ClinicalTrials.gg
RecruitingNCT07544862Updated Jun 10, 2026

A Study of Stapokibart Injection in Patients With Atopic Dermatitis (AD)

An observational study in Atopic Dermatitis (AD), sponsored by Chengdu Kangnuoxing Biopharma,Inc.. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-10.

Sponsored by Chengdu Kangnuoxing Biopharma,Inc. · Observational

From the registry’s dates

  • Started Jun 2026; still recruiting 5 months later.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
1,000
Ages
18 Years and older
Sex
All
01

Study summary

This study is an open label, prospective study to evaluate the safety and efficacy of Stapokibart Injection in patients with AD.

02

Conditions studied

  • Atopic Dermatitis (AD)

Browse trials for

03

In context

Dermatitis, Atopic

1,591 studies on the registry are indexed under Dermatitis, Atopic; 286 are open to participants now.

This study's planned enrollment of 1,000 is above the median of 150 across 282 observational studies indexed under Dermatitis, Atopic.

Browse Dermatitis, Atopic studies →

Lead sponsor

Chengdu Kangnuoxing Biopharma,Inc. is the lead sponsor of 6 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • Known history of allergic reaction to Stapokibart Injection.
  • Trial participants currently or plan participating in any interventional clinical trial.
  • Trial participants with hematologic .
  • Women with pregnant.
  • Any condition that, in the opinion of the investigator, may interfere with trial participants' ability to participate in the study.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
1,000 participants (estimated)
Target follow-up
52 Weeks
Patient registry
Yes

Groups and cohorts

  • Group of Stapokibart Injection

    Biological: Stapokibart

Interventions

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: From enrollment to the end of treatment at 52 weeks.

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jun 2026 (actual). Primary completion is estimated for Dec 2027, 18 months after the start.

Of 74 industry-sponsored observational studies under Dermatitis, Atopic, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 84. This study's planned 18 months is below that.

Counting every sponsor, half of 170 studies reached it within 35 months; a quarter within 17.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 16, 2026
First posted
Apr 22, 2026
StartActual
Jun 2, 2026
Primary completionEst.
Dec 2027
CompletionEst.
Feb 2028
Last update
Jun 10, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07544862
Lead sponsor
Chengdu Kangnuoxing Biopharma,Inc.
Responsible party
Sponsor
First posted
Apr 22, 2026
Start date
Jun 2, 2026
Primary completion
Dec 2027 (estimated)
Completion
Feb 2028 (estimated)
Last update
Jun 10, 2026

Study contacts

Qian Jia
Contact
clinicaltrial@keymedbio.com
028-88610620

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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