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This Phase II Trial is Meant to Evaluate the Efficacy, and Safety of JYB1904 Injection in Patients With Perennial Allergic Rhinitis.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JYB1904 Q8W | Experimental | JYB1904 will be administered SC. |
|
| JYB1904 Q12W | Experimental | 300mg JYB1904 will be administered as a subcutaneous (SC) injection. |
|
| Placebo | Placebo Comparator | Placebo will be administered SC. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhiren Fang | Contact | 021-58306003 | fangzhiren@jeyoupharma.com |
| Name | Affiliation | Role |
|---|---|---|
| Luo Zhang | Beijing Tongren Hospital | Principal Investigator |
| Chengshuo Wang | Beijing Tongren Hospital | Principal Investigator |
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| ID | Term |
|---|---|
| D012221 | Rhinitis, Allergic, Perennial |
| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
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| JYB1904 | Biological | 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+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. |
|
| 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 |
| 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 |
| 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 |
| D012130 |
| Respiratory Hypersensitivity |
| D010038 | Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |