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Pumecitinib

Spray nasal PG-011 pour la rhinite allergique saisonnière

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Ce qui est testé

PG-011 nasal spray 0.6%(twice daily)

+ Placebo
Médicament
Qui peut participer

Seasonal Allergic Rhinitis

+ SAR
De 18 à 65 ans
+25 critères d'éligibilité

Voir tous les critères d'éligibilité

Comment se déroule l'étude

Étude thérapeutique

Groupe Placebo
Phase 3
Interventionnel
Date de début : septembre 2025

Voir le détail du protocole

Résumé

Sponsor principalPrime Gene Therapeutics Co., Ltd.
Contacts de l'étudeLuo Zhang, Professor
Dernière mise à jour : 28 août 2025
Issu d'une base de données validée par les autorités. Revendiquer cette étude
Date de début de l'étude : 15 septembre 2025Date à laquelle le premier participant a commencé l'étude.

Cette étude clinique vise à déterminer l'efficacité et la sécurité d'un spray nasal appelé PG-011 chez les adultes souffrant de rhinite allergique saisonnière modérée à sévère, communément appelée fièvre des foins. L'étude inclut des adultes âgés de 18 à 65 ans qui présentent des symptômes significatifs pendant la saison des allergies. L'objectif est de vérifier si le PG-011 peut offrir un soulagement supérieur des symptômes allergiques par rapport à un placebo, qui est un spray sans médicament actif. Cette recherche est importante car les allergies saisonnières affectent de nombreuses personnes et trouver un traitement efficace peut grandement améliorer leur qualité de vie. Les participants à cette étude sont répartis aléatoirement en deux groupes, deux tiers recevant le spray nasal PG-011 et un tiers recevant le placebo. Les deux traitements sont administrés sous forme de spray nasal deux fois par jour pendant 14 jours. Après la période de traitement, les participants sont surveillés pendant 21 jours supplémentaires pour assurer la sécurité et suivre tout effet secondaire. L'étude vise à mesurer dans quelle mesure le spray nasal réduit les symptômes allergiques et à observer tout risque ou effet secondaire potentiel associé à son utilisation. Les résultats aideront à déterminer si le PG-011 est une option viable pour le traitement des allergies saisonnières.

Titre officielA 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 
Sponsor principalPrime Gene Therapeutics Co., Ltd.
Contacts de l'étudeLuo Zhang, Professor
Dernière mise à jour : 28 août 2025
Issu d'une base de données validée par les autorités. Revendiquer cette étude

Protocole

Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.
Détails du design
600 participants à inclureNombre total de participants que l'essai clinique vise à recruter.
Traitement
Cette étude teste un ou plusieurs traitements pour évaluer leur efficacité contre une maladie ou un problème de santé spécifique. L'objectif est de voir si un nouveau médicament ou une thérapie fonctionne mieux, ou provoque moins d'effets secondaires que les options existantes.

Comment les participants sont répartis entre les groupes de l'étude
Dans cette étude clinique, les participants sont répartis de manière aléatoire, comme lors d'un tirage au sort. Cela garantit l'équité et réduit les biais, rendant les résultats plus fiables. En attribuant les participants au hasard, les chercheurs peuvent comparer les traitements sans influence extérieure.

Autres méthodes de répartition
Répartition non aléatoire : basée sur des critères spécifiques comme l'état de santé ou la décision du médecin.
Aucune (un seul groupe de participants) : tous les participants reçoivent le même traitement, aucune répartition n'est nécessaire.

Comment les traitements sont administrés aux participants
Les participants sont répartis en groupes distincts, chaque groupe recevant un traitement différent en même temps. Cela permet de comparer directement l'efficacité de plusieurs traitements.

Autres façons d'administrer les traitements
Groupe unique : tous les participants reçoivent le même traitement.
Affectation croisée : les participants passent d'un traitement à un autre au cours de l'étude.
Plan factoriel : les participants reçoivent des combinaisons de traitements pour évaluer leurs interactions.
Plan séquentiel : les traitements sont administrés successivement selon un ordre prédéterminé, pouvant varier selon la réaction du participant.
Autre type d'attribution : L'attribution des traitements ne suit pas de schéma standard ni de protocole prédéfini.

Comment l'efficacité du traitement est contrôlée
Un placebo est utilisé pour comparer les effets du traitement expérimental à ceux d’une substance inactive, ce qui permet d’évaluer son efficacité réelle.

Autres options possibles
Non contrôlée par placebo : aucun placebo n'est utilisé. Tous les participants reçoivent un traitement actif, souvent le traitement standard, pour permettre une comparaison directe.

Comment la nature du traitement est tenue confidentielle
Les participants, les chercheurs et les personnes chargées de l'évaluation des résultats ne savent pas quel traitement est administré. Cela permet de limiter les biais non seulement pendant l'étude, mais aussi au moment de l'analyse des résultats.

Autres méthodes de masquage
En ouvert : tout le monde connaît le traitement administré.
Simple aveugle : les participants ignorent le traitement reçu, mais les chercheurs le connaissent.
Double aveugle : ni les participants ni les chercheurs ne savent quel traitement est administré.
Quadruple aveugle : Les participants, les chercheurs, les personnes qui analysent les résultats et les professionnels de santé en charge du suivi ne savent pas non plus quel traitement est administré.

Éligibilité

Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.
Conditions
Critères
Tout sexeLe sexe biologique des participants éligibles à s'inscrire.
De 18 à 65 ansTranche d'âge des participants éligibles à participer.
Volontaires sains non autorisésIndique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.
Conditions
Pathologie
Seasonal Allergic Rhinitis
SAR
Critères
5 critères d'inclusion nécessaires pour participer
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

Voir plus de critères

20 critères d'exclusion empêchent la participation
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

Voir plus de critères

Plan de l'étude

Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.
Groupes de traitement
Objectifs de l'étude
2 groupes d'intervention 

sont désignés dans cette étude

50% de chances 

d'être dans le groupe placebo en aveugle

Groupes de traitement
Groupe I
Expérimental
2 sprays in each nostril, twice daily for 14-day treatment period.
Groupe II
Placebo
2 sprays in each nostril, twice daily for 14-day treatment period.
Objectifs de l'étude
Objectifs principaux

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.
Objectifs secondaires

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)

Centres d'étude

Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.
Cette étude comporte 38 sites
Suspendu
Beijing Shijitan Hospital, Capital Medical UniversityBeijing, ChinaVoir le site
Suspendu
Beijing Tongren Hospital, Capital Medical UniversityBeijing, China
Suspendu
Beijing Youan Hospital, Capital Medical UniversityBeijing, China
Suspendu
Peking University Third HospitalBeijing, China
Recrutement imminent38 Centres d'Étude