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Un estudio de extensión a largo plazo de JNJ-77242113 en participantes con psoriasis en placas de moderada a grave (FRONTIER 2)

29 de mayo de 2026 actualizado por: Janssen Research & Development, LLC

Un estudio de fase 2b multicéntrico, de extensión a largo plazo y de rango de dosis para evaluar la eficacia y la seguridad de JNJ-77242113 para el tratamiento de la psoriasis en placas de moderada a grave

El propósito de este estudio es evaluar la respuesta clínica a largo plazo del tratamiento con JNJ-77242113 en participantes con psoriasis en placas de moderada a grave.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

La población de personas que viven con psoriasis de moderada a grave es de aproximadamente 3500 millones, que en su mayoría se tratan con terapias tópicas y convencionales. JNJ-77242113, fármaco en investigación, se dirige a las respuestas inmunitarias del cuerpo y la piel que afectan a enfermedades como la psoriasis y este estudio evalúa JNJ-77242113 como opciones de terapias avanzadas en la psoriasis en placas de moderada a grave. Este es un estudio de extensión a largo plazo de JNJ-77242113 en participantes elegibles que completaron la visita de la semana 16 del estudio original 77242113PSO2001. La duración total de este estudio será de hasta 40 semanas, lo que incluirá un período de tratamiento de 36 semanas y un período de seguimiento de seguridad de 4 semanas después de la administración de la última intervención del estudio. La seguridad se evaluará mediante eventos adversos (AA), evaluaciones de laboratorio de seguridad clínica, electrocardiogramas (ECG), signos vitales y exámenes físicos.

Tipo de estudio

Intervencionista

Inscripción (Actual)

