A Study of GR1802 Injection in Patients With Seasonal Allergic Rhinitis.

Официальное название

A Multicenter Clinical Trial Evaluating the Efficacy, Safety, Pharmacokinetics, and Immunogenicity of GR1802 Injection in Combination With Background Therapy in Patients With Seasonal Allergic Rhinitis.

Обзор

Allergic rhinitis (AR) is a non-infectious chronic inflammatory disease of the nasal mucosa mainly mediated by immunoglobulin E after exposure to allergens in atopic individuals. The typical symptoms of AR are paroxysmal sneezing, watery rhinorrhea, itching, and nasal congestion, which may be accompanied by ocular symptoms, including eye itching, tearing, redness, and burning sensation, which are more common in patients with hay fever allergies.

Вмешательства

• Биопрепарат GR1802 injection
  Recombinant fully human anti-IL4Rα monoclonal antibody drug.
• Биопрепарат Placebo
  Placebo

Первичные конечные точки

• Adverse events (AEs)(Part One) [Срок оценки: up to 12 weeks]
• Change from Baseline in rTNSS( reflective total nasal symptom scores)(Part Two) [Срок оценки: up to 2 weeks]

Вторичные конечные точки (7)

• Change from Baseline in rTOSS( reflective total ocular symptom scores)(Part One/Two) [Срок оценки: up to 2、4 weeks]
• Percentage Change from Baseline in rTNSS(Part One/Two) [Срок оценки: up to 2、4 weeks]
• Mean change from baseline in iTNSS(instantaneous total nasal symptom scores)(Part One/Two) [Срок оценки: week 2、4]
• Mean change from baseline in iTOSS(instantaneous total ocular symptom scores)(Part One/Two) [Срок оценки: week 2、4]
• Change from baseline in RQLQ(Rhinoconjunctivitis Quality of Life Questionnaire) scores(Part One/Two) [Срок оценки: week2、4]
• Incidence of ADAs(Part One/Two) [Срок оценки: up to 12 weeks]
• drug concentration、Ctrough(Part One/Two) [Срок оценки: up to 12 weeks]

Критерии участия

Main Inclusion Criteria:

• Voluntarily sign the informed consent form.
• Seasonal allergic rhinitis has been prevalent for at least 2 years.Positive for allergens associated with seasonal allergic rhinitis.
• Poor control of seasonal allergic rhinitis with nasal glucocorticoids or other therapeutic agents during the same pollen season in the past.
• Weight≥30kg.
• Symptom severity scores for the season met the enrollment criteria.

Main Exclusion Criteria:

• Other nasal comorbidities or co-morbidities/states that may be present at the time of screening that affect efficacy determination.
• Subjects whose allergen exposures in their home or work environments may be expected to change significantly during the trial period.
• Subjects with poorly controlled recent asthma conditions.
• Presence of current or past history of infection of special concern, e.g., active tuberculosis, helminthic infections, severe herpes virus infections, etc.
• Previous use of anti-interleukin 4 receptor alpha subunit (IL4Rα) monoclonal antibody.
• Have a serious underlying medical condition that, in the opinion of the investigator, may pose a risk to subject safety by participation in a clinical trial.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Zhongnan Hospital of Wuhan university — Ухань

Идентификаторы

NCT: NCT07199257 · GR1802-015

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