NCT07678931|RecruitingPhase 3

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

Chengdu Kangnuoxing Biopharma,Inc.ClinicalTrials.gov

Compare

1 other identifier

CM310-107208

Study Type

interventional

Target

136

Locations

1 country

Sites

Timeline

RegisteredJul 2026

StartedAug 2026

CompletionDec 2026

Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

136

participants targeted

Target at P25-P50 for phase_3

Timeline

2mo left

Started Aug 2026

Shorter than P25 for phase_3

Geographic Reach

1 country

27 active sites

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

4 months study duration

Study Progress48%

Aug 2026Dec 2026

First Submitted

Initial submission to the registry

June 25, 2026

Completed

6 days until next milestone

First Posted

Study publicly available on registry

July 1, 2026

Completed

1 month until next milestone

Study Start

First participant enrolled

August 13, 2026

Completed

4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

September 3, 2026

Status Verified

June 1, 2026

Enrollment Period

4 months

First QC Date

June 25, 2026

Last Update Submit

September 1, 2026

Conditions

Seasonal Allergic Rhinitis (SAR)

Outcome Measures

Primary Outcomes (1)

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.With higher scores indicating a greater impact on quality of life.
Up to week 4

Secondary Outcomes (18)

Mean change from baseline in daily rTNSS over 4 weeks of treatment
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
Up to week 4
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
Up to week 4
Mean percent change from baseline in daily rTNSS over 2 and 4 weeks of treatment
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
Up to week 4
+13 more secondary outcomes

Study Arms (2)

Stapokibart group

EXPERIMENTAL

Biological: Stapokibart

Placebo group

PLACEBO COMPARATOR

Drug: Placebo

Interventions

StapokibartBIOLOGICAL

subcutaneous injection

Stapokibart group

PlaceboDRUG

subcutaneous injection

Placebo group

Eligibility Criteria

Age12 Years - 18 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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.

You may not qualify if:

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.

Contact the study team to confirm eligibility.