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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05769777




Registration number
NCT05769777
Ethics application status
Date submitted
3/03/2023
Date registered
15/03/2023
Date last updated
21/11/2024

Titles & IDs
Public title
Open Label, Long-term Study Evaluating Safety and Efficacy of Subcutaneous Amlitelimab in Participants Aged 12 Years and Older With Moderate to Severe Atopic Dermatitis
Scientific title
An Open-Label Multinational, Multicenter Study to Evaluate the Long-term Safety, Tolerability and Efficacy of Subcutaneous Amlitelimab in Participants Aged 12 Years and Older With Moderate to Severe Atopic Dermatitis
Secondary ID [1] 0 0
U1111-1280-6080
Secondary ID [2] 0 0
LTS17789
Universal Trial Number (UTN)
Trial acronym
ATLANTIS
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

Experimental: Amlitelimab - Subcutaneous injection as per protocol


Treatment: Drugs: Amlitelimab
Pharmaceutical form: Solution for injection; Route of administration: Subcutaneous (SC)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of participants who experienced Treatment-Emergent Adverse Events (TEAEs)
Timepoint [1] 0 0
Baseline up to end of study (EOS) (Week 176)
Primary outcome [2] 0 0
Percentage of participants who experienced Treatment-Emergent Serious Adverse Events (TESAEs)
Timepoint [2] 0 0
Baseline up to EOS (Week 176)
Secondary outcome [1] 0 0
Percentage of participants who experienced Treatment-Emergent Adverse Events of Special Interest (AESI)
Timepoint [1] 0 0
Baseline up to EOS (Week 176)
Secondary outcome [2] 0 0
Percentage of participants with Potentially Clinically Significant Abnormalities (PCSA) for vital signs and clinical laboratory assessments, and electrocardiogram (ECG)
Timepoint [2] 0 0
Baseline up to EOS (Week 176)
Secondary outcome [3] 0 0
Percentage of participants discontinued from study treatment due to Adverse Events (AEs)
Timepoint [3] 0 0
Baseline up to EOS (Week 176)
Secondary outcome [4] 0 0
Percent change from baseline in Eczema Area and Severity Index (EASI) score
Timepoint [4] 0 0
Baseline to EOS (Week 176)
Secondary outcome [5] 0 0
Proportion of participants with at least a =75% reduction in EASI score (EASI-75) from baseline
Timepoint [5] 0 0
Baseline to EOS (Week 176)
Secondary outcome [6] 0 0
Proportion of participants with EASI-50 /EASI-90 /EASI-100
Timepoint [6] 0 0
Baseline to EOS (Week 176)
Secondary outcome [7] 0 0
Proportion of participants with Validated Investigator Global Assessment scale for Atopic Dermatitis (vIGA-AD) of 0 (clear) or 1 (almost clear) and a reduction of =2 points from baseline
Timepoint [7] 0 0
Baseline to EOS (Week 176)
Secondary outcome [8] 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) from baseline
Timepoint [8] 0 0
Baseline to EOS (Week 176)
Secondary outcome [9] 0 0
Change in percent Body Surface Area (BSA) affected by AD from baseline
Timepoint [9] 0 0
Baseline to EOS (Week 176)
Secondary outcome [10] 0 0
Percent change in Scoring Atopic Dermatitis (SCORAD) index from baseline
Timepoint [10] 0 0
Baseline to EOS (Week 176)
Secondary outcome [11] 0 0
Proportion of participants requiring rescue treatment at each visit
Timepoint [11] 0 0
Baseline to EOS (Week 176)
Secondary outcome [12] 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 [12] 0 0
Baseline to EOS (Week 176)
Secondary outcome [13] 0 0
Percent change in weekly average of daily PP-NRS from baseline
Timepoint [13] 0 0
Baseline to EOS (Week 176)
Secondary outcome [14] 0 0
Change in weekly average of daily Skin Pain-Numerical Rating Scale (SP-NRS) from baseline
