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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06407934




Registration number
NCT06407934
Ethics application status
Date submitted
6/05/2024
Date registered
9/05/2024
Date last updated
8/10/2024

Titles & IDs
Public title
A Study to Evaluate the Treatment Response and Safety of Two Dose Regimens of Subcutaneous Amlitelimab Monotherapy Compared With Treatment Withdrawal in Participants Aged 12 Years and Older With Moderate-to-severe Atopic Dermatitis
Scientific title
A Phase 3, Multinational, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group 48-week Extension Study to Evaluate the Treatment Response and Safety of Two Amlitelimab Dose Regimens Administered as Monotherapy by Subcutaneous Injection in Participants Aged 12 Years and Older With Moderate-to-severe Atopic Dermatitis
Secondary ID [1] 0 0
U1111-1290-9215
Secondary ID [2] 0 0
EFC17600
Universal Trial Number (UTN)
Trial acronym
ESTUARY
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
Pharmaceutical form: Injection solution

Route of administration: Subcutaneous (SC) injection

Treatment: Drugs: Placebo
Pharmaceutical form: Injection solution

Route of administration: SC injection
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of participants who maintain clinical response at Week 48 of ESTUARY.
Timepoint [1] 0 0
Week 48
Secondary outcome [1] 0 0
Responders from parent studies: Proportion of participants who continue to be EASI-75 among the participants who met EASI-75 at baseline of ESTUARY
Timepoint [1] 0 0
Up to Week 48
Secondary outcome [2] 0 0
Responders from parent studies: Proportion of participants who continue to be vIGA-AD 0 (clear) or 1 (almost clear) among participants who met vIGA-AD 0 (clear) or 1 (almost clear) at baseline of ESTUARY
Timepoint [2] 0 0
Up to Week 48
Secondary outcome [3] 0 0
Responders from parent studies: Proportion of participants who continue to be vIGA-AD 0 or 1 with presence of only barely perceptible erythema among those who are vIGA-AD 0 or 1 with presence of only barely perceptible erythema at baseline of ESTUARY
Timepoint [3] 0 0
Up to Week 48
Secondary outcome [4] 0 0
Responders from parent studies: Proportion of participants who maintained weekly average of daily PP-NRS reduction of =4 among the participants with weekly average of daily PP-NRS reduction of = 4 at baseline of ESTUARY
Timepoint [4] 0 0
Up to Week 48
Secondary outcome [5] 0 0
Responders from parent studies: Percent change in EASI from parent study baseline
Timepoint [5] 0 0
Parent study baseline to Week 48
Secondary outcome [6] 0 0
Responders from parent studies: Proportion of participants with EASI-75
Timepoint [6] 0 0
Up to Week 48
Secondary outcome [7] 0 0
Responders from parent studies: Proportion of participants who continue to be EASI-50 among the participants who met EASI-50 at baseline of ESTUARY
Timepoint [7] 0 0
Up to Week 48
Secondary outcome [8] 0 0
Responders from parent studies: Proportion of participants with EASI-50
Timepoint [8] 0 0
Up to Week 48
Secondary outcome [9] 0 0
Responders from parent studies: Proportion of participants who continue to be EASI-90 among the participants who met EASI-90 at baseline of ESTUARY
Timepoint [9] 0 0
Up to Week 48
Secondary outcome [10] 0 0
Responders from parent studies: Proportion of participants with EASI-90
Timepoint [10] 0 0
Up to Week 48
Secondary outcome [11] 0 0
Responders from parent studies: Proportion of participants who continue to be EASI-100 among the participants who met EASI-100 at baseline of ESTUARY
Timepoint [11] 0 0
Up to Week 48
Secondary outcome [12] 0 0
Responders from parent studies: Proportion of participants with EASI-100
Timepoint [12] 0 0
Up to Week 48
Secondary outcome [13] 0 0
Responders from parent studies: Time to the first event of loss of EASI-75 response among the participants who were EASI-75 responders at baseline of ESTUARY
Timepoint [13] 0 0
Up to Week 48
Secondary outcome [14] 0 0
Responders from parent studies: Time to the first event of loss of EASI-50 response among the participants who were EASI-50 responders at baseline of ESTUARY