227

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

  • Alemania
      • Bad Bentheim, Alemania, 48455
        • Fachklinik Bad Bentheim
      • Berlin, Alemania, 10789
        • ISA - Interdisciplinary Study Association GmbH
      • Berlin, Alemania, 13627
        • CRS Clinical Research Services Berlin GMBH
      • Bochum, Alemania, 44793
        • Niesmann & Othlinghaus GbR
      • Darmstadt, Alemania, 64283
        • Rosenpark Research GmbH
      • Frankfurt am Main, Alemania, 60590
        • Universitätsklinikum Frankfurt
      • Friedrichshafen, Alemania, 88045
        • Derma-Study-Center Friedrichshafen GmbH
      • Hamburg, Alemania, 22391
        • MensingDerma Research GmbH
      • Heidelberg, Alemania, 69120
        • Universitaetsklinikum Heidelberg
      • Kiel, Alemania, 24105
        • Universitatsklinikum Schleswig Holstein Kiel
      • Mahlow, Alemania, 15831
        • Gemeinschaftspraxis Scholz/Sebastian/Schilling
      • Witten, Alemania, 58453
        • Hautarztpraxis
  • Canadá
    • Ontario
      • Hamilton, Ontario, Canadá, L8N 1Y2
        • Dermatrials Research
      • Waterloo, Ontario, Canadá, N2J 1C4
        • Alliance Clinical Trials
      • Windsor, Ontario, Canadá, N8T 1E6
        • XLR8 Medical Research
    • Quebec
      • Montreal, Quebec, Canadá, H2H2B5
        • Innovaderm Research Inc.
  • Corea del Sur
      • Busan, Corea del Sur, 49241
        • Pusan National University Hospital
      • Gyeonggi-do, Corea del Sur, 13620
        • Seoul National University Bundang Hospital
      • Seoul, Corea del Sur, 03080
        • Seoul National University Hospital
      • Seoul, Corea del Sur, 05030
        • Konkuk University Medical Center
      • Seoul, Corea del Sur, 102-1703
        • KyungHee University Hospital
  • España
      • Barcelona, España, 08916
        • Hosp. Univ. Germans Trias I Pujol
      • Madrid, España, 28041
        • Hosp. Univ. 12 de Octubre
      • Valencia, España, 46940
        • Hosp. de Manises
      • Valencia, España, 46026
        • Hosp. Univ. I Politecni La Fe
  • Estados Unidos
    • California
      • Sacramento, California, Estados Unidos, 95815
        • Pacific Skin Institute
    • Florida
      • Ocala, Florida, Estados Unidos, 34470
        • Renstar Medical Research
      • Tampa, Florida, Estados Unidos, 33613
        • Forcare Clinical Research Inc
    • Illinois
      • Rolling Meadows, Illinois, Estados Unidos, 60008
        • Arlington Dermatology
    • Indiana
      • Plainfield, Indiana, Estados Unidos, 46168
        • Indiana Clinical Trial Center
    • Michigan
      • Fort Gratiot, Michigan, Estados Unidos, 48059
        • Hamzavi Dermatology
    • Nevada
      • Las Vegas, Nevada, Estados Unidos, 89119
        • Vivida Dermatology
    • New Jersey
      • East Windsor, New Jersey, Estados Unidos, 08520
        • Windsor Dermatology, PC
    • Oregon
      • Portland, Oregon, Estados Unidos, 97210
        • Oregon Dermatology and Research Center
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Estados Unidos, 15213
        • University of Pittsburgh Department of Dermatology
    • Texas
      • Dallas, Texas, Estados Unidos, 75231
        • Modern Research Associates
      • Houston, Texas, Estados Unidos, 77004
        • Center for Clinical Studies
      • Webster, Texas, Estados Unidos, 77598
        • Center for Clinical Studies
    • Washington
      • Spokane, Washington, Estados Unidos, 99202
        • Premier Clinical Research
  • Francia
      • Le Mans, Francia, 72037
        • Centre Hospitalier Le Mans
      • Rouen, Francia, 76031
        • Hôpital Charles Nicolle
      • Toulon, Francia, 83800
        • Hia Sainte Anne
  • Japón
      • Obihiro-shi, Japón, 080-0013
        • Takagi Dermatological Clinic
      • Sakai, Japón, 593 8324
        • Kume Clinic
      • Sapporo, Japón, 060-0063
        • Sapporo Skin Clinic
      • Shizuoka, Japón, 420-8527
        • Shizuoka General Hospital
      • Takaoka, Japón, 933-0871
        • Shirasaki dermatology clinic
      • Toyama, Japón, 930 8550
        • Toyama Prefectural Central Hospital
      • Yokohama, Japón, 221 0825
        • Nomura Dermatology Clinic
  • Polonia
      • Bialystok, Polonia, 15-351
        • Nzoz Zdrowie Osteo-Medic
      • Lodz, Polonia, 90-265
        • Dermed Centrum Medyczne Sp z o o
      • Osielsko, Polonia, 86031
        • Dermodent Centrum Medyczne Aldona Czajkowska Rafal Czajkowski S C
      • Warsaw, Polonia, 02-953
        • Klinika Ambroziak Estederm Sp. z o.o
      • Wroclaw, Polonia, 51-685
        • Wro Medica
  • Reino Unido
      • London, Reino Unido, SE1 9RT
        • Guys and St Thomas NHS Foundation Trust
      • Southampton, Reino Unido, SO16 6YD
        • University Hospital Southampton NHS Foundation Trust
  • Taiwán
      • Kaohsiung City, Taiwán, 83342
        • Chang Gung Memorial Hospital
      • Tainan, Taiwán, 704
        • National Cheng Kung University Hospital
      • Taipei, Taiwán, 10048
        • National Taiwan University Hospital
      • Taoyuan, Taiwán, 333
        • Chang-Gung Memorial Hospital, LinKou Branch

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

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Descripción

Criterios de inclusión:

  • Debe haber completado la visita de la Semana 16 en el Protocolo 77242113PSO2001
  • En opinión del investigador, puede beneficiarse de la inclusión en este estudio de extensión a largo plazo (LTE)
  • Debe aceptar evitar la exposición prolongada al sol y evitar el uso de cabinas de bronceado u otras fuentes de luz ultravioleta durante el estudio.
  • Debe aceptar suspender todas las terapias tópicas que podrían afectar la psoriasis o el índice de gravedad del área de la psoriasis (PASI) o la evaluación global del investigador (IGA), que no sean champús con emolientes y ácido salicílico no medicados, antes de la primera administración de la intervención del estudio.
  • Aceptar no recibir una vacuna con virus vivos o bacterias vivas durante el estudio, o dentro de las 4 semanas posteriores a la última administración de la intervención del estudio

Criterio de exclusión:

  • Se suspendió permanentemente de la intervención del estudio en el Protocolo 77242113PSO2001 por cualquier motivo
  • Ha recibido alguna terapia biológica o terapia experimental desde la finalización del estudio de origen, 77242113PSO2001
  • Ha recibido cualquier virus vivo o vacuna bacteriana dentro de las 12 semanas anteriores a la primera administración de la intervención del estudio.
  • Ha recibido la vacuna del bacilo Calmette-Guerin (BCG) dentro de los 12 meses posteriores a la primera administración de la intervención del estudio.
  • Actualmente tiene antígeno de superficie de hepatitis B (HBsAg) o anticuerpo de hepatitis C (anti-HCV) positivo, o tiene otra enfermedad hepática clínicamente activa, o prueba positiva para HBsAg o anti-HCV

