Long-term Safety and Efficacy Evaluation of Subcutaneous Amlitelimab in Adult Participants With Moderate-to-severe Asthma Who Completed Treatment Period of Previous Amlitelimab Asthma Clinical Study

NCT06033833 | Active Not Recruiting Phase 2 DMC FDA Drug

• 3 other identifiers: LTS17510U1111-1280-53212023-503385-24
• Study Type: interventional
• Target: 335
• Locations: 14 countries
• Sites: 68

Brief Summary

This is a study of amlitelimab for the treatment of participants with moderate-to-severe asthma. The study will have a double-blind treatment period until Week 24 for each participant and an open-label treatment period where each participant will receive open-label amlitelimab from Week 24 onwards. The purpose of this study is to evaluate long-term safety, tolerability, and efficacy of amlitelimab for the treatment of adult participants with moderate-to-severe asthma who have previously been enrolled and completed the treatment period of the parent study. The study duration will be up to 156 weeks. The treatment duration will be up to 144 weeks. The number of visits will be 18.

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• Percentage of participants with treatment-emergent adverse events

  Percentage of participants with treatment emergent Adverse Events.

  From baseline up to Week 156 (EOS of LTS17510)

Secondary Outcomes (21)

• Percentage of participants who experienced adverse events.

  From baseline up to Week 156 (End of Study [EOS] of LTS17510)

• Annualized rate of severe exacerbation events over treatment period from parent study baseline

  From baseline of the parent study up to Week 144 (End of Treatment [EOT] of LTS17510)

• Annualized rate of severe exacerbation events over treatment period from LTS17510 study baseline

  From baseline of the LTS17510 study Up to Week 144 (EOT of LTS17510)

• Time to first exacerbation event from LTS17510 study baseline

  From baseline of the LTS17510 study Up to Week 144 (EOT of LTS17510)

• Annualized rate of severe asthma exacerbations requiring hospitalization or emergency room or urgent care visit over treatment period from parent study baseline

  From baseline of the parent study up to Week 144 (EOT of LTS17510)

Study Arms (2)

Treatment group 1

EXPERIMENTAL

Subcutaneous Injection as per protocol

Drug: Amlitelimab

Treatment group 2

EXPERIMENTAL

Subcutaneous injection as per protocol

Drug: Placebo

Interventions

Amlitelimab DRUG

Injection Solution: by subcutaneous injection (SCI)

Treatment group 1

Placebo DRUG

Injection Solution: by subcutaneous injection (SCI)

Treatment group 2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants with moderate-to-severe asthma who completed the treatment period of the parent study per protocol
• Participants on background dose with medium-to-high doses of ICS therapy (≥500 µg of fluticasone propionate daily or comparable ICS dosage up to a maximum of 2000 µg/day of fluticasone propionate or clinically comparable) in combination with a second or third controller (eg, LABA, LTRA, LAMA, methylxanthines), with or without OCS (up to a maximum of 15 mg prednisone or equivalent daily or 30 mg every other day) as maintained during the parent study in which they participated Note for Japan: participants must be on ≥400 μg of fluticasone propionate daily or equivalent.
• Contraception for male and female participants;
• For female participants:
• incapable of becoming pregnant
• not pregnant or breast feeding
• not to donate or cryopreserve eggs for female participants For male participants
• No sperm donation or cryopreserving sperms

You may not qualify if:

• Participants are excluded from the study if any of the following criteria apply:
• Chronic lung disease other than asthma
• Participants who developed a new medical condition or a change in status of an established medical condition or require a new treatment or medication prior to enrollment, which (per Investigator's medical judgment) would adversely affect the participation in this study or would require permanent IMP discontinuation
• Current smoker or active vaping of any products and/or marijuana smoking
• Prescription drug or substance abuse, including alcohol, considered significant by the Investigator
• Any new development with the participant's disease or condition or any significant laboratory test abnormality during the parent study that, in the opinion of the Investigator, may present an unreasonable risk for the participant
• Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the Investigator, contraindicates participation in the study
• Individuals accommodated in an institution because of regulatory or legal order; prisoners or participants who are legally institutionalized
• 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
• Participants are employees of the investigative site or other individuals directly involved in the conduct of the study, or immediate family members of such individuals
• The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (68)

