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Pumecitinib

Spray nasal PG-011 para la rinitis alérgica estacional

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Qué se está evaluando

PG-011 nasal spray 0.6%(twice daily)

+ Placebo
Medicamento
Quiénes están siendo reclutados

Seasonal Allergic Rhinitis

+ SAR
De 18 a 65 años
+25 Criterios de eligibilidad

Ver todos los criterios de elegibilidad

Cómo está diseñado el estudio

Estudio de Tratamiento

Controlado con Placebo
Fase 3
Intervencional
Inicio del estudio: septiembre de 2025

Ver detalles del protocolo

Resumen

Patrocinador PrincipalPrime Gene Therapeutics Co., Ltd.
Contacto del EstudioLuo Zhang, Professor
Última actualización: 28 de agosto de 2025
Extraido de una base de datos validada por el gobierno.Reclamar como socio
Fecha de inicio: 15 de septiembre de 2025Fecha en la que se inscribió al primer participante.

Este estudio clínico se centra en determinar la eficacia y seguridad de un spray nasal llamado PG-011 para adultos que padecen rinitis alérgica estacional moderada a grave, también conocida como fiebre del heno. El estudio incluye a adultos de entre 18 y 65 años que experimentan síntomas significativos durante la temporada de alergias. El objetivo es verificar si el PG-011 puede proporcionar un alivio mejor de los síntomas alérgicos en comparación con un placebo, que es un spray sin medicación activa. Esta investigación es importante porque las alergias estacionales afectan a muchas personas y encontrar un tratamiento efectivo puede mejorar considerablemente su calidad de vida. Los participantes en este estudio se dividen aleatoriamente en dos grupos, con dos tercios recibiendo el spray nasal PG-011 y un tercio recibiendo el placebo. Ambos tratamientos se administran como un spray nasal dos veces al día durante 14 días. Después del período de tratamiento, los participantes son monitoreados durante otros 21 días para garantizar la seguridad y registrar cualquier efecto secundario. El estudio tiene como objetivo medir qué tan bien el spray nasal reduce los síntomas alérgicos y observar cualquier riesgo o efecto secundario potencial asociado con su uso. Los resultados ayudarán a determinar si el PG-011 es una opción viable para el tratamiento de las alergias estacionales.

Título OficialA Multicenter, Randomized, Double-blind, Placebo-controlled Phase IIb/III Study to Assess the Efficacy and Safety of PG-011 Nasal Spray in Adults With Moderate to Severe Seasonal Allergic Rhinitis 
Patrocinador PrincipalPrime Gene Therapeutics Co., Ltd.
Contacto del EstudioLuo Zhang, Professor
Última actualización: 28 de agosto de 2025
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Protocolo

Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.
Detalles del Diseño
Se reclutarán 600 pacientesNúmero total de participantes que el ensayo clínico espera reclutar.
Estudio de Tratamiento
Estos estudios prueban nuevas formas de tratar una enfermedad, condición o problema de salud. El objetivo es determinar si un nuevo medicamento, terapia o enfoque funciona mejor o tiene menos efectos secundarios que las opciones existentes.

Cómo se asignan los participantes a diferentes grupos/brazos
En este estudio clínico, los participantes se colocan en grupos de forma aleatoria, como si se lanzara una moneda. Esto garantiza que el estudio sea justo e imparcial, lo que hace que los resultados sean más confiables. Al asignar a los participantes al azar, los investigadores pueden comparar mejor los tratamientos sin influencias externas.

Otras formas de asignar participantes
Asignación no aleatoria: Los participantes se asignan en función de factores específicos, como su condición médica o la decisión de un médico.
Ninguna (ensayo de un solo brazo): Si el estudio tiene un solo grupo, todos los participantes reciben el mismo tratamiento y no se necesita asignación.

Cómo se administran los tratamientos a los participantes
Los participantes se dividen en diferentes grupos, y cada uno recibe un tratamiento específico al mismo tiempo. Esto ayuda a los investigadores a comparar la eficacia de los distintos tratamientos entre sí.

Otras formas de asignar tratamientos
Asignación a un solo grupo: Todos reciben el mismo tratamiento.
Asignación cruzada: Los participantes cambian de tratamiento durante el estudio.
Asignación factorial: Los participantes reciben diferentes combinaciones de tratamientos.
Asignación secuencial: Los participantes reciben tratamientos uno tras otro en un orden específico, posiblemente según su respuesta individual.
Otra asignación: La asignación de tratamientos no sigue un diseño estándar o predefinido.