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: No aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Doble

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Grupo 1: JNJ-77242113 Dosis 1 una vez al día (QD)
Los participantes originalmente asignados al azar a JNJ-77242113 Dosis 1 QD en el estudio original 77242113PSO2001 continuarán recibiendo JNJ-77242113 Dosis 1 QD desde la Semana 0 hasta la Semana 36 en este estudio.
Droga: JNJ-77242113
La tableta JNJ-77242113 se administrará por vía oral.
Experimental: Grupo 2: JNJ-77242113 Dosis 2 QD
Los participantes originalmente asignados al azar a JNJ-77242113 Dosis 2 QD en el estudio original 77242113PSO2001 continuarán recibiendo JNJ-77242113 Dosis 2 QD desde la Semana 0 hasta la Semana 36 en este estudio.
Droga: JNJ-77242113
La tableta JNJ-77242113 se administrará por vía oral.
Experimental: Grupo 3: JNJ-77242113 Dosis 3 QD
Los participantes originalmente asignados al azar a JNJ-77242113 Dosis 3 QD en el estudio original 77242113PSO2001 continuarán recibiendo JNJ-77242113 Dosis 3 QD desde la Semana 0 hasta la Semana 36 en este estudio.
Droga: JNJ-77242113
La tableta JNJ-77242113 se administrará por vía oral.
Experimental: Grupo 4: JNJ-77242113 Dosis 1 dos veces al día (BID)
Los participantes originalmente asignados al azar a JNJ-77242113 Dosis 1 BID en el estudio original 77242113PSO2001 continuarán recibiendo JNJ-77242113 Dosis 1 BID desde la Semana 0 hasta la Semana 36 en este estudio.
Droga: JNJ-77242113
La tableta JNJ-77242113 se administrará por vía oral.
Experimental: Grupo 5: JNJ-77242113 Dosis 3 BID
Los participantes originalmente asignados al azar a JNJ-77242113 Dosis 3 BID en el estudio original 77242113PSO2001 continuarán recibiendo JNJ-77242113 Dosis 3 BID desde la Semana 0 hasta la Semana 36 en este estudio.
Droga: JNJ-77242113
La tableta JNJ-77242113 se administrará por vía oral.
Experimental: Grupo 6: JNJ-77242113 Dosis 3 QD
Los participantes originalmente asignados al azar a placebo en el estudio original 77242113PSO2001 recibirán JNJ-77242113 dosis 3 QD desde la semana 0 hasta la semana 36 en este estudio.
Droga: JNJ-77242113
La tableta JNJ-77242113 se administrará por vía oral.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Percentage of Participants Who Achieved Greater Than or Equal to (>=) 75 Percent (%) Improvement From Baseline in Psoriasis Area Severity Index Score (PASI-75) at LTE Week 36
Periodo de tiempo: Baseline (Week 0 of originating study 77242113PSO2001), LTE Week 36 (52 weeks from originating study baseline)
Percentage of participants who achieved >=75% improvement from baseline in PASI score at LTE Week 36 was reported. The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0=none, 1=slight, 2=moderate, 3=severe, 4=very severe) and extent of involvement from 0 (no involvement) to 6 (90% - 100% involvement). The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated more severe disease. The baseline was defined as the closest measurement taken prior to or at the time of first study drug administration date in 77242113PSO2001 study.
Baseline (Week 0 of originating study 77242113PSO2001), LTE Week 36 (52 weeks from originating study baseline)

