Trial of JYB1904 Injection in Patients With Perennial Allergic Rhinitis

A Phase II, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Clinical Study to Evaluate the Efficacy and Safety of JYB1904 Injection Combined With Background Therapy in Patients With Perennial Allergic Rhinitis

This Phase II Trial is Meant to Evaluate the Efficacy, and Safety of JYB1904 Injection in Patients With Perennial Allergic Rhinitis.

Study Overview

• Status: Not yet recruiting
• Conditions: Perennial Allergic Rhinitis
• Intervention / Treatment: Biological: JYB1904; Biological: JYB1904; Biological: Placebo+JYB1904

Detailed Description

This study is a randomized, double-blind, placebo-controlled Phase II study to evaluate the efficacy and safety of JYB1904 injection compared to placebo in patients with PAR.

• Study Type: Interventional
• Enrollment (Estimated): 135
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Zhiren Fang; Phone Number: 021-58306003; Email: fangzhiren@jeyoupharma.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Adult participants ≥18 years and ≤65 years of age at the time of signing the informed consent form (ICF).
2. Physician-diagnosed PAR at screening, symptoms of allergic rhinitis present for a minimum of 2 years.
3. Participants must have been on stable treatment with intranasal corticosteroids (INCS), with or without other background medications for at least four consecutive weeks before randomization, and rTNSS≥6 at screening.
4. Within 1 year prior to screening or at screening, participants must have positive indoor allergen SPT and/or positive antigen-specific serum IgE to indoor allergens . Participants must have clinical symptoms associated with perennial allergen positivity (assessed by SPT) or positive serum antigen-specific IgE at study entry .
5. A participant who has a known history of dermatographism or identified during the SPT may participate in this study with a positive serum antigen-specific IgE test.
6. Participants who have concomitant asthma must use permitted regular asthma treatment during the study and have been stable in the 3 months prior to screening.
7. Is willing and able to comply with daily eDiary.
8. Participants must complete the eDiary during the baseline evaluation period (2 weeks prior to randomization) and meet the following criteria: (1) complete the eDiary for at least 4 days per week; and (2) rTNSS score ≥6 at randomization (average of Day-7 to Day-1).

Exclusion Criteria:

1. Is currently on AIT subcutaneous immunotherapy or sublingual immunotherapy.
2. Have received treatment with any rescue medication or adjustment to background therapy medications during the baseline evaluation period.
3. Prior intolerance or inadequate response to omalizumab.
4. Contraindications or hypersensitivity to antihistamines or intranasal corticosteroids, or history of anaphylaxis.
5. Have a history of seasonal worsening of AR and if the seasonal worsening is expected during the 2-week baseline evaluation period and the 24-week double-blind induction period.
6. Anticipates significant changes in their daily environmental exposure during the 2-week baseline evaluation period and the 24-week double-blind induction period.
7. Has a history of nasal polyps or nasal polyps present at screening, moderate-to-severe nasal septum deviation, or rhinitis secondary to other causes.
8. Has a known history of recurrent acute or chronic sinusitis.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: JYB1904 Q8W; JYB1904 will be administered SC.	Biological: JYB1904; Double-blind Induction Period: 150mg -450mg JYB1904 will be administered SC in Day1, Week 8 and Week 16. Open-label Treatment Period: 300mg JYB1904 will be administered SC every 12 weeks (Q12W) from Week 24 to Week 48.; Biological: JYB1904; Double-blind Induction Period: 300mg JYB1904 will be administered SC in Day1 and Week 12. Open-label Treatment Period: 300mg JYB1904 will be administered SC Q12W from Week 24 to Week 48.
Experimental: JYB1904 Q12W; 300mg JYB1904 will be administered as a subcutaneous (SC) injection.	Biological: JYB1904; Double-blind Induction Period: 150mg -450mg JYB1904 will be administered SC in Day1, Week 8 and Week 16. Open-label Treatment Period: 300mg JYB1904 will be administered SC every 12 weeks (Q12W) from Week 24 to Week 48.; Biological: JYB1904; Double-blind Induction Period: 300mg JYB1904 will be administered SC in Day1 and Week 12. Open-label Treatment Period: 300mg JYB1904 will be administered SC Q12W from Week 24 to Week 48.
Placebo Comparator: Placebo; Placebo will be administered SC.	Biological: Placebo+JYB1904; Double-blind Induction Period: Placebo will be administered SC in Day1, Week 8, Week 12 and Week16. Open-label Treatment Period: 300mg JYB1904 will be administered SC Q12W from Week 24 to Week 48.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in Reflective Total Nasal Symptom Score (rTNSS) at Week 8 (JYB1904 Q8W vs Placebo) or Week 12 (JYB1904 Q12W vs Placebo)	rTNSS was a composite of 4 symptoms (rhinorrhea, nasal congestion, nasal itching and sneezing), each symptom was scored on a scale of 0 = none, 1 = mild, 2 = moderate, 3 = severe. The total score ranged from 0 to 12. The higher the score was, the more severe the symptoms were.	baseline, Week 8, Week 12