Cómo se controla la efectividad del tratamiento
En un estudio controlado con placebo, algunos participantes reciben el tratamiento experimental, mientras que otros reciben una sustancia inerte (placebo) para comparar los resultados. Este método ayuda a aislar el efecto del tratamiento de los efectos psicológicos de recibir cualquier intervención.

Otras opciones
No controlado con placebo: No se utiliza placebo. Todos los participantes reciben el tratamiento real o intervenciones alternativas (a menudo el tratamiento estándar), y las comparaciones se realizan entre estos tratamientos.

Cómo se mantiene la confidencialidad de las intervenciones asignadas a los participantes
Participantes, investigadores y evaluadores de resultados no saben qué tratamiento se está administrando. Esto ayuda a reducir el sesgo tanto durante el estudio como al momento de analizar los resultados.

Otras formas de enmascarar la información
Abierto: Todos saben qué tratamiento se está administrando.
Simple ciego: Los participantes no saben qué tratamiento están recibiendo, pero los investigadores sí.
Doble ciego: Ni los participantes ni los investigadores saben qué tratamiento se está administrando.
Cuádruple ciego: Participantes, investigadores, evaluadores de resultados y personal de atención no saben qué tratamiento se está administrando.

Elegibilidad

Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.
Condiciones
Criterios
Cualquier sexoSexo biológico de los participantes elegibles para inscribirse.
De 18 a 65 añosRango de edades de los participantes que pueden unirse al estudio.
Voluntarios sanos no permitidosIndica si personas sanas, sin la condición que se estudia, pueden participar.
Condiciones
Patología
Seasonal Allergic Rhinitis
SAR
Criterios
5 criterios de inclusión requeridos para participar
Male or female aged 18 to 65 (including threshold)
Reflective total nasal symptom score ( rTNSS) score≥ 6 and retrospective nasal obstruction ≥ 2 on the day of screening visit, D-4 and D1. Meanwhile, the baseline average rTNSS score(Calculated as the average of rTNSS score of D-3, D-2, D-1 morning, D-1 evening, and D1 morning) ≥ 6
History of SAR for at least 2 years. and positive results for any local allergen in the current season tested by either the skin prick test (SPT) (where the wheal diameter is at least 5 mm larger than that of the negative control) or the serum - specific IgE (sIgE) test (the sIgE test results obtained within ≤ 1 year before random enrollment are acceptable)
Willingness to avoid pregnancy or fathering children from the signing of the informed consent form until three month after after the end of the study

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20 criterios de exclusión impiden participar
Participants are diagnosed of active or latent tuberculosis infection
Participants are diagnosed of moderate to severe asthma
Participants who had active pulmonary diseases or infections, upper respiratory tract infections or sinus infections within 2 weeks before screening, and/or those who had respiratory infections during the lead-in period
Participants received nasal or sinus surgery within 3 months before screening or had nasal trauma that had not fully healed

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Plan de Estudio

Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.
Grupos de Tratamiento
Objetivos del Estudio
2 grupos de intervención 

están designados en este estudio

50% de probabilidad 

de ser asignado al grupo placebo

Grupos de Tratamiento
Grupo I
Experimental
2 sprays in each nostril, twice daily for 14-day treatment period.
Grupo II
Placebo
2 sprays in each nostril, twice daily for 14-day treatment period.
Objetivos del Estudio
Objetivos Primarios

The reflective Total Nasal Symptom Score (rTNSS) was assessed by 12-hour reflective scoring (AM, PM) of the severity of four nasal symptoms (rhinorrhea, sneezing, nasal congestion, nasal itching). Scores ranged from 0 (no signs/symptoms evident) to 3 (severe signs/symptoms that is hard to tolerate). The rTNSS was calculated as the sum of the subject-reported severity scores for nasal symptoms, and value ranged from 0 (no signs/symptoms evident) to 12 (severe signs/symptoms that is hard to tolerate). Higher scores indicate more severe nasal symptoms, while lower scores indicate less severe nasal symptoms.
Objetivos Secundarios

The reflective Total Nasal Symptom Score (rTNSS) was assessed by 12-hour reflective scoring (AM, PM) of the severity of four nasal symptoms (rhinorrhea, sneezing, nasal congestion, nasal itching). Scores ranged from 0 (no signs/symptoms evident) to 3 (severe signs/symptoms that is hard to tolerate). The rTNSS was calculated as the sum of the subject-reported severity scores for nasal symptoms, and value ranged from 0 (no signs/symptoms evident) to 12 (severe signs/symptoms that is hard to tolerate). Higher scores indicate more severe nasal symptoms, while lower scores indicate less severe nasal symptoms. Percent change is calculated as (Change from baseline / Baseline result \*100).

