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Estudo de Fase 2a de Eficácia e Segurança do OpSCF na Dermatite Atópica Moderada a Grave

17 de agosto de 2026 atualizado por: Insmed Incorporated

Um estudo randomizado, duplo-cego, controlado por placebo, de fase 2a para avaliar a eficácia e segurança do OpSCF no tratamento de adultos com dermatite atópica moderada a grave

O objetivo deste estudo é determinar a eficácia e segurança deste anticorpo monoclonal, OpSCF, no tratamento de adultos com Dermatite Atópica (Eczema) moderada a grave. OpSCF será comparado a um placebo.

OpSCF ou placebo serão administrados a cada 2 semanas durante 14 semanas, e a eficácia será avaliada duas semanas depois. Depois disso, os sujeitos podem optar por entrar em uma fase de extensão aberta, na qual todos os sujeitos receberão OpSCF a cada 4 semanas por 40 semanas adicionais.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Real)

50

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

  • Canadá
    • Ontario
      • Oshawa, Ontario, Canadá, L1H 1B9
        • Oshawa Clinic Dermatology Trials
      • Toronto, Ontario, Canadá, M4W 2N2
        • Research Toronto
    • Quebec
      • Montreal, Quebec, Canadá, H2X 2V1
        • Innovaderm Research Inc
      • Québec, Quebec, Canadá, G1W 4R4
        • Centre de Recherche Saint-Louis
  • Estados Unidos
    • Alabama
      • Birmingham, Alabama, Estados Unidos, 33607
        • Cahaba Dermatology & Skin Health Center
    • California
      • Fountain Valley, California, Estados Unidos, 92708
        • First OC Dermatology Research
      • Inglewood, California, Estados Unidos, 90301
        • Axon Clinical Research
      • San Diego, California, Estados Unidos, 92123
        • University Clinical Trials
      • Sherman Oaks, California, Estados Unidos, 91403
        • Unison Clinical Trials
    • Florida
      • Boca Raton, Florida, Estados Unidos, 33456
        • Skin Care Research
      • Miami, Florida, Estados Unidos, 33173
        • Skin Research of South Florida
      • Miami Lakes, Florida, Estados Unidos, 33014
        • RM Medical Research
      • Tampa, Florida, Estados Unidos, 33607
        • Advanced Clinical Research Institute
    • Illinois
      • Rolling Meadows, Illinois, Estados Unidos, 60008
        • Arlington Dermatology
    • Indiana
      • West Lafayette, Indiana, Estados Unidos, 47906
        • Options Research Group
    • Kentucky
      • Louisville, Kentucky, Estados Unidos, 40241
        • DS Research of Kentucky
    • Michigan
      • Auburn Hills, Michigan, Estados Unidos, 48326
        • Oakland Hills Dermatology P.C
      • Bay City, Michigan, Estados Unidos, 48706
        • Saginaw Bay Dermatology
    • Nevada
      • Reno, Nevada, Estados Unidos, 89509
        • Skin Cancer and Dermatology Institute
    • New York
      • Kew Gardens, New York, Estados Unidos, 11415
        • Forest Hills Dermatology Group
    • Texas
      • Frisco, Texas, Estados Unidos, 75034
        • Rodgers Dermatology
    • Washington
      • Bellevue, Washington, Estados Unidos, 98004
        • Dermatology Of Seattle

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

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

Critério de inclusão:

  • O sujeito tem diagnóstico clinicamente confirmado de DA ativa
  • O sujeito tem pelo menos 6 meses de história de DA
  • O sujeito está disposto a usar métodos anticoncepcionais eficazes

Critério de exclusão:

  • O sujeito é uma mulher que está amamentando, grávida ou que planeja engravidar durante o estudo.
  • O sujeito tem qualquer condição médica clinicamente significativa que o colocaria em risco indevido ou interferiria na interpretação dos resultados do estudo.
  • O indivíduo usou dupilumabe nas 26 semanas anteriores ao Dia 1
  • O indivíduo usou tralocinumabe nas 12 semanas anteriores ao Dia 1

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: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Quadruplicar

