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RECRUITING
NCT07678931
PHASE3

Study on the Treatment of Adolescent Patients With Seasonal Allergic Rhinitis

Sponsor: Chengdu Kangnuoxing Biopharma,Inc.

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

12 Years - 18 Years

Study Type

INTERVENTIONAL

Enrollment

136

Start Date

2026-08-13

Completion Date

2026-12

Last Updated

2026-09-03

Healthy Volunteers

No

Interventions

BIOLOGICAL

Stapokibart

subcutaneous injection

DRUG

Placebo

subcutaneous injection

Locations (27)

Beijing Children's Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Beijing Tongren Hospital, CMU

Beijing, Beijing Municipality, China

China-Japan Friendship Hospital

Beijing, Beijing Municipality, China

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College

Beijing, Beijing Municipality, China

Peking University Third Hospital

Beijing, Beijing Municipality, China

Hebei Petroleum Central Hospital

Langfang, Beijing Municipality, China

Affiliated Hospital of Hebei University

Baoding, Hebei, China

Cangzhou Central Hospital

Cangzhou, Hebei, China

Hebei General Hospital

Shijiazhuang, Hebei, China

Hebei Provincial Hospital of Traditional Chinese Medicine

Shijiazhuang, Hebei, China

The First Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

First Affiliated Hospital of Hebei North University

Zhangjiakou, Hebei, China

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Baotou Central Hospital

Baotou, Inner Mongolia, China

The Affiliated Hospital of Inner Mongolia Medical University

Hohhot, Inner Mongolia, China

China-Japan Union Hospital of Jilin University

Changchun, Jilin, China

Shengjing Hospital of China Medical University

Shenyang, Liaoning, China

Yinchuan First People's Hospital

Yinchuan, Ningxia, China

Shandong Second Provincial General Hospital

Jinan, Shandong, China

Yantai Yuhuangding Hospital

Yantai, Shandong, China

Zibo Central Hospital

Zibo, Shandong, China

Shanxi Bethune Hospital

Taiyuan, Shanxi, China

The First Hospital of Shanxi Medical University

Taiyuan, Shanxi, China

The Second Hospital of Shanxi Medical University

Taiyuan, Shanxi, China

The Second Affiliated Hospital of Xi'an Jiaotong University

Xi’an, Shanxi, China

Tianjin First Central Hospital

Tianjin, Tianjin Municipality, China