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NCT Number: NCT07617324

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

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.

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Key information

Conditions

Seasonal Allergic Rhinitis (SAR) Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Rhinitis Rhinitis, Allergic Rhinitis, Allergic, Seasonal

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Beijing Tongren Hospital, CMU

Beijing, Beijing Municipality, China

Location contact

Qian Jia

CONTACT

[email protected]

86+028-88610620

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Stapokibart Injection

Biological

subcutaneous injection

Primary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Qian Jia

CONTACT

[email protected]

028-88610620

Sponsors and collaborators

Lead sponsor

Chengdu Kangnuoxing Biopharma,Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Jun 1, 2026
Registry last updated
Jun 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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