The Study of CM326 in Moderate-to-severe Atopic Dermatitis

NCT ID: NCT05671432

Last Updated: 2023-01-04

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

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-27

Study Completion Date

2024-12-30

Brief Summary

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This is a multi-center, randomized, double blind, placebo-controlled study to evaluate the efficacy, safety, tolerance, pharmacokinetics, pharmacodynamics, and immunogenicity of CM326 in moderate-severe atopic dermatitis subjects.

Detailed Description

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The study consists of 3 periods, a up-to-4-week Screening Period, a 52-week Treatment Period and a 8-week Safety Follow-up Period.

Conditions

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Moderate-to-severe Atopic Dermatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Group A

Group A: CM326, subcutaneous (SC)

Group Type EXPERIMENTAL

CM326

Intervention Type BIOLOGICAL

CM326 injection

Group B

Group A: CM326, subcutaneous (SC)

Group Type EXPERIMENTAL

CM326

Intervention Type BIOLOGICAL

CM326 injection

Group C

Group C: placebo, subcutaneous (SC)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo

Interventions

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CM326

CM326 injection

Intervention Type BIOLOGICAL

Placebo

Placebo

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* With confirmed Atopic Dermatitis (AD) at the screening.
* Age ≥ 18 years and ≤ 75 years, male or female.
* Have the ability to understand the nature of the study and voluntarily sign the informed consent.
* Be able to communicate well with investigators and follow up protocol requirements.

Exclusion Criteria

* Not enough washing-out period for previous therapy.
* Received allergen specific immunotherapy (desensitization) within 6 months prior to baseline.
* Major surgery is planned during the study period.
* Women who are pregnant or breastfeeding, or who plan to become pregnant during the study.
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

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

+862888610620

Facility Contacts

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Jianzhong Zhang

Role: primary

Other Identifiers

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CM326-101102

Identifier Type: -

Identifier Source: org_study_id

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