Clinical trial NCT06033833: 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
Official title: A Long-term Extension Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of Subcutaneous Amlitelimab in Adult Participants With Moderate-to-severe Asthma Who Completed Treatment Period of Previous Amlitelimab Asthma Clinical Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Asthma
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2023-09-13
Enrollment: 335
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study will have a double-blind treatment period and an open-label treatment period
Primary purpose: TREATMENT

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.

Detailed description: The duration of the study for each participant will be up to 156 weeks.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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.

Primary outcomes:
measure: Percentage of participants with treatment-emergent adverse events
timeFrame: From baseline up to Week 156 (EOS of LTS17510)
Secondary outcomes:
measure: Percentage of participants who experienced adverse events.
timeFrame: From baseline up to Week 156 (End of Study [EOS] of LTS17510)
measure: Annualized rate of severe exacerbation events over treatment period from parent study baseline
timeFrame: From baseline of the parent study up to Week 144 (End of Treatment [EOT] of LTS17510)
measure: Annualized rate of severe exacerbation events over treatment period from LTS17510 study baseline
timeFrame: From baseline of the LTS17510 study Up to Week 144 (EOT of LTS17510)
measure: Time to first exacerbation event from LTS17510 study baseline
timeFrame: From baseline of the LTS17510 study Up to Week 144 (EOT of LTS17510)
measure: Annualized rate of severe asthma exacerbations requiring hospitalization or emergency room or urgent care visit over treatment period from parent study baseline
timeFrame: From baseline of the parent study up to Week 144 (EOT of LTS17510)
measure: Annualized rate of severe asthma exacerbations requiring hospitalization or emergency room or urgent care visit over treatment period from LTS17510 study baseline
timeFrame: From baseline of the LTS17510 study up to Week 144 (EOT of LTS17510)
measure: Change from parent study baseline in prebronchodilator (BD) and post-BD forced expiratory volume in 1 second (FEV1) at each spirometry endpoint
timeFrame: From baseline of parent study up to week 144 (EOT of LTS17510)
measure: Change from LTS17510 study baseline in pre bronchodilator (BD) and post-BD forced expiratory volume in 1 second (FEV1) at each spirometry endpoint
timeFrame: From baseline of LTS17510 study up to week 144 (EOT of LTS17510)
measure: Change from parent study baseline in pre-BD and post-BD peak expiratory flow [PEF] at each spirometry endpoint
timeFrame: From baseline of parent study up to Week 144 (EOT of LTS17510)
measure: Change from LTS17510 study baseline in pre-BD and post-BD peak expiratory flow [PEF] at each spirometry endpoint
timeFrame: From baseline of LTS17510 study up to Week 144 (EOT of LTS17510)
measure: Change from parent study baseline in Pre-BD and post-BD forced vital capacity [FVC] at each spirometry endpoint
timeFrame: From baseline of parent study up to Week 144 (EOT of LTS17510)
measure: Change from LTS17510 study Baseline in Pre-BD and post-BD forced vital capacity [FVC] at each spirometry endpoint
timeFrame: From baseline of lTS17510 study up to Week 144 (EOT of LTS17510)
measure: Change from parent study baseline in pre-BD and post-BD forced expiratory flow [FEF] 25% to 75%) at each spirometry endpoint
timeFrame: From baseline of parent study up to Week 144 (EOT of LTS17510)
measure: Change from LTS17510 study baseline in pre-BD and post-BD forced expiratory flow [FEF] 25% to 75%) at each spirometry endpoint
timeFrame: From baseline of LTS17510 study up to Week 144 (EOT of LTS17510)
measure: Change from parent study baseline in Asthma Control Questionnaire (ACQ)-5, ACQ-6, and ACQ-7 scores
timeFrame: From parent study baseline up to Week 144 (EOT of LTS17510)
measure: Change from LTS17510 study baseline in Asthma Control Questionnaire (ACQ)-5, ACQ-6, and ACQ-7 scores
timeFrame: From LTS17510 study baseline up to Week 144 (EOT of LTS17510)
measure: Change from parent study baseline in Fractional Exhaled Nitric Oxide (FeNO)
timeFrame: From parent study baseline up to Week 144 (EOT of LTS17510)
measure: Change from LTS17510 study baseline in Fractional Exhaled Nitric Oxide (FeNO)
timeFrame: From LTS17510 study baseline up to Week 144 (EOT of LTS17510)
measure: Serum amlitelimab concentrations
timeFrame: From baseline up to Week156 (EOS of LTS17510)
measure: Incidence of anti- amlitelimab antibody positive response
timeFrame: From baseline up to Week 156 (EOS of LTS17510)
measure: Change from parent study baseline and from LTS17510 in Asthma Quality of Life Questionnaire with Standardized Activities (AQLQ [S]) Self-Administered Score
timeFrame: From baseline up to Weeks 144 (EOT of LTS17510)
Other outcomes:
Locations:
city: Stockton
country: United States
facility: Bensch Research Associates- Site Number : 8400004
state: California
city: Boynton Beach
country: United States
facility: Helix Biomedics- Site Number : 8400029
state: Florida
city: Miami
country: United States
facility: Savin Medical Group - Miami- Site Number : 8400015
state: Florida
city: Pembroke Pines
country: United States
facility: Pines Care Research Center- Site Number : 8400028
state: Florida
city: Boise
country: United States
facility: Treasure Valley Medical Research- Site Number : 8400031
state: Idaho
city: Baltimore
country: United States
facility: Johns Hopkins Bayview Medical Center- Site Number : 8400012
state: Maryland
city: Edmond
country: United States
