Study of Stapokibart Injection in Adolescent Subjects With Seasonal Allergic Rhinitis (SAR)

May 24, 2026 updated by: Chengdu Kangnuoxing Biopharma,Inc.

A Multicenter, Single-arm, Open-label Study to Evaluate the Safety and Pharmacokinetics of Stapokibart Injection in Adolescent Patients With SAR Under Background Therapy

This study is a multicenter, single-arm, open-label, phase II study to evaluate the safety, pharmacokinetics, and immunogenicity of Stapokibart injection in Adolescent Patients with SAR.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

15

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Voluntarily sign the Informed Consent Form.
  • Age ≥ 12 years old and <18 years old, weight ≥ 40 kg.
  • With a diagnosis of SAR, with or without allergic conjunctivitis, and the SAR duration was ≥ 2 years.

Exclusion Criteria:

  • Not enough washing-out period for previous therapies.
  • With other poorly controlled serious diseases or chronic conditions.
  • With any conditions that are not suitable for participation in this study by investigators.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group of Stapokibart Injection
Biological: Stapokibart injection
subcutaneous injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety parameters
Time Frame: From the signing of ICF(Informed Consent Form) until study completion (or early withdrawal),about 0.5 years
Incidence of adverse events
From the signing of ICF(Informed Consent Form) until study completion (or early withdrawal),about 0.5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chengdu Kangnuoxing Biopharma,Inc.

Investigators

  • Study Chair: Luo Zhang, Beijing Tongren Hospital, CMU

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

February 1, 2027

Study Registration Dates

First Submitted

May 21, 2026

First Submitted That Met QC Criteria

May 24, 2026

First Posted (Actual)

June 1, 2026

Study Record Updates

Last Update Posted (Actual)

June 1, 2026

Last Update Submitted That Met QC Criteria

May 24, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CM310-107110

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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