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: OpSCF 600 mg
Participants received OpSCF 600 milligrams (mg), once every 2 weeks (Q2W), subcutaneously (SC), up to 14 weeks in the placebo-controlled period.
Biológico: OpSCF
Administered SC.
Outros nomes:
  • Humanized IgG4k, SCF248
Comparador de Placebo: OpSCF Matching-Placebo
Participants received OpSCF matching-placebo, Q2W, SC, up to 14 weeks in the placebo-controlled period.
Biológico: Placebo
Administered SC.
Experimental: OpSCF 600 mg/OpSCF 600mg
Participants who received OpSCF 600 mg and completed placebo-controlled treatment received OpSCF 600mg, once every 4 weeks (Q4W), SC, up to 36 weeks in the open-label extension (OLE) period.
Biológico: OpSCF
Administered SC.
Outros nomes:
  • Humanized IgG4k, SCF248
Biológico: Placebo
Administered SC.
Comparador de Placebo: OpSCF Matching-Placebo/OpSCF 600 mg
Participants who received OpSCF matching-placebo and completed placebo-controlled treatment received OpSCF 600mg, Q4W, SC, up to 36 weeks in the OLE period.
Biológico: OpSCF
Administered SC.
Outros nomes:
  • Humanized IgG4k, SCF248
Biológico: Placebo
Administered SC.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Percent Change From Baseline in Eczema Area and Severity Index (EASI) at Week 16
Prazo: Baseline, Week 16
The EASI quantifies the severity of a participant's AD based on both lesion severity and the % of body surface area (BSA) affected. Severity of clinical signs of AD lesions (erythema [E], induration/papulation[I], excoriation[Ex] & lichenification[L]) was scored separately for each of 4 body regions[head(h), upper extremities(u), trunk(t), lower extremities(l)] on a 4-point scale:0= absent; 1= mild;2= moderate;3= severe. EASI area score was based on % BSA with AD in body region: 0(no involvement), 1(< 10%),2 (10 to <30%), 3(30 to <50%), 4(50 to <70%), 5(70 to <90%) and 6(90 to 100%). The EASI score is obtained as: EASI(A) = 0.1*(Eh+Ih+Exh+Lh)*Ah + 0.2*(Eu+Iu+Exu+Lu)*Au + 0.3*(Et +It+Ext+Lt)*At + 0.4*(El+Il+Exl+Ll)*Al. Total EASI score = 0.0 to 72.0; higher scores indicate greater severity of AD. Here, a negative change from baseline indicates less severity in AD.
Baseline, Week 16

