Study of CM310 Injection in Adolescent Subjects With Atopic Dermatis

Phase 3

Not yet recruiting

• Conditions: Atopic Dermatitis
• Interventions: Other: placebo; Biological: CM310

• Registration Number: NCT06277765
• Lead Sponsor: Keymed Biosciences Co.Ltd

Brief Summary

This is a multi-center, randomized, double blind, placebo-controlled phase 3 study to evaluate the efficacy, safety, PK, PD and immunogenicity of CM310 in children patients with moderate-to-severe atopic dermatitis.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-01
• Study First Submitted: 2024-02-18
• Study First Submitted QC: 2024-02-18
• Last Update Submitted: 2024-02-18
• Study First Posted: 2024-02-26
• Last Update Posted: 2024-02-26
• Study Start: 2024-05-30
• Primary Completion: 2025-05-30
• Study Completion: 2025-05-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

• Have the ability to understand the study and voluntarily sign a written informed consent form (ICF).
• With Atopic Dermatitis.

Exclusion Criteria

• Not enough washing-out period for previous therapies.
• Any major surgery planned during the research period.
• With intestinal parasitic infection within the 6 months before screening.
• With any circumstance that is not suitable to participate in this study.
• Major surgeries are planned during the study period.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	placebo	-
CM310 group	CM310	-

Primary Outcome Measures

Name	Time	Method
Proportion of subjects achieving EASI-75 at week 18	Up to week 18	The EASI is a composite index with scores ranging from 0 to 72. Four AD disease characteristics (erythema, edema/papulation, excoriation, lichenification) will each be assessed for severity by the investigator on a scale of "0" (none) through "3" (severe).

Trial Locations

Locations (1)

Peking University People's hospital; 🇨🇳 Beijing, China