Timepoint [14] 0 0
Up to Week 48
Secondary outcome [15] 0 0
Responders from parent studies: Time to the first event of loss of EASI-90 response among the participants who were EASI-90 responders at baseline of ESTUARY
Timepoint [15] 0 0
Up to Week 48
Secondary outcome [16] 0 0
Responders from parent studies: Time to the first event of loss of EASI-100 among participants who were EASI-100 at baseline of ESTUARY
Timepoint [16] 0 0
Up to Week 48
Secondary outcome [17] 0 0
Responders from parent studies: Proportion of participants with vIGA-AD 0 (clear) or 1 (almost clear)
Timepoint [17] 0 0
Up to Week 48
Secondary outcome [18] 0 0
Responders from parent studies: Proportion of participants who are vIGA-AD 0 (clear) or 1 (almost clear) with presence of only barely perceptible erythema (no induration/papulation, no lichenification, no oozing or crusting)
Timepoint [18] 0 0
Up to Week 48
Secondary outcome [19] 0 0
Responders from parent studies: Time to first event of vIGA-AD =3 (moderate or severe) among those participants who were vIGA-AD 0 (clear) or 1 (almost clear) at baseline of ESTUARY
Timepoint [19] 0 0
Up to Week 48
Secondary outcome [20] 0 0
Responders from parent studies: Time to first event of vIGA-AD =3 (moderate or severe) among those participants who were vIGA-AD 0 (clear) at baseline of ESTUARY
Timepoint [20] 0 0
Up to Week 48
Secondary outcome [21] 0 0
Responders from parent studies: Proportion of participants who have an increase of =2 points in vIGA-AD from ESTUARY baseline among the participants who were vIGA-AD 0 (clear) or 1 (almost clear) at baseline of ESTUARY
Timepoint [21] 0 0
Up to Week 48
Secondary outcome [22] 0 0
Responders from parent studies: Proportion of participants who have an increase of =2 points in vIGA-AD from ESTUARY baseline among the participants who were vIGA-AD 3 (moderate) at baseline of parent study
Timepoint [22] 0 0
Up to Week 48
Secondary outcome [23] 0 0
Responders from parent studies: Proportion of participants who have an increase of =2 points in vIGA-AD from ESTUARY baseline among the participants who were vIGA-AD 4 (severe) at baseline of parent study
Timepoint [23] 0 0
Up to Week 48
Secondary outcome [24] 0 0
Responders from parent studies: Proportion of participants with vIGA-AD 0 (clear) or 1 (almost clear) and/or EASI-75 among the participants who were vIGA-AD 0 (clear) or 1 (almost clear) and/or EASI-75 at baseline of ESTUARY
Timepoint [24] 0 0
Up to Week 48
Secondary outcome [25] 0 0
Responders from parent studies: Proportion of participants with = 4 points reduction in weekly average of daily PP-NRS from parent study baseline
Timepoint [25] 0 0
Up to Week 48
Secondary outcome [26] 0 0
Responders from parent studies: Percent change in weekly average of daily PP-NRS from parent study baseline
Timepoint [26] 0 0
Parent study baseline to Week 48
Secondary outcome [27] 0 0
Responders from parent studies: Absolute change in weekly average of daily PP-NRS from parent study baseline
Timepoint [27] 0 0
Parent study baseline to Week 48
Secondary outcome [28] 0 0
Responders from parent studies: Proportion of participants who maintained PP-NRS 0 or 1 among the participants who were PP-NRS 0 or 1 at baseline of ESTUARY
Timepoint [28] 0 0
Up to Week 48
Secondary outcome [29] 0 0
Responders from parent studies: Proportion of participants who maintained vIGA-AD 0 or 1 and/or EASI-75 and weekly average of daily (WAD) PP-NRS reduction >4 among those who were vIGA-AD 0 or 1 and/or EASI-75 and WAD PP-NRS reduction >4 at BL of ESTUARY
Timepoint [29] 0 0
Up to Week 48
Secondary outcome [30] 0 0
Responders from parent studies: Absolute change in weekly average of daily SD-NRS from parent study baseline
Timepoint [30] 0 0
Parent study baseline to Week 48
Secondary outcome [31] 0 0
Responders from parent studies: Proportion of participants who maintained weekly average of daily SD-NRS reduction of = 3 among the participants with weekly average of daily SD-NRS reduction of =3 at baseline of ESTUARY
Timepoint [31] 0 0
Up to Week 48
Secondary outcome [32] 0 0