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Percentage of Participants Who Achieved at Least 90% Improvement From Baseline in PASI Score (PASI-90) at LTE Week 36
Periodo de tiempo: Baseline (Week 0 of originating study 77242113PSO2001), LTE Week 36 (52 weeks from originating study baseline)
Percentage of participants who achieved >=90% improvement from baseline in PASI score at LTE Week 36 was reported. The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0=none, 1=slight, 2=moderate, 3=severe, 4=very severe) and extent of involvement from 0 (no involvement) to 6 (90% - 100% involvement). The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated more severe disease. The baseline was defined as the closest measurement taken prior to or at the time of first study drug administration date in 77242113PSO2001 study.
Baseline (Week 0 of originating study 77242113PSO2001), LTE Week 36 (52 weeks from originating study baseline)
Percentage of Participants Who Achieved 100% Improvement From Baseline in PASI Score (PASI-100) at LTE Week 36
Periodo de tiempo: Baseline (Week 0 of originating study 77242113PSO2001), LTE Week 36 (52 weeks from originating study baseline)
Percentage of participants who achieved 100% improvement from baseline in PASI score at LTE Week 36 was reported. PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In PASI system, body was divided into 4 regions: head, trunk, upper extremities, and lower extremities. Each of these areas were assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0=none, 1=slight, 2=moderate, 3=severe and 4=very severe) and extent of involvement from 0 (no involvement) to 6 (90% - 100% involvement). The PASI produced a numeric total score that could range on a scale of 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated more severe disease. The baseline was defined as the closest measurement taken prior to or at the time of first study drug administration date in 77242113PSO2001 study.
Baseline (Week 0 of originating study 77242113PSO2001), LTE Week 36 (52 weeks from originating study baseline)
Change From Baseline in PASI Total Score at LTE Week 36
Periodo de tiempo: Baseline (Week 0 of originating study 77242113PSO2001), LTE Week 36 (52 weeks from originating study baseline)
Change from baseline in PASI total score at LTE Week 36 was reported. The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0 = none, 1 = slight, 2 = moderate, 3 = severe and 4 = very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement). The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated greater severity of psoriasis. The baseline was defined as the closest measurement taken prior to or at the time of first study drug administration date in 77242113PSO2001 study.
Baseline (Week 0 of originating study 77242113PSO2001), LTE Week 36 (52 weeks from originating study baseline)
Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) at LTE Week 36
Periodo de tiempo: At LTE Week 36 (52 weeks from originating study baseline)
The IGA assesses participant's plaque psoriasis. Lesions were graded for induration, erythema and scaling, each using a 5 point scale. Induration: 0 = no evidence of plaque elevation, 1 = minimal plaque elevation, = 0.25 millimeters (mm); 2 = mild plaque elevation, = 0.5 mm; 3 = moderate plaque elevation, = 0.75 mm; 4 = severe plaque elevation, greater than (>)1 mm; Erythema: 0 = no evidence of erythema, hyperpigmentation may be present, 1 = faint erythema, 2 = light red coloration, 3 = moderate red coloration, 4 = bright red coloration; Scaling: 0 = no evidence of scaling, 1 = minimal; occasional fine scale over less than 5% of the lesion, 2 = mild; fine scale dominates, 3 = moderate; coarse scale predominates, 4 = severe; thick, scale predominates. Final IGA score of psoriasis was based upon the average of induration, erythema and scaling scores assessed on a 5 point scale: cleared (0), minimal (1), mild (2), moderate (3), or severe (4). A higher score indicated more severe disease.
At LTE Week 36 (52 weeks from originating study baseline)
Change From Baseline in Psoriasis Symptoms and Signs Diary (PSSD) Symptoms Scores at LTE Week 36
Periodo de tiempo: Baseline (Week 0 of originating study 77242113PSO2001), LTE Week 36 (52 weeks from originating study baseline)
Change from baseline in PSSD symptoms scores at LTE Week 36 was reported. PSSD was a patient-reported outcome (PRO) questionnaire designed to measure severity of psoriasis symptoms and signs for the assessment of treatment benefit. PSSD: self-administered PRO instrument that included 11 items covering symptoms (itch, pain, stinging, burning and skin tightness) and participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness and bleeding) using 0 to 10 numerical scales for severity. Items were averaged on the daily symptom score when at least 3 items (>=50 percentage of 5 items) on these scales were answered. The average value was converted into 0-100 scoring, such that symptom score = average value*10, where, 0=least severe and 100=most severe. Higher score indicated more severe disease. Baseline was defined as the closest measurement taken prior to or at the time of first study drug administration date in 77242113PSO2001 study.
Baseline (Week 0 of originating study 77242113PSO2001), LTE Week 36 (52 weeks from originating study baseline)
Change From Baseline in PSSD Signs Score at LTE Week 36
Periodo de tiempo: Baseline (Week 0 of originating study 77242113PSO2001), LTE Week 36 (52 weeks from originating study baseline)
Change from baseline in PSSD sign scores at LTE Week 36 was reported. PSSD was a PRO questionnaire designed to measure severity of psoriasis symptoms and signs for assessment of treatment benefit. PSSD was a self-administered PRO instrument that included 11 items covering symptoms (itch, pain, stinging, burning and skin tightness) and participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness and bleeding) using 0 to 10 numerical rating scales for severity. Items were averaged on the daily sign score when at least 3 items (>=50 percentage of 6 items) on these scales were answered. The average value was converted into 0-100 scoring, such that sign score = average value*10, where, 0= least severe and 100= most severe. Higher score indicated more severe disease. The baseline was defined as the closest measurement taken prior to or at the time of first study drug administration date in 77242113PSO2001 study.
Baseline (Week 0 of originating study 77242113PSO2001), LTE Week 36 (52 weeks from originating study baseline)
Percentage of Participants Who Achieved PSSD Symptoms Score Equal (=) 0 at LTE Week 36 Among Participants With a Baseline (Week 0 of the Originating Study) Symptoms Score >=1
Periodo de tiempo: Baseline (Week 0 of originating study 77242113PSO2001), LTE Week 36 (52 weeks from originating study baseline)
The PSSD was a PRO questionnaire designed to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit. PSSD was a self-administered PRO instrument that included 11 items covering symptoms (itch, pain, stinging, burning and skin tightness) and participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness and bleeding) using 0 to 10 numerical rating scales for severity. Items were averaged on the daily symptom score when at least 3 items (>=50 percentage of 5 items) on these scales are answered. The average value is converted into 0-100 scoring, such that symptom score = average value*10, where, 0= least severe and 100= most severe. Higher score indicated more severe disease. The baseline was defined as the closest measurement taken prior to or at the time of first study drug administration date in 77242113PSO2001 study.
Baseline (Week 0 of originating study 77242113PSO2001), LTE Week 36 (52 weeks from originating study baseline)
Percentage of Participants Achieving PSSD Signs Score=0 at Week 36 Among Participants With a Baseline (Week 0 of the Originating Study) Signs Score >=1
Periodo de tiempo: Baseline (Week 0 of originating study 77242113PSO2001), LTE Week 36 (52 weeks from originating study baseline)
The PSSD was a PRO questionnaire designed to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit. PSSD was a self-administered PRO instrument that included 11 items covering symptoms (itch, pain, stinging, burning and skin tightness) and participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness and bleeding) using 0 to 10 numerical rating scales for severity. Items were averaged on the daily sign score when at least 3 items (>=50 percentage of 6 items) on these scales are answered. The average value is converted into 0-100 scoring, such that sign score = average value*10, where, 0= least severe and 100= most severe. Higher score indicated more severe disease. The baseline was defined as the closest measurement taken prior to or at the time of first study drug administration date in 77242113PSO2001 study.
Baseline (Week 0 of originating study 77242113PSO2001), LTE Week 36 (52 weeks from originating study baseline)
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
Periodo de tiempo: From LTE Week 0 up to LTE Week 40
An adverse event (AE) was any untoward medical occurrence in a clinical investigation where participants administered a product or medical device; the event needed not necessarily have a causal relationship with the treatment or usage. A serious adverse event (SAE) was any untoward medical occurrence at any dose that: resulted in death, was life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or resulted in congenital anomaly/birth defect. TEAE was defined as any AE that occurred after receiving the treatment in originating study (77242113PSO2001). TEAEs and TESAEs that occurred during this study are reported.
From LTE Week 0 up to LTE Week 40

Colaboradores e Investigadores

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

Patrocinador

Janssen Research & Development, LLC

Investigadores

  • Director de estudio: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

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)

10 de junio de 2022

Finalización primaria (Actual)

29 de septiembre de 2023

Finalización del estudio (Actual)

29 de septiembre de 2023

Fechas de registro del estudio

Enviado por primera vez

3 de mayo de 2022

Primero enviado que cumplió con los criterios de control de calidad

3 de mayo de 2022

Publicado por primera vez (Actual)

6 de mayo de 2022

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

1 de junio de 2026

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

29 de mayo de 2026

Última verificación

1 de mayo de 2026

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • CR109155
  • 2021-004320-16 (Número EudraCT)
  • 77242113PSO2002 (Otro identificador: Janssen Research & Development, LLC)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

La política de intercambio de datos de Janssen Pharmaceutical Companies of Johnson & Johnson está disponible en www.janssen.com/clinical-trials/transparency. Como se indica en este sitio, las solicitudes de acceso a los datos del estudio se pueden enviar a través del sitio del proyecto Yale Open Data Access (YODA) en yoda.yale.edu

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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