A Study of CM310 in Patients With Moderate-to-Severe Atopic Dermatitis

NCT05265923 | Completed Phase 3

• 1 other identifier: CM310AD005
• Study Type: interventional
• Target: 500
• 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, PK, PD and immunogenicity of CM310 in patients with moderate-to-severe atopic dermatitis.

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (2)

• Proportion of subjects achieving EASI-75 at week 16

  Proportion of subjects achieving EASI-75 (≥75% reduction from baseline in Eczema Area and Severity Index score) at week 16. 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).

  16 weeks

• Proportion of subjects with IGA score of 0 or 1 and a reduction of IGA score by ≥2 points from baseline at week 16

  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 16. 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).

  16 weeks

Secondary Outcomes (6)

• Incidence of adverse events (AEs), abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing.

  64 weeks

• Percent change of EASI score from baseline

  52 weeks

• Percent change of NRS score from baseline

  52 weeks

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

  52 weeks

• Changes from baseline in Dermatology Life Quality Index (DLQI)

  52 weeks

Study Arms (2)

CM310

EXPERIMENTAL

CM310, 600mg for the initial dose, and 300mg for subsequent doses, subcutaneous injection (SC), every 2 weeks (Q2W)

Drug: CM310

Placebo

PLACEBO COMPARATOR

Double blind treatment period : Placebo Maintenance treatment period : CM310, 600mg for the initial dose, and 300mg for subsequent doses, subcutaneous injection (SC), every 2 weeks (Q2W)

Drug: CM310; Other: Placebo

Interventions

CM310 DRUG

IL-4Rα monoclonal antibody

CM310; Placebo

Placebo OTHER

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with AD for at least 12 months before Screening, with below requirements: 1) EASI score ≥16 at Screening and Baseline; 2) IGA score ≥3 at Screening and Baseline; 3) ≥10% BSA of AD involvement at Screening and Baseline; 4) Pruritus NRS average score ≥3 at Baseline.

You may not qualify if:

• Not enough washing-out period for previous therapy.
• Concurrent disease/status which may potentially affect the efficacy/safety judgement.
• Organ dysfunction.
• pregnancy.
• Other.

Sponsors & Collaborators

• Keymed Biosciences Co.Ltd: lead

Study Sites (1)

Peking University People's hospital

Beijing, China

Location

Related Publications (2)

• Zhao Y, Zhang L, Wu L, Yang B, Wang J, Li Y, Diao Q, Li J, Sun Q, Zhu X, Man X, Wang L, Feng Y, Cai T, Zeng H, Li L, Lu J, Ren H, Li F, Lu Q, Tao X, Xiao R, Ji C, Zhao W, Chu W, Chen B, Zhang J. Efficacy and Safety of Stapokibart in Adults With Moderate-to-Severe Atopic Dermatitis With and Without Type 2 Comorbidities: A Post Hoc Analysis of a Phase 3 Trial. Clin Transl Allergy. 2025 Nov;15(11):e70121. doi: 10.1002/clt2.70121.

  PMID: 41257453 DERIVED

• Zhao Y, Zhang L, Wu L, Yang B, Wang J, Li Y, Diao Q, Li J, Sun Q, Zhu X, Man X, Wang L, Feng Y, Cai T, Zeng H, Li L, Lu J, Ren H, Li F, Lu Q, Tao X, Xiao R, Ji C, Liang C, Qiu Y, Chen B, Zhang J. Patient-Reported Outcomes in Adults with Moderate-to-Severe Atopic Dermatitis Treated with Stapokibart over 52 weeks: A Post Hoc Analysis of a Phase 3 Trial. Adv Ther. 2025 Sep;42(9):4527-4539. doi: 10.1007/s12325-025-03284-7. Epub 2025 Jul 12.

  PMID: 40650707 DERIVED

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 17, 2022
• First Posted: March 4, 2022
• Study Start: April 22, 2022
• Primary Completion: October 31, 2023
• Study Completion: December 25, 2023
• Last Updated: November 8, 2024

Record last verified: 2024-10

Locations

CN (1)