Study of CM310 in Children Subjects With Moderate-to-severe Atopic Dermatis
A Multicenter, Single-arm, Open-label Study to Evaluate the Safety, Pharmacokinetics, and Pharmacokinetics of CM310 in Children Subjects With Moderate-to-severe Atopic Dermatitis
1 other identifier
interventional
24
1 country
1
Brief Summary
This is a multi-center, single arm, open-label study to evaluate safety in children patients with moderate-to severe atopic dermatis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Dec 2023
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 29, 2023
CompletedFirst Posted
Study publicly available on registry
December 8, 2023
CompletedStudy Start
First participant enrolled
December 22, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 4, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
July 4, 2024
CompletedOctober 15, 2024
November 1, 2023
7 months
November 29, 2023
October 14, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Adverse events
Incidence of adverse events.
up to week 16
Study Arms (2)
CM310 group A
EXPERIMENTALCM310 injection, subcutaneous injection, once every 3 weeks.
CM310 group B
EXPERIMENTALCM310 injection, subcutaneous injection, once every 2 weeks.
Interventions
Eligibility Criteria
You may qualify if:
- With atopic dermatis.
- Voluntarily sign the informed consent form.
You may not qualify if:
- Any major surgery planned during the research period.
- With intestinal parasitic infection within the first 6 months of screening.
- With any previous malignant tumors prior to screening.
- With any circumstance that is not suitable to participate in this study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Beijing Children's Hospital Capital Medical University
Beijing, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 29, 2023
First Posted
December 8, 2023
Study Start
December 22, 2023
Primary Completion
July 4, 2024
Study Completion
July 4, 2024
Last Updated
October 15, 2024
Record last verified: 2023-11