Study of CM310 Injection in Adolescent Subjects With Atopic Dermatis

NCT06277765 | Completed Phase 3

• 1 other identifier: CM310-101212
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (10)

• Percent change of Eczema Area and Severity Index (EASI) score from baseline

  up to week 18

• Percent change of NRS score from baseline

  up to week 18

• Body surface area (BSA) of involvement of atopic dermatitis

  up to week 18

• Children Dermatology Life Quality Index (CDLQI)

  up to week 18

• Patient-Oriented Eczema Measure (POEM)

  up to week 18

Study Arms (2)

CM310 group

EXPERIMENTAL

Biological: CM310

Placebo

PLACEBO COMPARATOR

Other: placebo

Interventions

CM310 BIOLOGICAL

Interleukin-4 receptor(IL-4Rα) monoclonal antibody

CM310 group

placebo OTHER

Placebo

Placebo

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Keymed Biosciences Co.Ltd: lead

Study Sites (1)

Peking University People's hospital

Beijing, China

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• jianzhong Zhang

  Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2024
• First Posted: February 26, 2024
• Study Start: March 21, 2024
• Primary Completion: January 23, 2025
• Study Completion: January 23, 2025
• Last Updated: October 2, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)