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

Asthma Clinical Trial

— RIVER-ASTHMA  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06033833
• Other study ID #: LTS17510
• Secondary ID: U1111-1280-53212
• Status: Recruiting
• Phase: Phase 2
• Start date: September 5, 2023
• Est. completion date: June 25, 2029

Study information

• Verified date: May 2024
• Source: Sanofi
• Contact: Trial transparency email recommended (Toll free number for US &
• Phone: 800-633-1610
• Email: contact-us[@]sanofi.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 380
• Est. completion date: June 25, 2029
• Est. primary completion date: June 25, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Amlitelimab
Injection Solution: by subcutaneous injection (SCI)
• Placebo
Injection Solution: by subcutaneous injection (SCI)

Locations

Country	Name	City	State
Argentina	Investigational Site Number : 0320009	Buenos Aires	Ciudad De Buenos Aires
Argentina	Investigational Site Number : 0320002	Caba	Buenos Aires
Argentina	Investigational Site Number : 0320004	Ciudad Autonoma Bs As
Argentina	Investigational Site Number : 0320001	Ciudad Autonoma Buenos Aires
Argentina	Investigational Site Number : 0320003	Ciudad Autonoma Buenos Aires
Argentina	Investigational Site Number : 0320008	La Plata	Buenos Aires
Argentina	Investigational Site Number : 0320005	Rosario	Santa Fe
Argentina	Investigational Site Number : 0320006	Rosario	Santa Fe
Argentina	Investigational Site Number : 0320007	Rosario	Santa Fe
Canada	Investigational Site Number : 1240007	Trois-Rivieres	Quebec
Chile	Investigational Site Number : 1520005	Quillota	Valparaíso
Chile	Investigational Site Number : 1520001	Santiago	Reg Metropolitana De Santiago
Chile	Investigational Site Number : 1520003	Santiago	Reg Metropolitana De Santiago
Chile	Investigational Site Number : 1520008	Santiago	Reg Metropolitana De Santiago
Chile	Investigational Site Number : 1520006	Talca	Maule
Hungary	Investigational Site Number : 3480009	Edelény
Hungary	Investigational Site Number : 3480011	Gödöllö
Japan	Investigational Site Number : 3920004	Chuo-ku	Tokyo
Japan	Investigational Site Number : 3920010	Sakai-shi	Osaka
Korea, Republic of	Investigational Site Number : 4100001	Seoul	Seoul-teukbyeolsi
Korea, Republic of	Investigational Site Number : 4100002	Seoul	Seoul-teukbyeolsi
Poland	Investigational Site Number : 6160004	Bialystok	Podlaskie
Poland	Investigational Site Number : 6160002	Gdansk
Poland	Investigational Site Number : 6160006	Krakow	Malopolskie
Poland	Investigational Site Number : 6160001	Poznan	Wielkopolskie
South Africa	Investigational Site Number : 7100007	Benoni
South Africa	Investigational Site Number : 7100001	Cape Town
South Africa	Investigational Site Number : 7100002	Cape Town
Turkey	Investigational Site Number : 7920001	Istanbul
Turkey	Investigational Site Number : 7920003	Izmir
Turkey	Investigational Site Number : 7920008	Kayseri
Turkey	Investigational Site Number : 7920005	Kocaeli
Turkey	Investigational Site Number : 7920002	Mersin
United Kingdom	Investigational Site Number : 8260001	Bradford
United States	TTS Research Site Number : 8400011	Boerne	Texas
United States	OK Clinical Research, LLC Site Number : 8400001	Edmond	Oklahoma
United States	Bensch Clinical Research LLC Site Number : 8400004	Stockton	California

