NCT07230483

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
246

participants targeted

Target at P75+ for phase_2

Timeline
18mo left

Started Dec 2025

Geographic Reach
1 country

1 active site

Status
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 Progress24%
Dec 2025Dec 2027

First Submitted

Initial submission to the registry

November 13, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 17, 2025

Completed
14 days until next milestone

Study Start

First participant enrolled

December 1, 2025

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

November 17, 2025

Status Verified

November 1, 2025

Enrollment Period

2 years

First QC Date

November 13, 2025

Last Update Submit

November 13, 2025

Conditions

Atopic Dermatitis (AD)

Outcome Measures

Primary Outcomes (1)

  • Adverse events

    The incidence of adverse events

    up to 52 weeks

Study Arms (4)

Group 1

EXPERIMENTAL
Biological: CM512

Group 2

EXPERIMENTAL
Biological: CM512

Group 3

EXPERIMENTAL
Biological: CM512

Group 4

EXPERIMENTAL
Biological: CM512

Interventions

CM512BIOLOGICAL

CM512 subcutaneous injection

Group 1Group 2Group 3Group 4

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, China

RECRUITING

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

Central Study Contacts

Qian Jia

CONTACT

+86-028-88610620qianjia@keymedbio.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 13, 2025

First Posted

November 17, 2025

Study Start

December 1, 2025

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

November 17, 2025

Record last verified: 2025-11

Locations

CN(1)