The instantaneous Total Nasal Symptom Score (iTNSS) was assessed by instantaneous symptom severity of four nasal symptoms (rhinorrhea, sneezing, nasal congestion, nasal itching). Scores ranged from 0 (no signs/symptoms evident) to 3 (severe signs/symptoms that is hard to tolerate).The iTNSS was calculated as the sum of the subject-reported severity scores for nasal symptoms, and value ranged from 0 (no signs/symptoms evident) to 12 (severe signs/symptoms that is hard to tolerate). Higher scores indicate more severe nasal symptoms, while lower scores indicate less severe nasal symptoms. Percent change is calculated as (Change from baseline / Baseline result \*100).

The reflective Ocular Symptom Total Score (rTOSS) was assessed by 12-hour reflective scoring (AM, PM) of the severity of three rocular symptoms (itching/burning, tearing/watering, and redness).Scores ranged from 0 (no signs/symptoms evident) to 3 (severe signs/symptoms that is hard to tolerate). . The Total Ocular Symptom Score (TOSS) ranged from 0 to 9. Higher scores indicate more severe ocular symptoms, while lower scores indicate less severe ocular symptoms. Percent change is calculated as (Change from baseline / Baseline result \*100).

The instantaneous Total ocular Symptom Score is a scale used to measure ocular symptom severity based on how the participant was feeling just before taking each dose of study medication. Scores ranged from 0 to 9, and calculated as the sum of participant's scoring of three individual ocular symptoms (itching/burning, tearing/watering, and redness) on a 0 to 3 categorical severity scale (0=absent, 1=mild, 2=moderate, and 3=severe). Percent change is calculated as (Change from baseline / Baseline result \*100).

This parameter evaluates the mean change in AM rTNSS from baseline over the 14-day treatment period. The AM rTNSS is a rating of the severity of nasal symptoms over the previous 12 hours and is performed in the morning.The rTNSS was calculated as the sum of the participant-reported severity scores for nasal symptoms, and value ranged from 0 (no signs/symptoms evident) to 12 (severe signs/symptoms that is hard to tolerate).

This parameter evaluates the mean change in PM rTNSS from baselineover the 14-day treatment period. The PM rTNSS is a rating of the severity of nasal symptoms over the previous 12 hours and is performed in the evening.The rTNSS was calculated as the sum of the participant-reported severity scores for nasal symptoms, and value ranged from 0 (no signs/symptoms evident) to 12 (severe signs/symptoms that is hard to tolerate).

This parameter evaluates the mean change in AM iTNSS from baselineover the 14-day treatment period. The AM iTNSS is the severity rating of the instantaneous nasal symptom at a time point. The iTNSS was calculated as the sum of the participant-reported severity scores for nasal symptoms, and value ranged from 0 (no signs/symptoms evident) to 12 (severe signs/symptoms) that is hard to tolerate.

This parameter evaluates the mean change in PM iTNSS from baselineover the 14-day treatment period.The PM iTNSS is the severity rating of the instantaneous nasal symptom at a time point. The iTNSS was calculated as the sum of the participant-reported severity scores for nasal symptoms, and value ranged from 0 (no signs/symptoms evident) to 12 (severe signs/symptoms) that is hard to tolerate.

This parameter evaluates the mean change in AM rTOSS from baselineover the 14-day treatment period. The AM rTOSS is a rating of the severity of ocular symptoms over the previous 12 hours and is performed in the morning.The total ocular symptom score (TOSS) is the sum of three symptom scores for itchy/burning eyes, watery eyes, and red eyes, where each symptom is scored on a scale of 0 to 3. Higher scores indicate more severe ocular symptoms, while lower scores indicate less severe ocular symptoms.

