Trial of JYB1904 Injection in Patients With Perennial Allergic Rhinitis
ConditionPerennial Allergic Rhinitis
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorJemincare
About this trial
This Phase II Trial is Meant to Evaluate the Efficacy, and Safety of JYB1904 Injection in Patients With Perennial Allergic Rhinitis.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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 .
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
JYB1904
Biological/VaccineDouble-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
Biological/VaccineDouble-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/VaccineDouble-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.
Treatment groups
135 Participants
are divided into 3 treatment groupsGroup A: JYB1904 Q8WExperimental treatment 1 intervention
Group B: JYB1904 Q12WExperimental treatment 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention
Trial outcomes
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.
Time frame
baseline, Week 8, Week 12Other outcomes
1
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.
Time frame
up to Week 602
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.
Time frame
up to Week 603
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.
Time frame
up to Week 8 or Week 124
Number of days with controlled symptoms up to Week 24
Time frame
up to Week 24Locations
Source ClinicalTrials.gov
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