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Not yet recruiting NCT07199257

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

Phase III Interventional Allergic Rhinitis, Seasonal

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: GR1802 injection, Placebo.
Who it may be relevant to
Registry conditions: Allergic Rhinitis, Seasonal. Basic parameters: 12 years — 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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.

Overview

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.

Interventions

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

Primary outcome measures

  • Adverse events (AEs)(Part One) [Time frame: up to 12 weeks]
  • Change from Baseline in rTNSS( reflective total nasal symptom scores)(Part Two) [Time frame: up to 2 weeks]
Secondary outcome measures (7)
  • Change from Baseline in rTOSS( reflective total ocular symptom scores)(Part One/Two) [Time frame: up to 2、4 weeks]
  • Percentage Change from Baseline in rTNSS(Part One/Two) [Time frame: up to 2、4 weeks]
  • Mean change from baseline in iTNSS(instantaneous total nasal symptom scores)(Part One/Two) [Time frame: week 2、4]
  • Mean change from baseline in iTOSS(instantaneous total ocular symptom scores)(Part One/Two) [Time frame: week 2、4]
  • Change from baseline in RQLQ(Rhinoconjunctivitis Quality of Life Questionnaire) scores(Part One/Two) [Time frame: week2、4]
  • Incidence of ADAs(Part One/Two) [Time frame: up to 12 weeks]
  • drug concentration、Ctrough(Part One/Two) [Time frame: up to 12 weeks]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Zhongnan Hospital of Wuhan university — Wuhan

Identifiers

NCT: NCT07199257 · GR1802-015

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