Study of CM310 Injection in Adolescent Subjects With Atopic Dermatis

Phase 3

Completed

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

• 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, pharmacokinetics(PK), pharmacodynamics(PD) and immunogenicity of CM310 in children patients with moderate-to-severe atopic dermatitis.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-02-18
• Study First Submitted QC: 2024-02-18
• Study First Posted: 2024-02-26
• Study Start: 2024-03-21
• Primary Completion: 2025-01-23
• Study Completion: 2025-01-23
• Status Verified: 2025-09
• Last Update Submitted: 2025-09-27
• Last Update Posted: 2025-10-02

Recruitment & Eligibility

• Status: COMPLETED
• 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
CM310 group	CM310	-
Placebo	placebo	-

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).
Proportion of subjects with IGA score of 0 or 1 and a reduction of IGA score by ≥2 points from baseline	up to week 18	Proportion of subjects with Investigator's Global Assessment (IGA) score of 0 or 1 and a reduction of IGA score by ≥2 points from baseline at week 18. IGA is an assessment instrument used in clinical studies to rate the severity of AD globally, based on a 5-point scale ranging from 0 (clear) to 4 (severe).

Secondary Outcome Measures

Name	Time	Method
Percent change of Eczema Area and Severity Index (EASI) score from baseline	up to week 18	The EASI is a composite index with scores ranging from 0 to 72. Four AD disease characteristics (erythema, thickness \[induration, papulation, edema\], scratching \[excoriation\], and lichenification) will each be assessed for severity by the investigator on a scale of "0" (absent) through "3" (severe).
Percent change of NRS score from baseline	up to week 18	The range of Pruritus Numerical Rating Scale (NRS) is from 0 (no itch)-10 (worst imaginable itch)
Body surface area (BSA) of involvement of atopic dermatitis	up to week 18	Change from baseline in percent of BSA
Children Dermatology Life Quality Index (CDLQI)	up to week 18	Changes from baseline in CDLQI
Patient-Oriented Eczema Measure (POEM)	up to week 18	Changes from baseline in POEM
EuroQol Five Dimensions Questionnaire (EQ-5D)	up to week 18	Changes from baseline in EQ-5D
Safety parameters	up to week 26	Incidence of Adverse Event(AE), abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing.
Pharmacokinetics parameters	up to week 26	Trough concentration and exposure of CM310
Pharmacodynamics	up to week 26	Serum concentration of Thymus and activation regulated chemokine (TARC) , total immunoglobulin E (IgE) and lactate dehydrogenase (LDH)
Immunogenicity	up to week 26	Detection of anti-drug antibody (ADA)

Trial Locations

Locations (1)

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