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ENROLLING BY INVITATION

NCT05492578

PHASE2/PHASE3

Long-Term Safety and Efficacy Evaluation of Amlitelimab in Participants of Previous Amlitelimab Moderate to Severe Atopic Dermatitis Clinical Trials

Sponsor: Sanofi

View on ClinicalTrials.gov

Summary

This is an open-label, Phase 2/Phase 3, long-term extension study for treatment of participants of previous amlitelimab clinical trials in moderate to severe atopic dermatitis. The purpose of this study is to characterize the safety and efficacy of amlitelimab in treated participants with moderate to severe atopic dermatitis (AD) who have previously been enrolled in an amlitelimab clinical trial. All participants will have visits during the treatment period every 4 weeks. Responder participants rolling over from EFC17599 and EFC17600, and responder participants enrolling through screening from DRI17366 will be initiated into drug withdrawal (with no drug administration) at LTS17367 baseline visit to monitor durability of treatment response. If these responder participants relapse during LTS17367, they will have treatment restored. Non-responder participants rolling over from EFC17599 or EFC17600, and non-responder participants enrolling through screening from DRI17366 will have treatment administration from LTS17367 baseline. Participants rolling over from DRI17366, SFY17915 and INT18404 will also have treatment administration from LTS17367 baseline. Remote visits with home dosing are allowed for the purpose of study drug administration, when applicable. In the case of remote visit with home dosing, the participant or a caregiver may administer study drug after appropriate training. Alternatively, if needed, and based on the investigator's judgement, home visits with healthcare professional assistance or on-site study drug administration visits can be performed. Where participants discontinue amlitelimab permanently during LTS17367, safety follow up will be performed for a minimum of 140 days from the last amlitelimab administration.

Official title: A Long-term Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of Subcutaneous Amlitelimab in Participants of Previous Amlitelimab Clinical Trials in Moderate to Severe Atopic Dermatitis.

Key Details

Gender

All

Age Range

12 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1663

Start Date

2022-08-22

Completion Date

2029-01-22

Last Updated

2026-03-19

Healthy Volunteers

Conditions

Dermatitis Atopic

Interventions

DRUG

Amlitelimab

Pharmaceutical form: Solution for injection Route of administration: Subcutaneous

DRUG

Topical corticosteroids

Pharmaceutical form: Topical Route of administration: Topical

DRUG

Topical calcineurin inhibitors

Pharmaceutical form: Topical Route of administration: Topical

DRUG

Oral corticosteroids

Pharmaceutical form: Oral Route of administration: Oral

Inclusion Criteria: * Participant must be at least 12 years of age inclusive at the time of signing the informed consent. * Participated in an amlitelimab clinical trial for moderate to severe AD and received study treatment, adequately completed the assessments required for the treatment period. * Have reached the rollover timepoint to LTS17367 at the last visit of the treatment period of their feeder study SFY17915, INT18404, EFC17599, or EFC17600 * Participants in DRI17366 must only be enrolled from 1 of the following 3 groups: * The first group: participants at Week 24 in the DRI17336 study who have not achieved an ≥ Eczema Area and Skin Severity Index (EASI)-75 and are Investigator Global Assessment (IGA) ≥ 2. * The second group: participants entering LTS17367 between Week 28 and Week 52 of the feeder study, due to loss of clinical response in the part 2 of the feeder study. Timepoints for entering LTS17367 are Weeks 28, 32, 36, 40, 44, 48 or 52. * The third group: participants at Week 24 in DRI17366 who have been re-randomized and who subsequently complete the study to Week 52, enter safety follow-up and experience worsening of their AD during safety follow-up. * Participated in DRI17366 completing the previous study safety follow up (Week 68) and wish to re-initiate treatment with amlitelimab up to one year after the last visit * Complied with the previous clinical trial protocol to the satisfaction of the investigator * Body weight must be ≥25 kg * Provided signed informed assent/or consent and able to comply with the requirements of the protocol 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 the section for permanent discontinuation of the feeder study or LTS17367 protocol * Known history of or suspected current significant immunosuppression, including history of invasive opportunistic infections or helminthic infections despite infection resolution or otherwise recurrent infections of abnormal frequency or prolonged duration * History of solid organ or stem cell transplant * 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) * Participants positive for human immunodeficiency virus (HIV); participants with any of the following results at Screening (Visit 1) or at any point during the feeder study: presence of HBsAg with or without HBV DNA PCR test, or presence of anti-HBc Ab or presence of anti-HBs Ab with positive HBV DNA PCR test; positive HCVAb confirmed by positive HCV RNA PCR test * History (within last 2 years prior to baseline) of prescription drug or substance abuse, including alcohol, considered significant by the Investigator * Participants with active 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 * Participants with an indeterminate or a confirmed positive IGRA test are excluded from the study unless all of the following conditions are met: 1. Have a history of prior documented completed chemoprophylaxis for latent TB infection (with a treatment regimen as per local guidelines), OR treated for active TB infection 2. Have been in written form approved for participation in the present trial by a TB specialist who ruled out latent or active TB infection or other mycobacterial infection in the participant 3. For whom review and approval from Sponsor have been granted are eligible * Severe concomitant illness that would in the Investigator's opinion inhibit the participant's participation in the study, including for example, but not limited to, hypertension, renal disease, neurological conditions, heart failure and pulmonary disease * Skin co-morbidity that would adversely affect the ability to undertake AD assessments (e.g., psoriasis, tinea corporis, lupus erythematosus) as per Investigator's judgment * Any medical condition which, in the opinion of the Investigator may present an unreasonable risk to the study participant as a result of his/her participation in this clinical study, may make participant's participation unreliable, or may interfere with study assessments * In the Investigator's opinion, medical conditions related to prior AD medications that have not healed/fully recovered for more than 2 weeks before screening visit, including, but not limited to, conjunctivitis, keratitis, eosinophilic conditions, arthralgia, herpes zoster, thrombosis The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Locations (353)

