A Study of IL4Rα Monoclonal Antibody in Patients With Seasonal Allergic Rhinitis

NCT07154342 | Recruiting Phase 3

• 1 other identifier: GR1802-014
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Allergic Rhinitis, Seasonal

Outcome Measures

Primary Outcomes (1)

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

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

  up to 2 weeks

Secondary Outcomes (8)

• Change from Baseline in rTOSS( reflective total ocular symptom scores)

  up to 2、4 weeks

• Change from Baseline in rTNSS

  up to 4 weeks

• Mean change from baseline in iTNSS(instantaneous total nasal symptom scores)

  week 2、4

• Mean change from baseline in iTOSS(instantaneous total ocular symptom scores)

  week 2、4

• Change from baseline in RQLQ(Rhinoconjunctivitis Quality of Life Questionnaire) scores

  week2、4

Study Arms (2)

Interleukin-4 receptor responder

EXPERIMENTAL

Biological: GR1802 injection

Placebo

PLACEBO COMPARATOR

Biological: Placebo

Interventions

GR1802 injection BIOLOGICAL

Recombinant fully human anti-IL4Rα monoclonal antibody drug.

Interleukin-4 receptor responder

Placebo BIOLOGICAL

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntarily sign the informed consent form.
• Seasonal allergic rhinitis has been prevalent for at least 2 years.
• Poor control of seasonal allergic rhinitis with nasal glucocorticoids or other therapeutic agents during the same pollen season in the past.
• Positive serum-specific IgE test results.
• Symptom severity scores for the season met the enrollment criteria.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Genrix (Shanghai) Biopharmaceutical Co., Ltd.: lead

Study Sites (1)

Zhongnan Hospital of Wuhan university

Wuhan, Hubei, 430000, China

RECRUITING

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal

Condition Hierarchy (Ancestors)

Rhinitis, Allergic; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Central Study Contacts

liaison officer

CONTACT

021-50805988-8039; fangxiaoyan@genrixbio.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2025
• First Posted: September 4, 2025
• Study Start: August 15, 2025
• Primary Completion: April 30, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: September 4, 2025

Record last verified: 2025-08

Locations

CN (1)