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Estudio de fase 2a de eficacia y seguridad de OpSCF en dermatitis atópica de moderada a grave

17 de agosto de 2026 actualizado por: Insmed Incorporated

Un estudio de fase 2a aleatorizado, doble ciego y controladora con placebo para evaluar la eficacia y seguridad de OpSCF en el tratamiento de sujetos adultos con dermatitis atópica de moderada a grave

El propósito de este estudio es determinar la eficacia y seguridad de un anticuerpo monoclonal, OpSCF, en el tratamiento de adultos con dermatitis atópica (eccema) de moderada a grave. OpSCF se comparará con un placebo.

Se administrará OpSCF o placebo cada 2 semanas durante 14 semanas y la eficacia se evaluará dos semanas después. Después de eso, los sujetos pueden optar por ingresar a una fase de extensión de etiqueta abierta en la que todos los sujetos recibirán OpSCF cada 4 semanas durante 40 semanas adicionales.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

50

Fase

  • Fase 2

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • 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

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

Criterios de inclusión:

  • El sujeto tiene un diagnóstico clínicamente confirmado de EA activa.
  • El sujeto tiene al menos un historial de 6 meses de EA.
  • El sujeto está dispuesto a utilizar un método anticonceptivo eficaz.

Criterio de exclusión:

  • El sujeto es una mujer que está amamantando, embarazada o que planea quedar embarazada durante el estudio.
  • El sujeto tiene alguna condición médica clínicamente significativa que lo pondría en riesgo indebido o interferiría con la interpretación de los resultados del estudio.
  • El sujeto ha utilizado dupilumab en las 26 semanas anteriores al día 1.
  • El sujeto ha usado tralokinumab en las 12 semanas anteriores al día 1.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Cuadruplicar

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
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.
Otros nombres:
  • Humanized IgG4k, SCF248
Comparador de placebos: 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.
Otros nombres:
  • Humanized IgG4k, SCF248
Biológico: Placebo
Administered SC.
Comparador de placebos: 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.
Otros nombres:
  • Humanized IgG4k, SCF248
Biológico: Placebo
Administered SC.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Percent Change From Baseline in Eczema Area and Severity Index (EASI) at Week 16
Periodo de tiempo: 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 resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Number of Participants Who Experienced At-Least One Treatment Emergent Adverse Event (TEAE) and Serious Adverse Events (SAEs)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: Days 141, 169, 197, 225, 253, 281, 309 and 337
Days 141, 169, 197, 225, 253, 281, 309 and 337

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Cambio desde el valor inicial en biomarcadores sanguíneos e IgE en las semanas 4, 8, 12 y 16
Periodo de tiempo: 16 semanas
Análisis de sangre
16 semanas
Cambio desde el inicio en los biomarcadores de piel recopilados mediante biopsias de piel en las semanas 4 y 16 (opcional para sujetos que den su consentimiento)
Periodo de tiempo: 16 semanas
Examen histopatológico
16 semanas
Cambio desde el inicio en los biomarcadores de la piel recopilados mediante tiras de cinta adhesiva en las semanas 4 y 16 (opcional para sujetos que den su consentimiento)
Periodo de tiempo: 16 semanas
Análisis de proteómica y niveles de ARNm.
16 semanas

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Insmed Incorporated

Colaboradores

Innovaderm Research Inc.

Investigadores

  • Director de estudio: Study Director, Insmed Incorporated

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

21 de noviembre de 2023

Finalización primaria (Actual)

3 de septiembre de 2024

Finalización del estudio (Actual)

18 de agosto de 2025

Fechas de registro del estudio

Enviado por primera vez

19 de octubre de 2023

Primero enviado que cumplió con los criterios de control de calidad

25 de octubre de 2023

Publicado por primera vez (Actual)

26 de octubre de 2023

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

11 de septiembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

17 de agosto de 2026

Última verificación

1 de agosto de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • OpSCF-201

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

Sí

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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