/province [44] 0 0
Antony
Country [45] 0 0
France
State/province [45] 0 0
Nantes
Country [46] 0 0
France
State/province [46] 0 0
Paris
Country [47] 0 0
France
State/province [47] 0 0
Reims
Country [48] 0 0
France
State/province [48] 0 0
Romans-sur-isère
Country [49] 0 0
Germany
State/province [49] 0 0
Bad Bentheim
Country [50] 0 0
Germany
State/province [50] 0 0
Buxtehude
Country [51] 0 0
Germany
State/province [51] 0 0
Hamburg
Country [52] 0 0
Germany
State/province [52] 0 0
Kiel
Country [53] 0 0
Germany
State/province [53] 0 0
Magdeburg
Country [54] 0 0
Germany
State/province [54] 0 0
Mainz
Country [55] 0 0
Germany
State/province [55] 0 0
Münster
Country [56] 0 0
Greece
State/province [56] 0 0
Athens
Country [57] 0 0
Greece
State/province [57] 0 0
Thessaloniki
Country [58] 0 0
India
State/province [58] 0 0
Ahmedabad
Country [59] 0 0
India
State/province [59] 0 0
Belagavi
Country [60] 0 0
India
State/province [60] 0 0
Bengaluru
Country [61] 0 0
India
State/province [61] 0 0
Chandigarh
Country [62] 0 0
India
State/province [62] 0 0
Haryana
Country [63] 0 0
India
State/province [63] 0 0
Kolkata
Country [64] 0 0
India
State/province [64] 0 0
Nagpur
Country [65] 0 0
India
State/province [65] 0 0
Pune
Country [66] 0 0
Israel
State/province [66] 0 0
Afula
Country [67] 0 0
Israel
State/province [67] 0 0
Be'er Sheva
Country [68] 0 0
Israel
State/province [68] 0 0
Haifa
Country [69] 0 0
Israel
State/province [69] 0 0
Jerusalem
Country [70] 0 0
Israel
State/province [70] 0 0
Petah Tikva
Country [71] 0 0
Korea, Republic of
State/province [71] 0 0
Daegu-gwangyeoksi
Country [72] 0 0
Korea, Republic of
State/province [72] 0 0
Gyeonggi-do
Country [73] 0 0
Korea, Republic of
State/province [73] 0 0
Gyeongsangnam-do
Country [74] 0 0
Korea, Republic of
State/province [74] 0 0
Incheon-gwangyeoksi
Country [75] 0 0
Korea, Republic of
State/province [75] 0 0
Seoul-teukbyeolsi
Country [76] 0 0
Korea, Republic of
State/province [76] 0 0
Gwangju
Country [77] 0 0
Poland
State/province [77] 0 0
Pomorskie
Country [78] 0 0
Poland
State/province [78] 0 0
Slaskie
Country [79] 0 0
Poland
State/province [79] 0 0
Krakow
Country [80] 0 0
Poland
State/province [80] 0 0
Lodz
Country [81] 0 0
Poland
State/province [81] 0 0
Lublin
Country [82] 0 0
Poland
State/province [82] 0 0
Olsztyn
Country [83] 0 0
Poland
State/province [83] 0 0
Tarnow
Country [84] 0 0
Poland
State/province [84] 0 0
Warsaw
Country [85] 0 0
Taiwan
State/province [85] 0 0
Kaohsiung City
Country [86] 0 0
Taiwan
State/province [86] 0 0
Taichung
Country [87] 0 0
Taiwan
State/province [87] 0 0
Taipei City
Country [88] 0 0
Taiwan
State/province [88] 0 0
Taipei
Country [89] 0 0
Taiwan
State/province [89] 0 0
Taoyuan County

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Sciences & Operations
Address 0 0
Sanofi
Country 0 0
Phone 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
Email 0 0
contact-us@sanofi.com
Contact person for scientific queries

Data sharing statement


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/NCT06130566