Timepoint [14] 0 0
Baseline to EOS (Week 176)
Secondary outcome [15] 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 [15] 0 0
Baseline to EOS (Week 176)
Secondary outcome [16] 0 0
Change in weekly average of daily Sleep Disturbance-Numerical Rating Scale (SD-NRS) from baseline
Timepoint [16] 0 0
Baseline to EOS (Week 176)
Secondary outcome [17] 0 0
Proportion of participants with a reduction in weekly average of daily SD-NRS =2 from baseline in participants with Baseline weekly average of daily SDNRS =2
Timepoint [17] 0 0
Baseline to EOS (Week 176)
Secondary outcome [18] 0 0
Change in Patient Oriented Eczema Measure (POEM) from baseline
Timepoint [18] 0 0
Baseline to EOS (Week 176)
Secondary outcome [19] 0 0
Proportion of participants with a reduction in POEM =4 from Baseline in participants with POEM baseline =4
Timepoint [19] 0 0
Baseline to EOS (Week 176)
Secondary outcome [20] 0 0
Proportion of adolescent participants with a reduction in POEM =6 from Baseline in adolescents participants with POEM baseline =6
Timepoint [20] 0 0
Baseline to EOS (Week 176)
Secondary outcome [21] 0 0
Change in Atopic Dermatitis Control Test (ADCT) from baseline
Timepoint [21] 0 0
Baseline to EOS (Week 176)
Secondary outcome [22] 0 0
Proportion of participants with a reduction in ADCT =5 from baseline in participants with baseline ADCT=5
Timepoint [22] 0 0
Baseline to EOS (Week 176)
Secondary outcome [23] 0 0
Change in Dermatology Quality of Life Index (DLQI) from baseline in participants with age =16 years old
Timepoint [23] 0 0
Baseline to EOS (Week 176)
Secondary outcome [24] 0 0
Change in Children's Dermatology Life Quality Index (CDLQI) from baseline in participants with age =12 to <16 years old
Timepoint [24] 0 0
Baseline to EOS (Week 176)
Secondary outcome [25] 0 0
Proportion of participants with age =12 to <16 with a reduction in CDLQI =4 from Baseline in participants with age =12 to <16 with CDLQI at baseline =4
Timepoint [25] 0 0
Baseline to EOS (Week 176)
Secondary outcome [26] 0 0
Proportion of participants with a reduction in DLQI =4 from Baseline in participants with age =16 years old and with DLQI at baseline =4
Timepoint [26] 0 0
Baseline to EOS (Week 176)
Secondary outcome [27] 0 0
Change in Patient Global Impression of Severity (PGIS) from baseline
Timepoint [27] 0 0
Baseline to EOS (Week 176)
Secondary outcome [28] 0 0
Proportions of participants who report symptoms to be "No" on the PGIS score
Timepoint [28] 0 0
Baseline to EOS (Week 176)
Secondary outcome [29] 0 0
Proportions of participants who report symptoms to be "No" or "Mild" on the PGIS score
Timepoint [29] 0 0
Baseline to EOS (Week 176)
Secondary outcome [30] 0 0
Proportion of participants who respond "Much better" on the Patient Global Impression of (PGIC) scale
Timepoint [30] 0 0
Week 16 to EOS (Week 176)
Secondary outcome [31] 0 0
Proportion of participants who respond "Much better" or "A little better" on the PGIC scale
Timepoint [31] 0 0
Week 16 to EOS (Week 176)
Secondary outcome [32] 0 0
Proportion of participants by PGIC responses
Timepoint [32] 0 0
Week 16 to EOS (Week 176)
Secondary outcome [33] 0 0
Change in Hospital Anxiety Depression Scale (HADS) from baseline
Timepoint [33] 0 0
Baseline to EOS (Week 176)
Secondary outcome [34] 0 0
Proportion of participants with HADS subscale Anxiety (HADS-A) <8 in participants with baseline HADS-A =8
Timepoint [34] 0 0
Baseline to EOS (Week 176)
Secondary outcome [35] 0 0
Proportion of participants with HADS subscale Depression (HADS-D) <8 in participants with HADS-D Baseline =8
Timepoint [35] 0 0
Baseline to EOS (Week 176)