Allervie Clinical Research - Birmingham- Site Number : 8401101

Birmingham, Alabama, United States

Cahaba Dermatology & Skin Health Center- Site Number : 8401066

Birmingham, Alabama, United States

Center for Dermatology and Plastic Surgery- Site Number : 8401119

Scottsdale, Arizona, United States

Scottsdale Clinical Trials- Site Number : 8401149

Scottsdale, Arizona, United States

Arkansas Research Trials- Site Number : 8401244

North Little Rock, Arkansas, United States

Orange County Clinical Trials- Site Number : 8401271

Anaheim, California, United States

Encino Research Center- Site Number : 8401042

Encino, California, United States

First OC Dermatology- Site Number : 8401025

Fountain Valley, California, United States

Center for Dermatology Clinical Research- Site Number : 8401018

Fremont, California, United States

Marvel Clinical Research- Site Number : 8401102

Huntington Beach, California, United States

Sunwise Clinical Research- Site Number : 8401022

Lafayette, California, United States

Antelope Valley Clinical Trials- Site Number : 8401099

Lancaster, California, United States

Torrance Clinical Research - Narbonne Avenue- Site Number : 8401027

Lomita, California, United States

Long Beach Clinical Trials- Site Number : 8401188

Long Beach, California, United States

Dermatology Research Associates - Los Angeles- Site Number : 8401092

Los Angeles, California, United States

LA Universal Research Center- Site Number : 8401064

Los Angeles, California, United States

Cura Clinical Research - Oxnard- Site Number : 8401142

Oxnard, California, United States

Southern California Dermatology- Site Number : 8401043

Santa Ana, California, United States

Clinical Science Institute- Site Number : 8401028

Santa Monica, California, United States

Paradigm Clinical Research - Wheat Ridge- Site Number : 8401245

Wheat Ridge, Colorado, United States

Encore Medical Research of Boynton Beach- Site Number : 8401030

Boynton Beach, Florida, United States

Pediatric Skin Research- Site Number : 8401198

Coral Gables, Florida, United States

St. Jude Clinical Research- Site Number : 8401287

Doral, Florida, United States

Alliance for Multispeciality Research - Fort Myers- Site Number : 8401111

Fort Myers, Florida, United States

Direct Helpers Research Center- Site Number : 8401056

Hialeah, Florida, United States

Doral Medical Research - Hialeah- Site Number : 8401094

Hialeah, Florida, United States

Apex Clinical Research - Jacksonville- Site Number : 8401332

Jacksonville, Florida, United States

Clever Medical Research- Site Number : 8401160

Miami, Florida, United States

Miami Dermatology and Laser Research - Miami - South Miami Avenue- Site Number : 8401086

Miami, Florida, United States

Medical Research Center of Miami II- Site Number : 8401019

Miami, Florida, United States

Acevedo Clinical Research Associates- Site Number : 8401088

Miami, Florida, United States

Future Care Solution - Miami- Site Number : 8401144

Miami, Florida, United States

Sanchez Clinical Research- Site Number : 8401095

Miami, Florida, United States

Florida International Research Center- Site Number : 8401091

Miami, Florida, United States

Savin Medical Group - Miami Lakes- Site Number : 8401085

Miami Lakes, Florida, United States

Wellness Clinical Research - Miami Lakes - 8181 Northwest 154th Street- Site Number : 8401109

Miami Lakes, Florida, United States

K2 South Orlando - South Orange Avenue- Site Number : 8401268

Orlando, Florida, United States

Nuline Clinical Trial Center- Site Number : 8401161

Pompano Beach, Florida, United States

Global Clinical Professionals (GCP)- Site Number : 8401045

St. Petersburg, Florida, United States

Clinical Research Trials of Florida- Site Number : 8401023

Tampa, Florida, United States

Alliance Clinical Research of Tampa- Site Number : 8401013

Tampa, Florida, United States

Cleaver Medical Group- Site Number : 8401138

Dawsonville, Georgia, United States

First Georgia Physician Group- Site Number : 8401190

Fayetteville, Georgia, United States

Aeroallergy Research Laboratory- Site Number : 8401004

Savannah, Georgia, United States

Northwestern University- Site Number : 8401038

Chicago, Illinois, United States

Equity Medical - Bowling Green- Site Number : 8401296

Bowling Green, Kentucky, United States

Skin Sciences- Site Number : 8401039

Louisville, Kentucky, United States

Velocity Clinical Research at The Dermatology Clinic - Baton Rouge- Site Number : 8401072

