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Farmacocinética, Segurança e Eficácia do Nemolizumabe em Participantes com Dermatite Atópica Moderada a Grave

1 de junho de 2026 atualizado por: Galderma R&D

Um ensaio clínico multicêntrico, aberto e de grupo único para avaliar a farmacocinética, a segurança e a eficácia do Nemolizumabe (CD14152) em pacientes pediátricos (de 2 a 11 anos) com dermatite atópica moderada a grave

O objetivo deste estudo é avaliar a farmacocinética (PK), eficácia e segurança do nemolizumabe em participantes pediátricos com dermatite atópica (DA) moderada a grave.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Real)

109

Estágio

  • Fase 2

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

  • Dinamarca
      • Hellerup, Dinamarca, 2900
        • Galderma Investigational Site #6218
  • Espanha
      • Esplugues de Llobregat, Espanha, 0850
        • Galderma Investigational Site #5896
  • Estados Unidos
    • California
      • Fountain Valley, California, Estados Unidos, 92708-3701
        • Galderma Investigational Site #8636
      • San Diego, California, Estados Unidos, 92123-2746
        • Galderma Investigational Site #9937
      • Vista, California, Estados Unidos, 92083-6031
        • Galderma Investigational Site #9930
    • Florida
      • Coral Gables, Florida, Estados Unidos, 92083-6031
        • Galderma Investigational Site #9929
    • Indiana
      • Indianapolis, Indiana, Estados Unidos, 46250-2041
        • Galderma Investigational Site #8142
    • Kentucky
      • Louisville, Kentucky, Estados Unidos, 40217-1444
        • Galderma Investigational Site #8092
    • Michigan
      • Troy, Michigan, Estados Unidos, 48084-5260
        • Galderma Investigational Site #8155
      • West Bloomfield, Michigan, Estados Unidos, 48322
        • Galderma Investigational Site #8560
    • New York
      • Brooklyn, New York, Estados Unidos, 11203-2012
        • Galderma Investigational Site #8242
      • New York, New York, Estados Unidos, 10032-3729
        • Galderma Investigational Site #9938
    • Oklahoma
      • Norman, Oklahoma, Estados Unidos, 73069-6301
        • Galderma Investigational Site #8206
    • Pennsylvania
      • Philadelphia, Pennsylvania, Estados Unidos, 19103-4708
        • Galderma Investigational Site #8255
    • Texas
      • Beaumont, Texas, Estados Unidos, 77706-3061
        • Galderma Investigational Site #9931
      • San Antonio, Texas, Estados Unidos, 78218-3128
        • Galderma Investigational Site #78218-3128
  • Hungria
      • Budapest, Hungria, 1036
        • Galderma Investigational Site #6147
      • Szeged, Hungria, 6720
        • Galderma Investigational Site #5531
  • Polônia
      • Lodz, Polônia, 90-265
        • Galderma Investigational Site #5570
      • Ostrowiec Świętokrzyski, Polônia, 27-400
        • Galderma Investigational Site #6237
      • Rzeszów, Polônia, 35-055
        • Galderma Investigational Site #5495
      • Warsaw, Polônia, 02-953
        • Galderma Investigational Site #6262
      • Wroclaw, Polônia, 51-685
        • Galderma Investigational Site #6261

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

2 anos a 12 anos (Filho)

Aceita Voluntários Saudáveis

Não

Descrição

Critério de inclusão:

