Study of Stapokibatrt in Children Subjects With Atopic Dermatitis

NCT06956196 | Not Yet Recruiting Phase 3

• 1 other identifier: CM310-101217
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

• Proportion of subjects achieving Eczema Area and Severity Index(EASI-75) at week 18

  The EASI is a composite index with scores ranging from 0 to 72. Four Atopic Dermatitis(AD) disease characteristics (erythema, edema/papulation, excoriation, lichenification) will each be assessed for severity by the investigator on a scale of "0" (none) through "3" (severe).

  Up to week 18

Study Arms (2)

Stapokibatrt group

EXPERIMENTAL

Biological: Stapokibatrt

Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

Stapokibatrt BIOLOGICAL

Stapokibatrt 1 or 2 ml,Subcutaneous injection(SC)

Stapokibatrt group

Placebo OTHER

Placebo of matching volume，Subcutaneous injection(SC)

Placebo

Eligibility Criteria

• Age: 2 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Keymed Biosciences Co.Ltd: lead

Study Sites (1)

Beijing Children's Hospital Capital Medical University

Beijing, China

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Lin Ma

  Beijing Children's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qian Jia

CONTACT

028-88610620; qianjia@keymedbio.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2025
• First Posted: May 4, 2025
• Study Start: May 1, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: May 4, 2025

Record last verified: 2025-04

Locations

CN (1)