A Study of CM310 in Subjects With Moderate-to-Severe Atopic Dermatitis

August 19, 2026 updated by: Keymed Biosciences Co.Ltd

An Multi-center, Open-label, Single-arm Phase 2 Study to Evaluate the Long-term Safety and Efficacy of CM310 in Subjects With Moderate-to-severe Atopic Dermatitis

This is a multi-center, open-label phase 2 study to evaluate the long-term safety and efficacy of CM310 in subjects with moderate-to-severe atopic dermatitis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study consists of an screening period, treatment period, and safety follow-up period.

Study Type

Interventional

Enrollment (Actual)

263

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China
        • Peking University People's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Have the ability to understand the study and voluntarily sign a written informed consent form (ICF).
  • Age ≥ 18 and ≤ 75 years old.
  • With Atopic Dermatitis.

Exclusion Criteria:

  • Not enough washing-out period for previous therapy.
  • Concurrent disease/status which may potentially affect the efficacy/safety judgement.
  • Major surgeries are planned during the study period.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CM310
Biological: CM310
CM310, subcutaneous injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events (AEs)
Time Frame: up to Week 60
Incidence of adverse events (AEs).
up to Week 60

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of subjects achieving an Investigator's Global Assessment (IGA) score of 0 at each scheduled assessment visit
Time Frame: up to Week 60
up to Week 60
Percentage of subjects achieving an Investigator's Global Assessment (IGA) score of 1 at each scheduled assessment visit
Time Frame: up to Week 60
up to Week 60
Percentage of subjects achieving ≥75% improvement from baseline in the Eczema Area and Severity Index (EASI-75) at each scheduled assessment visit
Time Frame: up to Week 60
up to Week 60
Percentage of subjects achieving ≥90% improvement from baseline in the Eczema Area and Severity Index (EASI-90) at each scheduled assessment visit
Time Frame: up to Week 60
up to Week 60
Change from baseline in Eczema Area and Severity Index (EASI) score at each scheduled assessment visit
Time Frame: up to Week 60
up to Week 60
Percentage change from baseline in Eczema Area and Severity Index (EASI) score at each scheduled assessment visit
Time Frame: up to Week 60
up to Week 60
Change and percentage change from baseline in Eczema Area and Severity Index (EASI) score at each scheduled assessment visit
Time Frame: up to Week 60
up to Week 60
Percentage of subjects achieving a ≥4-point reduction from baseline in the weekly mean of daily Peak Pruritus Numerical Rating Scale (PP-NRS) scores
Time Frame: up to Week 60
up to Week 60
Percentage of subjects achieving a ≥3-point reduction from baseline in the weekly mean of daily Peak Pruritus Numerical Rating Scale (PP-NRS) scores
Time Frame: up to Week 60
up to Week 60
Change and percentage change from baseline in the weekly mean of daily Peak Pruritus Numerical Rating Scale (PP-NRS) scores
Time Frame: up to Week 60
up to Week 60
Change and percentage change from baseline in the body surface area (BSA) affected by atopic dermatitis (AD) at each scheduled assessment visit
Time Frame: up to Week 60
up to Week 60
Change from baseline in Dermatology Life Quality Index (DLQI) score at each scheduled assessment visit
Time Frame: up to Week 60
up to Week 60
Trough concentration (Ctrough) of CM310
Time Frame: up to Week 60
up to Week 60
Incidence of treatment-emergent anti-drug antibodies (ADA)
Time Frame: up to Week 60
up to Week 60
Incidence of neutralizing antibodies (NAb)
Time Frame: up to Week 60
up to Week 60

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Keymed Biosciences Co.Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 21, 2023

Primary Completion (Actual)

November 26, 2025

Study Completion (Actual)

November 26, 2025

Study Registration Dates

First Submitted

October 30, 2023

First Submitted That Met QC Criteria

October 30, 2023

First Posted (Actual)

November 3, 2023

Study Record Updates

Last Update Posted (Actual)

August 20, 2026

Last Update Submitted That Met QC Criteria

August 19, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CM310-101116

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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