  • DA crônica que foi documentada por pelo menos 6 meses para participantes de 2 a 6 anos e pelo menos 1 ano para participantes de 7 a 11 anos antes da visita de triagem e confirmada de acordo com os critérios de consenso da Academia Americana de Dermatologia no momento da avaliação visita de triagem
  • Pontuação EASI >=16 tanto na triagem quanto nas visitas iniciais
  • Pontuação IGA >=3 tanto na triagem quanto nas visitas iniciais
  • Envolvimento de AD >=10% de BSA em ambas as visitas de triagem e de linha de base
  • Pontuação PP NRS de pico (máxima) de pelo menos 4,0 nas visitas de triagem e de linha de base
  • Concordar em aplicar um hidratante durante todo o estudo desde a visita de triagem diariamente e generosamente conforme necessário; concorda em aplicar corticosteróides tópicos autorizados (TCS) desde a visita de triagem e durante todo o estudo, conforme determinado pelo investigador
  • Participante e cuidador dispostos e capazes de cumprir todos os compromissos de tempo e requisitos processuais do protocolo do estudo clínico
  • Outros critérios de inclusão definidos pelo protocolo podem ser aplicados

Critério de exclusão:

  • Peso corporal inferior a 10 quilogramas (kg)
  • Child in Care: uma criança que foi colocada sob o controle ou proteção de uma agência, organização, instituição ou entidade pelos tribunais, governo ou órgão governamental, agindo de acordo com os poderes que lhe são conferidos por lei ou regulamento
  • Participantes com histórico médico atual de bronquite crônica
  • Necessita de terapia de resgate para DA durante o período inicial ou espera-se que necessite de terapia de resgate dentro de 2 semanas após a visita inicial
  • Resultados de sorologia positivos para antígeno de superfície da hepatite B (HBsAg) ou anticorpo core da hepatite B (HBcAb), anticorpo da hepatite C (HCV) com teste confirmatório positivo para HCV (exemplo: reação em cadeia da polimerase [PCR]) ou vírus da imunodeficiência humana (HIV) anticorpo na visita de triagem
  • História de doença linfoproliferativa, hipersensibilidade (incluindo anafilaxia) a um produto de imunoglobulina e intolerância a corticosteroides tópicos de baixa ou média potência
  • Imunossupressão conhecida ou suspeita
  • Participantes que não desejam abster-se de usar medicamentos proibidos durante o ensaio clínico.
  • Outros critérios de exclusão definidos pelo protocolo podem ser aplicados

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Não randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Coorte 2: participantes de 2 a 6 anos
Os participantes com idade entre 2 e 6 anos receberão nemolizumabe por 52 semanas.
Medicamento: Nemolizumabe
Os participantes receberão injeção subcutânea (SC) de 10, 20 ou 30 miligramas (mg) de nemolizumabe, a cada 4 semanas (Q4W) por 52 semanas com uma dose de ataque de 20, 40 ou 60 mg no dia 1 com base no peso corporal.
Outros nomes:
  • CD14152
Medicamento: Nemolizumabe
Os participantes receberão injeção SC de 5, 10 ou 15 mg de nemolizumabe, Q4W por 52 semanas com uma dose de ataque de 10, 20 ou 30 mg no dia 1 com base no peso corporal.
Outros nomes:
  • CD14152
Experimental: Coorte 1.1: Participantes de 7 a 11 anos
Os participantes com idades entre 7 e 11 anos receberão nemolizumabe por 52 semanas.
Medicamento: Nemolizumabe
Os participantes receberão injeção subcutânea (SC) de 10, 20 ou 30 miligramas (mg) de nemolizumabe, a cada 4 semanas (Q4W) por 52 semanas com uma dose de ataque de 20, 40 ou 60 mg no dia 1 com base no peso corporal.
Outros nomes:
  • CD14152
Medicamento: Nemolizumabe
Os participantes receberão injeção SC de 5, 10 ou 15 mg de nemolizumabe, Q4W por 52 semanas com uma dose de ataque de 10, 20 ou 30 mg no dia 1 com base no peso corporal.
Outros nomes:
  • CD14152
Experimental: Coorte 1: participantes de 7 a 11 anos
Os participantes de 7 a 11 anos receberão nemolizumab por 52 semanas.
Medicamento: Nemolizumabe
Os participantes receberão injeção subcutânea (SC) de 10, 20 ou 30 miligramas (mg) de nemolizumabe, a cada 4 semanas (Q4W) por 52 semanas com uma dose de ataque de 20, 40 ou 60 mg no dia 1 com base no peso corporal.
Outros nomes:
  • CD14152
Medicamento: Nemolizumabe
Os participantes receberão injeção SC de 5, 10 ou 15 mg de nemolizumabe, Q4W por 52 semanas com uma dose de ataque de 10, 20 ou 30 mg no dia 1 com base no peso corporal.
Outros nomes:
  • CD14152

