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Clinical Trials in the UK / NCT05769777
Active, not recruiting Phase 2

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

NCT05769777 · tracked via the Priya Life Science UK tracker
Sponsor
Sanofi
Phase
Phase 2
Started
2023-04-03
Last updated
2026-04-23

Condition(s) studied

Dermatitis Atopic

Investigational drug(s) / intervention(s)

Amlitelimab

Amlitelimab: Pharmaceutical form: Solution for injection; Route of administration: Subcutaneous (SC)

Study 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 284 weeks, including:

* A screening period of up to 2 to 4 weeks
* An open label treatment period of up to 268 weeks (approximately 5 years)
* A post-treatment safety follow-up period of at least 20 weeks after the last dose administration (last IMP administration at Week 264)

The planned number of visits will be 35 visits.

Eligibility

Sex
ALL
Min age
12 Years
Max age
Healthy volunteers
No
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 inadequate response (including inadequate efficacy or medical inadvisability) to topical treatments and/or inadequate response to systemic therapies (within 12 months prior to screening visit). * 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. * Body weight must be greater than or equal to 25 kg. * 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. 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 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, hematology, coagulation, 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.

Primary outcome measure(s)

Trial sites (174)

FacilityCityRegionStatus
Allervie Clinical Research - Birmingham- Site Number : 8400050 Birmingham Alabama
Research Solutions of Arizona- Site Number : 8400020 Litchfield Park Arizona
Dermatology Trial Associates- Site Number : 8400027 Bryant Arkansas
University Dermatology Trials- Site Number : 8400052 Newport Beach California
Children's Hospital Colorado - Aurora- Site Number : 8400041 Aurora Colorado
IMMUNOe International Research Centers - Centennial- Site Number : 8400024 Centennial Colorado
Renaissance Research and Medical Group- Site Number : 8400006 Cape Coral Florida
Florida Pharmaceutical Research and Associates- Site Number : 8400018 Miami Florida
Miami Clinical Research Tower- Site Number : 8400036 Miami Florida
Florida Research Center- Site Number : 8400011 Miami Florida
Clinical Research Trials of Florida- Site Number : 8400054 Tampa Florida
Advanced Medical Research - Atlanta- Site Number : 8400044 Atlanta Georgia
Georgia Skin & Cancer Clinic- Site Number : 8400048 Savannah Georgia
Sneeze Wheeze & Itch Associates- Site Number : 8400002 Normal Illinois
Kentucky Advanced Medical Research- Site Number : 8400014 Murray Kentucky
The Derm Institute of West Michigan- Site Number : 8400043 Caledonia Michigan
Michigan Dermatology Institute - Livonia- Site Number : 8401010 Livonia Michigan
Michigan Dermatology Institute - Waterford- Site Number : 8400010 Waterford Michigan
Dermatology Research Center of Oklahoma- Site Number : 8400035 Tulsa Oklahoma
The Children's Hospital of Philadelphia- Site Number : 8400009 Philadelphia Pennsylvania
Texas Dermatology and Laser Specialists - San Antonio - Oakwell Court- Site Number : 8400053 San Antonio Texas
Private Practice - Dr. Marthe N. Dika- Site Number : 8400022 Burlington Wisconsin
Investigational Site Number : 0320022 General Pico La Pampa Province
Investigational Site Number : 0320006 Rosario Santa Fe Province
Investigational Site Number : 0320007 Rosario Santa Fe Province
Investigational Site Number : 0320008 Buenos Aires Argentina
Investigational Site Number : 0320001 Buenos Aires Argentina
Investigational Site Number : 0320003 Buenos Aires Argentina
Investigational Site Number : 0320002 Buenos Aires Argentina
Investigational Site Number : 0320004 Buenos Aires Argentina
Investigational Site Number : 0320009 Buenos Aires Argentina
Investigational Site Number : 0320005 Buenos Aires Argentina
Investigational Site Number : 0360002 Kogarah New South Wales
Investigational Site Number : 0360001 Sydney New South Wales
Centro de Pesquisas da Clínica IBIS- Site Number : 0760002 Salvador Estado de Bahia
Hospital de Clinicas da Universidade Federal do Parana- Site Number : 0760022 Curitiba Paraná
Pontifica Universidade Catolica do Parana- Site Number : 0760023 Curitiba Paraná
Irmandade da Santa Casa de Misericórdia de Porto Alegre- Site Number : 0760005 Porto Alegre Rio Grande do Sul
Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto- Site Number : 0760008 Ribeirão Preto São Paulo
Faculdade de Medicina do ABC- Site Number : 0760001 Santo André São Paulo

+ 134 more sites — see the full list on the official registry below.

More Sanofi trials in the UK

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05769777 on ClinicalTrials.gov ↗ ← All trials in the UK