Responders from parent studies: Proportion of participants with =3 points reduction in weekly average of daily SD-NRS from parent study baseline
Timepoint [32] 0 0
Up to Week 48
Secondary outcome [33] 0 0
Responders from parent studies: Proportion of participants with = 4 points reduction in weekly average of daily SP-NRS from parent study baseline
Timepoint [33] 0 0
Up to Week 48
Secondary outcome [34] 0 0
Responders from parent studies: Proportion of participants who maintained weekly average of daily SP-NRS reduction of = 4 among the participants with weekly average of daily SP-NRS reduction of =4 at ESTUARY baseline
Timepoint [34] 0 0
Up to Week 48
Secondary outcome [35] 0 0
Responders from parent studies: Absolute change in weekly average of daily SP-NRS from parent study baseline
Timepoint [35] 0 0
Parent study baseline to Week 48
Secondary outcome [36] 0 0
Responders from parent studies: Proportion of participants who maintained SCORAD = 8.7 among participants with reduction in SCORAD = 8.7 at baseline of ESTUARY
Timepoint [36] 0 0
Up to Week 48
Secondary outcome [37] 0 0
Responders from parent studies: Percent change in SCORAD index from parent study baseline
Timepoint [37] 0 0
Parent study baseline to Week 48
Secondary outcome [38] 0 0
Responders from parent studies: Absolute change in SCORAD index from parent study baseline
Timepoint [38] 0 0
Parent study baseline to Week 48
Secondary outcome [39] 0 0
Responders from parent studies: Change in percent Body Surface Area (BSA) affected by AD from parent study baseline
Timepoint [39] 0 0
Parent study baseline to Week 48
Secondary outcome [40] 0 0
Responders from parent studies: Proportion of participants who maintained POEM =4 among the participants with reduction in POEM =4 at baseline of ESTUARY
Timepoint [40] 0 0
Up to Week 48
Secondary outcome [41] 0 0
Responders from parent studies: Change in POEM from parent study baseline
Timepoint [41] 0 0
Parent study baseline to Week 48
Secondary outcome [42] 0 0
Responders from parent studies: Proportion of participants with a reduction in Children's Dermatology Life Quality Index (CDLQI) =6 among participants aged =12 to <16 years old and with CDLQI baseline =6
Timepoint [42] 0 0
Up to Week 48
Secondary outcome [43] 0 0
Responders from parent studies: Change in CDLQI in participants with age =12 to <16 years old
Timepoint [43] 0 0
Parent study baseline to Week 48
Secondary outcome [44] 0 0
Responders from parent studies: Change in Dermatology Life Quality Index (DLQI) in participants with age =16 years among the participants with DLQI =4 at parent study baseline
Timepoint [44] 0 0
Parent study baseline to Week 48
Secondary outcome [45] 0 0
Responders from parent studies: Proportion of participants with = 4 points reduction in DLQI from parent study baseline among the participants with DLQI =4 at parent study baseline
Timepoint [45] 0 0
Up to Week 48
Secondary outcome [46] 0 0
Responders from parent studies: Proportion of participants with HADS-D <8 among the participants who had HADS-D =8 at parent study baseline
Timepoint [46] 0 0
Up to Week 48
Secondary outcome [47] 0 0
Responders from parent studies: Proportion of participants with HADS-A <8 among the participants who had HADS-A =8 at parent study baseline
Timepoint [47] 0 0
Up to Week 48
Secondary outcome [48] 0 0
Responders from parent studies: Proportion of participants requiring rescue medication during the study up to Week 48 of ESTUARY
Timepoint [48] 0 0
Up to Week 48
Secondary outcome [49] 0 0
Responders from parent studies: Time to first rescue medication initiation
Timepoint [49] 0 0
Up to Week 48
Secondary outcome [50] 0 0
Non-responders from parent studies: Percent change in EASI from parent study baseline
Timepoint [50] 0 0
Parent study baseline to Week 48
Secondary outcome [51] 0 0
Non-responders from parent studies: Proportion of participants with EASI-75
Timepoint [51] 0 0
Up to Week 48
Secondary outcome [52] 0 0
Non-responders from parent studies: Proportion of participants who continue to be EASI-50 among the participants who met EASI-50 at baseline of ESTUARY
Timepoint [52] 0 0