Eligibility
Key inclusion criteria
* Participant must be at least 12 years of age inclusive, at the time of signing the informed consent.
* Participants must have AD as defined by the American Academy of Dermatology Consensus Criteria for 1 year or longer at baseline.
* Participant must have documented history within 6 months prior to screening visit, of either inadequate response or inadvisability of topical treatments.
* Eczema Area Severity Index (EASI) of 16 or higher at baseline visit/Visit 2.
* Validated Investigator Global Assessment scale for atopic dermatitis (vIGA-AD) of 3 or 4 at baseline visit/Visit 2.
* AD involvement of 10% or more of body surface area (BSA) at baseline visit/Visit 2.
* Weekly average of daily Peak Pruritus-Numerical Rating Scale (PP-NRS) of = 4 at baseline visit/Visit 2.
* Able and willing to comply with requested study visits and procedures.
* Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Female participants must not be pregnant or breastfeeding.
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 as per investigator's judgement
* Known history of or suspected significant current immunosuppression, including history of invasive opportunistic or helminthic infections despite infection resolution or otherwise recurrent infections of abnormal frequency or prolonged duration.
* Any malignancies or history of malignancies prior to baseline (except for non-melanoma skin cancer that has been excised and completely cured for more than 5 years prior to baseline).
* History of solid organ or stem cell transplant.
* Any pre-planned major elective surgery known about at baseline that in the opinion of the investigator would necessitate that IMP be permanently discontinued or require more than three doses to be missed.
* Severe concomitant illness that would in the Investigator's opinion inhibit the participant's participation in the study.
* Any medical or psychiatric condition which, in the opinion of the Investigator may present an unreasonable risk to the study participants as a result of his/her participation in this clinical study, may make participant's participation unreliable, or may interfere with study assessments.
* 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); and any infection (including confirmed Covid-19 infection at screening or baseline) which as per Investigator's opinion precludes the participant's participation in the study.
* Treatment with live (attenuated) vaccines within 12 weeks prior to baseline; failure to complete non-live immunizations required by local regulation (eg, vaccination for COVID-19) at least 14 days prior to baseline.
* Having received any of the specified therapy within the specified timeframe(s) prior to the baseline visit.
* Positive for human immunodeficiency virus (HIV), hepatitis B or hepatitis C at the screening visit.
* Participants with active tuberculosis (TB), latent TB, a history of incompletely treated TB, suspected extrapulmonary TB infection, non-TB mycobacterial infection, or who are at high risk of contracting TB (such as close contact with individuals with active or latent TB) or received Bacillus Calmette-Guérin (BCG)-vaccination within 12 weeks prior to Screening.
* In the Investigator's opinion, any clinically significant laboratory results from the clinical chemistry, haematology or urinalysis tests at the screening visit.
* In the Investigator's opinion, any significant abnormality on 12-lead electrocardiogram (ECG) at the screening visit that could be suggestive of an unstable or underlying cardio-vascular condition that could preclude the participant's participation in the study.
* History of hypersensitivity or allergy to any of the excipients or IMP or other allergy that, in the opinion of the Investigator, contraindicates participation in the study.

