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

Allergic Rhinitis Clinical Trial

Official 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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06315426
• Other study ID #: GR1802-011
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: March 2024
• Est. completion date: December 2024

Study information

• Verified date: March 2024
• Source: Genrix (Shanghai) Biopharmaceutical Co., Ltd.
• Contact: Zheng Liu, PHD
• Phone: 027-83665555
• Email: zmsx77[@]163.com
• Is FDA regulated: No
• Study type: Interventional

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: December 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Main Inclusion Criteria:

1. Voluntarily sign the informed consent form.

2. Seasonal allergic rhinitis has been prevalent for at least 2 years.

3. Poor control of seasonal allergic rhinitis with nasal glucocorticoids or other therapeutic agents during the same pollen season in the past.

4. Positive SPT or serum-specific IgE test results.

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 (IL4Ra) 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.

Related Conditions & MeSH terms

• Allergic Rhinitis
• Rhinitis
• Rhinitis, Allergic

Intervention

Biological:
• GR1802 injection
Recombinant fully human anti-IL4Ra monoclonal antibody drug.
• Placebo
Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Genrix (Shanghai) Biopharmaceutical Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in rTNSS( reflective total nasal symptom scores)	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.	Over 2 weeks
Secondary	Change from Baseline in rTOSS( reflective total ocular symptom scores)	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.	Over 2?4 weeks
Secondary	Change from Baseline in rTNSS	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.	Over 4 weeks
Secondary	Mean change from baseline in iTNSS(instantaneous total nasal symptom scores)	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.	week 2?4
Secondary	Mean change from baseline in iTOSS(instantaneous total ocular symptom scores)	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.	week 2?4
Secondary	Change from baseline in VAS(Visual Analog Scale) score	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.	week2?4
Secondary	Change from baseline in RQLQ(Rhinoconjunctivitis Quality of Life Questionnaire) scores	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.	week2?4
Secondary	Adverse events (AEs)	Incidence of AEs.	up to 12 weeks
Secondary	Immunogenicity characteristics	Positive rate of ADA(anti-drug antibody) testing	up to 12 weeks