Perennial Allergic RhinitisPhase 2NCT07459452
Trial of JYB1904 Injection in Patients With Perennial Allergic Rhinitis
A Phase 2 study testing JYB1904 in people with Perennial Allergic Rhinitis, run by Jemincare.
Trial summary
This Phase II Trial is Meant to Evaluate the Efficacy, and Safety of JYB1904 Injection in Patients With Perennial Allergic Rhinitis. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Perennial Allergic Rhinitis
- What is being tested?
- JYB1904
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 135 participants
- Where
- No sites listed yet
- Study dates
- Apr 2026to Oct 2028
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Conditions
- Perennial Allergic Rhinitis
- Being tested
- JYB1904, Placebo+JYB1904
- Keywords
- PAR
- Medical subject headings
- Rhinitis, Allergic, Perennial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JYB1904Biological
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.
JYB1904Biological
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+JYB1904Biological
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.
| Study group | Role | What they receive |
|---|---|---|
| JYB1904 Q8W | Experimental | JYB1904 will be administered SC. Receives: Biological: JYB1904 |
| JYB1904 Q12W | Experimental | 300mg JYB1904 will be administered as a subcutaneous (SC) injection. Receives: Biological: JYB1904 |
| Placebo | Placebo comparator | Placebo will be administered SC. Receives: Biological: Placebo+JYB1904 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline, Week 8, Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2026
- Study startApr 2026 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perennial Allergic RhinitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 135 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jemincare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Luo Zhang, Principal investigator, Beijing Tongren HospitalChengshuo Wang, Principal investigator, Beijing Tongren Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07459452
- Sponsor's protocol ID
- JYB1904-204
- Status last verified
- Feb 2026
- First submitted
- 27 Feb 2026
- Last updated
- 9 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No