This is a randomized, double-blind phase II clinical study to evaluate the efficacy and safety of AK139 in the treatment of participants with moderate to severe SAR
This is a randomized, double-blind phase II clinical study to evaluate the efficacy and safety of AK139 in the treatment of participants with moderate to severe SAR. Participants will be randomized to receive AK139 regimen or placebo subcutaneous injection and followed up to week 12
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
111
Beijing Tong-Ren hospital
Beijing, China
Mean change from baseline in daily reflective total nasal symptom scores (rTNSS) over 2 weeks of treatment
Time frame: Up to week 2
Incidence of adverse events (AEs)
Time frame: Up to week 12
Mean change from baseline in daily rTNSS over 2 and 4 weeks of treatment
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
Time frame: Up to week 4
Serum AK139 concentration
Time frame: Up to week 12
Number of participants with detectable anti-drug antibodies (ADA) and neutralizing antibodies (Nab) after treatment.
Time frame: Up to week 12
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