Avaliação de segurança e eficácia de longo prazo do amlitelimabe subcutâneo em participantes adultos com asma moderada a grave que completaram o período de tratamento do estudo clínico anterior sobre asma com amlitelimabe (RIVER-ASTHMA)
Um estudo de extensão de longo prazo para avaliar a segurança, tolerabilidade e eficácia de longo prazo do amlitelimabe subcutâneo em participantes adultos com asma moderada a grave que completaram o período de tratamento do estudo clínico anterior de asma com amlitelimabe
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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
The duration of the study for each participant will be up to 156 weeks.
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 2
Contactos e Locais
Locais de estudo
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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, Brasil, 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, Brasil, 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, Brasil, 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, Brasil, 99010-170
- Instituto Méderi de Pesquisa e Saúde- Site Number : 0760001
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Porto Alegre, Rio Grande do Sul, Brasil, 90020-090
- Irmandade da Santa Casa de Misericórdia de Porto Alegre- Site Number : 0760007
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Porto Alegre, Rio Grande do Sul, Brasil, 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, Brasil, 18040-425
- Clinica de Alergia Martti Antila- Site Number : 0760003
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Ontario
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Ottawa, Ontario, Canadá, K1G 6C6
- Investigational Site Number : 1240008
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Quebec
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Trois-Rivières, Quebec, Canadá, 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, Coréia do Sul, 42415
- Investigational Site Number : 4100004
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Seoul-teukbyeolsi
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Seoul, Seoul-teukbyeolsi, Coréia do Sul, 05505
- Investigational Site Number : 4100002
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Seoul, Seoul-teukbyeolsi, Coréia do Sul, 03722
- Investigational Site Number : 4100001
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Seoul, Seoul-teukbyeolsi, Coréia do Sul, 05030
- Investigational Site Number : 4100005
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Seoul, Seoul-teukbyeolsi, Coréia do Sul, 06591
- Investigational Site Number : 4100006
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California
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Stockton, California, Estados Unidos, 95207
- Bensch Research Associates- Site Number : 8400004
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Florida
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Boynton Beach, Florida, Estados Unidos, 33435
- Helix Biomedics- Site Number : 8400029
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Miami Lakes, Florida, Estados Unidos, 33014
- Savin Medical Group - Miami Lakes- Site Number : 8400015
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Pembroke Pines, Florida, Estados Unidos, 33025
- Pines Care Research Center- Site Number : 8400028
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Idaho
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Boise, Idaho, Estados Unidos, 83706
- Treasure Valley Medical Research- Site Number : 8400031
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Maryland
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Baltimore, Maryland, Estados Unidos, 21224
- Johns Hopkins Bayview Medical Center- Site Number : 8400012
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Oklahoma
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Edmond, Oklahoma, Estados Unidos, 73034
- OK Clinical Research- Site Number : 8400001
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Texas
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Boerne, Texas, Estados Unidos, 78006
- South Texas Medical Research Institute - TTS Research- Site Number : 8400011
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Edelény, Hungria, 3780
- Investigational Site Number : 3480009
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Gödöllő, Hungria, 2100
- Investigational Site Number : 3480011
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Püspökladány, Hungria, 4150
- Investigational Site Number : 3480006
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Százhalombatta, Hungria, 2440
- Investigational Site Number : 3480012
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Verona, Itália, 37134
- Investigational Site Number : 3800001
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Napoli
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Naples, Napoli, Itália, 80131
- Investigational Site Number : 3800004
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Roma
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Rome, Roma, Itália, 00168
- Investigational Site Number : 3800003
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Hiroshima, Japão, 732-0052
- Investigational Site Number : 3920019
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Tokyo, Japão, 140-8522
- Investigational Site Number : 3920001
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Tokyo, Japão, 103-0027
- Investigational Site Number : 3920005
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Osaka
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Sakai, Osaka, Japão, 591-8555
- Investigational Site Number : 3920010
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Tokyo
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Chūō, Tokyo, Japão, 104-0031
- Investigational Site Number : 3920004
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Chihuahua City, México, 31000
- Investigational Site Number : 4840002
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Jalisco
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Guadalajara, Jalisco, México, 44100
- Investigational Site Number : 4840001
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Guadalajara, Jalisco, México, 44670
- Investigational Site Number : 4840005
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Yucatán
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Mérida, Yucatán, México, 97070
- Investigational Site Number : 4840008
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Elblag, Polônia, 82-300
- Investigational Site Number : 6160003
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Greater Poland Voivodeship
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Poznan, Greater Poland Voivodeship, Polônia, 60-693
- Investigational Site Number : 6160001
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Lesser Poland Voivodeship
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Krakow, Lesser Poland Voivodeship, Polônia, 31-209
- Investigational Site Number : 6160006
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Tarnów, Lesser Poland Voivodeship, Polônia, 33-100
- Investigational Site Number : 6160007
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Podlaskie Voivodeship
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Bialystok, Podlaskie Voivodeship, Polônia, 15-044
- Investigational Site Number : 6160004
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Pomeranian Voivodeship
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Gdansk, Pomeranian Voivodeship, Polônia, 80-405
- Investigational Site Number : 6160002
