Valutazione della sicurezza e dell’efficacia a lungo termine di amlitelimab sottocutaneo in partecipanti adulti con asma da moderato a grave che hanno completato il periodo di trattamento del precedente studio clinico sull’asma con amlitelimab (RIVER-ASTHMA)
Uno studio di estensione a lungo termine per valutare la sicurezza, la tollerabilità e l’efficacia a lungo termine di amlitelimab sottocutaneo in partecipanti adulti con asma da moderato a grave che hanno completato il periodo di trattamento del precedente studio clinico sull’asma con amlitelimab
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.
Panoramica dello studio
Descrizione dettagliata
The duration of the study for each participant will be up to 156 weeks.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 2
Contatti e Sedi
Luoghi di studio
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Buenos Aires, Argentina, 1425
- Investigational Site Number : 0320001
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Buenos Aires, Argentina, 1121
- Investigational Site Number : 0320004
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Buenos Aires, Argentina, 1414
- Investigational Site Number : 0320003
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Buenos Aires, Argentina, 1425
- Investigational Site Number : 0320002
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Buenos Aires, Argentina, 1650
- Investigational Site Number : 0320009
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Buenos Aires
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La Plata, Buenos Aires, Argentina, 1900
- Investigational Site Number : 0320008
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Santa Fe Province
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Rosario, Santa Fe Province, Argentina, 2000
- Investigational Site Number : 0320006
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Rosario, Santa Fe Province, Argentina, 2000
- Investigational Site Number : 0320007
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Rosario, Santa Fe Province, Argentina, 2000
- Investigational Site Number : 0320005
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São Paulo, Brasile, 05403-000
- Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo- Site Number : 0760008
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Espírito Santo
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Vitória, Espírito Santo, Brasile, 29055-450
- Centro de Diagnostico e Pesquisa da Osteoporose do Espirito Santo- Site Number : 0760002
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Estado de Bahia
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Salvador, Estado de Bahia, Brasile, 40060-330
- Associacao Proar- Site Number : 0760004
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Rio Grande do Sul
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Passo Fundo, Rio Grande do Sul, Brasile, 99010-170
- Instituto Méderi de Pesquisa e Saúde- Site Number : 0760001
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Porto Alegre, Rio Grande do Sul, Brasile, 90020-090
- Irmandade da Santa Casa de Misericórdia de Porto Alegre- Site Number : 0760007
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Porto Alegre, Rio Grande do Sul, Brasile, 90610-000
- Hospital São Lucas da PUCRS - Porto Alegre - Avenida Ipiranga- Site Number : 0760006
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São Paulo
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Sorocaba, São Paulo, Brasile, 18040-425
- Clinica de Alergia Martti Antila- Site Number : 0760003
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Ontario
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Ottawa, Ontario, Canada, K1G 6C6
- Investigational Site Number : 1240008
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Quebec
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Trois-Rivières, Quebec, Canada, G8T 7A1
- Investigational Site Number : 1240007
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Maule Region
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Talca, Maule Region, Chile, 3465584
- Investigational Site Number : 1520006
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Reg Metropolitana de Santiago
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Santiago, Reg Metropolitana de Santiago, Chile, 7500692
- Investigational Site Number : 1520001
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Santiago, Reg Metropolitana de Santiago, Chile, 7750495
- Investigational Site Number : 1520003
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Santiago, Reg Metropolitana de Santiago, Chile, 8380465
- Investigational Site Number : 1520008
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Valparaiso
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Quillota, Valparaiso, Chile, 2260877
- Investigational Site Number : 1520005
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Gyeongsangbuk-do
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Daegu, Gyeongsangbuk-do, Corea del Sud, 42415
- Investigational Site Number : 4100004
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Seoul-teukbyeolsi
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Seoul, Seoul-teukbyeolsi, Corea del Sud, 05505
- Investigational Site Number : 4100002
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Seoul, Seoul-teukbyeolsi, Corea del Sud, 03722
- Investigational Site Number : 4100001
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Seoul, Seoul-teukbyeolsi, Corea del Sud, 05030
- Investigational Site Number : 4100005
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Seoul, Seoul-teukbyeolsi, Corea del Sud, 06591
- Investigational Site Number : 4100006
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Hiroshima, Giappone, 732-0052
- Investigational Site Number : 3920019
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Tokyo, Giappone, 140-8522
- Investigational Site Number : 3920001
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Tokyo, Giappone, 103-0027
- Investigational Site Number : 3920005
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Osaka
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Sakai, Osaka, Giappone, 591-8555
- Investigational Site Number : 3920010
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Tokyo
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Chūō, Tokyo, Giappone, 104-0031
- Investigational Site Number : 3920004
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Verona, Italia, 37134
- Investigational Site Number : 3800001
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Napoli
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Naples, Napoli, Italia, 80131
- Investigational Site Number : 3800004
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Roma
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Rome, Roma, Italia, 00168
- Investigational Site Number : 3800003
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Chihuahua City, Messico, 31000
- Investigational Site Number : 4840002
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Jalisco
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Guadalajara, Jalisco, Messico, 44100
- Investigational Site Number : 4840001
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Guadalajara, Jalisco, Messico, 44670
- Investigational Site Number : 4840005
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Yucatán
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Mérida, Yucatán, Messico, 97070
- Investigational Site Number : 4840008
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Elblag, Polonia, 82-300
- Investigational Site Number : 6160003
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Greater Poland Voivodeship
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Poznan, Greater Poland Voivodeship, Polonia, 60-693
- Investigational Site Number : 6160001
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Lesser Poland Voivodeship
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Krakow, Lesser Poland Voivodeship, Polonia, 31-209
- Investigational Site Number : 6160006
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Tarnów, Lesser Poland Voivodeship, Polonia, 33-100
- Investigational Site Number : 6160007
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Podlaskie Voivodeship
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Bialystok, Podlaskie Voivodeship, Polonia, 15-044
- Investigational Site Number : 6160004
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Pomeranian Voivodeship
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Gdansk, Pomeranian Voivodeship, Polonia, 80-405
- Investigational Site Number : 6160002
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Bradford, Regno Unito, BD9 6RJ
- Investigational Site Number : 8260001
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California
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Stockton, California, Stati Uniti, 95207
- Bensch Research Associates- Site Number : 8400004
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Florida
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Boynton Beach, Florida, Stati Uniti, 33435
- Helix Biomedics- Site Number : 8400029
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Miami Lakes, Florida, Stati Uniti, 33014
- Savin Medical Group - Miami Lakes- Site Number : 8400015
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Pembroke Pines, Florida, Stati Uniti, 33025
- Pines Care Research Center- Site Number : 8400028
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Idaho
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Boise, Idaho, Stati Uniti, 83706
- Treasure Valley Medical Research- Site Number : 8400031
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Maryland
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Baltimore, Maryland, Stati Uniti, 21224
- Johns Hopkins Bayview Medical Center- Site Number : 8400012
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Oklahoma
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Edmond, Oklahoma, Stati Uniti, 73034
- OK Clinical Research- Site Number : 8400001
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Texas
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Boerne, Texas, Stati Uniti, 78006
- South Texas Medical Research Institute - TTS Research- Site Number : 8400011
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Benoni, Sud Africa, 1500
- Investigational Site Number : 7100007
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Cape Town, Sud Africa, 7530
- Investigational Site Number : 7100002
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Cape Town, Sud Africa, 7700
- Investigational Site Number : 7100001
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Middelburg, Sud Africa, 1055
- Investigational Site Number : 7100004
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Istanbul, Turchia (Türkiye), 34098
- Investigational Site Number : 7920001
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Izmir, Turchia (Türkiye), 35100
- Investigational Site Number : 7920003
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Kayseri, Turchia (Türkiye), 38039
- Investigational Site Number : 7920008
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Mersin, Turchia (Türkiye), 33070
- Investigational Site Number : 7920002
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İzmit, Turchia (Türkiye), 41001
- Investigational Site Number : 7920005
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Edelény, Ungheria, 3780
- Investigational Site Number : 3480009
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Gödöllő, Ungheria, 2100
- Investigational Site Number : 3480011
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Püspökladány, Ungheria, 4150
- Investigational Site Number : 3480006
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Százhalombatta, Ungheria, 2440
- Investigational Site Number : 3480012
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Non randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Triplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: Treatment group 1
Subcutaneous Injection as per protocol |
Injection Solution: by subcutaneous injection (SCI) |
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Sperimentale: Treatment group 2
Subcutaneous injection as per protocol |
Injection Solution: by subcutaneous injection (SCI) |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Percentage of participants with treatment-emergent adverse events
Lasso di tempo: From baseline up to Week 156 (EOS of LTS17510)
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Percentage of participants with treatment emergent Adverse Events. |
From baseline up to Week 156 (EOS of LTS17510)
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Variazione rispetto al basale dello studio genitore nel volume espiratorio forzato pre-broncodilatatore (BD) e post-BD in 1 secondo (FEV1) a ciascun endpoint spirometrico
Lasso di tempo: Dal basale dello studio genitore fino alla settimana 144 (EOT di LTS17510)
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Dal basale dello studio genitore fino alla settimana 144 (EOT di LTS17510)
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Variazione rispetto al basale dello studio LTS17510 nel volume espiratorio forzato in 1 secondo (FEV1) pre-broncodilatatore (BD) e post-BD a ciascun endpoint spirometrico
Lasso di tempo: Dal basale dello studio LTS17510 fino alla settimana 144 (EOT di LTS17510)
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Dal basale dello studio LTS17510 fino alla settimana 144 (EOT di LTS17510)
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Variazione rispetto al basale dello studio originale del picco di flusso espiratorio [PEF] pre-BD e post-BD a ciascun endpoint spirometrico
Lasso di tempo: Dal basale dello studio genitore fino alla settimana 144 (EOT di LTS17510)
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Dal basale dello studio genitore fino alla settimana 144 (EOT di LTS17510)
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Variazione rispetto al basale dello studio LTS17510 nel picco di flusso espiratorio [PEF] pre-BD e post-BD a ciascun endpoint spirometrico
Lasso di tempo: Dal basale dello studio LTS17510 fino alla settimana 144 (EOT di LTS17510)
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Dal basale dello studio LTS17510 fino alla settimana 144 (EOT di LTS17510)
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Variazione rispetto al basale dello studio originale della capacità vitale forzata [FVC] pre-BD e post-BD a ciascun endpoint spirometrico
Lasso di tempo: Dal basale dello studio genitore fino alla settimana 144 (EOT di LTS17510)
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Dal basale dello studio genitore fino alla settimana 144 (EOT di LTS17510)
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Variazione rispetto al basale dello studio LTS17510 nella capacità vitale forzata [FVC] pre-BD e post-BD a ciascun endpoint spirometrico
Lasso di tempo: Dal basale dello studio lTS17510 fino alla settimana 144 (EOT di LTS17510)
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Dal basale dello studio lTS17510 fino alla settimana 144 (EOT di LTS17510)
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Variazione rispetto al basale dello studio originale nel flusso espiratorio forzato [FEF] pre-BD e post-BD dal 25% al 75%) a ciascun endpoint spirometrico
Lasso di tempo: Dal basale dello studio genitore fino alla settimana 144 (EOT di LTS17510)
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Dal basale dello studio genitore fino alla settimana 144 (EOT di LTS17510)
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Variazione rispetto al basale dello studio LTS17510 nel flusso espiratorio forzato [FEF] pre-BD e post-BD dal 25% al 75%) a ciascun endpoint spirometrico
Lasso di tempo: Dal basale dello studio LTS17510 fino alla settimana 144 (EOT di LTS17510)