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetic (PK) profile of JYB1904 injection	Serum concentration of JYB1904	Through study completion, an average of 72 weeks
Pharmacodynamic (PD) profile of JYB1904 injection	PD parameters: Changes in serum level of total and free IgE	Through study completion, an average of 72 weeks
Change from Baseline in rTNSS at Each Visit	rTNSS was a composite of 4 symptoms (rhinorrhea, nasal congestion, nasal itching and sneezing), each symptom was scored on a scale of 0 = none, 1 = mild, 2 = moderate, 3 = severe. The total score ranged from 0 to 12. The higher the score was, the more severe the symptoms were.	up to Week 60
Change from baseline in Rhinoconjunctivitis Quality of Life Questionnaire Standardized Version [RQLQ(S)] at each Visit	The Rhinoconjunctivitis Quality of Life Questionnaire Standardized Version comprises 28 items that are grouped into 7 domains, each item was scored on a scale of 0 = Not troubled, 1 = Hardly troubled at all, 2 = Somewhat troubled, 3 = Moderately troubled, 4 = Quite a bit troubled, 5 = Very troubled, 6 = Extremely troubled. RQLQ(S) total mean scores will be calculated, with a range from 0 to 6. The higher the score was, the more serious the impact on the patient's life.	up to Week 60
Number of days with controlled symptoms up to Week 8 (JYB1904 Q8W vs Placebo) or Week 12 (JYB1904 Q12W vs Placebo)	Controlled symptoms defined as rTNSS ≤4 with each individual item score ≤1. rTNSS was a composite of 4 symptoms (rhinorrhea, nasal congestion, nasal itching and sneezing), each symptom was scored on a scale of 0 = none, 1 = mild, 2 = moderate, 3 = severe. The total score ranged from 0 to 12. The higher the score was, the more severe the symptoms were.	up to Week 8 or Week 12
Number of days with controlled symptoms up to Week 24		up to Week 24
Proportion of participants requiring rescue therapy at each visit up to Week 24		up to Week 24
Proportion of participants with ≥30% reduction from baseline in rTNSS at each visit up to Week 24		up to Week 24
Proportion of participants with ≥50% reduction from baseline in rTNSS at each visit up to Week 24		up to Week 24
Change from Baseline in total ocular symptom score (TOSS) at each Visit	TOSS is the sum of two symptom scores for itchy/red eyes and watery eyes, where each symptom is scored on a scale of 0 to 3. The higher the score was, the more severe the symptoms were.	up to Week 24
Change from baseline in AR overall control Visual Analog Scale (VAS) at each visit	The VAS, in which the participant rates the degree of bother caused by AR symptoms over the past 7 days on a 100 mm-long horizontal line, where 0 mm = no bother and 100 mm = extreme bother.	up to Week 24
Adverse Events(AEs) and Serious Adverse Events (SAEs)	Incidence and features of AEs and SAEs assessed by CTCAE v5.0, and related safety parameters analysis	Through study completion, an average of 72 weeks
Immunogenicity of JYB1904 injection	Immunogenicity parameters: Positive detection rate of anti-drug antibodies (ADA)/neutralizing ADA (Nab)	Through study completion, an average of 72 weeks

Collaborators and Investigators

• Sponsor: Jemincare
• Investigators: Principal Investigator: Chengshuo Wang, Beijing Tongren Hospital; Principal Investigator: Luo Zhang, Beijing Tongren Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2028

Study Registration Dates

• First Submitted: February 27, 2026
• First Submitted That Met QC Criteria: March 5, 2026
• First Posted (Actual): March 9, 2026

Study Record Updates

• Last Update Posted (Actual): March 9, 2026
• Last Update Submitted That Met QC Criteria: March 5, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: PAR
• Additional Relevant MeSH Terms: Immune System Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Nose Diseases; Otorhinolaryngologic Diseases; Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial
• Other Study ID Numbers: JYB1904-204

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No