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

ConditionSeasonal Allergic Rhinitis (SAR)
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age12-18
SponsorChengdu Kangnuoxing Biopharma,Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Design model

Single group

Treatments tested in this trial

  • Stapokibart injection

    Biological/Vaccine

    subcutaneous injection

Treatment groups

15 Participants
are divided into 1 treatment group
Group A: Group of Stapokibart InjectionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Safety parameters

Incidence of adverse events

Time frame
From the signing of ICF(Informed Consent Form) until study completion (or early withdrawal),about 0.5 years

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Chengdu Kangnuoxing Biopharma,Inc.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: