Study of CM310 Injection in Adolescent Subjects With Atopic Dermatis

A Randomized, Double Blind, Placebo-controlled Phase 3 Study to Evaluate the Efficacy and Safety of CM310 in Adolescent Patients With Moderate-to-severe Atopic Dermatitis

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.

Study Overview

• Status: Completed
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Other: placebo; Biological: CM310

• Study Type: Interventional
• Enrollment (Actual): 180
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Peking University People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Other: placebo; Placebo
Experimental: CM310 group	Biological: CM310; Interleukin-4 receptor(IL-4Rα) monoclonal antibody

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of subjects achieving EASI-75 at 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).	Up to week 18
Proportion of subjects with IGA score of 0 or 1 and a reduction of IGA score by ≥2 points from baseline	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).	up to week 18

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent change of Eczema Area and Severity Index (EASI) score from baseline	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).	up to week 18
Percent change of NRS score from baseline	The range of Pruritus Numerical Rating Scale (NRS) is from 0 (no itch)-10 (worst imaginable itch)	up to week 18
Body surface area (BSA) of involvement of atopic dermatitis	Change from baseline in percent of BSA	up to week 18
Children Dermatology Life Quality Index (CDLQI)	Changes from baseline in CDLQI	up to week 18
Patient-Oriented Eczema Measure (POEM)	Changes from baseline in POEM	up to week 18
EuroQol Five Dimensions Questionnaire (EQ-5D)	Changes from baseline in EQ-5D	up to week 18
Safety parameters	Incidence of Adverse Event(AE), abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing.	up to week 26
Pharmacokinetics parameters	Trough concentration and exposure of CM310	up to week 26
Pharmacodynamics	Serum concentration of Thymus and activation regulated chemokine (TARC) , total immunoglobulin E (IgE) and lactate dehydrogenase (LDH)	up to week 26
Immunogenicity	Detection of anti-drug antibody (ADA)	up to week 26

Collaborators and Investigators

• Sponsor: Keymed Biosciences Co.Ltd
• Investigators: Principal Investigator: Jianzhong Zhang, Peking University People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 21, 2024
• Primary Completion (Actual): January 23, 2025
• Study Completion (Actual): January 23, 2025

Study Registration Dates

• First Submitted: February 18, 2024
• First Submitted That Met QC Criteria: February 18, 2024
• First Posted (Actual): February 26, 2024

Study Record Updates

• Last Update Posted (Estimated): October 2, 2025
• Last Update Submitted That Met QC Criteria: September 27, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Skin Diseases; Skin Diseases, Genetic; Skin Diseases, Eczematous; Dermatitis; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin and Connective Tissue Diseases; Dermatitis, Atopic
• Other Study ID Numbers: CM310-101212

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No