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

• Sponsor: Keymed Biosciences Co.Ltd (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06116565
• Collaborator: (none)
• Enrollment: 300
• Arm: 1
• Anticipated Duration (Months): 24

Study Details

Study Description

Brief Summary

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.

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

Detailed Description

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

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 300 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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
• Anticipated Study Start Date: Mar 30, 2024
• Anticipated Primary Completion Date: Mar 30, 2026
• Anticipated Study Completion Date: Mar 30, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CM310	Biological: CM310; CM310, subcutaneous injection

Outcome Measures

Primary Outcome Measures

1. Adverse events (AEs) [up to Week 60]

   Incidence of adverse events (AEs).

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 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.

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: NCT06116565
• Other Study ID Numbers: CM310-101116
• First Posted: Nov 3, 2023
• Last Update Posted: Nov 3, 2023
• Last Verified: Oct 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 Nov 3, 2023