A Study of CM310 in Children Patients With Moderate-to-severe Atopic Dermatis

• Sponsor: Keymed Biosciences Co.Ltd (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05579925
• Collaborator: (none)
• Enrollment: 24
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 12.7
• Patients Per Site Per Month: 1.9

Study Details

Study Description

Brief Summary

This is a multi-center, single arm, open-label study to evaluate safety and primary efficacy in children patients with moderate-to severe atopic dermatis.

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

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 24 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Multicenter, Single-arm, Open-label Study to Evaluate the Safety, Pharmacokinetics, and Pharmacokinetics of CM310 in Adolescent Subjects With Moderate-to-severe Atopic Dermatitis
• Actual Study Start Date: Oct 7, 2022
• Anticipated Primary Completion Date: Oct 30, 2023
• Anticipated Study Completion Date: Oct 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CM310 600 mg + 300 mg, subcutaneous injection, once every two weeks	Biological: CM310; CM310 600 mg + 300 mg, subcutaneous injection

Outcome Measures

Primary Outcome Measures

1. Adverse events [at week 14]

   Incidence of adverse events.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 12 years ≤ age ≤ 18 years

• With atopic dermatis

• Voluntarily sign the informed consent form

Exclusion Criteria:

• Weight < 30 kg

• Major surgery planed during the study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beijing Children's Hospital Capital Medical University	Beijing		China

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: NCT05579925
• Other Study ID Numbers: CM310-101108
• First Posted: Oct 14, 2022
• Last Update Posted: Jan 4, 2023
• Last Verified: Oct 1, 2022

• 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 Jan 4, 2023