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Active, Not Recruiting

NCT Number: NCT06315426

A Study of IL4Rα Monoclonal Antibody in Patients With Seasonal Allergic Rhinitis(SAR).

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. Bronchial asthma is associated with bronchial asthma in 40% of patients with AR, suggesting a comorbid feature of allergic disease.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hebei Petro China Central Hospital, Langfang, Hebei, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Main Inclusion Criteria:

  • 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 SPT or serum-specific IgE test results.
  • 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.

Treatment and study plan

GR1802 injection

Biological

Recombinant fully human anti-IL4Rα monoclonal antibody drug.

Placebo

Biological

Placebo

Primary outcomes

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

    Time frame: Over 2 weeks

    TNSS is the sum of the four symptom scores of runny nose, nasal congestion, nasal itching, and sneezing, with each symptom scoring from 0 to 3. The total score is 12, the higher the score, the worse the symptoms.

Secondary outcomes

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

    Time frame: Over 2、4 weeks

    TOSS is the sum of symptom scores of eye itching/foreign body sensation/redness and tearing, with each symptom scoring from 0 to 3. The total score is 6, the higher the score, the worse the symptoms.

  2. Change from Baseline in rTNSS

    Time frame: Over 4 weeks

    TNSS is the sum of the four symptom scores of runny nose, nasal congestion, nasal itching, and sneezing, with each symptom scoring from 0 to 3. The total score is 12, the higher the score, the worse the symptoms.

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

    Time frame: week 2、4

    TNSS is the sum of the four symptom scores of runny nose, nasal congestion, nasal itching, and sneezing, with each symptom scoring from 0 to 3. The total score is 12, the higher the score, the worse the symptoms.

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

    Time frame: week 2、4

    TOSS is the sum of symptom scores of eye itching/foreign body sensation/redness and tearing, with each symptom scoring from 0 to 3. The total score is 6, the higher the score, the worse the symptoms.

  5. Change from baseline in VAS(Visual Analog Scale) score

    Time frame: week2、4

    Patients marked the score corresponding to the severity of the current overall AR symptoms by drawing a line on a 0-10 cm scale，the higher the score, the worse the symptoms.

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

    Time frame: week2、4

    The RQLQ is used to measure the problems that adults with rhinoconjunctivitis experience in their daily lives. It has 28 questions in 7 domains. The total score is the sum of the 7 domain scores, with higher scores being associated with poorer quality of life.

  7. Adverse events (AEs)

    Time frame: up to 12 weeks

    Incidence of AEs.

  8. Immunogenicity characteristics

    Time frame: up to 12 weeks

    Positive rate of ADA(anti-drug antibody) testing

Sponsors and collaborators

Lead sponsor

Genrix (Shanghai) Biopharmaceutical Co., Ltd.

Industry

Registry information

Official study title

A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase II Clinical Trial to Evaluate the Efficacy and Safety of GR1802 Injection in Combination With Background Therapy in Patients With SAR.

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 18, 2024
Registry last updated
Apr 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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