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Number of Participants Who Experienced At-Least One Treatment Emergent Adverse Event (TEAE) and Serious Adverse Events (SAEs)
Prazo: From first dose of study drug up to end of follow-up (up to Week 67)
An adverse event (AE) was any untoward medical occurrence in participant administered a pharmaceutical product & that does not necessarily have a causal relationship with this treatment. It can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study product, whether or not considered related to the study product. An SAE was any untoward medical occurrence that, at any dose resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization resulted in persistent or significant disability/incapacity & was a congenital anomaly/birth defect. Any AE starting on or after the first dose date will be considered TEAE.
From first dose of study drug up to end of follow-up (up to Week 67)
Percent Change From Baseline in EASI at Weeks 2, 4, 6, 8, 10, 12, and 14
Prazo: Baseline, Weeks 2, 4, 6, 8, 10, 12 and 14
The EASI quantifies the severity of a participant's AD based on both lesion severity and the % of body surface area (BSA) affected. Severity of clinical signs of AD lesions (erythema [E], induration/papulation[I], excoriation[Ex] & lichenification[L]) was scored separately for each of 4 body regions[head(h), upper extremities(u), trunk(t), lower extremities(l)] on a 4-point scale:0= absent; 1= mild;2= moderate;3= severe. EASI area score was based on % BSA with AD in body region: 0(no involvement), 1(< 10%),2 (10 to <30%), 3(30 to <50%), 4(50 to <70%), 5(70 to <90%) and 6(90 to 100%). The EASI score is obtained as: EASI(A) = 0.1*(Eh+Ih+Exh+Lh)*Ah + 0.2*(Eu+Iu+Exu+Lu)*Au + 0.3*(Et +It+Ext+Lt)*At + 0.4*(El+Il+Exl+Ll)*Al. Total EASI score = 0.0 to 72.0; higher scores indicate greater severity of AD. Here, a negative change from baseline indicates less severity in AD.
Baseline, Weeks 2, 4, 6, 8, 10, 12 and 14
Change From Baseline in EASI at Weeks 2, 4, 6, 8, 10, 12, 14, and 16
Prazo: Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, and 16
The EASI quantifies the severity of a participant's AD based on both lesion severity and the % of body surface area (BSA) affected. Severity of clinical signs of AD lesions (erythema [E], induration/papulation[I], excoriation[Ex] & lichenification[L]) was scored separately for each of 4 body regions[head(h), upper extremities(u), trunk(t), lower extremities(l)] on a 4-point scale:0= absent; 1= mild;2= moderate;3= severe. EASI area score was based on % BSA with AD in body region: 0(no involvement), 1(< 10%),2 (10 to <30%), 3(30 to <50%), 4(50 to <70%), 5(70 to <90%) and 6(90 to 100%). The EASI score is obtained as: EASI(A) = 0.1*(Eh+Ih+Exh+Lh)*Ah + 0.2*(Eu+Iu+Exu+Lu)*Au + 0.3*(Et +It+Ext+Lt)*At + 0.4*(El+Il+Exl+Ll)*Al. Total EASI score = 0.0 to 72.0; higher scores indicate greater severity of AD. Here, a negative change from baseline indicates less severity in AD.
Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, and 16
Percentage of Participants Achieving At-Least 50% Improvement From Baseline in EASI (EASI50)
Prazo: At Weeks 2, 4, 6, 8, 10, 12, 14, and 16
The EASI quantifies severity of a participant's AD based on both lesion severity & % of body surface area (BSA) affected. Severity of clinical signs of AD lesions (erythema [E], induration/papulation[I], excoriation[Ex] & lichenification[L]) was scored separately for each of 4 body regions[head(h), upper extremities(u), trunk(t), lower extremities(l)] on a 4-point scale:0=absent; 1=mild; 2=moderate; 3=severe. EASI area score was based on % BSA with AD in body region: 0(no involvement), 1(< 10%),2 (10 to <30%), 3(30 to <50%), 4(50 to <70%), 5(70 to <90%) & 6(90 to 100%). EASI score is obtained as: EASI(A) = 0.1*(Eh+Ih+Exh+Lh)*Ah + 0.2*(Eu+Iu+Exu+Lu)*Au + 0.3*(Et +It+Ext+Lt)*At + 0.4*(El+Il+Exl+Ll)*Al. Total EASI score = 0.0 to 72.0; higher scores indicate greater severity of AD. Here, a negative change from baseline indicates less severity in AD. EASI 50 response was defined as at least a 50% improvement in EASI relative to Baseline. 90% CI was based on exact Clopper-Pearson method.
At Weeks 2, 4, 6, 8, 10, 12, 14, and 16
Percentage of Participants Achieving At-Least 75% Improvement From Baseline in EASI (EASI75)
Prazo: At Weeks 2, 4, 6, 8, 10, 12, 14, and 16
The EASI quantifies severity of a participant's AD based on both lesion severity & % of body surface area (BSA) affected. Severity of clinical signs of AD lesions (erythema [E], induration/papulation[I], excoriation[Ex] & lichenification[L]) was scored separately for each of 4 body regions[head(h), upper extremities(u), trunk(t), lower extremities(l)] on a 4-point scale:0=absent; 1=mild; 2=moderate; 3=severe. EASI area score was based on % BSA with AD in body region: 0(no involvement), 1(< 10%),2 (10 to <30%), 3(30 to <50%), 4(50 to <70%), 5(70 to <90%) & 6(90 to 100%). EASI score is obtained as: EASI(A) = 0.1*(Eh+Ih+Exh+Lh)*Ah + 0.2*(Eu+Iu+Exu+Lu)*Au + 0.3*(Et +It+Ext+Lt)*At + 0.4*(El+Il+Exl+Ll)*Al. Total EASI score = 0.0 to 72.0; higher scores indicate greater severity of AD. Here, a negative change from baseline indicates less severity in AD. EASI 75 response was defined as at least a 75% improvement in EASI relative to Baseline. 90% CI was based on exact Clopper-Pearson method.
At Weeks 2, 4, 6, 8, 10, 12, 14, and 16
Percentage of Participants Achieving At-Least 90% Improvement From Baseline in EASI (EASI90)
Prazo: At Weeks 2, 4, 6, 8, 10, 12, 14, and 16
The EASI quantifies severity of a participant's AD based on both lesion severity & % of body surface area (BSA) affected. Severity of clinical signs of AD lesions (erythema [E], induration/papulation[I], excoriation[Ex] & lichenification[L]) was scored separately for each of 4 body regions[head(h), upper extremities(u), trunk(t), lower extremities(l)] on a 4-point scale:0=absent; 1=mild; 2=moderate; 3=severe. EASI area score was based on % BSA with AD in body region: 0(no involvement), 1(< 10%),2 (10 to <30%), 3(30 to <50%), 4(50 to <70%), 5(70 to <90%) & 6(90 to 100%). EASI score is obtained as: EASI(A) = 0.1*(Eh+Ih+Exh+Lh)*Ah + 0.2*(Eu+Iu+Exu+Lu)*Au + 0.3*(Et +It+Ext+Lt)*At + 0.4*(El+Il+Exl+Ll)*Al. Total EASI score = 0.0 to 72.0; higher scores indicate greater severity of AD. Here, a negative change from baseline indicates less severity in AD. EASI 90 response was defined as at least a 90% improvement in EASI relative to Baseline. 90% CI was based on exact Clopper-Pearson method.
At Weeks 2, 4, 6, 8, 10, 12, 14, and 16
Percentage of Participants Achieving At-Least a 2-grade Reduction From Baseline to Clear (0) or Almost Clear (1) in Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD)
Prazo: At Weeks 2, 4, 6, 8, 10, 12, 14, and 16
