Study on the Treatment of Adolescent Patients With Seasonal Allergic Rhinitis

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Seasonal Allergic Rhinitis (SAR)
• Intervention / Treatment: Drug: Placebo; Biological: Stapokibart

Detailed Description

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. Stapokibart or placebo will be administered as add-on therapy.

• Study Type: Interventional
• Enrollment (Estimated): 136
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Qian Jia; Phone Number: 028-88610620; Email: clinicaltrial@keymedbio.com

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China
      • Beijing Tongren Hospital, CMU
      • Contact: Qian Jia; Phone Number: 028-88610620; Email: clinicaltrial@keymedbio.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Subjects who received anti-interleukin-4 receptor alpha(anti-IL-4Rα), anti-thymic stromal lymphopoietin(anti-TSLP), anti-immunoglobulin E(anti-IgE) monoclonal antibodies or other biologics within 10 weeks or 5 half-lives prior to screening (whichever is longer), or have a history of inadequate therapeutic response or intolerance to prior anti-IL-4Rα monoclonal antibody treatment for seasonal allergic rhinitis.
• Subjects with known hypersensitivity to stapokibart, any anti-IL-4Rα monoclonal antibody, or any ingredients of background concomitant medications.
• Subjects who newly initiate allergen-specific immunotherapy within 3 months before screening or intend to receive such therapy during the trial, or whose allergen exposure at home or workplace is expected to change significantly throughout the study period.
• Subjects with poorly controlled recent asthma or concomitant severe asthma with percent predicted Forced Expiratory Volume in one second(FEV1) ≤50% at screening.
• Subjects presenting other active nasal comorbidities at screening (chronic rhinitis, drug-induced rhinitis, chronic rhinosinusitis with or without nasal polyps, severe nasal septal deviation, etc.) that may interfere with efficacy determination.
• Subjects with current or past history of infections of special concern (active tuberculosis, helminthic infections, severe herpes virus infections, etc.), or diagnosed with malignant tumors within 5 years before screening, excluding fully cured cervical carcinoma in situ and non-metastatic cutaneous squamous or basal cell carcinoma.
• Subjects with severe underlying medical conditions including severe hepatic and renal impairment, autoimmune diseases, cardiovascular and cerebrovascular disorders, HIV infection, active hepatitis B/C, immunosuppression, or history of solid organ/hematopoietic stem cell transplantation which, in the investigator's opinion, may pose safety risks via trial participation.
• Have a serious underlying medical condition that, in the opinion of the investigator, may pose a risk to subject safety by participation in a clinical trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo group	Drug: Placebo; subcutaneous injection
Experimental: Stapokibart group	Biological: Stapokibart; subcutaneous injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to week 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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	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.	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.	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.	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.	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.	Up to week 4
Change and percent change from baseline of human thymus and activation-regulated chemokine (TARC)	Collect the blood samples for Pharmacodynamics analysis	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	Up to week 12
The development of anti-drug antibody (ADA) and neutralizing antibody (Nab)	Collect the blood samples for anti-drug antibody testing	Up to week 12
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 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.	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 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.	Up to week 4
Mean percent change from baseline in daily AM pre-dose iTOSS 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.	Up to week 4
The change from baseline in rhinoconjunctivitis quality of life questionnaire (RQLQ(S)≥12) score in allergic rhinitis participants over 2 weeks and 4 weeks of treatment	The Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ(S)≥12) is a 28-item, self-administered, disease-specific (AR) quality of life scale used by participants to assess quality of life over a week.	Up to week 4
Incidence of adverse events (AEs)	Evaluate the incidence of treatment-emergency adverse events.	Up to week 12
Serum Stapokibart concentration	Collect the blood samples for Pharmacokinetics analysis	Up to week 12
change and percent change from baseline of total immunoglobulin E (IgE)	Collect the blood samples for Pharmacodynamics analysis	Up to week 12

Collaborators and Investigators

• Sponsor: Chengdu Kangnuoxing Biopharma,Inc.
• Investigators: Principal Investigator: Luo Zhang, Beijing Tongren Hospital Affiliated to Capital Medical University; Principal Investigator: Chengshuo Wang, Beijing Tongren Hospital Affiliated to Capital Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: June 25, 2026
• First Submitted That Met QC Criteria: June 25, 2026
• First Posted (Actual): July 1, 2026

Study Record Updates

• Last Update Posted (Actual): July 1, 2026
• Last Update Submitted That Met QC Criteria: June 25, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Nose Diseases; Otorhinolaryngologic Diseases; Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
• Other Study ID Numbers: CM310-107208

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No