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

Chengdu Kangnuoxing Biopharma,Inc.

Status and phase: Not yet enrolling; Phase 2

Conditions: Seasonal Allergic Rhinitis (SAR)

Treatments: Biological: Stapokibart injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT07617324

CM310-107110

Details and patient eligibility

About

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.

Enrollment: 15 estimated patients

Sex: All

Ages: 12 to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Group of Stapokibart Injection

Experimental group

Treatment:

Biological: Stapokibart injection