Study of Stapokibart Injection in Adolescent Subjects Wit... | NCT07617324

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

NCT07617324

Sponsor

Chengdu Kangnuoxing Biopharma,Inc.

Status

Not yet recruiting

Last Update Posted

Jun 1, 2026Actual

Enrollment

15Estimated

Phase

Phase 2

Conditions

Seasonal Allergic Rhinitis (SAR)

Interventions

Stapokibart injection

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2026Estimated

Primary Completion Date

Oct 2026Estimated

Completion Date

Feb 2027Estimated

First Submitted Date

May 21, 2026

First Submission Date that Met QC Criteria

May 24, 2026

First Posted Date

Jun 1, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 24, 2026

Last Update Posted Date

Jun 1, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

15Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group of Stapokibart Injection	Experimental		Biological: Stapokibart injection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Stapokibart injection	Biological	subcutaneous injection	Group of Stapokibart Injection

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Qian Jia	Contact	028-88610620		clinicaltrial@keymedbio.com

Overall Officials

Name	Affiliation	Role
Luo Zhang	Beijing Tongren Hospital, CMU	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Beijing Tongren Hospital, CMU		Beijing	Beijing Municipality		China

Condition Browse Module

MeSH Terms

ID	Term
D006255	Rhinitis, Allergic, Seasonal

Ancestor Terms

ID	Term
D065631	Rhinitis, Allergic
D012220	Rhinitis
D009668	Nose Diseases
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided