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

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age12-18
SponsorGenrix (Shanghai) Biopharmaceutical Co., Ltd.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • GR1802 injection

    Biological/Vaccine

    Recombinant fully human anti-IL4Rα monoclonal antibody drug.

  • Placebo

    Biological/Vaccine

    Placebo

Treatment groups

144 Participants
are divided into 3 treatment groups
Group A: Interleukin-4 receptor responder(Part One)Experimental treatment 1 intervention
Group B: Interleukin-4 receptor responder(Part Two)Experimental treatment 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Adverse events (AEs)(Part One)

Time frame
up to 12 weeks
2

Change from Baseline in rTNSS( reflective total nasal symptom scores)(Part Two)

Scores range from 0 to 12, with higher scores indicating more severe symptoms.

Time frame
up to 2 weeks

Secondary outcomes

1

Change from Baseline in rTOSS( reflective total ocular symptom scores)(Part One/Two)

Scores range from 0 to 9, with higher scores indicating more severe symptoms.

Time frame
up to 2、4 weeks
2

Percentage Change from Baseline in rTNSS(Part One/Two)

Scores range from 0 to 12, with higher scores indicating more severe symptoms.

Time frame
up to 2、4 weeks
3

Mean change from baseline in iTNSS(instantaneous total nasal symptom scores)(Part One/Two)

Scores range from 0 to 12, with higher scores indicating more severe symptoms.

Time frame
week 2、4
4

Mean change from baseline in iTOSS(instantaneous total ocular symptom scores)(Part One/Two)

Scores range from 0 to 9, with higher scores indicating more severe symptoms.

Time frame
week 2、4

Other outcomes

Sponsors and contacts

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