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ACTIVE NOT RECRUITING

NCT05769777

PHASE2

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

Sponsor: Sanofi

View on ClinicalTrials.gov

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.

Official 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

Key Details

Gender

All

Age Range

12 Years - Any

Study Type

INTERVENTIONAL

Enrollment

999

Start Date

2023-04-03

Completion Date

2031-06-11

Last Updated

2026-04-23

Healthy Volunteers

Conditions

Dermatitis Atopic

Interventions

DRUG

Amlitelimab

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

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.

Locations (174)

Allervie Clinical Research - Birmingham- Site Number : 8400050

Birmingham, Alabama, United States

Research Solutions of Arizona- Site Number : 8400020

Litchfield Park, Arizona, United States

Dermatology Trial Associates- Site Number : 8400027

Bryant, Arkansas, United States

University Dermatology Trials- Site Number : 8400052

Newport Beach, California, United States

Children's Hospital Colorado - Aurora- Site Number : 8400041

Aurora, Colorado, United States

IMMUNOe International Research Centers - Centennial- Site Number : 8400024

Centennial, Colorado, United States

Renaissance Research and Medical Group- Site Number : 8400006

Cape Coral, Florida, United States

Florida Pharmaceutical Research and Associates- Site Number : 8400018

Miami, Florida, United States

Miami Clinical Research Tower- Site Number : 8400036

Miami, Florida, United States

Florida Research Center- Site Number : 8400011

Miami, Florida, United States

Clinical Research Trials of Florida- Site Number : 8400054

Tampa, Florida, United States

Advanced Medical Research - Atlanta- Site Number : 8400044

Atlanta, Georgia, United States

Georgia Skin & Cancer Clinic- Site Number : 8400048

Savannah, Georgia, United States

Sneeze Wheeze & Itch Associates- Site Number : 8400002

Normal, Illinois, United States

Kentucky Advanced Medical Research- Site Number : 8400014

Murray, Kentucky, United States

The Derm Institute of West Michigan- Site Number : 8400043

Caledonia, Michigan, United States

Michigan Dermatology Institute - Livonia- Site Number : 8401010

Livonia, Michigan, United States

Michigan Dermatology Institute - Waterford- Site Number : 8400010

Waterford, Michigan, United States

Dermatology Research Center of Oklahoma- Site Number : 8400035

Tulsa, Oklahoma, United States

The Children's Hospital of Philadelphia- Site Number : 8400009

Philadelphia, Pennsylvania, United States

Texas Dermatology and Laser Specialists - San Antonio - Oakwell Court- Site Number : 8400053

San Antonio, Texas, United States

Private Practice - Dr. Marthe N. Dika- Site Number : 8400022

Burlington, Wisconsin, United States

Investigational Site Number : 0320022

General Pico, La Pampa Province, Argentina

Investigational Site Number : 0320006

Rosario, Santa Fe Province, Argentina

Investigational Site Number : 0320007

Rosario, Santa Fe Province, Argentina

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, Australia

Investigational Site Number : 0360001

Sydney, New South Wales, Australia

Centro de Pesquisas da Clínica IBIS- Site Number : 0760002

Salvador, Estado de Bahia, Brazil

Hospital de Clinicas da Universidade Federal do Parana- Site Number : 0760022

Curitiba, Paraná, Brazil

Pontifica Universidade Catolica do Parana- Site Number : 0760023

Curitiba, Paraná, Brazil

Irmandade da Santa Casa de Misericórdia de Porto Alegre- Site Number : 0760005

Porto Alegre, Rio Grande do Sul, Brazil

Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto- Site Number : 0760008

Ribeirão Preto, São Paulo, Brazil

Faculdade de Medicina do ABC- Site Number : 0760001

Santo André, São Paulo, Brazil

Fundação Faculdade Regional de Medicina de São José do Rio Preto- Site Number : 0760003

São José do Rio Preto, São Paulo, Brazil

Clinica de Alergia Martti Antila- Site Number : 0760006

Sorocaba, São Paulo, Brazil

IDERJ - Instituto de Dermatologia e Estética do Brasil- Site Number : 0760004

Rio de Janeiro, Brazil

Investigational Site Number : 1240001

Calgary, Alberta, Canada

Investigational Site Number : 1240051

Vancouver, British Columbia, Canada

Investigational Site Number : 1240009

Etobicoke, Ontario, Canada

Investigational Site Number : 1240008

Mississauga, Ontario, Canada

Investigational Site Number : 1240011

Oakville, Ontario, Canada

Investigational Site Number : 1240004

Peterborough, Ontario, Canada

Investigational Site Number : 1240003

Richmond Hill, Ontario, Canada

Investigational Site Number : 1240012

Toronto, Ontario, Canada

Investigational Site Number : 1240002

Montreal, Quebec, Canada

Investigational Site Number : 1240010

Québec, Quebec, Canada

Investigational Site Number : 1240006

Québec, Quebec, Canada

Investigational Site Number : 1240044

Saskatoon, Saskatchewan, Canada

Investigational Site Number : 1520009

Osorno, Los Lagos Region, Chile

Investigational Site Number : 1520004

Valdivia, Los Ríos Region, Chile

Investigational Site Number : 1520013

Lo Barnechea, Reg Metropolitana de Santiago, Chile

Investigational Site Number : 1520011