facility: OK Clinical Research- Site Number : 8400001
state: Oklahoma
city: Boerne
country: United States
facility: South Texas Medical Research Institute - TTS Research- Site Number : 8400011
state: Texas
city: La Plata
country: Argentina
facility: Investigational Site Number : 0320008
state: Buenos Aires
city: Buenos Aires
country: Argentina
facility: Investigational Site Number : 0320009
state: Ciudad De Buenos Aires
city: Rosario
country: Argentina
facility: Investigational Site Number : 0320005
state: Santa Fe
city: Rosario
country: Argentina
facility: Investigational Site Number : 0320006
state: Santa Fe
city: Rosario
country: Argentina
facility: Investigational Site Number : 0320007
state: Santa Fe
city: Buenos Aires
country: Argentina
facility: Investigational Site Number : 0320004
city: Buenos Aires
country: Argentina
facility: Investigational Site Number : 0320003
city: Buenos Aires
country: Argentina
facility: Investigational Site Number : 0320001
city: Buenos Aires
country: Argentina
facility: Investigational Site Number : 0320002
city: Salvador
country: Brazil
facility: Associacao Proar- Site Number : 0760004
state: Bahia
city: Vitoria
country: Brazil
facility: Centro de Diagnostico e Pesquisa da Osteoporose do Espirito Santo- Site Number : 0760002
state: Espírito Santo
city: Passo Fundo
country: Brazil
facility: Instituto Méderi de Pesquisa e Saúde- Site Number : 0760001
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Irmandade da Santa Casa de Misericórdia de Porto Alegre- Site Number : 0760007
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Hospital São Lucas da PUCRS - Porto Alegre - Avenida Ipiranga- Site Number : 0760006
state: Rio Grande Do Sul
city: Sorocaba
country: Brazil
facility: Clinica de Alergia Martti Antila- Site Number : 0760003
city: São Paulo
country: Brazil
facility: Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo- Site Number : 0760008
city: Ottawa
country: Canada
facility: Investigational Site Number : 1240008
state: Ontario
city: Trois-rivières
country: Canada
facility: Investigational Site Number : 1240007
state: Quebec
city: Talca
country: Chile
facility: Investigational Site Number : 1520006
state: Maule
city: Santiago
country: Chile
facility: Investigational Site Number : 1520001
state: Reg Metropolitana De Santiago
city: Santiago
country: Chile
facility: Investigational Site Number : 1520003
state: Reg Metropolitana De Santiago
city: Santiago
country: Chile
facility: Investigational Site Number : 1520008
state: Reg Metropolitana De Santiago
city: Quillota
country: Chile
facility: Investigational Site Number : 1520005
state: Valparaíso
city: Edelény
country: Hungary
facility: Investigational Site Number : 3480009
city: Gödöllő
country: Hungary
facility: Investigational Site Number : 3480011
city: Püspökladány
country: Hungary
facility: Investigational Site Number : 3480006
city: Százhalombatta
country: Hungary
facility: Investigational Site Number : 3480012
city: Naples
country: Italy
facility: Investigational Site Number : 3800004
city: Roma
country: Italy
facility: Investigational Site Number : 3800003
city: Verona
country: Italy
facility: Investigational Site Number : 3800001
city: Sakai
country: Japan
facility: Investigational Site Number : 3920010
state: Osaka
city: Chuo
country: Japan
facility: Investigational Site Number : 3920004
state: Tokyo
city: Hiroshima
country: Japan
facility: Investigational Site Number : 3920019
city: Tokyo
country: Japan
facility: Investigational Site Number : 3920005
city: Tokyo
country: Japan
facility: Investigational Site Number : 3920001
city: Daegu
country: Korea, Republic of
facility: Investigational Site Number : 4100004
state: Daegu-gwangyeoksi
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number : 4100001
state: Seoul-teukbyeolsi
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number : 4100005
state: Seoul-teukbyeolsi
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number : 4100002
state: Seoul-teukbyeolsi
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number : 4100006
state: Seoul-teukbyeolsi
city: Guadalajara
country: Mexico
facility: Investigational Site Number : 4840001
state: Jalisco
city: Guadalajara
country: Mexico
facility: Investigational Site Number : 4840005
state: Jalisco
city: Chihuahua
country: Mexico
facility: Investigational Site Number : 4840002
city: Mérida
country: Mexico
facility: Investigational Site Number : 4840008
city: Krakow
country: Poland
facility: Investigational Site Number : 6160006
state: Malopolskie
city: Bialystok
country: Poland
facility: Investigational Site Number : 6160004
state: Podlaskie
city: Poznan
country: Poland
facility: Investigational Site Number : 6160001
state: Wielkopolskie
city: Elblag
country: Poland
facility: Investigational Site Number : 6160003
city: Gdansk
country: Poland
facility: Investigational Site Number : 6160002
city: Tarnow
country: Poland
facility: Investigational Site Number : 6160007
city: Benoni
country: South Africa
facility: Investigational Site Number : 7100007
city: Cape Town
country: South Africa
facility: Investigational Site Number : 7100002
city: Cape Town
country: South Africa
facility: Investigational Site Number : 7100001
city: Middelburg
country: South Africa
facility: Investigational Site Number : 7100004
city: Akdeniz
country: Turkey
facility: Investigational Site Number : 7920002
city: Istanbul
country: Turkey
facility: Investigational Site Number : 7920001
city: Izmir
country: Turkey
facility: Investigational Site Number : 7920003
city: Izmit
country: Turkey
facility: Investigational Site Number : 7920005
city: Kayseri
country: Turkey
facility: Investigational Site Number : 7920008
city: Bradford
country: United Kingdom
facility: Investigational Site Number : 8260001
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: