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

Atopic Dermatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05265923
• Other study ID #: CM310AD005
• Status: Recruiting
• Phase: Phase 3
• Start date: April 22, 2022
• Est. completion date: July 30, 2024

Study information

• Verified date: March 2023
• Source: Keymed Biosciences Co.Ltd
• Contact: Qian Jia
• Phone: 028-88610620
• Email: qianjia[@]keymedbio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The study consists of an up-to-4-week screening period, a 16-week double-blind treatment period, a 36-week maintenance treatment period, and a 8-week safety follow-up period.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: July 30, 2024
• Est. primary completion date: July 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Not enough washing-out period for previous therapy.

• Concurrent disease/status which may potentially affect the efficacy/safety judgement.

• Organ dysfunction.

• pregnancy.

• Other.

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• CM310
IL-4Ra monoclonal antibody

Other:
• Placebo
Placebo

Locations

Country	Name	City	State
China	Peking University People's hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Keymed Biosciences Co.Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Incidence of adverse events (AEs), abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing.	Incidence of adverse events (AEs), abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing.	64 weeks
Secondary	Percent change of 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).	52 weeks
Secondary	Percent change of NRS score from baseline	The range of Pruritus Numerical Rating Scale (NRS) is from 0 (no itch)-10 (worst imaginable itch)	52 weeks
Secondary	Body surface area (BSA) of involvement of atopic dermatitis	Change from baseline in percent of BSA	52 weeks
Secondary	Changes from baseline in Dermatology Life Quality Index (DLQI)	The DLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of AD disease symptoms and treatment on quality of life. It is a 10-question questionnaire with a score of 0 (not at all) to 3 (very much) for each question. A high score is indicative of a poor quality of life.	52 weeks
Secondary	Immunogenicity: anti-drug antibody (ADA) and neutralizing antibody (Nab)	anti-drug antibody (ADA) and neutralizing antibody (Nab)	64 weeks