Trial of JYB1904 Injection in Patients With Perennial Allergic Rhinitis

NCT07459452 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: JYB1904-204
• Study Type: interventional
• Target: 135
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Perennial Allergic Rhinitis

Keywords

PAR

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• Change from Baseline in rTNSS at Each Visit

  up to Week 60

• Change from baseline in Rhinoconjunctivitis Quality of Life Questionnaire Standardized Version [RQLQ(S)] at each Visit

  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)

  up to Week 8 or Week 12

Study Arms (3)

JYB1904 Q8W

EXPERIMENTAL

JYB1904 will be administered SC.

Biological: JYB1904

JYB1904 Q12W

EXPERIMENTAL

300mg JYB1904 will be administered as a subcutaneous (SC) injection.

Biological: JYB1904

Placebo

PLACEBO COMPARATOR

Placebo will be administered SC.

Biological: Placebo+JYB1904

Interventions

JYB1904 BIOLOGICAL

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.

JYB1904 Q8W

Placebo+JYB1904 BIOLOGICAL

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.

Placebo

Eligibility Criteria

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

You may qualify if:

• Adult participants ≥18 years and ≤65 years of age at the time of signing the informed consent form (ICF).
• Physician-diagnosed PAR at screening, symptoms of allergic rhinitis present for a minimum of 2 years.
• 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.
• 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 .
• 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.
• 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.
• Is willing and able to comply with daily eDiary.
• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Jemincare: lead

MeSH Terms

Conditions

Rhinitis, Allergic, Perennial

Condition Hierarchy (Ancestors)

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

Study Officials

• Luo Zhang

  Beijing Tongren Hospital

  PRINCIPAL INVESTIGATOR

• Chengshuo Wang

  Beijing Tongren Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhiren Fang

CONTACT

021-58306003; fangzhiren@jeyoupharma.com

Study Design

• Study Type: interventional
• Phase: phase 2
• 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: February 27, 2026
• First Posted: March 9, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2028
• Last Updated: March 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share