NCT05579925

Brief Summary

This is a multi-center, single arm, open-label study to evaluate safety and primary efficacy in children patients with moderate-to severe atopic dermatis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Oct 2022

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

October 7, 2022

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

October 11, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 14, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 28, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 28, 2023

Completed
Last Updated

November 8, 2024

Status Verified

June 1, 2023

Enrollment Period

10 months

First QC Date

October 11, 2022

Last Update Submit

November 7, 2024

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

  • Adverse events

    Incidence of adverse events.

    at week 14

Study Arms (1)

CM310

EXPERIMENTAL

600 mg + 300 mg, subcutaneous injection, once every two weeks

Biological: CM310

Interventions

CM310BIOLOGICAL

CM310 600 mg + 300 mg, subcutaneous injection

CM310

Eligibility Criteria

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

You may qualify if:

  • years ≤ age ≤ 18 years
  • With atopic dermatis
  • Voluntarily sign the informed consent form

You may not qualify if:

  • Weight \< 30 kg
  • Major surgery planed during the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Children's Hospital Capital Medical University

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 Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 11, 2022

First Posted

October 14, 2022

Study Start

October 7, 2022

Primary Completion

July 28, 2023

Study Completion

July 28, 2023

Last Updated

November 8, 2024

Record last verified: 2023-06

Locations

CN(1)