NCT07617324

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_2

Timeline
6mo left

Started Jun 2026

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress26%
Jun 2026Feb 2027

First Submitted

Initial submission to the registry

May 21, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 1, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

June 1, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2027

Last Updated

June 1, 2026

Status Verified

May 1, 2026

Enrollment Period

4 months

First QC Date

May 21, 2026

Last Update Submit

May 24, 2026

Conditions

Seasonal Allergic Rhinitis (SAR)

Outcome Measures

Primary Outcomes (1)

  • Safety parameters

    Incidence of adverse events

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

Study Arms (1)

Group of Stapokibart Injection

EXPERIMENTAL
Biological: Stapokibart injection

Interventions

Stapokibart injectionBIOLOGICAL

subcutaneous injection

Group of Stapokibart Injection

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Tongren Hospital, CMU

Beijing, Beijing Municipality, China

Location

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal

Condition Hierarchy (Ancestors)

Rhinitis, AllergicRhinitisNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Luo Zhang

    Beijing Tongren Hospital, CMU

    STUDY CHAIR

Central Study Contacts

Qian Jia

CONTACT

028-88610620clinicaltrial@keymedbio.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 21, 2026

First Posted

June 1, 2026

Study Start

June 1, 2026

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

February 1, 2027

Last Updated

June 1, 2026

Record last verified: 2026-05

Locations

CN(1)