The vIGA-AD was assessed by the principal investigator or sub-investigator using the descriptors that best described the overall appearance of the lesions. It is a 5-point morphological assessment of overall disease severity that ranges from 0 to 4, where 0 = Clear; No inflammatory signs of atopic dermatitis 1 = Almost clear; Barely perceptible erythema, barely perceptible induration/papulation, and/or minimal lichenification 2 = Mild; Slight but definite erythema (pink), slight but definite induration/papulation, and/ or slight but definite lichenification 3 = Moderate; Clearly perceptible erythema (dull red), clearly perceptible induration/papulation, and/or clearly perceptible lichenification 4 = Severe; Marked erythema (deep or bright red), marked induration/ papulation, and/or marked lichenification. Percentage of participants who achieved at least a 2-grade reduction from baseline to clear (0) or Almost Clear (1) in vIGA-AD are reported here.
At Weeks 2, 4, 6, 8, 10, 12, 14, and 16
Percentage of Participants Achieving At-Least a 2-grade Reduction From Baseline in vIGA-AD
Prazo: At Weeks 2, 4, 6, 8, 10, 12, 14, and 16
The vIGA-AD was assessed by the principal investigator or sub-investigator using the descriptors that best described the overall appearance of the lesions. It is a 5-point morphological assessment of overall disease severity that ranges from 0 to 4, where 0 = Clear; No inflammatory signs of atopic dermatitis 1 = Almost clear; Barely perceptible erythema, barely perceptible induration/papulation, and/or minimal lichenification 2 = Mild; Slight but definite erythema (pink), slight but definite induration/papulation, and/ or slight but definite lichenification 3 = Moderate; Clearly perceptible erythema (dull red), clearly perceptible induration/papulation, and/or clearly perceptible lichenification 4 = Severe; Marked erythema (deep or bright red), marked induration/ papulation, and/or marked lichenification. The percentage of participants with reduction from baseline of ≥2 grade in vIGA-AD score has been reported.
At Weeks 2, 4, 6, 8, 10, 12, 14, and 16
Change From Baseline in Weekly Average of the Daily Peak Pruritus Numeric Rating Scale (PP-NRS)
Prazo: Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, and 16
PP-NRS is based on the Numeric Rating Scale which was used to assess the level of itch the participant was experiencing. The following question was asked to participants: "On a scale of 0 to 10, with 0 = "no itch" and 10 = "worst itch imaginable", how would you rate your itch at the worst moment during the previous 24 hours?" Based on the score provided by participant, the PP-NRS score was assigned. Higher score indicates more severity. A negative change from baseline indicates improvement.
Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, and 16
Percent Change From Baseline in Weekly Average of the Daily PP-NRS
Prazo: Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, and 16
PP-NRS is based on the Numeric Rating Scale which was used to assess the level of itch the participant was experiencing. The following question was asked to participants: "On a scale of 0 to 10, with 0 = "no itch" and 10 = "worst itch imaginable", how would you rate your itch at the worst moment during the previous 24 hours?" Based on the score provided by participant, the PP-NRS score was assigned. Higher score indicates more severity. A negative change from baseline indicates improvement.
Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, and 16
Percentage of Participants Achieving At-Least a 4-point Reduction From Baseline in Weekly Average of the Daily PP-NRS
Prazo: Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, and 16
PP-NRS is based on the Numeric Rating Scale which was used to assess the level of itch the participant was experiencing. The following question was be asked to participants: "On a scale of 0 to 10, with 0 = "no itch" and 10 = "worst itch imaginable", how would you rate your itch at the worst moment during the previous 24 hours?" Based on the score provided by participant, the PP-NRS score was assigned. Higher score indicates more severity. A negative change from Baseline indicates improvement. The percentage of participants who had at least a 4-point reduction in the NRS score at post-baseline visits has been reported.
Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, and 16
Change From Baseline in Body Surface Area (BSA) Involved With Atopic Dermatitis (AD)
Prazo: Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, and 16
The overall BSA affected by AD was evaluated (from 0% to 100%). It was calculated using the palm surface area method. This method states that palmar surface of 1 hand (using the participant's hand and including the fingers) represents 1% of his or her total BSA.
Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, and 16
Percent Change From Baseline in BSA Involved With AD
Prazo: Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, and 16
The overall BSA affected by AD was evaluated (from 0% to 100%). It was calculated using the palm surface area method. This method states that palmar surface of 1 hand (using the participant's hand and including the fingers) represents 1% of his or her total BSA.
Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, and 16
Change From Baseline in Atopic Dermatitis Control Tool (ADCT) at Weeks 2, 4, 8, 12, and 16
Prazo: Baseline, Weeks 2, 4, 8,12 and 16
ADCT questionnaire is a self-assessment comprised of 6 concise questions to evaluate participant's perceptions of AD symptoms and impacts on their life and function over the last week. Each question carries equal weight and is scored from 0 to 4, for a total score ranging between 0 and 24. Higher score indicates higher severity. A negative change from baseline indicates improvement.
Baseline, Weeks 2, 4, 8,12 and 16
Change From Baseline in Patient-Oriented Eczema Measure (POEM) at Weeks 2, 4, 8, 12, and 16
Prazo: Baseline, Weeks 2, 4, 8,12 and 16
POEM is a self-assessment of disease severity using 7 questions asked to participant. A maximum value of 28 can be assigned based on the participant's response to 7 questions scored from 0 to 4, where 0 = No days, 1 = 1-2 days, 2 = 3-4 days, 3 = 5-6 days and 4 = Every day. Higher score indicates high severity. A negative change from baseline indicates improvement.
Baseline, Weeks 2, 4, 8,12 and 16
Change From Baseline in Dermatology Life Quality Index (DLQI) at Weeks 2, 4, 8, 12, and 16
Prazo: Baseline, Weeks 2, 4, 8,12 and 16
DLQI is a 10 questions questionnaire to measure how much skin problems have affected a participant's life over the last week. Each question is scored from 0 to 3 (0 = Not at all, 1 = A little, 2 = A lot and 3 = Very much). The DLQI is calculated by summing the score of each question, giving a total score ranging from 0 (not at all) to 30 (very much). The higher the score the more quality of life is impaired. A negative change from baseline indicates improvement in QoL.
Baseline, Weeks 2, 4, 8,12 and 16
Placebo-controlled Period: Serum Concentrations of OpSCF Over Time
Prazo: Days 15, 29, 43, 57, 85, 99, 102, 106 and 113
Days 15, 29, 43, 57, 85, 99, 102, 106 and 113
OLE Period: Serum Concentrations of OpSCF Over Time
Prazo: Days 141, 169, 197, 225, 253, 281, 309 and 337
Days 141, 169, 197, 225, 253, 281, 309 and 337

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
Alteração da linha de base nos biomarcadores sanguíneos e IgE nas semanas 4, 8, 12 e 16
Prazo: 16 semanas
Exames de sangue
16 semanas
Alteração da linha de base nos biomarcadores de pele coletados por meio de biópsias de pele nas semanas 4 e 16 (opcional para indivíduos que consentiram)
Prazo: 16 semanas
Exame histopatológico
16 semanas
Alteração da linha de base nos biomarcadores cutâneos coletados usando tiras de fita nas semanas 4 e 16 (opcional para indivíduos que consentiram)
Prazo: 16 semanas
Análise de proteômica e níveis de mRNA
16 semanas

Colaboradores e Investigadores

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

Patrocinador

Insmed Incorporated

Colaboradores

Innovaderm Research Inc.

Investigadores

  • Diretor de estudo: Study Director, Insmed Incorporated

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)

21 de novembro de 2023

Conclusão Primária (Real)

3 de setembro de 2024

Conclusão do estudo (Real)

18 de agosto de 2025

Datas de inscrição no estudo

Enviado pela primeira vez

19 de outubro de 2023

Enviado pela primeira vez que atendeu aos critérios de CQ

25 de outubro de 2023

Primeira postagem (Real)

26 de outubro de 2023

Atualizações de registro de estudo

Última Atualização Postada (Real)

11 de setembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

17 de agosto de 2026

Última verificação

1 de agosto de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • OpSCF-201

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

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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