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

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
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 2
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
3/04/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
9/10/2028
Actual
Sample size
Target
901
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Investigational Site Number : 0360001 - Sydney
Recruitment postcode(s) [1] 0 0
2010 - Sydney
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arkansas
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Michigan
Country [4] 0 0
United States of America
State/province [4] 0 0
New York
Country [5] 0 0
Argentina
State/province [5] 0 0
Ciudad De Buenos Aires
Country [6] 0 0
Argentina
State/province [6] 0 0
La Pampa
Country [7] 0 0
Argentina
State/province [7] 0 0
Santa Fe
Country [8] 0 0
Argentina
State/province [8] 0 0
Buenos Aires
Country [9] 0 0
Brazil
State/province [9] 0 0
Bahia
Country [10] 0 0
Brazil
State/province [10] 0 0
Paraná
Country [11] 0 0
Brazil
State/province [11] 0 0
Rio Grande Do Sul
Country [12] 0 0
Brazil
State/province [12] 0 0
São Paulo
Country [13] 0 0
Brazil
State/province [13] 0 0
Rio de Janeiro
Country [14] 0 0
Canada
State/province [14] 0 0
Alberta
Country [15] 0 0
Canada
State/province [15] 0 0
Ontario
Country [16] 0 0
Canada
State/province [16] 0 0
Quebec
Country [17] 0 0
Canada
State/province [17] 0 0
Saskatchewan
Country [18] 0 0
Canada
State/province [18] 0 0
Richmond Hill
Country [19] 0 0
Chile
State/province [19] 0 0
Los Lagos
Country [20] 0 0
Chile
State/province [20] 0 0
Los Ríos
Country [21] 0 0
Chile
State/province [21] 0 0
Reg Metropolitana De Santiago
Country [22] 0 0
China
State/province [22] 0 0
Changchun
Country [23] 0 0
China
State/province [23] 0 0
Changsha
Country [24] 0 0
China
State/province [24] 0 0
Chengdu
Country [25] 0 0
China
State/province [25] 0 0
Hangzhou
Country [26] 0 0
China
State/province [26] 0 0
Jingzhou
Country [27] 0 0
China
State/province [27] 0 0
Shanghai
Country [28] 0 0
China
State/province [28] 0 0
Suzhou
Country [29] 0 0
China
State/province [29] 0 0
Taiyuan
Country [30] 0 0
China
State/province [30] 0 0
Xinxiang
Country [31] 0 0
China
State/province [31] 0 0
Yinchuan
Country [32] 0 0
China
State/province [32] 0 0
Zhenjiang
Country [33] 0 0
Czechia
State/province [33] 0 0
Nový Jicín
Country [34] 0 0
Czechia
State/province [34] 0 0
Ostrava
Country [35] 0 0
Czechia
State/province [35] 0 0
Prague
Country [36] 0 0
Denmark
State/province [36] 0 0
Aarhus
Country [37] 0 0
France
State/province [37] 0 0
Créteil
Country [38] 0 0
France
State/province [38] 0 0
Lille
Country [39] 0 0
France
State/province [39] 0 0
Marseille
Country [40] 0 0
France
State/province [40] 0 0
Paris
Country [41] 0 0
France
State/province [41] 0 0
Pierre-bénite
Country [42] 0 0
France
State/province [42] 0 0
Toulouse
Country [43] 0 0
Germany
State/province [43] 0 0
Bad Bentheim
Country [44] 0 0
Germany
State/province [44] 0 0
Berlin
Country [45] 0 0
Germany
State/province [45] 0 0
Münster
Country [46] 0 0
Germany
State/province [46] 0 0
Osnabrück
Country [47] 0 0
India
State/province [47] 0 0
Bikaner
Country [48] 0 0
India
State/province [48] 0 0
Gurgaon
Country [49] 0 0
India
State/province [49] 0 0
Kolkata
Country [50] 0 0
India
State/province [50] 0 0
Mangaluru
Country [51] 0 0
India
State/province [51] 0 0
Nashik
Country [52] 0 0
India
State/province [52] 0 0
Surat
Country [53] 0 0
Italy
State/province [53] 0 0
Lombardia
Country [54] 0 0
Italy
State/province [54] 0 0
Napoli
Country [55] 0 0
Italy
State/province [55] 0 0
Roma
Country [56] 0 0
Italy
State/province [56] 0 0
Brescia
Country [57] 0 0
Japan
State/province [57] 0 0
Hokkaido
Country [58] 0 0
Japan
State/province [58] 0 0
Osaka
Country [59] 0 0
Japan
State/province [59] 0 0
Tochigi
Country [60] 0 0
Japan
State/province [60] 0 0
Tokyo
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
Gyeongsangnam-do
Country [64] 0 0
Korea, Republic of
State/province [64] 0 0
Incheon-gwangyeoksi
Country [65] 0 0
Korea, Republic of
State/province [65] 0 0
Seoul-teukbyeolsi
Country [66] 0 0
Korea, Republic of
State/province [66] 0 0
Seoul
Country [67] 0 0
Netherlands
State/province [67] 0 0
Breda
Country [68] 0 0
Netherlands
State/province [68] 0 0
Rotterdam
Country [69] 0 0
Netherlands
State/province [69] 0 0
Utrecht
Country [70] 0 0
Poland
State/province [70] 0 0
Pomorskie
Country [71] 0 0
Poland
State/province [71] 0 0
Slaskie
Country [72] 0 0
Poland
State/province [72] 0 0
Chorzow
Country [73] 0 0
Poland
State/province [73] 0 0
Warsaw
Country [74] 0 0
South Africa
State/province [74] 0 0
Boksburg
Country [75] 0 0
South Africa
State/province [75] 0 0
Cape Town
Country [76] 0 0
South Africa
State/province [76] 0 0
Durban
Country [77] 0 0
South Africa
State/province [77] 0 0
Johannesburg
Country [78] 0 0
South Africa
State/province [78] 0 0
Middelburg
Country [79] 0 0
South Africa
State/province [79] 0 0
Pretoria
Country [80] 0 0
Spain
State/province [80] 0 0
Catalunya [Cataluña]
Country [81] 0 0
Spain
State/province [81] 0 0
Madrid, Comunidad De
Country [82] 0 0
Spain
State/province [82] 0 0
Alicante
Country [83] 0 0
Spain
State/province [83] 0 0
Córdoba
Country [84] 0 0
Spain
State/province [84] 0 0
Valencia
Country [85] 0 0
Taiwan
State/province [85] 0 0
Hsinchu
Country [86] 0 0
Taiwan
State/province [86] 0 0
Kaohsiung City
Country [87] 0 0
Taiwan
State/province [87] 0 0
New Taipei City
Country [88] 0 0
Taiwan
State/province [88] 0 0
Taichung
Country [89] 0 0
Taiwan
State/province [89] 0 0
Taipei City
Country [90] 0 0
Taiwan
State/province [90] 0 0
Taoyuan City
Country [91] 0 0
United Kingdom
State/province [91] 0 0
London, City Of
Country [92] 0 0
United Kingdom
State/province [92] 0 0
Edinburgh
Country [93] 0 0
United Kingdom
State/province [93] 0 0
Sheffield

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

Ethics approval
Ethics application status

Summary
Brief summary
This is a single group, 1-arm, long-term safety study for treatment of participants with moderate to severe atopic dermatitis (AD).

The purpose of this study is to characterize the long-term safety and efficacy of amlitelimab in treated participants with age =12 years old with moderate to severe AD.

The study duration per participant will be up to 180 weeks, including:

* A screening period of up to 2 to 4 weeks
* An open label treatment period of up to 160 weeks (approximately 3 years)
* A post-treatment safety follow-up period of at least 20 weeks after the last dose administration

The planned number of visits will be 26 visits.
Trial website
https://clinicaltrials.gov/study/NCT05769777
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 number 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/NCT05769777