Atopic Dermatitis (AD)NCT07544862
A Study of Stapokibart Injection in Patients With Atopic Dermatitis (AD)
An observational study of Atopic Dermatitis (AD), run by Chengdu Kangnuoxing Biopharma,Inc. at 1 site in China.
Trial summary
This study is an open label, prospective study to evaluate the safety and efficacy of Stapokibart Injection in patients with AD. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atopic Dermatitis (AD)
- What is being tested?
- Stapokibart
- Type of treatment
- Injection or infusion
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 2 Jun 2026to Feb 2028
- How long will I take part?
- 52 Weeks
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who are treated with Stapokibart Injection for AD at the physician's discretion (according to the China-specific prescribing information).
Who may be able to join
- Trial participants aged 18 years or older at baseline, with no restrictions on gender.
- Physician decision to treat trial participants with Stapokibart Injection for AD (according to the China-specific prescribing information) made prior to and independently of the participant's participation in the study.
Who cannot join
- Known history of allergic reaction to Stapokibart Injection.
- Trial participants currently or plan participating in any interventional clinical trial.
- Trial participants with hematologic malignancies.
- Women with pregnant.
- Any condition that, in the opinion of the investigator, may interfere with trial participants' ability to participate in the study.
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, 1 recruiting
- Recruiting
Peking University People's Hospital
Beijing, Beijing Municipality
Qian Jia, 028-88610620, clinicaltrial@keymedbio.com
About this study
Official title: A Prospective Study of Stapokibart Injection in Patients With Moderate-to-Severe Atopic Dermatitis (AD)
This study is an open label, prospective study to evaluate the safety and efficacy of Stapokibart Injection in patients with AD.
- Conditions
- Atopic Dermatitis (AD)
- Being tested
- Stapokibart
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StapokibartBiological
subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Group of Stapokibart Injection | Not described Receives: Biological: Stapokibart |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence rate of adverse reactions
Number of Adverse Reactions is calculated based on Adverse Events and Serious Adverse Events that were assessed by the investigator as related to the study drug and categorized according to the Medical Dictionary for Regulatory Activities.
Measured: From enrollment to the end of treatment at 52 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2026
- Study start2 Jun 2026
- Primary completionDec 2027 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic Dermatitis (AD)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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 52 Weeks
Sponsor and investigators
- Lead sponsor
- Chengdu Kangnuoxing Biopharma,Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07544862
- Sponsor's protocol ID
- CM310-101301
- Status last verified
- Jun 2026
- First submitted
- 16 Apr 2026
- Last updated
- 10 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 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study of Stapokibart Injection in Patients With Moderate-to-Severe Atopic Dermatitis (AD)
- ClinicalTrials.gov ID
- NCT07544862
- Acronym / sponsor ID
- CM310-101301
- Conditions
- Atopic Dermatitis (AD)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Chengdu Kangnuoxing Biopharma,Inc.Industry (pharma, biotech, devices)
- Study start
- 2 Jun 2026 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 22 Apr 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 an open label, prospective study to evaluate the safety and efficacy of Stapokibart Injection in patients with AD.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 52 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group of Stapokibart Injection | – | Biological: Stapokibart |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are treated with Stapokibart Injection for AD at the physician's discretion (according to the China-specific prescribing information).
Key inclusion criteria (2 listed)
- Trial participants aged 18 years or older at baseline, with no restrictions on gender.
- Physician decision to treat trial participants with Stapokibart Injection for AD (according to the China-specific prescribing information) made prior to and independently of the participant's participation in the study.
Key exclusion criteria (5 listed)
- Known history of allergic reaction to Stapokibart Injection.
- Trial participants currently or plan participating in any interventional clinical trial.
- Trial participants with hematologic malignancies.
- Women with pregnant.
- Any condition that, in the opinion of the investigator, may interfere with trial participants' ability to participate in the study.
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 |
|---|---|---|
| Stapokibartsubcutaneous injection | Biological | Group of Stapokibart Injection |
Primary outcome
The incidence rate of adverse reactions
Time frame: From enrollment to the end of treatment at 52 weeks.
Number of Adverse Reactions is calculated based on Adverse Events and Serious Adverse Events that were assessed by the investigator as related to the study drug and categorized according to the Medical Dictionary for Regulatory Activities.
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 10 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atopic Dermatitis (AD), 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 2 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 10 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.
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?
The incidence rate of adverse reactions (time frame: From enrollment to the end of treatment at 52 weeks.). 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 10 Jun 2026.