NCT06495229

Brief Summary

This is a multi-center, single arm, open label phase 3 study to evaluate the safety and efficacy of CM310 in children patients with moderate-to-severe atopic dermatitis.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P25-P50 for phase_3

Timeline
4mo left

Started Aug 2024

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress85%
Aug 2024Aug 2026

First Submitted

Initial submission to the registry

July 2, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 10, 2024

Completed
23 days until next milestone

Study Start

First participant enrolled

August 2, 2024

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2026

Last Updated

October 2, 2025

Status Verified

September 1, 2025

Enrollment Period

2.1 years

First QC Date

July 2, 2024

Last Update Submit

September 27, 2025

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

  • Adverse events

    Incidence of adverse events.

    up to week 52

Secondary Outcomes (9)

  • Change from baseline in Eczema Area and Severity Index (EASI)

    up to week 62

  • Proportion of subjects with Immunoglobulin A(IGA) 0 or 1 and a reduction of from baseline of ≥ 2 points

    up to week 62

  • Improvement of Numerical Rating Scale (NRS)

    up to week 62

  • Body surface area (BSA) of involvement of atopic dermatitis

    up to week 62

  • Children Dermatology Life Quality Index (CDLQI)

    up to week 62

  • +4 more secondary outcomes

Study Arms (1)

CM310 group

EXPERIMENTAL
Biological: CM310

Interventions

CM310BIOLOGICAL

Interleukin-4 receptor(IL-4Rα) monoclonal antibody

CM310 group

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Have the ability to understand the study and voluntarily sign a written informed consent form (ICF).
  • Subjects who must complete the evaluation of Week 18 of the main study.
  • With Atopic Dermatitis.

You may not qualify if:

  • Any major surgery planned during the research period.
  • Subjects with potential fertility do not agree to adopt efficient contraceptive measures throughout the entire study period; Pregnant or breastfeeding women, or women planning to conceive or breastfeed during the study period.
  • With any circumstance that the subject is not suitable to participate in this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University People's hospital

Beijing, China

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • jianzhong Zhang

    Peking University People's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 2, 2024

First Posted

July 10, 2024

Study Start

August 2, 2024

Primary Completion (Estimated)

August 30, 2026

Study Completion (Estimated)

August 30, 2026

Last Updated

October 2, 2025

Record last verified: 2025-09

Locations

CN(1)