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

NCT ID: NCT07230483

Last Updated: 2025-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

246 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-31

Study Completion Date

2027-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Atopic Dermatitis (AD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group 1

Group Type EXPERIMENTAL

CM512

Intervention Type BIOLOGICAL

CM512 subcutaneous injection

Group 2

Group Type EXPERIMENTAL

CM512

Intervention Type BIOLOGICAL

CM512 subcutaneous injection

Group 3

Group Type EXPERIMENTAL

CM512

Intervention Type BIOLOGICAL

CM512 subcutaneous injection

Group 4

Group Type EXPERIMENTAL

CM512

Intervention Type BIOLOGICAL

CM512 subcutaneous injection

Interventions

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CM512

CM512 subcutaneous injection

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Keymed Biosciences Co.Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jianzhong Zhang

Role: PRINCIPAL_INVESTIGATOR

Peking University People's Hospital

Locations

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Peking University People's Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Qian Jia

Role: CONTACT

+86-028-88610620

Facility Contacts

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Jianzhong Zhang

Role: primary

15545433012

Other Identifiers

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CM512-101103

Identifier Type: -

Identifier Source: org_study_id

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