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Langsiktig sikkerhet og effektevaluering av subkutan amlitelimab hos voksne deltakere med moderat til alvorlig astma som fullførte behandlingsperioden for tidligere amlitelimab astma klinisk studie (RIVER-ASTHMA)

29. september 2026 oppdatert av: Sanofi

En langsiktig utvidelsesstudie for å evaluere langsiktig sikkerhet, tolerabilitet og effekt av subkutan amlitelimab hos voksne deltakere med moderat til alvorlig astma som fullførte behandlingsperioden fra tidligere amlitelimab astma-studie

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.

Studieoversikt

Status

Avsluttet

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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

Studietype

Intervensjonell

Registrering (Faktiske)

335

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Argentina
      • Buenos Aires, Argentina, 1425
        • Investigational Site Number : 0320001
      • Buenos Aires, Argentina, 1121
        • Investigational Site Number : 0320004
      • Buenos Aires, Argentina, 1414
        • Investigational Site Number : 0320003
      • Buenos Aires, Argentina, 1425
        • Investigational Site Number : 0320002
      • Buenos Aires, Argentina, 1650
        • Investigational Site Number : 0320009
    • Buenos Aires
      • La Plata, Buenos Aires, Argentina, 1900
        • Investigational Site Number : 0320008
    • Santa Fe Province
      • Rosario, Santa Fe Province, Argentina, 2000
        • Investigational Site Number : 0320006
      • Rosario, Santa Fe Province, Argentina, 2000
        • Investigational Site Number : 0320007
      • Rosario, Santa Fe Province, Argentina, 2000
        • Investigational Site Number : 0320005
  • Brasil
      • São Paulo, Brasil, 05403-000
        • Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo- Site Number : 0760008
    • Espírito Santo
      • Vitória, Espírito Santo, Brasil, 29055-450
        • Centro de Diagnostico e Pesquisa da Osteoporose do Espirito Santo- Site Number : 0760002
    • Estado de Bahia
      • Salvador, Estado de Bahia, Brasil, 40060-330
        • Associacao Proar- Site Number : 0760004
    • Rio Grande do Sul
      • Passo Fundo, Rio Grande do Sul, Brasil, 99010-170
        • Instituto Méderi de Pesquisa e Saúde- Site Number : 0760001
      • Porto Alegre, Rio Grande do Sul, Brasil, 90020-090
        • Irmandade da Santa Casa de Misericórdia de Porto Alegre- Site Number : 0760007
      • Porto Alegre, Rio Grande do Sul, Brasil, 90610-000
        • Hospital São Lucas da PUCRS - Porto Alegre - Avenida Ipiranga- Site Number : 0760006
    • São Paulo
      • Sorocaba, São Paulo, Brasil, 18040-425
        • Clinica de Alergia Martti Antila- Site Number : 0760003
  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1G 6C6
        • Investigational Site Number : 1240008
    • Quebec
      • Trois-Rivières, Quebec, Canada, G8T 7A1
        • Investigational Site Number : 1240007
  • Chile
    • Maule Region
      • Talca, Maule Region, Chile, 3465584
        • Investigational Site Number : 1520006
    • Reg Metropolitana de Santiago
      • Santiago, Reg Metropolitana de Santiago, Chile, 7500692
        • Investigational Site Number : 1520001
      • Santiago, Reg Metropolitana de Santiago, Chile, 7750495
        • Investigational Site Number : 1520003
      • Santiago, Reg Metropolitana de Santiago, Chile, 8380465
        • Investigational Site Number : 1520008
    • Valparaiso
      • Quillota, Valparaiso, Chile, 2260877
        • Investigational Site Number : 1520005
  • Forente stater
    • California
      • Stockton, California, Forente stater, 95207
        • Bensch Research Associates- Site Number : 8400004
    • Florida
      • Boynton Beach, Florida, Forente stater, 33435
        • Helix Biomedics- Site Number : 8400029
      • Miami Lakes, Florida, Forente stater, 33014
        • Savin Medical Group - Miami Lakes- Site Number : 8400015
      • Pembroke Pines, Florida, Forente stater, 33025
        • Pines Care Research Center- Site Number : 8400028
    • Idaho
      • Boise, Idaho, Forente stater, 83706
        • Treasure Valley Medical Research- Site Number : 8400031
    • Maryland
      • Baltimore, Maryland, Forente stater, 21224
        • Johns Hopkins Bayview Medical Center- Site Number : 8400012
    • Oklahoma
      • Edmond, Oklahoma, Forente stater, 73034
        • OK Clinical Research- Site Number : 8400001
    • Texas
      • Boerne, Texas, Forente stater, 78006
        • South Texas Medical Research Institute - TTS Research- Site Number : 8400011
  • Italia
      • Verona, Italia, 37134
        • Investigational Site Number : 3800001
    • Napoli
      • Naples, Napoli, Italia, 80131
        • Investigational Site Number : 3800004
    • Roma
      • Rome, Roma, Italia, 00168
        • Investigational Site Number : 3800003
  • Japan
      • Hiroshima, Japan, 732-0052
        • Investigational Site Number : 3920019
      • Tokyo, Japan, 140-8522
        • Investigational Site Number : 3920001
      • Tokyo, Japan, 103-0027
        • Investigational Site Number : 3920005
    • Osaka
      • Sakai, Osaka, Japan, 591-8555
        • Investigational Site Number : 3920010
    • Tokyo
      • Chūō, Tokyo, Japan, 104-0031
        • Investigational Site Number : 3920004
  • Mexico
      • Chihuahua City, Mexico, 31000
        • Investigational Site Number : 4840002
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44100
        • Investigational Site Number : 4840001
      • Guadalajara, Jalisco, Mexico, 44670
        • Investigational Site Number : 4840005
    • Yucatán
      • Mérida, Yucatán, Mexico, 97070
        • Investigational Site Number : 4840008
  • Polen
      • Elblag, Polen, 82-300
        • Investigational Site Number : 6160003
    • Greater Poland Voivodeship
      • Poznan, Greater Poland Voivodeship, Polen, 60-693
        • Investigational Site Number : 6160001
    • Lesser Poland Voivodeship
      • Krakow, Lesser Poland Voivodeship, Polen, 31-209
        • Investigational Site Number : 6160006
      • Tarnów, Lesser Poland Voivodeship, Polen, 33-100
        • Investigational Site Number : 6160007
    • Podlaskie Voivodeship
      • Bialystok, Podlaskie Voivodeship, Polen, 15-044
        • Investigational Site Number : 6160004
    • Pomeranian Voivodeship
      • Gdansk, Pomeranian Voivodeship, Polen, 80-405
        • Investigational Site Number : 6160002
  • Storbritannia
      • Bradford, Storbritannia, BD9 6RJ
        • Investigational Site Number : 8260001
  • Sør -Korea
    • Gyeongsangbuk-do
      • Daegu, Gyeongsangbuk-do, Sør -Korea, 42415
        • Investigational Site Number : 4100004
    • Seoul-teukbyeolsi
      • Seoul, Seoul-teukbyeolsi, Sør -Korea, 05505
        • Investigational Site Number : 4100002
      • Seoul, Seoul-teukbyeolsi, Sør -Korea, 03722
        • Investigational Site Number : 4100001
      • Seoul, Seoul-teukbyeolsi, Sør -Korea, 05030
        • Investigational Site Number : 4100005
      • Seoul, Seoul-teukbyeolsi, Sør -Korea, 06591
        • Investigational Site Number : 4100006
  • Sør-Afrika
      • Benoni, Sør-Afrika, 1500
        • Investigational Site Number : 7100007
      • Cape Town, Sør-Afrika, 7530
        • Investigational Site Number : 7100002
      • Cape Town, Sør-Afrika, 7700
        • Investigational Site Number : 7100001
      • Middelburg, Sør-Afrika, 1055
        • Investigational Site Number : 7100004
  • Tyrkia (Türkiye)
      • Istanbul, Tyrkia (Türkiye), 34098
        • Investigational Site Number : 7920001
      • Izmir, Tyrkia (Türkiye), 35100
        • Investigational Site Number : 7920003
      • Kayseri, Tyrkia (Türkiye), 38039
        • Investigational Site Number : 7920008
      • Mersin, Tyrkia (Türkiye), 33070
        • Investigational Site Number : 7920002
      • İzmit, Tyrkia (Türkiye), 41001
        • Investigational Site Number : 7920005
  • Ungarn
      • Edelény, Ungarn, 3780
        • Investigational Site Number : 3480009
      • Gödöllő, Ungarn, 2100
        • Investigational Site Number : 3480011
      • Püspökladány, Ungarn, 4150
        • Investigational Site Number : 3480006
      • Százhalombatta, Ungarn, 2440
        • Investigational Site Number : 3480012

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 75 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Trippel

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Treatment group 1

Subcutaneous Injection as per protocol
Legemiddel: Amlitelimab

Injection Solution: by subcutaneous injection (SCI)
Eksperimentell: Treatment group 2

Subcutaneous injection as per protocol
Legemiddel: Placebo

Injection Solution: by subcutaneous injection (SCI)

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Percentage of participants with treatment-emergent adverse events
Tidsramme: From baseline up to Week 156 (EOS of LTS17510)

Percentage of participants with treatment emergent Adverse Events.
From baseline up to Week 156 (EOS of LTS17510)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Endring fra foreldrestudiens baseline i prebronkodilatator (BD) og post-BD tvungen ekspirasjonsvolum på 1 sekund (FEV1) ved hvert spirometriendepunkt
Tidsramme: Fra grunnlinjen av foreldrestudien til uke 144 (EOT av LTS17510)
Fra grunnlinjen av foreldrestudien til uke 144 (EOT av LTS17510)
Endring fra LTS17510 studiens baseline i pre bronkodilatator (BD) og post-BD tvunget ekspiratorisk volum på 1 sekund (FEV1) ved hvert spirometriendepunkt
Tidsramme: Fra baseline av LTS17510-studien til uke 144 (EOT av LTS17510)
Fra baseline av LTS17510-studien til uke 144 (EOT av LTS17510)
Endring fra foreldrestudiens baseline i pre-BD og post-BD peak ekspiratorisk flow [PEF] ved hvert spirometriendepunkt
Tidsramme: Fra grunnlinjen for foreldrestudien til uke 144 (EOT av LTS17510)
Fra grunnlinjen for foreldrestudien til uke 144 (EOT av LTS17510)
Endring fra LTS17510-studiens baseline i pre-BD og post-BD peak ekspiratorisk flow [PEF] ved hvert spirometriendepunkt
Tidsramme: Fra baseline av LTS17510-studien til uke 144 (EOT av LTS17510)
Fra baseline av LTS17510-studien til uke 144 (EOT av LTS17510)
Endring fra foreldrestudiens baseline i pre-BD og post-BD tvungen vitalkapasitet [FVC] ved hvert spirometriendepunkt
Tidsramme: Fra grunnlinjen for foreldrestudien til uke 144 (EOT av LTS17510)
Fra grunnlinjen for foreldrestudien til uke 144 (EOT av LTS17510)
Endring fra LTS17510-studiens baseline i pre-BD og post-BD tvungen vitalkapasitet [FVC] ved hvert spirometriendepunkt
Tidsramme: Fra baseline av lTS17510-studien til uke 144 (EOT av LTS17510)
Fra baseline av lTS17510-studien til uke 144 (EOT av LTS17510)
Endring fra foreldrestudiens baseline i pre-BD og post-BD tvungen ekspirasjonsstrøm [FEF] 25 % til 75 %) ved hvert spirometriendepunkt
Tidsramme: Fra grunnlinjen for foreldrestudien til uke 144 (EOT av LTS17510)
Fra grunnlinjen for foreldrestudien til uke 144 (EOT av LTS17510)
Endring fra LTS17510-studiens baseline i pre-BD og post-BD tvungen ekspiratorisk flow [FEF] 25 % til 75 %) ved hvert spirometriendepunkt
Tidsramme: Fra baseline av LTS17510-studien til uke 144 (EOT av LTS17510)
Fra baseline av LTS17510-studien til uke 144 (EOT av LTS17510)
Endring fra foreldrestudiens baseline i fraksjonert utåndet nitrogenoksid (FeNO)
Tidsramme: Fra grunnlinje for foreldrestudie opp til uke 144 (EOT av LTS17510)
Fra grunnlinje for foreldrestudie opp til uke 144 (EOT av LTS17510)
Endring fra LTS17510-studiens baseline i fraksjonert utåndet nitrogenoksid (FeNO)
Tidsramme: Fra LTS17510-studiens baseline opp til uke 144 (EOT av LTS17510)
Fra LTS17510-studiens baseline opp til uke 144 (EOT av LTS17510)
Serum amlitelimab konsentrasjoner
Tidsramme: Fra baseline opp til uke 156 (EOS av LTS17510)
Fra baseline opp til uke 156 (EOS av LTS17510)
Forekomst av anti-amlitelimab antistoff positiv respons
Tidsramme: Fra baseline opp til uke 156 (EOS av LTS17510)
Fra baseline opp til uke 156 (EOS av LTS17510)
Tid til første eksacerbasjonshendelse fra LTS17510-studiens baseline
Tidsramme: Fra baseline av LTS17510-studien til uke 144 (EOT av LTS17510)
Fra baseline av LTS17510-studien til uke 144 (EOT av LTS17510)
Percentage of participants who experienced adverse events.
Tidsramme: 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).
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
Tidsramme: 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.
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
Tidsramme: 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.
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
Tidsramme: 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.
From baseline of the parent 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 LTS17510 study baseline
Tidsramme: 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.
From baseline of the LTS17510 study up to Week 144 (EOT of LTS17510)
Change from parent study baseline in Asthma Control Questionnaire (ACQ)-5, ACQ-6, and ACQ-7 scores
Tidsramme: 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).
From parent study baseline up to Week 144 (EOT of LTS17510)
Change from LTS17510 study baseline in Asthma Control Questionnaire (ACQ)-5, ACQ-6, and ACQ-7 scores
Tidsramme: 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).
From LTS17510 study baseline up to Week 144 (EOT of LTS17510)
Change from parent study baseline and from LTS17510 in Asthma Quality of Life Questionnaire with Standardized Activities (AQLQ [S]) Self-Administered Score
Tidsramme: 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.
From baseline up to Weeks 144 (EOT of LTS17510)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Sanofi

Etterforskere

  • Studieleder: Clinical Sciences & Operations, Sanofi

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

5. september 2023

Primær fullføring (Faktiske)

22. september 2026

Studiet fullført (Faktiske)

22. september 2026

Datoer for studieregistrering

Først innsendt

5. september 2023

Først innsendt som oppfylte QC-kriteriene

5. september 2023

Først lagt ut (Faktiske)

13. september 2023

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

2. oktober 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

29. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • LTS17510
  • U1111-1280-5321 (Registeridentifikator: ICTRP)
  • 2023-503385-24 (Registeridentifikator: CTIS)
  • 2023 (U.S. NIH-stipend/kontrakt)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere