Study of Stapokibatrt in Children Subjects With Atopic Dermatitis

Keymed Biosciences

Status and phase

Not yet enrolling

Phase 3

Conditions

Atopic Dermatitis

Treatments

Biological: Stapokibatrt

Other: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT06956196

CM310-101217

Details and patient eligibility

About

This is a multi-center, randomized, double blind, placebo-controlled phase 3 study to evaluate the efficacy, safety, Pharmacokinetics(PK), PharmacoDynamics(PD) and immunogenicity of Stapokibatrt in children with moderate-to-severe atopic dermatitis.

Enrollment

240 estimated patients

Sex

All

Ages

2 to 11 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age ≥ 2 and ≤ 11 years old.
Diagnosis of AD according to the American Academy of Dermatology Consensus (2014) Criteria.
With moderate-to-severe AD, and inadequate response to topical medications.

Exclusion criteria

Prior treatment with Stapokibart
Treatment with dupilumab within 13 weeks prior to the baseline visit, or treatment with anti-IgE(Immunoglobulin E) monoclonal antibody，other biological agents within 5 half-lives prior to the baseline visit .
Treatment with immunosuppressants/immunomodulatory drugs, ultraviolet therapy, or systemic traditional Chinese medicine for AD within 4 weeks prior to the baseline visit.
Treatment with a topical corticosteroids (TCS), topical calcineurin inhibitor (TCI) or topical Phosphodiesterase-4(PDE-4) inhibitor within 1 weeks prior to the baseline visit.
History of atopic keratoconjunctivitis invading cornea.
Acute attacks of Atopic Dermatitis within 4 weeks prior to the baseline visit.
Planned major surgical procedure during the patient's participation in this study.