Up to Week 48
Secondary outcome [53] 0 0
Non-responders from parent studies: Proportion of participants with EASI-50
Timepoint [53] 0 0
Up to Week 48
Secondary outcome [54] 0 0
Non-responders from parent studies: Proportion of participants with EASI-90
Timepoint [54] 0 0
Up to Week 48
Secondary outcome [55] 0 0
Non-responders from parent studies: Proportion of participants with EASI-100
Timepoint [55] 0 0
Up to Week 48
Secondary outcome [56] 0 0
Non-responders from parent studies: Proportion of participants with vIGA-AD 0 (clear) or 1 (almost clear)
Timepoint [56] 0 0
Up to Week 48
Secondary outcome [57] 0 0
Non-responders from parent studies: Proportion of participants who are vIGA-AD 0 (clear) or 1 (almost clear) with presence of only barely perceptible erythema (no induration/papulation, no lichenification, no oozing or crusting)
Timepoint [57] 0 0
Up to Week 48
Secondary outcome [58] 0 0
Non-responders from parent studies: Proportion of participants with = 4 points reduction in weekly average of daily PP-NRS from parent study baseline
Timepoint [58] 0 0
Up to Week 48
Secondary outcome [59] 0 0
Non-responders from parent studies: Percent change in weekly average of daily PP-NRS from parent study baseline
Timepoint [59] 0 0
Parent study baseline to Week 48
Secondary outcome [60] 0 0
Non-responders from parent studies: Absolute change in weekly average of daily PP-NRS from parent study baseline
Timepoint [60] 0 0
Parent study baseline to Week 48
Secondary outcome [61] 0 0
Non-responders from parent studies: Absolute change in weekly average of daily SD-NRS from parent study baseline
Timepoint [61] 0 0
Parent study baseline to Week 48
Secondary outcome [62] 0 0
Non-responders from parent studies: Proportion of participants with =3 points reduction in weekly average of daily SD-NRS from parent study baseline
Timepoint [62] 0 0
Up to Week 48
Secondary outcome [63] 0 0
Non-responders from parent studies: Proportion of participants with = 4 points reduction in weekly average of daily SP-NRS from parent study baseline [
Timepoint [63] 0 0
Up to Week 48
Secondary outcome [64] 0 0
Non-responders from parent studies: Absolute change in weekly average of daily SP-NRS from parent study baseline
Timepoint [64] 0 0
Parent study baseline to Week 48
Secondary outcome [65] 0 0
Non-responders from parent studies: Proportion of participants with a reduction in CDLQI =6 among participants aged =12 to <16 years old and with CDLQI =6 at parent study baseline
Timepoint [65] 0 0
Up to Week 48
Secondary outcome [66] 0 0
Non-responders from parent studies: Change in CDLQI in participants with age =12 to <16 years old
Timepoint [66] 0 0
Parent study baseline to Week 48
Secondary outcome [67] 0 0
Non-responders from parent studies: Change in DLQI in participants with age =16 years among the participants with DLQI =4 at parent study baseline
Timepoint [67] 0 0
Parent study baseline to Week 48
Secondary outcome [68] 0 0
Non-responders from parent studies: Proportion of participants with = 4 points reduction in DLQI from parent study baseline among the participants with DLQI =4 at parent study baseline
Timepoint [68] 0 0
Up to Week 48
Secondary outcome [69] 0 0
Non-responders from parent studies: Proportion of participants with HADS-D <8 among the participants who had HADS-D =8 at parent study baseline
Timepoint [69] 0 0
Up to Week 48
Secondary outcome [70] 0 0
Non-responders from parent studies: Proportion of participants with HADS-A <8 among the participants who had HADS-A =8 at parent study baseline
Timepoint [70] 0 0
Up to Week 48
Secondary outcome [71] 0 0
All participants: Percentage of participants who experienced Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs) and/or Treatment-Emergent Adverse Events of Special Interest (AESI)
Timepoint [71] 0 0
Up to week 64
Secondary outcome [72] 0 0
All participants: Serum amlitelimab concentrations measured at prespecified timepoints
Timepoint [72] 0 0
Up to Week 64
Secondary outcome [73] 0 0
All participants: Incidence of antidrug antibodies (ADAs) of amlitelimab
Timepoint [73] 0 0
Up to Week 64

