Study of CM512 in Patients With Moderate-to-Severe Atopic Dermatitis

NCT ID: NCT06947980

Last Updated: 2025-08-17

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

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-19

Study Completion Date

2026-11-07

Brief Summary

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A Phase 2 study designed to evaluate the efficacy and safety of CM512 in adult patients with moderate-to-severe Atopic Dermatitis (AD).

Detailed Description

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Conditions

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Atopic Dermatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Group 1

Group Type PLACEBO_COMPARATOR

Placebo Comparator

Intervention Type DRUG

Placebo 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

Group 5

Group Type PLACEBO_COMPARATOR

Placebo Comparator

Intervention Type DRUG

Placebo subcutaneous injection

Interventions

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Placebo Comparator

Placebo subcutaneous injection

Intervention Type DRUG

CM512

CM512 subcutaneous injection

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Patients with a diagnosis of AD for at least 1 year according to the American Academy of Dermatology's consensus criteria prior to the screening visit meeting all of the following criteria:
* EASI≥16 at Screening and Baseline visits;
* Investigator's Global Assessment (IGA) score of≥3 at Screening and Baseline visits;

* 10% Body Surface Area (BSA) of AD involvement at Screening and Baseline visits;
* Mean of weekly Pruritus Numeric Rating Scale (NRS) severity score≥4 at Baseline;

Exclusion Criteria

* Not enough washing-out period for previous therapy.
* Concurrent disease/status which may potentially affect the efficacy/safety judgement.
* Organ dysfunction.
* Pregnancy.
* Other.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 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, , 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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CM512-101102

Identifier Type: -

Identifier Source: org_study_id

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