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

NCT ID: NCT05715320

Last Updated: 2024-10-15

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-10

Study Completion Date

2024-07-18

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Atopic Dermatitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group A

CM310, subcutaneous

Group Type EXPERIMENTAL

CM310

Intervention Type BIOLOGICAL

IL-4Rα monoclonal antibody

Group B

CM310, subcutaneous

Group Type EXPERIMENTAL

CM310

Intervention Type BIOLOGICAL

IL-4Rα monoclonal antibody

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

CM310

IL-4Rα monoclonal antibody

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Keymed Biosciences Co.Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hangzhou First People's Hospital

Hangzhou, Zhejiang, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CM310-101109

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Study of CM310 in Adolescent Subjects With Atopic Dermatis
NCT06495229 ACTIVE_NOT_RECRUITING PHASE3