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

United States,  Argentina,  Canada,  Chile,  Hungary,  Japan,  Korea, Republic of,  Poland,  South Africa,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Percentage of participants who experienced adverse events.	Data reported for participants who experienced adverse events of special interest (AESI) and serious adverse events (SAEs).	From baseline up to Week 156 (End of Study [EOS] of LTS17510)
Secondary	Annualized rate of severe exacerbation events over treatment period from parent study baseline	Severe exacerbation events over treatment period from parent study baseline are defined as: Worsening of asthma requiring the use of systemic corticosteroids for =3 days or, in the case of a stable maintenance regimen of oral corticosteroids for the treatment of asthma, a doubling of the dose for 3 or more days; or Hospitalization or emergency room visit because of asthma, requiring systemic corticosteroids.	From baseline of the parent study up to Week 144 (End of Treatment [EOT] of LTS17510)
Secondary	Annualized rate of severe exacerbation events over treatment period from LTS17510 study baseline	Severe exacerbation events over treatment period from LTS17510 study baseline defined as: Worsening of asthma requiring the use of systemic corticosteroids for =3 days or, in the case of a stable maintenance regimen of oral corticosteroids for the treatment of asthma, a doubling of the dose for 3 or more days; or Hospitalization or emergency room visit because of asthma, requiring systemic corticosteroids.	From baseline of the LTS17510 study Up to Week 144 (EOT of LTS17510)
Secondary	Time to first exacerbation event from LTS17510 study baseline		From baseline of the LTS17510 study Up to Week 144 (EOT of LTS17510)
Secondary	Annualized rate of severe asthma exacerbations requiring hospitalization or emergency room or urgent care visit over treatment period from parent study baseline	Severe asthma exacerbations are defined as: Worsening of asthma requiring the use of systemic corticosteroids for =3 days or, in the case of a stable maintenance regimen of oral corticosteroids for the treatment of asthma, a doubling of the dose for 3 or more days; or Hospitalization or emergency room visit because of asthma, requiring systemic corticosteroids.	From baseline of the parent study up to Week 144 (EOT of LTS17510)
Secondary	Annualized rate of severe asthma exacerbations requiring hospitalization or emergency room or urgent care visit over treatment period from LTS17510 study baseline	Severe asthma exacerbations are defined as: Worsening of asthma requiring the use of systemic corticosteroids for =3 days or, in the case of a stable maintenance regimen of oral corticosteroids for the treatment of asthma, a doubling of the dose for 3 or more days; or Hospitalization or emergency room visit because of asthma, requiring systemic corticosteroids.	From baseline of the LTS17510 study up to Week 144 (EOT of LTS17510)
Secondary	Change from parent study baseline in prebronchodilator (BD) and post-BD forced expiratory volume in 1 second (FEV1) at each spirometry endpoint		From baseline of parent study up to week 144 (EOT of LTS17510)
Secondary	Change from LTS17510 study baseline in pre bronchodilator (BD) and post-BD forced expiratory volume in 1 second (FEV1) at each spirometry endpoint		From baseline of LTS17510 study up to week 144 (EOT of LTS17510)
Secondary	Change from parent study baseline in pre-BD and post-BD peak expiratory flow [PEF] at each spirometry endpoint		From baseline of parent study up to Week 144 (EOT of LTS17510)
Secondary	Change from LTS17510 study baseline in pre-BD and post-BD peak expiratory flow [PEF] at each spirometry endpoint		From baseline of LTS17510 study up to Week 144 (EOT of LTS17510)
Secondary	Change from parent study baseline in Pre-BD and post-BD forced vital capacity [FVC] at each spirometry endpoint		From baseline of parent study up to Week 144 (EOT of LTS17510)
Secondary	Change from LTS17510 study Baseline in Pre-BD and post-BD forced vital capacity [FVC] at each spirometry endpoint		From baseline of lTS17510 study up to Week 144 (EOT of LTS17510)
Secondary	Change from parent study baseline in pre-BD and post-BD forced expiratory flow [FEF] 25% to 75%) at each spirometry endpoint		From baseline of parent study up to Week 144 (EOT of LTS17510)
Secondary	Change from LTS17510 study baseline in pre-BD and post-BD forced expiratory flow [FEF] 25% to 75%) at each spirometry endpoint		From baseline of LTS17510 study up to Week 144 (EOT of LTS17510)
Secondary	Change from parent study baseline in Asthma Control Questionnaire (ACQ)-5, ACQ-6, and ACQ-7 scores	The ACQ is a validated questionnaire that measures the adequacy of asthma control and any changes in asthma control that may occur spontaneously or as a result of treatment. Each item of the ACQ is measured on a 7-point response scale (0=no impairment, 6=maximum impairment). The ACQ score is the mean of the item responses and ranges from 0 (totally controlled) and 6 (severely uncontrolled).	From parent study baseline up to Week 144 (EOT of LTS17510)
Secondary	Change from LTS17510 study baseline in Asthma Control Questionnaire (ACQ)-5, ACQ-6, and ACQ-7 scores	The ACQ is a validated questionnaire that measures the adequacy of asthma control and any changes in asthma control that may occur spontaneously or as a result of treatment. Each item of the ACQ is measured on a 7-point response scale (0=no impairment, 6=maximum impairment). The ACQ score is the mean of the item responses and ranges from 0 (totally controlled) and 6 (severely uncontrolled).	From LTS17510 study baseline up to Week 144 (EOT of LTS17510)
Secondary	Change from parent study baseline in Fractional Exhaled Nitric Oxide (FeNO)		From parent study baseline up to Week 144 (EOT of LTS17510)
Secondary	Change from LTS17510 study baseline in Fractional Exhaled Nitric Oxide (FeNO)		From LTS17510 study baseline up to Week 144 (EOT of LTS17510)
Secondary	Serum amlitelimab concentrations		From baseline up to Week156 (EOS of LTS17510)
Secondary	Incidence of anti- amlitelimab antibody positive response		From baseline up to Week 156 (EOS of LTS17510)
Secondary	Change from parent study baseline and from LTS17510 in Asthma Quality of Life Questionnaire with Standardized Activities (AQLQ [S]) Self-Administered Score	The AQLQ(S) was designed as a self-administered participant reported outcome to measure the functional impairments that are most troublesome to adolescents and adults =12 years of age as a result of their asthma over the past two weeks. The instrument is comprised of 32 items, each rated on a 7-point Likert scales from 1 to 7.	From baseline up to Weeks 144 (EOT of LTS17510)