A Study of Stapokibatrt in Children Subjects With Atopic Dermatitis

Sponsor
Keymed Biosciences Co.Ltd
Study ID
NCT07106372
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
2 Years - 12 Years
Healthy Volunteers
Not accepted

Interventions

  • Stapokibatrt — BIOLOGICAL
    Stapokibatrt Subcutaneous injection

Study Details

This is a multi-center, single-arm, open-label phase 3 study to evaluate the safety, efficacy, Pharmacokinetics(PK) and immunogenicity of Stapokibatrt in children with Atopic Dermatitis.

Key Dates

First listed
Aug 6, 2025
Start date
Sep 30, 2025
Status verified
Aug 2025
Primary completion
Feb 28, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
240 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Stapokibatrt group

Primary Outcome Measure

Adverse events [ Time Frame: up to week 44 ]

Central Contacts

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