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Dal basale dello studio LTS17510 fino alla settimana 144 (EOT di LTS17510)
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Variazione rispetto al basale dello studio originale nell'ossido nitrico esalato frazionario (FeNO)
Lasso di tempo: Dal basale dello studio principale fino alla settimana 144 (EOT di LTS17510)
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Dal basale dello studio principale fino alla settimana 144 (EOT di LTS17510)
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Variazione rispetto al basale dello studio LTS17510 relativo all'ossido nitrico esalato frazionario (FeNO)
Lasso di tempo: Dal basale dello studio LTS17510 fino alla settimana 144 (EOT di LTS17510)
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Dal basale dello studio LTS17510 fino alla settimana 144 (EOT di LTS17510)
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Concentrazioni sieriche di amlitelimab
Lasso di tempo: Dal basale fino alla settimana 156 (EOS di LTS17510)
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Dal basale fino alla settimana 156 (EOS di LTS17510)
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Incidenza della risposta positiva agli anticorpi anti-amlitelimab
Lasso di tempo: Dal basale fino alla settimana 156 (EOS di LTS17510)
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Dal basale fino alla settimana 156 (EOS di LTS17510)
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Tempo al primo evento di riacutizzazione dal basale dello studio LTS17510
Lasso di tempo: Dal basale dello studio LTS17510 Fino alla settimana 144 (EOT di LTS17510)
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Dal basale dello studio LTS17510 Fino alla settimana 144 (EOT di LTS17510)
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Percentage of participants who experienced adverse events.
Lasso di tempo: From baseline up to Week 156 (End of Study [EOS] of LTS17510)
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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)
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Annualized rate of severe exacerbation events over treatment period from parent study baseline
Lasso di tempo: From baseline of the parent study up to Week 144 (End of Treatment [EOT] of LTS17510)
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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)
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Annualized rate of severe exacerbation events over treatment period from LTS17510 study baseline
Lasso di tempo: From baseline of the LTS17510 study Up to Week 144 (EOT of LTS17510)
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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)
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Annualized rate of severe asthma exacerbations requiring hospitalization or emergency room or urgent care visit over treatment period from parent study baseline
Lasso di tempo: From baseline of the parent study up to Week 144 (EOT of LTS17510)
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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)
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Annualized rate of severe asthma exacerbations requiring hospitalization or emergency room or urgent care visit over treatment period from LTS17510 study baseline
Lasso di tempo: From baseline of the LTS17510 study up to Week 144 (EOT of LTS17510)
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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)
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Change from parent study baseline in Asthma Control Questionnaire (ACQ)-5, ACQ-6, and ACQ-7 scores
Lasso di tempo: From parent study baseline up to Week 144 (EOT of LTS17510)
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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)
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Change from LTS17510 study baseline in Asthma Control Questionnaire (ACQ)-5, ACQ-6, and ACQ-7 scores
Lasso di tempo: From LTS17510 study baseline up to Week 144 (EOT of LTS17510)
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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)
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Change from parent study baseline and from LTS17510 in Asthma Quality of Life Questionnaire with Standardized Activities (AQLQ [S]) Self-Administered Score
Lasso di tempo: From baseline up to Weeks 144 (EOT of LTS17510)
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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)
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Collaboratori e investigatori
Sponsor
Investigatori
- Direttore dello studio: Clinical Sciences & Operations, Sanofi
Pubblicazioni e link utili
Collegamenti utili
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- LTS17510
- U1111-1280-5321 (Identificatore di registro: ICTRP)
- 2023-503385-24 (Identificatore di registro: CTIS)
- 2023 (Sovvenzione/contratto NIH degli Stati Uniti)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
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
Informazioni su farmaci e dispositivi, documenti di studio
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .