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

• Sponsor: Keymed Biosciences Co.Ltd (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05715320
• Collaborator: (none)
• Enrollment: 160
• Arms: 2
• Anticipated Duration (Months): 12

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Atopic Dermatitis	Biological: CM310	Phase 2

Detailed Description

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

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 160 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: 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
• Anticipated Study Start Date: Mar 30, 2023
• Anticipated Primary Completion Date: Mar 30, 2024
• Anticipated Study Completion Date: Mar 30, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Proportion of subjects achieving EASI-75 [up to week 12]

   Proportion of subjects achieving EASI-75 (≥75% reduction from baseline in Eczema Area and Severity Index score).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Keymed Biosciences Co.Ltd

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Keymed Biosciences Co.Ltd
• ClinicalTrials.gov Identifier: NCT05715320
• Other Study ID Numbers: CM310-101109
• First Posted: Feb 8, 2023
• Last Update Posted: Feb 8, 2023
• Last Verified: Jan 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema

Study Results

No Results Posted as of Feb 8, 2023