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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorChengdu Kangnuoxing Biopharma,Inc.

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

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

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • Stapokibart

    Biological/Vaccine

    subcutaneous injection

Treatment groups

1,000 Participants
are divided into 1 treatment group
Group A: Group of Stapokibart Injection1 intervention

Trial outcomes

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.

Secondary outcomes

Other outcomes

Sponsors and contacts

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