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Recruiting NCT07230483

A Long-term Safety and Efficacy Study Evaluating CM512 in Atopic Dermatitis.

Phase II Interventional Atopic Dermatitis (AD)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: CM512.
Who it may be relevant to
Registry conditions: Atopic Dermatitis (AD). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

An Open-Label, Multicenter Study to Evaluate Long-Term Safety and Efficacy of CM512 in Atopic Dermatitis Patients.

Overview

This is an Open-label ,Multicenter Study to evaluate Long-Term Safety and Efficacy of CM512 in patients with Atopic Dermatitis who have completed treatment in parent CM512 Study.

Interventions

  • Biological CM512
    CM512 subcutaneous injection

Primary outcome measures

  • Adverse events [Time frame: up to 52 weeks]

Eligibility criteria

Inclusion criteria

  • Have the ability to understand the study and voluntarily sign a written informed consent form (ICF).
  • Subjects who have completed the week 18 evaluation in the parent study CM512-101102 or the End of Study(EOS) visit in the parent study CM512-100001.

Exclusion criteria

  • Not enough washing-out period for previous therapy.
  • Any other condition assessed by the investigator that makes participants unsuitable for participation in this study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Peking University People's Hospital — Beijing

Identifiers

NCT: NCT07230483 · CM512-101103

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