The Study of CM326 in Adult Subjects With Atopic Dermatitis

July 28, 2023 updated by: Keymed Biosciences Co.Ltd

An Open, Multineutral Study Evaluating the Safety and Efficacy of CM326 in the Long-term Treatment of Adult Subjects With Atopic Dermatitis

This is a open-label, multi-center study to evaluate the safety and efficacy of CM326 in atopic adrmatitis subjects.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

100

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 Contact

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • Peking University People's Hospital
        • Contact:
          • Jianzhong Zhang

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

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • With confirmed Atopic Dermatitis (AD) at the screening.
  • 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.
  • The subjects agreed to use highly effective contraceptive measures during the study.

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.

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: CM326
CM326 injection, subcutaneous (SC)
Biological: CM326
CM326 injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of treatment-emergent adverse events
Time Frame: at week 52
Incidence of treatment-emergent Adverse events related to CM326
at week 52

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)

February 9, 2023

Primary Completion (Estimated)

March 28, 2024

Study Completion (Estimated)

March 28, 2025

Study Registration Dates

First Submitted

December 26, 2022

First Submitted That Met QC Criteria

December 31, 2022

First Posted (Actual)

January 4, 2023

Study Record Updates

Last Update Posted (Actual)

August 1, 2023

Last Update Submitted That Met QC Criteria

July 28, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CM326-101105

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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