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Bradford, Reino Unido, BD9 6RJ
- Investigational Site Number : 8260001
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Istanbul, Turquia (Türkiye), 34098
- Investigational Site Number : 7920001
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Izmir, Turquia (Türkiye), 35100
- Investigational Site Number : 7920003
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Kayseri, Turquia (Türkiye), 38039
- Investigational Site Number : 7920008
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Mersin, Turquia (Türkiye), 33070
- Investigational Site Number : 7920002
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İzmit, Turquia (Türkiye), 41001
- Investigational Site Number : 7920005
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Benoni, África do Sul, 1500
- Investigational Site Number : 7100007
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Cape Town, África do Sul, 7530
- Investigational Site Number : 7100002
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Cape Town, África do Sul, 7700
- Investigational Site Number : 7100001
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Middelburg, África do Sul, 1055
- Investigational Site Number : 7100004
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Triplo
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: Treatment group 1
Subcutaneous Injection as per protocol |
Injection Solution: by subcutaneous injection (SCI) |
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Experimental: Treatment group 2
Subcutaneous injection as per protocol |
Injection Solution: by subcutaneous injection (SCI) |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Percentage of participants with treatment-emergent adverse events
Prazo: 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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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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Alteração da linha de base do estudo principal no volume expiratório forçado pré-broncodilatador (BD) e pós-BD em 1 segundo (FEV1) em cada endpoint de espirometria
Prazo: Desde a linha de base do estudo principal até a semana 144 (EOT de LTS17510)
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Desde a linha de base do estudo principal até a semana 144 (EOT de LTS17510)
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Alteração da linha de base do estudo LTS17510 no volume expiratório forçado pré-broncodilatador (BD) e pós-BD em 1 segundo (FEV1) em cada ponto final da espirometria
Prazo: Desde a linha de base do estudo LTS17510 até a semana 144 (EOT de LTS17510)
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Desde a linha de base do estudo LTS17510 até a semana 144 (EOT de LTS17510)
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Alteração da linha de base do estudo principal no pico de fluxo expiratório [PFE] pré-BD e pós-BD em cada ponto final da espirometria
Prazo: Desde a linha de base do estudo principal até a Semana 144 (EOT de LTS17510)
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Desde a linha de base do estudo principal até a Semana 144 (EOT de LTS17510)
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Alteração da linha de base do estudo LTS17510 no pico de fluxo expiratório [PFE] pré-BD e pós-BD em cada endpoint de espirometria
Prazo: Desde a linha de base do estudo LTS17510 até a Semana 144 (EOT de LTS17510)
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Desde a linha de base do estudo LTS17510 até a Semana 144 (EOT de LTS17510)
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Alteração da linha de base do estudo principal na capacidade vital forçada [CVF] pré-BD e pós-BD em cada endpoint de espirometria
Prazo: Desde a linha de base do estudo principal até a Semana 144 (EOT de LTS17510)
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Desde a linha de base do estudo principal até a Semana 144 (EOT de LTS17510)
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Alteração da linha de base do estudo LTS17510 na capacidade vital forçada pré-BD e pós-BD [CVF] em cada endpoint de espirometria
Prazo: Desde a linha de base do estudo lTS17510 até a Semana 144 (EOT de LTS17510)
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Desde a linha de base do estudo lTS17510 até a Semana 144 (EOT de LTS17510)
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Alteração da linha de base do estudo principal no fluxo expiratório forçado [FEF] pré-BD e pós-BD de 25% a 75%) em cada endpoint de espirometria
Prazo: Desde a linha de base do estudo principal até a Semana 144 (EOT de LTS17510)
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Desde a linha de base do estudo principal até a Semana 144 (EOT de LTS17510)
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Alteração da linha de base do estudo LTS17510 no fluxo expiratório forçado pré-BD e pós-BD [FEF] de 25% a 75%) em cada endpoint de espirometria
Prazo: Desde a linha de base do estudo LTS17510 até a Semana 144 (EOT de LTS17510)
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Desde a linha de base do estudo LTS17510 até a Semana 144 (EOT de LTS17510)
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Alteração da linha de base do estudo principal em óxido nítrico exalado fracionado (FeNO)
Prazo: Desde a linha de base do estudo principal até a Semana 144 (EOT de LTS17510)
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Desde a linha de base do estudo principal até a Semana 144 (EOT de LTS17510)
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Alteração da linha de base do estudo LTS17510 em óxido nítrico exalado fracionado (FeNO)
Prazo: Desde a linha de base do estudo LTS17510 até a Semana 144 (EOT de LTS17510)
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Desde a linha de base do estudo LTS17510 até a Semana 144 (EOT de LTS17510)
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Concentrações séricas de amlitelimabe
Prazo: Da linha de base até a Semana 156 (EOS de LTS17510)
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Da linha de base até a Semana 156 (EOS de LTS17510)
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Incidência de resposta positiva de anticorpo anti-amlitelimab
Prazo: Da linha de base até a semana 156 (EOS de LTS17510)
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Da linha de base até a semana 156 (EOS de LTS17510)
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Tempo até o primeiro evento de exacerbação desde a linha de base do estudo LTS17510
Prazo: Desde a linha de base do estudo LTS17510 até a semana 144 (EOT de LTS17510)
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Desde a linha de base do estudo LTS17510 até a semana 144 (EOT de LTS17510)
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Percentage of participants who experienced adverse events.
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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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Colaboradores e Investigadores
Patrocinador
Investigadores
- Diretor de estudo: Clinical Sciences & Operations, Sanofi
Publicações e links úteis
Links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- LTS17510
- U1111-1280-5321 (Identificador de registro: ICTRP)
- 2023-503385-24 (Identificador de registro: CTIS)
- 2023 (Concessão/Contrato do NIH dos EUA)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano 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
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
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