This parameter evaluates the mean change in PM rTOSS from baselineover the 14-day treatment period. The PM rTOSS is a rating of the severity of ocular symptoms over the previous 12 hours and is performed in the morning.The total ocular symptom score (TOSS) is the sum of three symptom scores for itchy/burning eyes, watery eyes, and red eyes, where each symptom is scored on a scale of 0 to 3. Higher scores indicate more severe ocular symptoms, while lower scores indicate less severe ocular symptoms.

This parameter evaluates the mean change in AM iTOSS from baselineover the 14-day treatment period. The AM iTOSS is the severity rating of the ocular symptom at a time point.The total ocular symptom score (TOSS) is the sum of three symptom scores for itchy/burning eyes, watery eyes, and red eyes, where each symptom is scored on a scale of 0 to 3. Higher scores indicate more severe ocular symptoms, while lower scores indicate less severe ocular symptoms.

This parameter evaluates the mean change in PM iTOSS from baselineover the 14-day treatment period. The PM iTOSS is the severity rating of the ocular symptom at a time point.The total ocular symptom score (TOSS) is the sum of three symptom scores for itchy/burning eyes, watery eyes, and red eyes, where each symptom is scored on a scale of 0 to 3. Higher scores indicate more severe ocular symptoms, while lower scores indicate less severe ocular symptoms.

This parameter evaluates the mean change in rTNSS (ie Day 1 measurement = Average of the PM assessment on Day 1 and AM assessment of Day 2 and so on) from baseline for each day.The rTNSS was calculated as the sum of the participant-reported severity scores for nasal symptoms, and value ranged from 0 (no signs/symptoms evident) to 12 (severe signs/symptoms that is hard to tolerate).

This parameter evaluates the mean change in iTNSS (ie Day 1 measurement = Average of the PM assessment on Day 1 and AM assessment of Day 2 and so on) from baseline for each day.The iTNSS was calculated as the sum of the participant-reported severity scores for nasal symptoms, and value ranged from 0 (no signs/symptoms evident) to 12 (severe signs/symptoms that is hard to tolerate).

This parameter evaluates the mean change in rTOSS (ie Day 1 measurement = Average of the PM assessment on Day 1 and AM assessment of Day 2 and so on) from baseline for each day. The total ocular symptom score (TOSS) is the sum of three symptom scores for itchy/burning eyes, watery eyes, and red eyes, where each symptom is scored on a scale of 0 to 3. Higher scores indicate more severe ocular symptoms, while lower scores indicate less severe ocular symptoms.

This parameter evaluates the mean change in iTOSS (ie Day 1 measurement = Average of the PM assessment on Day 1 and AM assessment of Day 2 and so on) from baseline for each day. The total ocular symptom score (TOSS) is the sum of three symptom scores for itchy/burning eyes, watery eyes, and red eyes, where each symptom is scored on a scale of 0 to 3. Higher scores indicate more severe ocular symptoms, while lower scores indicate less severe ocular symptoms.

This parameter evaluates the mean change in AM rTNSS from baseline for each day.The rTNSS was calculated as the sum of the participant-reported severity scores for nasal symptoms, and value ranged from 0 (no signs/symptoms evident) to 12 (severe signs/symptoms that is hard to tolerate).

This parameter evaluates the mean change in PM rTNSS from baseline for each day.The rTNSS was calculated as the sum of the participant-reported severity scores for nasal symptoms, and value ranged from 0 (no signs/symptoms evident) to 12 (severe signs/symptoms that is hard to tolerate).

This parameter evaluates the mean change in AM iTNSS from baseline for each day.The iTNSS was calculated as the sum of the participant-reported severity scores for nasal symptoms, and value ranged from 0 (no signs/symptoms evident) to 12 (severe signs/symptoms that is hard to tolerate).

This parameter evaluates the mean change in PM iTNSS from baseline for each day.The iTNSS was calculated as the sum of the participant-reported severity scores for nasal symptoms, and value ranged from 0 (no signs/symptoms evident) to 12 (severe signs/symptoms that is hard to tolerate).

This parameter evaluates the mean change in AM rTOSS from baseline for each day. The total ocular symptom score (TOSS) is the sum of three symptom scores for itchy/burning eyes, watery eyes, and red eyes, where each symptom is scored on a scale of 0 to 3. Higher scores indicate more severe ocular symptoms, while lower scores indicate less severe ocular symptoms.

This parameter evaluates the mean change in PM rTOSS from baseline for each day. The total ocular symptom score (TOSS) is the sum of three symptom scores for itchy/burning eyes, watery eyes, and red eyes, where each symptom is scored on a scale of 0 to 3. Higher scores indicate more severe ocular symptoms, while lower scores indicate less severe ocular symptoms.

This parameter evaluates the mean change in AM iTOSS from baseline for each day. The total ocular symptom score (TOSS) is the sum of three symptom scores for itchy/burning eyes, watery eyes, and red eyes, where each symptom is scored on a scale of 0 to 3. Higher scores indicate more severe ocular symptoms, while lower scores indicate less severe ocular symptoms.

This parameter evaluates the mean change in PM iTOSS from baseline for each day. The total ocular symptom score (TOSS) is the sum of three symptom scores for itchy/burning eyes, watery eyes, and red eyes, where each symptom is scored on a scale of 0 to 3. Higher scores indicate more severe ocular symptoms, while lower scores indicate less severe ocular symptoms.

This parameter evaluates the mean change in individual nasal symptoms (runny nose, nasal congestion, nasal itching and sneezing) of rTNSS from baseline over the 14-day treatment period. The individual nasal symptoms (rhinorrhea, nasal congestion, nasal itching, and sneezing) is scored on a scale of 0 to 3, higher scores indicate more severe symptoms, while lower scores indicate less severe symptoms.

This parameter evaluates the mean change in individual nasal symptoms (runny nose, nasal congestion, nasal itching and sneezing) of AM rTNSS from baseline over the 14-day treatment period. The individual nasal symptoms (rhinorrhea, nasal congestion, nasal itching, and sneezing) is scored on a scale of 0 to 3, higher scores indicate more severe symptoms, while lower scores indicate less severe symptoms.

This parameter evaluates the mean change in individual nasal symptoms (runny nose, nasal congestion, nasal itching and sneezing) of PM rTNSS from baseline over the 14-day treatment period. The individual nasal symptoms (rhinorrhea, nasal congestion, nasal itching, and sneezing) is scored on a scale of 0 to 3, higher scores indicate more severe symptoms, while lower scores indicate less severe symptoms.

This parameter evaluates the mean change in individual ocular symptoms (itching/burning eyes, tearing/watering eyes, and redness eyes) of rTOSS from baseline over the 14-day treatment period. The individual ocular symptoms (itching/burning eyes, tearing/watering eyes, and redness eyes) of rTOSS is scored on a scale of 0 to 3, higher scores indicate more severe symptoms, while lower scores indicate less severe symptoms.

This parameter evaluates the mean change in individual ocular symptoms (itching/burning eyes, tearing/watering eyes, and redness eyes) of AM rTOSS from baseline over the 14-day treatment period. The individual ocular symptoms (itching/burning eyes, tearing/watering eyes, and redness eyes) of rTOSS is scored on a scale of 0 to 3, higher scores indicate more severe symptoms, while lower scores indicate less severe symptoms.

This parameter evaluates the mean change in individual ocular symptoms (itching/burning eyes, tearing/watering eyes, and redness eyes) of PM rTOSS from baseline over the 14-day treatment period. The individual ocular symptoms (itching/burning eyes, tearing/watering eyes, and redness eyes) of rTOSS is scored on a scale of 0 to 3, higher scores indicate more severe symptoms, while lower scores indicate less severe symptoms.

The proportion of participants who use the rescue medication，and the frequency of usage during the treatment.

Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) has 28 questions in 7 domains (activity limitation, sleep problems, nose symptoms, eye symptoms, non-nose/eye symptoms, practical problems and emotional function). Each question on a 7-point scale (0 = not impaired at all - 6 = severely impaired). The overall RQLQ score is the mean of all 28 responses.

Incidence of treatment-emergent adverse events (AEs) and serious adverse events (SAEs)

Centros del Estudio

Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.
Este estudio tiene 38 ubicaciones
Suspendido
Beijing Shijitan Hospital, Capital Medical UniversityBeijing, ChinaVer ubicación
Suspendido
Beijing Tongren Hospital, Capital Medical UniversityBeijing, China
Suspendido
Beijing Youan Hospital, Capital Medical UniversityBeijing, China
Suspendido
Peking University Third HospitalBeijing, China
Reclutando Próximamente38 Centros de Estudio