This is a multicenter, randomized, double-blind, placebo-controlled phase III clinical study aimed at evaluating the efficacy and safety of CM310 in patients with seasonal allergic rhinitis, and observing the quality of life, PK, PD characteristics, and immunogenicity of subjects.
Allergic rhinitis (AR) is a non infectious chronic inflammatory disease of the nasal mucosa that is mainly mediated by immunoglobulin E (IgE) in atopic individuals exposed to allergens. All participants will receive standard of care treatment as concomitant medications. CM310 or placebo will be administered as add-on therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
108
Beijing Tong-Ren hospital
Beijing, China
Mean change from baseline in daily reflective total nasal symptom scores (rTNSS) over 2 weeks of treatment.
The total nasal symptom score (TNSS) is the sum of the four symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing, where each symptom is scored on a scale of 0 to 3.
Time frame: Up to week 4
Mean change from baseline in daily rTNSS over 4 weeks of treatment
The total nasal symptom score (TNSS) is the sum of the four symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing, where each symptom is scored on a scale of 0 to 3.
Time frame: Up to week 4
Mean change from baseline in the daily AM and PM reflective total nasal symptom score (AM and PM rTNSS) over 2 and 4 weeks of treatment
The total nasal symptom score (TNSS) is the sum of the four symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing, where each symptom is scored on a scale of 0 to 3.
Time frame: Up to week 4
Mean change and mean percent change from baseline in daily AM pre-dose instantaneous total nasal symptom score (iTNSS) over 2 weeks and 4 weeks of treatment
The instantaneous total symptom scores (iTNSS) are the rating of the severity of instantaneous symptoms at a time point.
Time frame: Up to week 4
Mean percent change from baseline in daily rTNSS over 2 and 4 weeks of treatment
The total nasal symptom score (TNSS) is the sum of the four symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing, where each symptom is scored on a scale of 0 to 3.
Time frame: Up to week 4
Mean change from baseline in daily rTNSS (including AM rTNSS and PM rTNSS) for individual nasal symptoms (rhinorrhea, nasal congestion, nasal itching, and sneezing) over 2 and 4 weeks of treatment
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The total nasal symptom score (TNSS) is the sum of the four symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing, where each symptom is scored on a scale of 0 to 3.
Time frame: Up to week 4
Mean change and mean percent change from baseline in daily reflective total ocular symptom score (rTOSS) over 2 weeks or 4 weeks of treatment
The total ocular symptom score (TOSS) is the sum of three symptom scores for itchy/burning eyes, watery eyes, and red eyes, where each symptom is scored on a scale of 0 to 3.
Time frame: Up to week 4
Mean change from baseline in daily AM and PM reflective total ocular symptom score (AM and PM rTOSS) over 2 weeks and 4 weeks of treatment
The total ocular symptom score (TOSS) is the sum of three symptom scores for itchy/burning eyes, watery eyes, and red eyes, where each symptom is scored on a scale of 0 to 3.
Time frame: Up to week 4
Mean change from baseline in daily AM pre-dose instantaneous total ocular symptom score (iTOSS) over 2 weeks and 4 weeks of treatment
The instantaneous total symptom scores (iTOSS) are the rating of the severity of instantaneous symptoms at a time point.
Time frame: Up to week 4
Mean percent change from baseline in daily rTOSS over 2 weeks and 4 weeks of treatment
The total ocular symptom score (TOSS) is the sum of three symptom scores for itchy/burning eyes, watery eyes, and red eyes, where each symptom is scored on a scale of 0 to 3.
Time frame: Up to week 4
Mean percent change from baseline in daily AM pre-dose iTOSS over 2 weeks and 4 weeks of treatment
The instantaneous total symptom scores (iTOSS) are the rating of the severity of instantaneous symptoms at a time point.
Time frame: Up to week 4
Mean change from baseline in daily rTOSS (including AM and PM rTOSS) for individual symptoms (itching/burning eyes, tearing/watering eyes, and eye redness) over 2 weeks and 4 weeks of treatment
The total ocular symptom score (TOSS) is the sum of three symptom scores for itchy/burning eyes, watery eyes, and red eyes, where each symptom is scored on a scale of 0 to 3.
Time frame: Up to week 4
The change from baseline in rhinoconjunctivitis quality of life questionnaire (RQLQ) score in allergic rhinitis participants over 2 weeks and 4 weeks of treatment
The Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) is a 28-item, self-administered, disease-specific (AR) quality of life scale used by participants to assess quality of life over a week.
Time frame: Up to week 4
Time to onset of treatment effect
The reflective scores (rTNSS, rTOSS) represent the participant's symptoms in the previous 12 hours. The instantaneous total symptom scores (iTNSS, iTOSS) are the rating of the severity of instantaneous symptoms at a time point.
Time frame: Up to week 4
Time to maximum treatment effect
The reflective scores (rTNSS, rTOSS) represent the participant's symptoms in the previous 12 hours. The instantaneous total symptom scores (iTNSS, iTOSS) are the rating of the severity of instantaneous symptoms at a time point.
Time frame: Up to week 4
Area under the curve of the change from baseline in the daily rTNSS over 2 weeks and 4 weeks of treatment
The total nasal symptom score (TNSS) is the sum of the four symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing, where each symptom is scored on a scale of 0 to 3.
Time frame: Up to week 4
Number of days with no or mild symptoms over 2 weeks and 4 weeks of treatment
Based on all the endpoints of TNSS and TOSS.
Time frame: Up to week 4
Incidence of adverse events (AEs)
Evaluate the incidence of treatment-emergency adverse events.
Time frame: Up to wee 12
Serum CM310 concentration
Collect the blood samples for Pharmacokinetics analysis
Time frame: Up to week 12
Change and percent change from baseline of human thymus and activation-regulated chemokine (TARC)
Collect the blood samples for Pharmacodynamics analysis
Time frame: Up to week 12
change and percent change from baseline of total immunoglobulin E (IgE) in serum/plasma
Collect the blood samples for Pharmacodynamics analysis
Time frame: Up to week 12
change and percent change from baseline of counts and ratios of eosinophil in blood
Collect the blood samples for Pharmacodynamics analysis
Time frame: Up to week 12
The development of anti-drug antibody (ADA) and neutralizing antibody (Nab)
Collect the blood samples for anti-drug antibody testing
Time frame: Up to week 12