Allergic rhinitis (AR) affects large population worldwide, the most commonly used medication include anti-histamine, nasal spray and anti-LTRAs inhibitors (leukotriene receptor antagonists), Even after those first-line treatment, there is still a large number of patient (\~20%) are not well/adequately controlled. Anti-IgE antibody has been approved to treat moderate to severe AR by PMDA/Japan in 2020, demonstrating the efficacy of IgE blockade in the treatment of allergic rhinitis. The current study presents a novel anti-IgE antibody (LP-003) with higher affinity to IgE, stronger efficacy and longer half-life.
The purpose of this study was to evaluate the efficacy and safety of LP-003 in combination with SoC (nasal corticosteroids and/or anti-histamine) in adult patients with Moderate to Severe Seasonal Allergic Rhinitis, whose symptoms were inadequately controlled despite the current recommended therapies (nasal corticosteroids and/or anti-histamine) in the previous 2 pollen seasons.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
180
Liquid in vial
Liquid in vial
Liquid in vial
Beijing Shijitan Hospital
Beijing, Beijing Municipality, China
Dongfang Hospital
Beijing, Beijing Municipality, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Peking University Third Hospital
Beijing, Beijing Municipality, China
Zhengzhou central hospital
Zhengzhou, Henan, China
Changchun University of Chinese Medicine Affiliated Hospital
Changchun, Jilin, China
Tonghua central hospital
Tonghua, Jilin, China
Yan Bian Chao Yi Hospital
Yanbian, Jilin, China
Yanbian University hospital
Yanji, Jilin, China
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China
...and 7 more locations
Mean nasal symptom score
Nasal symptoms (itchy, sneezing, rhinorrhea and nasal congestion) were recorded by the patient everyday in their e-Diary, on a scale of 0 (none) to 3 (intense/severe). Nasal symptom score (0-12 point) consisted of score for severity of itchy (0-3 point), sneezing (0-3 point), rhinorrhea (0-3 point) and nasal congestion (0-3 point). Peak pollen period was defined as the period between the first and last three consecutive days with ≥300 total pollen/1000 mm2 each day.
Time frame: peak pollen period(estimated average 4 weeks)
Daily nasal symptom medication score
The daily nasal symptom medication score consisted of the sum of the daily nasal symptom severity score (0-12 points) and the daily nasal rescue medication score.
Time frame: peak pollen period(estimated average 4 weeks)
Daily nasal symptom medication score
The daily nasal symptom medication score consisted of the sum of the daily nasal symptom severity score (0-12 points) and the daily nasal rescue medication score. Pollen period was defined as the period between the first day when the total daily pollen count was ≥80 total pollen/1000 mm2 to the first day when the total daily pollen count was \<80 total pollen/1000 mm2
Time frame: pollen period(estimated average 10 weeks)
Daily ocular symptom medication score
Ocular symptoms (itchy eyes/foreign body sensation/redness, tearing) were recorded by the patient everyday in their e-Diary, on a scale of 0 (none) to 3 (intense/severe). Ocular symptom score (0-6 point) consisted of score for severity of itchy eyes/foreign body sensation/redness (0-3 point) and tearing (0-3 point). The daily ocular symptom medication score consisted of the sum of the daily ocular symptom severity score (0-6 points) and the daily ocular rescue medication score.
Time frame: pollen period(estimated average 10 weeks)
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