Baton Rouge, Louisiana, United States

MedPharmics - Covington- Site Number : 8401137

Covington, Louisiana, United States

BRCR Global Gretna- Site Number : 8401243

Gretna, Louisiana, United States

Velocity Clinical Research - Lafayette- Site Number : 8401152

Lafayette, Louisiana, United States

MetroBoston Clinical Partners - Brighton- Site Number : 8401128

Brighton, Massachusetts, United States

Henry Ford Health System- Site Number : 8401044

Detroit, Michigan, United States

Revival Research Institute - Troy- Site Number : 8401012

Troy, Michigan, United States

Oakland Medical Center- Site Number : 8401116

Troy, Michigan, United States

Allergy & Immunology Associates of Ann Arbor- Site Number : 8401078

Ypsilanti, Michigan, United States

SKY Integrative Medical Center/SKYCRNG - Ridgeland- Site Number : 8401058

Ridgeland, Mississippi, United States

Skin Specialists- Site Number : 8401068

Omaha, Nebraska, United States

Pulmonology Group - Henderson- Site Number : 8401169

Henderson, Nevada, United States

Jubilee Clinical Research- Site Number : 8401054

Las Vegas, Nevada, United States

Schweiger Dermatology Group - East Windsor- Site Number : 8401338

East Windsor, New Jersey, United States

Care Access - Hoboken- Site Number : 8401132

Hoboken, New Jersey, United States

The University of New Mexico- Site Number : 8401263

Albuquerque, New Mexico, United States

Equity Medical- Site Number : 8401239

New York, New York, United States

Sadick Research Group - New York - Park Avenue- Site Number : 8401050

New York, New York, United States

Skin Search Rochester- Site Number : 8401216

Rochester, New York, United States

AXIS Clinicals - Fargo- Site Number : 8401196

Fargo, North Dakota, United States

Oregon Health & Science University (OHSU)- Site Number : 8401247

Portland, Oregon, United States

Best Skin Research - Camp Hill- Site Number : 8401031

Camp Hill, Pennsylvania, United States

Paddington Testing Company- Site Number : 8401041

Philadelphia, Pennsylvania, United States

Clinical Research of Philadelphia- Site Number : 8401193

Philadelphia, Pennsylvania, United States

Dermatology Associates of Plymouth Meeting- Site Number : 8401147

Plymouth Meeting, Pennsylvania, United States

Velocity Clinical Research - Columbia- Site Number : 8401176

Columbia, South Carolina, United States

Columbia Dermatology & Aesthetics- Site Number : 8401166

Columbia, South Carolina, United States

Health Concepts - Site Number : 8401059

Rapid City, South Dakota, United States

Arlington Research Center- Site Number : 8401248

Arlington, Texas, United States

Modern Research Associates- Site Number : 8401093

Dallas, Texas, United States

Reveal Research Institute - Dallas- Site Number : 8401219

Dallas, Texas, United States

Prolato Clinical Research Center- Site Number : 8401209

Houston, Texas, United States

SMS Clinical Research- Site Number : 8401182

Mesquite, Texas, United States

Synapse Clinical Research - Missouri City- Site Number : 8401148

Missouri City, Texas, United States

Stryde Research - Epiphany Dermatology- Site Number : 8401185

Southlake, Texas, United States

Complete Dermatology - Sugar Land- Site Number : 8401061

Sugar Land, Texas, United States

Care Access - Arlington- Site Number : 8401134

Arlington, Virginia, United States

Virginia Dermatology & Skin Cancer Center- Site Number : 8401047

Norfolk, Virginia, United States

Wyoming Research Foundation- Site Number : 8401234

Cheyenne, Wyoming, United States

Investigational Site Number : 0320021

Berazategui, Buenos Aires, Argentina

Investigational Site Number : 0320006

Rosario, Santa Fe Province, Argentina

Investigational Site Number : 0320007

Rosario, Santa Fe Province, Argentina

Investigational Site Number : 0320015

Rosario, Santa Fe Province, Argentina

Investigational Site Number : 0320020

San Miguel de Tucumán, Tucumán Province, Argentina

Investigational Site Number : 0320011

Buenos Aires, Argentina

Investigational Site Number : 0320016

Buenos Aires, Argentina

Investigational Site Number : 0320008

Buenos Aires, Argentina

Investigational Site Number : 0320001

Buenos Aires, Argentina

Investigational Site Number : 0320018

Buenos Aires, Argentina

Investigational Site Number : 0320010

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 : 0320019

Buenos Aires, Argentina

Investigational Site Number : 0320005

Buenos Aires, Argentina

Investigational Site Number : 0320012

Corrientes, Argentina

Investigational Site Number : 0320014

Córdoba, Argentina

Investigational Site Number : 0320013

Mendoza, Argentina

Investigational Site Number : 0360010

Westmead, New South Wales, Australia

Investigational Site Number : 0360007

Woolloongabba, Queensland, Australia

Investigational Site Number : 0363002

Carlton, Victoria, Australia

Investigational Site Number : 0363003

Melbourne, Victoria, Australia

Investigational Site Number : 0360006

Melbourne, Victoria, Australia

Investigational Site Number : 0363001

Parkville, Victoria, Australia

Investigational Site Number : 0361006

Traralgon, Victoria, Australia

Centro de Diagnostico e Pesquisa da Osteoporose do Espirito Santo- Site Number : 0760017

Vitória, Espírito Santo, Brazil

Centro de Pesquisas da Clínica IBIS- Site Number : 0760002

Salvador, Estado de Bahia, Brazil

PUC Trials- Nucleo de Pesquisa clinica da Escola de Medicina da PUCPR- 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 São Lucas da PUCRS - Porto Alegre - Avenida Ipiranga- Site Number : 0760024

Porto Alegre, Rio Grande do Sul, Brazil

Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto- Site Number : 0760015

Ribeirão Preto, São Paulo, Brazil

Faculdade de Medicina do ABC- Site Number : 0760001

Santo André, São Paulo, Brazil

Clinica de Alergia Martti Antila- Site Number : 0760006

Sorocaba, São Paulo, Brazil

CCBR / IBPClin - Instituto Brasil de Pesquisa Clínica- Site Number : 0760018

Rio de Janeiro, Brazil

Hospital Alemao Oswaldo Cruz - São Paulo- Site Number : 0760010

São Paulo, Brazil

Centro de Desenvolvimento em Estudos ClÌnicos Brasil- Site Number : 0760014

São Paulo, Brazil

Investigational Site Number : 1002007

Dupnitsa, Bulgaria

Investigational Site Number : 1002004

Pleven, Bulgaria

Investigational Site Number : 1002005

Sofia, Bulgaria

Investigational Site Number : 1002003

Sofia, Bulgaria

Investigational Site Number : 1002006

Sofia, Bulgaria

Investigational Site Number : 1002002

Sofia, Bulgaria

Investigational Site Number : 1240039

Calgary, Alberta, Canada

Investigational Site Number : 1240019

Calgary, Alberta, Canada

Investigational Site Number : 1240023

Calgary, Alberta, Canada

Investigational Site Number : 1240016

Edmonton, Alberta, Canada

Investigational Site Number : 1240031

Edmonton, Alberta, Canada

Investigational Site Number : 1240040

Surrey, British Columbia, Canada

Investigational Site Number : 1240041

Winnipeg, Manitoba, Canada

Investigational Site Number : 1240033

Ajax, Ontario, Canada

Investigational Site Number : 1240014

Barrie, Ontario, Canada

Investigational Site Number : 1240020

Hamilton, Ontario, Canada

Investigational Site Number : 1240029

London, Ontario, Canada

Investigational Site Number : 1240053

London, Ontario, Canada

Investigational Site Number : 1240017

London, Ontario, Canada

Investigational Site Number : 1241106

Markham, Ontario, Canada

Investigational Site Number : 1240018

Newmarket, Ontario, Canada

Investigational Site Number : 1241108

Niagara Falls, Ontario, Canada

Investigational Site Number : 1240034

Ottawa, Ontario, Canada

Investigational Site Number : 1240024

Richmond Hill, Ontario, Canada

Investigational Site Number : 1240038

Richmond Hill, Ontario, Canada

Investigational Site Number : 1240021

Toronto, Ontario, Canada

Investigational Site Number : 1240012

Toronto, Ontario, Canada

Investigational Site Number : 1240026

Toronto, Ontario, Canada

Investigational Site Number: 1240035

Toronto, Ontario, Canada

Investigational Site Number : 1241107

Waterloo, Ontario, Canada

Investigational Site Number : 1241101

Windsor, Ontario, Canada

Investigational Site Number : 1240006

Québec, Quebec, Canada

Investigational Site Number: 1240028

Regina, Saskatchewan, Canada

Investigational Site Number : 1240036

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