A Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Study to Evaluate the Efficacy and Safety of Stapokibart Injection in Adolescent Patients With Seasonal Allergic Rhinitis Receiving Background Therapy
Status: Recruiting
Location: See all (27) locations...
Intervention Type: Biological, Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
This is a multicenter, randomized, double-blind, placebo-controlled phase III clinical study aimed at evaluating the efficacy and safety of stapokibart in adolescent patients with seasonal allergic rhinitis, and observing the quality of life, Pharmakokinetics(PK), Pharmacodynamics (PD) characteristics, and immunogenicity of subjects.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Maximum Age: 18
Healthy Volunteers: f
View:
• Age range: ≥12 years to \<18 years
• Voluntarily sign the informed consent form.
• Seasonal allergic rhinitis has been prevalent for at least 2 years.Positive for allergens associated with seasonal allergic rhinitis.
• Poor control of seasonal allergic rhinitis with nasal glucocorticoids or other therapeutic agents during the same pollen season in the past.
• Weight≥40kg.
• Symptom severity scores for the season met the enrollment criteria.
Locations
Other Locations
China
Affiliated Hospital of Hebei University
NOT_YET_RECRUITING
Baoding
Baotou Central Hospital
NOT_YET_RECRUITING
Baotou
Beijing Children's Hospital, Capital Medical University
NOT_YET_RECRUITING
Beijing
Beijing Friendship Hospital, Capital Medical University
NOT_YET_RECRUITING
Beijing
Beijing Tongren Hospital, CMU
RECRUITING
Beijing
China-Japan Friendship Hospital
NOT_YET_RECRUITING
Beijing
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
NOT_YET_RECRUITING
Beijing
Peking University Third Hospital
NOT_YET_RECRUITING
Beijing
Cangzhou Central Hospital
NOT_YET_RECRUITING
Cangzhou
China-Japan Union Hospital of Jilin University
NOT_YET_RECRUITING
Changchun
The Affiliated Hospital of Inner Mongolia Medical University
NOT_YET_RECRUITING
Hohhot
Shandong Second Provincial General Hospital
NOT_YET_RECRUITING
Jinan
Hebei Petroleum Central Hospital
NOT_YET_RECRUITING
Langfang
Shengjing Hospital of China Medical University
NOT_YET_RECRUITING
Shenyang
Hebei General Hospital
NOT_YET_RECRUITING
Shijiazhuang
Hebei Provincial Hospital of Traditional Chinese Medicine
NOT_YET_RECRUITING
Shijiazhuang
The First Hospital of Hebei Medical University
NOT_YET_RECRUITING
Shijiazhuang
Shanxi Bethune Hospital
NOT_YET_RECRUITING
Taiyuan
The First Hospital of Shanxi Medical University
NOT_YET_RECRUITING
Taiyuan
The Second Hospital of Shanxi Medical University
NOT_YET_RECRUITING
Taiyuan
Tianjin First Central Hospital
NOT_YET_RECRUITING
Tianjin
The Second Affiliated Hospital of Xi'an Jiaotong University
NOT_YET_RECRUITING
Xi’an
Yantai Yuhuangding Hospital
NOT_YET_RECRUITING
Yantai
Yinchuan First People's Hospital
NOT_YET_RECRUITING
Yinchuan
First Affiliated Hospital of Hebei North University
NOT_YET_RECRUITING
Zhangjiakou
The First Affiliated Hospital of Zhengzhou University