NCT07459556

Brief Summary

This study is an open label, prospective study to evaluate the safety of Stapokibart Injection in subjects with SAR.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
18mo left

Started Mar 2026

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress22%
Mar 2026Feb 2028

Study Start

First participant enrolled

March 1, 2026

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

March 5, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 9, 2026

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2028

Last Updated

March 9, 2026

Status Verified

March 1, 2026

Enrollment Period

1.8 years

First QC Date

March 5, 2026

Last Update Submit

March 5, 2026

Conditions

SAR

Outcome Measures

Primary Outcomes (1)

  • The incidence rate of adverse reactions (ADR).

    Number of of Adverse Reactions （ADRs） is calculated based on Adverse Events （AEs） and Serious Adverse Events （SAEs） that were assessed by the investigator as related to the study drug and categorized according to the Medical Dictionary for Regulatory Activities （MedDRA）.

    From enrollment to the end of treatment at 10 weeks

Study Arms (1)

Group of Stapokibart Injection

Biological: Stapokibart

Interventions

StapokibartBIOLOGICAL

subcutaneous injection

Group of Stapokibart Injection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants who are treated with Stapokibart Injection for SAR at the physician's discretion (according to the China-specific prescribing information).

You may qualify if:

  • Physician decision to treat the participant with Stapokibart Injection for SAR (according to the China-specific prescribing information) made prior to and independently of the participant's participation in the study.

You may not qualify if:

  • Known history of allergic reaction to Stapokibart Injection.
  • Participants currently or plan participating in any interventional clinical trial.
  • Participants with hematologic malignancies.
  • Women with pregnant.
  • Any condition that, in the opinion of the Investigator, may interfere with the participant's ability to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Tongren Hospital, CMU

Beijing, China

Location

Central Study Contacts

Qian Jia

CONTACT

028-88610620clinicaltrial@keymedbio.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2026

First Posted

March 9, 2026

Study Start

March 1, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

February 1, 2028

Last Updated

March 9, 2026

Record last verified: 2026-03

Locations

CN(1)