Bensch Clinical Research LLC- Site Number : 8400004

Stockton, California, 95207, United States

Location

Helix Biomedics, LLC - Site Number : 8400029

Boynton Beach, Florida, 33435, United States

Location

Savin Medical Group - Miami- Site Number : 8400015

Miami, Florida, 33126, United States

Location

Pines Care Research Center LLC- Site Number : 8400028

Pembroke Pines, Florida, 33025, United States

Location

Treasure Valley Medical Research- Site Number : 8400031

Boise, Idaho, 83706, United States

Location

Johns Hopkins University School of Medicine- Site Number : 8400012

Baltimore, Maryland, 21224, United States

Location

OK Clinical Research, LLC- Site Number : 8400001

Edmond, Oklahoma, 73034, United States

Location

TTS Research- Site Number : 8400011

Boerne, Texas, 78006, United States

Location

Investigational Site Number : 0320002

CABA, Buenos Aires, C1425FVH, Argentina

Location

Investigational Site Number : 0320008

La Plata, Buenos Aires, B1900BNN, Argentina

Location

Investigational Site Number : 0320009

Buenos Aires, Buenos Aires F.D., 1060, Argentina

Location

Investigational Site Number : 0320006

Rosario, Santa Fe Province, 2000, Argentina

Location

Investigational Site Number : 0320007

Rosario, Santa Fe Province, S2000DEJ, Argentina

Location

Investigational Site Number : 0320005

Rosario, Santa Fe Province, S2000JKR, Argentina

Location

Investigational Site Number : 0320004

Ciudad Autonoma Bs As, C1121ABE, Argentina

Location

Investigational Site Number : 0320003

Ciudad Autonoma Buenos Aires, C1414AIF, Argentina

Location

Investigational Site Number : 0320001

Ciudad Autonoma Buenos Aires, C1425BEN, Argentina

Location

Centro de Diagnostico e Pesquisa da Osteoporose do Espirito Santo- Site Number : 0760002

