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

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

A Randomized, Double Blind, Parallel-controlled Phase 2 Study to Evaluate the Efficacy and Safety of CM310 Recombinant Humanized Monoclonal Antibody Injection in Subjects With Moderate-to-severe Atopic Dermatitis

This study is a multi-center, randomized, double-blind, parallel controlled phase 2 study, aimed at evaluating the efficacy and safety of CM310 in the treatment of patients with moderate-to-severe atopic dermatitis, and observing Pharmacokinetics characteristics, Pharmacodynamics effects and immunogenicity.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study includes screening, treatment and follow-up periods. 160 subjects will be enrolled to receive CM310.

Study Type

Interventional

Enrollment (Estimated)

160

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
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Recruiting
        • Hangzhou First People's Hospital
        • Contact:
          • Liming Wu

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:

  • Have the ability to understand the study and voluntarily sign a written ICF.
  • Age ≥ 18 and ≤ 75 years old, male or female.
  • The fertile subjects agreed to take effective contraceptive measures throughout the study period.
  • The subjects can communicate well with the investigators and complete the follow-up according to the protocol.

Exclusion Criteria:

  • Live vaccine or attenuated live vaccine has been vaccinated or planned to be vaccinated within 12 weeks before randomization.
  • He received allergen-specific immunotherapy (desensitization therapy) within 6 months before randomization.
  • Major surgery is planned during the study period.
  • Previous history of atopic keratoconjunctivitis and corneal involvement.
  • Other combined skin diseases that may affect the evaluation of the study.
  • Confronting IL-4R α Monoclonal antibody or CM310/placebo drug or ingredient allergy.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A
CM310, subcutaneous
Biological: CM310
IL-4Rα monoclonal antibody
Experimental: Group B
CM310, subcutaneous
Biological: CM310
IL-4Rα monoclonal antibody

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of subjects achieving EASI-75
Time Frame: up to week 12
Proportion of subjects achieving EASI-75 (≥75% reduction from baseline in Eczema Area and Severity Index score).
up to week 12

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)

March 10, 2023

Primary Completion (Estimated)

March 30, 2024

Study Completion (Estimated)

March 30, 2024

Study Registration Dates

First Submitted

January 27, 2023

First Submitted That Met QC Criteria

January 27, 2023

First Posted (Actual)

February 8, 2023

Study Record Updates

Last Update Posted (Actual)

August 1, 2023

Last Update Submitted That Met QC Criteria

July 28, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CM310-101109

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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