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

Genrix (Shanghai) Biopharmaceutical

Status and phase: Not yet enrolling; Phase 3

Conditions: Allergic Rhinitis, Seasonal

Treatments: Biological: Placebo; Biological: GR1802 injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT07199257

GR1802-015

Details and patient eligibility

About

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.

Enrollment: 144 estimated patients

Sex: All

Ages: 12 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Main Inclusion Criteria:

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

Main Exclusion Criteria:

1. Other nasal comorbidities or co-morbidities/states that may be present at the time of screening that affect efficacy determination.
2. Subjects whose allergen exposures in their home or work environments may be expected to change significantly during the trial period.
3. Subjects with poorly controlled recent asthma conditions.
4. Presence of current or past history of infection of special concern, e.g., active tuberculosis, helminthic infections, severe herpes virus infections, etc.
5. Previous use of anti-interleukin 4 receptor alpha subunit (IL4Rα) monoclonal antibody.
6. 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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144 participants in 3 patient groups, including a placebo group

Interleukin-4 receptor responder(Part One)

Experimental group

Description:

Part one

Treatment:

Biological: GR1802 injection

Interleukin-4 receptor responder(Part Two)

Experimental group

Description:

Part two

Treatment:

Biological: GR1802 injection

Placebo

Placebo Comparator group

Description:

Part two

Treatment:

Biological: Placebo