Eligibility
Key inclusion criteria
* Participants must be at least 12 years of age inclusive, at the time the informed consent is signed.
* Must have participated, received study treatment without permanent investigational medicinal product (IMP) discontinuation, and adequately completed the assessments required for the treatment period in one of the three 24-week parent studies EFC17559 (COAST-1), EFC17560 (COAST-2) or EFC17561 (SHORE) for moderate-to-severe AD.
* Able and willing to comply with requested study visit and procedures.
* Body weight must be = 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:

* Developed a medical condition that would preclude participation as described in Permanent Discontinuation of EFC17559 (COAST-1)/EFC17560 (COAST-2)/EFC17561 (SHORE) clinical trial protocols.
* Having received any prohibited medication or procedure for AD that resulted in IMP discontinuation in the parent study EFC17559 (COAST-1), EFC17560 (COAST-2) or EFC17561 (SHORE).
* Participants who, during their participation in the parent study EFC17559 (COAST-1) /EFC17560 (COAST-2)/EFC17561 (SHORE), developed an adverse event (AE) or a serious adverse event (SAE) deemed related to amlitelimab, which in the opinion of the Investigator could indicate that continued treatment with amlitelimab may present an unreasonable risk for the participant.
* Participants who have had IMP permanently discontinued for any reason before or at the time of the planned first dose in the EFC17600 (ESTUARY) study.
* Conditions in the parent study EFC17559 (COAST-1)/EFC17560 (COAST-2)/EFC17561 (SHORE) that led to Investigator - or Sponsor-initiated withdrawal of participant from the study (eg, non-compliance, inability to complete study assessments, etc.).
* Participant not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions, or participants potentially at risk of noncompliance to study procedures.

The above information is not intended to contain all considerations relevant to a patient's 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
8/05/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
5/01/2027
Actual
Sample size
Target
961
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Investigational Site Number : 0360010 - Westmead
Recruitment hospital [2] 0 0
Investigational Site Number : 0360006 - Melbourne
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment postcode(s) [2] 0 0
3004 - 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
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
Kentucky
Country [5] 0 0
United States of America
State/province [5] 0 0
Massachusetts
Country [6] 0 0
United States of America
State/province [6] 0 0
Michigan
Country [7] 0 0
United States of America
State/province [7] 0 0
Mississippi
Country [8] 0 0
United States of America
State/province [8] 0 0
New York
Country [9] 0 0
United States of America
State/province [9] 0 0
Oregon
Country [10] 0 0
United States of America
State/province [10] 0 0
Pennsylvania
Country [11] 0 0
United States of America
State/province [11] 0 0
South Dakota
Country [12] 0 0
United States of America
State/province [12] 0 0
Texas
Country [13] 0 0
United States of America
State/province [13] 0 0
Virginia
Country [14] 0 0
Canada
State/province [14] 0 0
Alberta
Country [15] 0 0
Canada
State/province [15] 0 0
British Columbia
Country [16] 0 0
Canada
State/province [16] 0 0
Manitoba
Country [17] 0 0
Canada
State/province [17] 0 0
Ontario
Country [18] 0 0
Canada
State/province [18] 0 0
Saskatchewan
Country [19] 0 0
Canada
State/province [19] 0 0
Quebec
Country [20] 0 0
Chile
State/province [20] 0 0
Reg Metropolitana De Santiago
Country [21] 0 0
Japan
State/province [21] 0 0
Kagoshima
Country [22] 0 0
Japan
State/province [22] 0 0
Kanagawa
Country [23] 0 0
Japan
State/province [23] 0 0
Tokyo
Country [24] 0 0
Japan
State/province [24] 0 0
Yokohama-shi
Country [25] 0 0
Korea, Republic of
State/province [25] 0 0
Gyeonggi-do
Country [26] 0 0
Korea, Republic of
State/province [26] 0 0
Gyeongsangnam-do
Country [27] 0 0
Korea, Republic of
State/province [27] 0 0
Seoul-teukbyeolsi

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

No information has been provided regarding IPD availability


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/NCT06407934