The Study of CM326 in Patients With Moderate-to-severe Atopic Dermatitis

Phase 1

• Conditions: Moderate-to-severe Atopic Dermatitis

• Registration Number: NCT05186922
• Lead Sponsor: Keymed Biosciences Co.Ltd

Brief Summary

This is a multi-center, randomized, double blind, placebo-controlled multiple dose escalation study to evaluate the safety, tolerance, PK, PD, immunogenicity and preliminary efficacy of CM326 in moderate-severe AD subjects.

Detailed Description

The study consists of 3 periods, a up-to-4-week Screening Period, a 12-week randomized Treatment Period and a 12-week Safety Follow-up Period.

Study Timeline

• Study First Submitted: 2021-12-13
• Study First Submitted QC: 2021-12-23
• Study First Posted: 2022-01-11
• Status Verified: 2022-02
• Study Start: 2022-02-17
• Last Update Submitted: 2022-02-21
• Last Update Posted: 2022-03-09
• Primary Completion: 2023-01
• Study Completion: 2023-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

• With confirmed Atopic Dermatitis (AD) at least 12 months before the screening
• Eczema Area and Severity Index (EASI) score ≥16 at screening and baseline
• Investigator's Global Assessment (IGA) score ≥3 at screening and baseline
• Body Surface Area (BSA) of involvement of atopic dermatitis ≥10% at screening and baseline
• The weekly mean score of daily peaks in pruritus NRS at baseline ≥4
• Provide signed informed consent

Exclusion Criteria

• Not enough washing-out period for previous therapy.
• Presence of other concomitant and poorly controlled serious diseases or recurrent chronic diseases, including but not limited to active infections, cardiovascular and cerebrovascular diseases, pulmonary tuberculosis or other pathogen infections, diabetes mellitus, autoimmune diseases, human immunodeficiency virus (HIV) infection, active hepatitis B, hepatitis C or parasitosis, neoplasm malignant, etc.
• Patients with severe hepatic or renal impairment, characterized by aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level > 2 times of upper limit of normal (ULN), total bilirubin >1.5 times of upper limit of normal (ULN) or serum creatinine level > upper limit of normal (ULN).
• Womens who are pregnant or breastfeeding, or who plan to become pregnant during the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
Incidence of Adverse Events (AE)	Up to week 24	Incidence of AEs, including any abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing.

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics (PK) parameter : Elimination half life (T1/2z)	Up to Week 24	Elimination half life (T1/2z)
Body surface area (BSA) of involvement of atopic dermatitis	Up to Week 24	Change from baseline in percent of BSA
Changes from baseline in Dermatology Life Quality Index (DLQI) at each visit	Up to Week 24	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
Pharmacokinetics (PK) parameter: Time to reach peak concentration (Tmax)	Up to Week 24	Time to reach peak concentration (Tmax)
Pharmacodynamics (PD): Changes from baseline in eosinophil count after CM326 administration	Up to Week 24	Changes from baseline in eosinophil count after CM326 administration
Pharmacokinetics (PK) parameter : Area under the plasma concentration-time curve (AUC)	Up to Week 24	Area under the plasma concentration-time curve (AUC)
Pharmacodynamics (PD): Changes from baseline in serum thymus activation regulation chemokine (TARC) concentration after CM326 administration	Up to Week 24	Changes from baseline in serum thymus activation regulation chemokine (TARC) concentration after CM326 administration
Pharmacodynamics (PD): Changes from baseline in plasma interleukin-5 (IL-5) concentration after CM326 administration	Up to Week 24	Changes from baseline in plasma interleukin-5 (IL-5) concentration after CM326 administration
Pharmacodynamics (PD): Changes from baseline in serum periostin concentration after CM326 administration	Up to Week 24	Changes from baseline in serum periostin concentration after CM326 administration
Proportion of patients with Eczema Area and Severity Index (EASI)-50 (≥50 percent reduction in EASI scores from baseline) at each visit	Up to Week 24	The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 to 72 points, with the higher scores reflecting the worse severity of AD
Proportion of patients with Eczema Area and Severity Index (EASI)-75 (≥75 percent reduction in EASI scores from baseline) at each visit	Up to Week 24	The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 to 72 points, with the higher scores reflecting the worse severity of AD
Pharmacokinetics (PK) parameter : Clearance rate (CL/F)	Up to Week 24	Clearance rate (CL/F)
Pharmacodynamics (PD): Changes from baseline in serum total immunoglobulin E (IgE) concentration after CM326 administration	Up to Week 24	Changes from baseline in serum total immunoglobulin E (IgE) concentration after CM326 administration
Immunogenicity: anti-drug antibody (ADA) and neutralizing antibody (Nab)	Up to Week 24	Detection of anti-drug antibody (ADA) and neutralizing antibody (Nab)
Proportion of patients with Investigator's Global Assessment (IGA) score = 0-1 at each visit	Up to Week 24	IGA is a 6-point scale ranging from 0 (clear) to 5 (very severe)
Change from baseline in Eczema Area and Severity Index (EASI) score at each visit	Up to Week 24	The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 to 72 points, with the higher scores reflecting the worse severity of AD
Proportion of patients with Eczema Area and Severity Index (EASI)-90 (≥90 percent reduction in EASI scores from baseline) at each visit	Up to Week 24	The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 to 72 points, with the higher scores reflecting the worse severity of AD
Proportion of patients with reduction of Pruritus Numerical Rating Scale (NRS) of ≥3 and ≥4 points from baseline	Up to Week 24	The range of NRS is from 0 (no itch)-10 (worst imaginable itch)
Percent change from baseline in Numerical Rating Scale (NRS)	Up to Week 24	The range of NRS is from 0 (no itch)-10 (worst imaginable itch)
Pharmacodynamics (PD): Changes from baseline in plasma interleukin-13 (IL-13) concentration after CM326 administration	Up to Week 24	Changes from baseline in plasma interleukin-13 (IL-13) concentration after CM326 administration
Proportion of patients with IGA reduction from baseline of ≥2 points at each visit	Up to Week 24	IGA is a 6-point scale ranging from 0 (clear) to 5 (very severe)
Pharmacokinetics (PK) parameter : Peak Plasma concentration (Cmax)	Up to Week 24	Peak Plasma concentration (Cmax)

Trial Locations

Locations (1)

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