Vitória, Espírito Santo, 29055-450, Brazil

Location

Proar- Site Number : 0760004

Salvador, Estado de Bahia, 40060-330, Brazil

Location

Instituto Méderi de Pesquisa e Saúde- Site Number : 0760001

Passo Fundo, Rio Grande do Sul, 99010-170, Brazil

Location

Irmandade da Santa Casa de Misericordia de Porto Alegre- Site Number : 0760007

Porto Alegre, Rio Grande do Sul, 90020-090, Brazil

Location

Hospital Sao Lucas da PUCRS- Site Number : 0760006

Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

Location

Hospital das Clinicas de Sao Paulo- Site Number : 0760008

São Paulo, São Paulo, 05403-000, Brazil

Location

Clínica de Alergia Martti Antila- Site Number : 0760003

Sorocaba, 18040-425, Brazil

Location

Investigational Site Number : 1240008

Ottawa, Ontario, K1G 6C6, Canada

Location

Investigational Site Number : 1240007

Trois-Rivières, Quebec, G8T 7A1, Canada

Location

Investigational Site Number : 1520006

Talca, Maule Region, 3465584, Chile

Location

Investigational Site Number : 1520001

Santiago, Reg Metropolitana de Santiago, 7500692, Chile

Location

Investigational Site Number : 1520003

Santiago, Reg Metropolitana de Santiago, 7750495, Chile

Location

Investigational Site Number : 1520008

Santiago, Reg Metropolitana de Santiago, 8380465, Chile

Location

Investigational Site Number : 1520005

Quillota, Región de Valparaíso, 2260877, Chile

Location

Investigational Site Number : 3480009

Edelény, 3780, Hungary

Location

Investigational Site Number : 3480011

Gödöllö, 2100, Hungary

Location

Investigational Site Number : 3480006

Püspökladány, 4150, Hungary

Location

Investigational Site Number : 3480012

Százhalombatta, 2440, Hungary

Location

Investigational Site Number : 3800003

Rome, Roma, 00168, Italy

Location

Investigational Site Number : 3800004

Naples, 80131, Italy

Location

Investigational Site Number : 3800001

Verona, 37134, Italy

Location

Investigational Site Number : 3920010

Sakai, Osaka, 591-8555, Japan

Location

Investigational Site Number : 3920005

Chuo-ku, Tokyo, 103-0027, Japan

Location

Investigational Site Number : 3920004

Chuo-ku, Tokyo, 104-0031, Japan

Location

Investigational Site Number : 3920001

Shinagawa-ku, Tokyo, 140-8522, Japan

Location

Investigational Site Number : 3920019

Hiroshima, 732-0052, Japan

Location

Investigational Site Number : 4840001

Guadalajara, Jalisco, 44100, Mexico

Location

Investigational Site Number : 4840005

Guadalajara, Jalisco, 44670, Mexico

Location

Investigational Site Number : 4840002

Chihuahua City, 31000, Mexico

Location

Investigational Site Number : 4840008

Mérida, 97070, Mexico

Location

Investigational Site Number : 6160001

Poznan, Greater Poland Voivodeship, 60-693, Poland

Location

Investigational Site Number : 6160006

Krakow, Lesser Poland Voivodeship, 31-559, Poland

Location

Investigational Site Number : 6160004

Bialystok, Podlaskie Voivodeship, 15-044, Poland

Location

Investigational Site Number : 6160003

Elblag, 82-300, Poland

Location

Investigational Site Number : 6160002

Gdansk, 80-405, Poland

Location

Investigational Site Number : 6160007

Tarnów, 33-100, Poland

Location

Investigational Site Number : 7100007

Benoni, 1501, South Africa

Location

Investigational Site Number : 7100002

Cape Town, 7530, South Africa

Location

Investigational Site Number : 7100001

Cape Town, 7937, South Africa

Location

Investigational Site Number : 7100004

Middelburg, 1055, South Africa

Location

Investigational Site Number : 4100004

Daegu, Daegu, 42415, South Korea

Location

Investigational Site Number : 4100006

Moncton, Seoul-teukbyeolsi, E1C 6Z8, South Korea

Location

Investigational Site Number : 4100001

Seoul, Seoul-teukbyeolsi, 03722, South Korea

Location

Investigational Site Number : 4100005

Seoul, Seoul-teukbyeolsi, 05030, South Korea

Location

Investigational Site Number : 4100002

Seoul, Seoul-teukbyeolsi, 138-878, South Korea

Location

Investigational Site Number : 7920001

Istanbul, 34098, Turkey (Türkiye)

Location

Investigational Site Number : 7920003

Izmir, 35100, Turkey (Türkiye)

Location

Investigational Site Number : 7920008

Kayseri, 38039, Turkey (Türkiye)

Location

Investigational Site Number : 7920005

Kocaeli, 41100, Turkey (Türkiye)

Location

Investigational Site Number : 7920002

Mersin, 33070, Turkey (Türkiye)

Location

Investigational Site Number : 8260001

Bradford, BD9 6RJ, United Kingdom

Location

Related Links

• LTS17510 Plain Language Results Summary

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: This study will have a double-blind treatment period and an open-label treatment period after week 24
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This study will have a double-blind treatment period and an open-label treatment period

Study Record Dates

• First Submitted: September 5, 2023
• First Posted: September 13, 2023
• Study Start: September 5, 2023
• Primary Completion (Estimated): June 25, 2029
• Study Completion (Estimated): June 25, 2029
• Last Updated: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share

Locations

CL (5); CA (2); IT (3); US (8); HU (4); JP (5); KR (5); TU (5); AR (9); GB (1); BR (7); PL (6); ME (4); ZA (4)