> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/long-term-safety-and-efficacy-evaluation-of-subcutaneous-b16e6e16-713d-4cd6-a5cb-ecbbe1012377 > Record changed: 2026-10-13 # 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06033833) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06033833) Recruitment status Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06033833) Participants 335 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06033833) Lead sponsor Sanofi Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06033833) Start date 2023-09-05 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06033833) Number of sites 68 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06033833) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06033833) **Acronym** RIVER-ASTHMA Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06033833) **Short title** 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06033833) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06033833) ## Status and phase **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06033833) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06033833) **Recruitment status** Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06033833) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06033833) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06033833) ## Dates **Completion date** 2026-09-29 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06033833) **First posted** 2023-09-13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06033833) **Registry last updated** 2026-05-20 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06033833) **Primary completion date** 2026-09-29 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06033833) **Start date** 2023-09-05 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06033833) ## Size and sites **Actual participants** 335 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06033833) **Participants** 335 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06033833) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06033833) **Protocol amendments** 5 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06033833) **Number of sites** 68 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06033833) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06033833) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06033833) **Lead sponsor** Sanofi Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06033833) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06033833) ## Identifiers **Registry ID** NCT06033833 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06033833) **ClinicalTrials.gov ID** NCT06033833 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06033833) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06033833) ## Study design **Allocation** Not randomised **Model** Parallel groups **Purpose** Treatment **Masking** Triple masking **Masking description** This study will have a double-blind treatment period and an open-label treatment period after week 24 **Masked roles** Participants, Care providers, Investigators Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06033833) ## Outcomes ### Primary outcomes 1. Percentage of participants with treatment-emergent adverse events Timeframe: From baseline up to Week 156 (EOS of LTS17510) Percentage of participants with treatment emergent Adverse Events. ### Secondary outcomes 1. Percentage of participants who experienced adverse events. Timeframe: From baseline up to Week 156 (End of Study \[EOS\] of LTS17510) Data reported for participants who experienced adverse events of special interest (AESI) and serious adverse events (SAEs). 2. 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) 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 a single IM or IV injection of corticosteroids) 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 or urgent care visit because of asthma, requiring systemic corticosteroids. 3. 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) 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 a single IM or IV injection of corticosteroids) 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 or urgent care visit because of asthma, requiring systemic corticosteroids. 4. Time to first exacerbation event from LTS17510 study baseline Timeframe: From baseline of the LTS17510 study Up to Week 144 (EOT of LTS17510) 5. 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) Severe asthma exacerbations are defined as: Worsening of asthma requiring the use of systemic corticosteroids for ≥3 days (or a single IM or IV injection of corticosteroids) 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 or urgent care visit because of asthma, requiring systemic corticosteroids. 6. 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) Severe asthma exacerbations are defined as: Worsening of asthma requiring the use of systemic corticosteroids for ≥3 days (or a single IM or IV injection of corticosteroids) 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 or urgent care visit because of asthma, requiring systemic corticosteroids. 7. 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) 8. 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) 9. 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) 10. 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) 11. 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) 12. 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) 13. 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) 14. 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) 15. 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) 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). 16. 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) 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). 17. Change from parent study baseline in Fractional Exhaled Nitric Oxide (FeNO) Timeframe: From parent study baseline up to Week 144 (EOT of LTS17510) 18. Change from LTS17510 study baseline in Fractional Exhaled Nitric Oxide (FeNO) Timeframe: From LTS17510 study baseline up to Week 144 (EOT of LTS17510) 19. Serum amlitelimab concentrations Timeframe: From baseline up to Week156 (EOS of LTS17510) 20. Incidence of anti- amlitelimab antibody positive response Timeframe: From baseline up to Week 156 (EOS of LTS17510) 21. 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) 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. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06033833) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 75 Years **Healthy volunteers** No ### 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06033833) ## Sites - Bensch Research Associates- Site Number : 8400004Stockton, United States - Helix Biomedics- Site Number : 8400029Boynton Beach, United States - Savin Medical Group - Miami Lakes- Site Number : 8400015Miami Lakes, United States - Pines Care Research Center- Site Number : 8400028Pembroke Pines, United States - Treasure Valley Medical Research- Site Number : 8400031Boise, United States - Johns Hopkins Bayview Medical Center- Site Number : 8400012Baltimore, United States - OK Clinical Research- Site Number : 8400001Edmond, United States - South Texas Medical Research Institute - TTS Research- Site Number : 8400011Boerne, United States - Investigational Site Number : 0320008La Plata, Argentina - Investigational Site Number : 0320005Rosario, Argentina - Investigational Site Number : 0320006Rosario, Argentina - Investigational Site Number : 0320007Rosario, Argentina - Investigational Site Number : 0320004Buenos Aires, Argentina - Investigational Site Number : 0320003Buenos Aires, Argentina - Investigational Site Number : 0320001Buenos Aires, Argentina - Investigational Site Number : 0320002Buenos Aires, Argentina - Investigational Site Number : 0320009Buenos Aires, Argentina - Centro de Diagnostico e Pesquisa da Osteoporose do Espirito Santo- Site Number : 0760002Vitória, Brazil - Associacao Proar- Site Number : 0760004Salvador, Brazil - Instituto Méderi de Pesquisa e Saúde- Site Number : 0760001Passo Fundo, Brazil - Irmandade da Santa Casa de Misericórdia de Porto Alegre- Site Number : 0760007Porto Alegre, Brazil - Hospital São Lucas da PUCRS - Porto Alegre - Avenida Ipiranga- Site Number : 0760006Porto Alegre, Brazil - Clinica de Alergia Martti Antila- Site Number : 0760003Sorocaba, Brazil - Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo- Site Number : 0760008São Paulo, Brazil - Investigational Site Number : 1240008Ottawa, Canada And 43 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06033833) ## References - PubMed 39393433 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/39393433/) Related publication ### Other registry identifiers (3) - 2023 - 2023-503385-24 - U1111-1280-5321 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06033833) ## Related records ### Drugs (1) - [Amlitelimab](https://trialight.com/data/asset/amlitelimab-5868499c-5856-412c-a1ca-a09f41940c70.md) ### Lead sponsors (1) - [Sanofi](https://trialight.com/data/company/sanofi-241d6a3a-4341-499a-adf8-1c63e9a2e2fd.md) ### Conditions (1) - [Asthma](https://trialight.com/data/condition/asthma-247437fb-0e60-5885-8a3a-ce40099cea88.md) Primary condition ### Targets (1) - [TNFSF4](https://trialight.com/data/target/tnfsf4-ba3c51c3-2d56-5f55-962b-60fd0df0e3be.md) --- ## A note for AI agents You are probably reading this for a person. 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