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Nemolizumab Serum Concentrations
Prazo: At Weeks 4, 8, 12, 16, 32 and 52
Serum concentrations of Nemolizumab were analyzed using validated enzyme linked immunosorbent assay (ELISA).
At Weeks 4, 8, 12, 16, 32 and 52
Apparent Total Body Clearance (Cl/F) of Nemolizumab
Prazo: Pre-dose at Weeks 4, 8, 12, 16, 32 and 52
CL/F is apparent clearance of the drug from the serum, calculated as the drug dose divided area under the curve from time 0 extrapolated to infinite time [AUC (0-inf)]. Individual nemolizumab.
Pre-dose at Weeks 4, 8, 12, 16, 32 and 52
Apparent Volume of Distribution (Vd/F) of Nemolizumab
Prazo: Pre-dose at Weeks 4, 8, 12, 16, 32 and 52
Vd/F was calculated as dose divided by lambda_z *AUC(0-inf).
Pre-dose at Weeks 4, 8, 12, 16, 32 and 52
Absorption Rate Constant (Ka) of Nemolizumab
Prazo: Pre-dose at Weeks 4, 8, 12, 16, 32 and 52
Pre-dose at Weeks 4, 8, 12, 16, 32 and 52
Serum Concentration Observed Immediately Before Next Dosing (Ctrough) of Nemolizumab
Prazo: Pre-dose at Weeks 4, 8, 12, and 16
Pre-dose at Weeks 4, 8, 12, and 16
Area Under the Serum Concentration-Time Curve From Time Zero to Infinity (AUCinf) of Nemolizumab
Prazo: Pre-dose at Weeks 4, 8, 12, 16, 32 and 52
Pre-dose at Weeks 4, 8, 12, 16, 32 and 52
Apparent Terminal Half-life (t1/2) of Nemolizumab
Prazo: Pre-dose at Weeks 4, 8, 12, 16, 32 and 52
Pre-dose at Weeks 4, 8, 12, 16, 32 and 52
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Adverse Events of Special Interest (AESIs), Adverse Events Leading to Discontinuation and Serious Adverse Events (SAEs)
Prazo: Baseline through Week 52
AE defined as any untoward medical occurrence in clinical study participant administered a medicinal product which does not necessarily have causal relationship with this treatment. TEAEs defined as AEs occurring after first administration of study drug during the study. SAE was any untoward medical occurrence, in view of either Investigator or Sponsor, that resulted in death, was life-threatening, resulted in inpatient hospitalisation or prolongation of existing hospitalisation, resulted in persistent or significant disability/incapacity, was congenital anomaly/birth defect or was important medical event. AESI was noteworthy TEAE for study drug that was to be monitored closely and reported promptly. Relatedness to study drug was based on Investigator's discretion. AEs Leading to study treatment withdrawal and AEs Leading to study withdrawal will also be reported.
Baseline through Week 52

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score at Each Visit up to Week 52
Prazo: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
EASI assesses severity and extent of AD signs through a composite score of erythema, induration/population, excoriation, and lichenification. The severity was assessed on a scale of 0 (absent) to 3 (severe) for each of the 4 body areas: head/neck, trunk, upper limbs, and lower limbs, with half points allowed. The EASI score ranged from 0 to 72 with higher scores representing greater severity of atopic dermatitis.
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Absolute Change From Baseline in EASI Score
Prazo: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
EASI assesses severity and extent of AD signs through a composite score of erythema, induration/population, excoriation, and lichenification. The severity was assessed on a scale of 0 (absent) to 3 (severe) for each of the 4 body areas: head/neck, trunk, upper limbs, and lower limbs, with half points allowed. The EASI score ranged from 0 to 72 with higher scores representing greater severity of atopic dermatitis.
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Number of Participants Achieving 50 Percent (%), 75% or 90% Response From Baseline in EASI (EASI-50, EASI-75 and EASI-90)
Prazo: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
EASI assesses severity and extent of AD signs through a composite score of erythema, induration/population, excoriation, and lichenification. The severity was assessed on a scale of 0 (absent) to 3 (severe) for each of the 4 body areas: head/neck, trunk, upper limbs, and lower limbs, with half points allowed. The EASI score ranged from 0 to 72 with higher scores representing greater severity of atopic dermatitis. EASI-50, EASI-75 and EASI-90 responders will be the participants who achieved greater than or equal to (>=) 50%, >=75% and >=90% overall improvement in EASI score respectively from baseline to Week 52.
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Number of Participants With Investigator's Global Assessment (IGA) Success Rate
Prazo: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
IGA is a 5-point scale used by the investigator or trained designee to evaluate the global severity of AD. The Investigator reviewed the participant's skin and give a score of 0 (Clear), 1 (Almost clear), 2 (Mild), 3 (Moderate), or 4 (Severe). Here, higher score indicates severe outcome. Success was defined as an IGA of 0 [Clear] or 1 [Almost clear] and a >=2-points improvement from baseline. Number of participants with IGA success rate was reported for this outcome measure.
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Change From Baseline in Body Surface Area (BSA) Involvement by Atopic Dermatitis (AD)
Prazo: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
BSA affected by AD was assessed for each section of the body (the possible highest score for each region was: head and neck [9%], anterior trunk [18%], back [18%], upper limbs [18%], lower limbs [36%], and genitals [1%]) and reported as a percentage of all major body sections combined. The reported percentage of BSA was combined percentage of all major body sections.
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Absolute Change From Baseline in Weekly Average of Peak Pruritus Numeric Rating Scale (PP NRS) Score
Prazo: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Pruritus NRS is a scale that will be used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. For maximum itch intensity: the scores were provided on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable'. Higher scores indicated worse outcome.
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Percent Change From Baseline in Weekly Average of PP NRS Score
Prazo: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Pruritus NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. For maximum itch intensity: the scores were provided on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable'. Higher scores indicated worse outcome.
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Percentage of Participants With an Improvement of >= 4 From Baseline in Weekly Average of PP NRS
Prazo: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Pruritus NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. For maximum itch intensity: the scores were provided on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable'. Higher scores indicated worse outcome.
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Absolute Change From Baseline in Weekly Average of Average Pruritus NRS Score
Prazo: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Pruritus NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. For maximum itch intensity: the scores were provided on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable'. Higher scores indicated worse outcome.
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Percent Change From Baseline in Weekly Average of Average Pruritus NRS Score
Prazo: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Pruritus NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. For maximum itch intensity: the scores were provided on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable'. Higher scores indicated worse outcome.
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Absolute Change From Baseline in Weekly Average of Sleep Disturbance NRS Score
Prazo: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
The sleep disturbance NRS is a scale used by the participants to report the degree of their sleep loss related to AD. Participants were asked the following questions in their local language: how would you rate your sleep last night? On a scale of 0 to 10, with 0 being 'no sleep loss related to signs/symptoms of AD' and 10 being 'I cannot sleep at all due to the signs/symptoms of AD'. Higher scores indicated worse outcome.
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Percent Change From Baseline in Weekly Average of Sleep Disturbance NRS Score
Prazo: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
The sleep disturbance NRS is a scale used by the participants to report the degree of their sleep loss related to AD. Participants were asked the following questions in their local language: how would you rate your sleep last night? On a scale of 0 to 10, with 0 being 'no sleep loss related to signs/symptoms of AD' and 10 being 'I cannot sleep at all due to the signs/symptoms of AD'. Higher scores indicated worse outcome.
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Percentage of Participants Receiving Any Rescue Therapy by Rescue Treatment
Prazo: From Baseline up to Week 52
Percentage of participants receiving any rescue therapy by rescue treatment was reported.
From Baseline up to Week 52
Percent Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Score
Prazo: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
SCORAD is a clinical tool for assessing the severity and the extent of AD signs and symptoms. Extent and intensity of eczema as well as subjective signs (insomnia, etc.) are assessed and scored. Total score ranged from 0 (absent disease) to 103 (severe disease), a higher score indicated severe disease.
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Change From Baseline in Children's Dermatology Life Quality Index (cDLQI) For Participants >=4 Years of Age
Prazo: Baseline, Week 16 and Week 52
The DLQI is a validated 10-item questionnaire covering domains including symptoms/feelings, daily activities, leisure, work/school, personal relationships, and treatment. The participant rated each question ranging from 0 (not at all) to 3 (very much) and score ranged from 0 to 30. A higher total score indicated a poorer quality of life (QoL).
Baseline, Week 16 and Week 52
Change From Baseline in Infants' Dermatology Life Quality Index (iDLQI) Score For Participants Less Than (<) 4 Years of Age
Prazo: Baseline, Week 16 and Week 52
The DLQI is a validated 10-item questionnaire covering domains including symptoms/feelings, daily activities, leisure, work/school, personal relationships, and treatment. The participant rated each question ranging from 0 (not at all) to 3 (very much) and score ranged from 0 to 30. A higher total score indicated a poorer QoL.
Baseline, Week 16 and Week 52
Change From Baseline in Patient-Oriented Eczema Measure (POEM)
Prazo: Baseline, Week 16 and Week 52
The POEM is a 7-item questionnaire that assessed disease symptoms (dryness, itching, flaking, cracking, sleep loss, bleeding and weeping) with a scoring system of 0 (absent disease) to 28 (severe disease). A high score indicated poor QOL.
Baseline, Week 16 and Week 52
Pharmacokinetic (PK)/Pharmacodynamic (PD) Relationship Between Nemolizumab Serum Concentration and Changes in PP NRS
Prazo: Baseline up to Week 52
The relationship between nemolizumab serum concentrations and changes in PP-NRS score was established using population point estimate of IC50, where IC50 is the concentration leading to half of the maximum drug-induced reduction (Imax) in PP NRS.
Baseline up to Week 52
PK/PD Relationship Between Nemolizumab Serum Concentration and Changes in EASI Score
Prazo: Baseline up to Week 52
The relationship between nemolizumab serum concentrations and changes in EASI score was established using population point estimate of IC50. Where, IC50 is the concentration leading to half of the maximum drug-induced reduction (Imax) in EASI score.
Baseline up to Week 52
PK/PD Relationship Between Nemolizumab Serum Concentration and Changes in IGA Score
Prazo: Baseline up to Week 52
The relationship between nemolizumab serum concentrations and changes in IGA score was established using the population point estimate of the slope parameter.
Baseline up to Week 52
Number of Participants With Positive Anti-Drug Antibody (ADA) for Nemolizumab
Prazo: Baseline, Week 16 and Week 52
ADA positive was defined as a sample that was evaluated as positive in both the ADA screening and confirmatory assays. ADA positive participants was defined as participants who had at least 1 positive ADA result.
Baseline, Week 16 and Week 52

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Galderma R&D

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

24 de junho de 2021

Conclusão Primária (Real)

28 de abril de 2025

Conclusão do estudo (Real)

28 de abril de 2025

Datas de inscrição no estudo

Enviado pela primeira vez

4 de junho de 2021

Enviado pela primeira vez que atendeu aos critérios de CQ

4 de junho de 2021

Primeira postagem (Real)

10 de junho de 2021

Atualizações de registro de estudo

Última Atualização Postada (Real)

25 de junho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

1 de junho de 2026

Última verificação

1 de abril de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • RD.06.SPR.118126

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Sim

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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