Seasonal Allergic Rhinitis (SAR)Phase 2NCT07617324
Study of Stapokibart Injection in Adolescent Subjects With Seasonal Allergic Rhinitis (SAR)
A Phase 2 study testing Stapokibart injection in people with Seasonal Allergic Rhinitis (SAR), run by Chengdu Kangnuoxing Biopharma,Inc. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Seasonal Allergic Rhinitis (SAR)
- What is being tested?
- Stapokibart injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteChina
- Study dates
- Jun 2026to Feb 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Beijing Tongren Hospital, CMU
Beijing, Beijing Municipality
Qian Jia, 86+028-88610620, clinicaltrial@keymedbio.com
About this study
Official title: A Multicenter, Single-arm, Open-label Study to Evaluate the Safety and Pharmacokinetics of Stapokibart Injection in Adolescent Patients With SAR Under Background Therapy
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.
- Conditions
- Seasonal Allergic Rhinitis (SAR)
- Being tested
- Stapokibart injection
- Medical subject headings
- Rhinitis, Allergic, Seasonal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stapokibart injectionBiological
subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Group of Stapokibart Injection | Experimental | Not described Receives: Biological: Stapokibart injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety parameters
Incidence of adverse events
Measured: From the signing of ICF(Informed Consent Form) until study completion (or early withdrawal),about 0.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2026
- Study startJun 2026 (estimated)
- Primary completionOct 2026 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Seasonal Allergic Rhinitis (SAR)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chengdu Kangnuoxing Biopharma,Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Luo Zhang, Study chair, Beijing Tongren Hospital, CMU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07617324
- Sponsor's protocol ID
- CM310-107110
- Status last verified
- May 2026
- First submitted
- 21 May 2026
- Last updated
- 1 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Single-arm, Open-label Study to Evaluate the Safety and Pharmacokinetics of Stapokibart Injection in Adolescent Patients With SAR Under Background Therapy
- ClinicalTrials.gov ID
- NCT07617324
- Acronym / sponsor ID
- CM310-107110
- Conditions
- Seasonal Allergic Rhinitis (SAR)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Chengdu Kangnuoxing Biopharma,Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2026 (estimated)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 1 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group of Stapokibart Injection | Experimental | Biological: Stapokibart injection |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stapokibart injectionsubcutaneous injection | Biological | Group of Stapokibart Injection |
Primary outcome
Safety parameters
Time frame: From the signing of ICF(Informed Consent Form) until study completion (or early withdrawal),about 0.5 years
Incidence of adverse events
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Luo Zhang study chair
Beijing Tongren Hospital, CMU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Stapokibart injection in people with Seasonal Allergic Rhinitis (SAR), run by Chengdu Kangnuoxing Biopharma,Inc. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qian Jia (028-88610620, clinicaltrial@keymedbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety parameters (time frame: From the signing of ICF(Informed Consent Form) until study completion (or early withdrawal),about 0.5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.