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

Moderate-to-severe Atopic Dermatitis Clinical Trial

Official title:

A Randomized, Double Blind, Placebo-Controlled, Multiple Dose Escalation, Phase 2 Study to Evaluate the Safety, Tolerance, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Preliminary Efficacy of CM326 in Patients With Moderate-severe Atopic Dermatitis Subjects

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05186922
• Other study ID #: CM326AD001
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: February 17, 2022
• Est. completion date: January 2023

Study information

• Verified date: February 2022
• Source: Keymed Biosciences Co.Ltd
• Contact: Qian Jia
• Phone: +862888610620
• Email: qianjia[@]keymedbio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 54
• Est. completion date: January 2023
• Est. primary completion date: January 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dermatitis
• Dermatitis, Atopic
• Eczema
• Moderate-to-severe Atopic Dermatitis

Intervention

Biological:
• CM326
CM326 injection

Other:
• Placebo
Placebo

Locations

Country	Name	City	State
China	Peking University People's hospital	Beijing	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	Incidence of Adverse Events (AE)	Incidence of AEs, including any abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing.	Up to week 24
Secondary	Pharmacokinetics (PK) parameter: Time to reach peak concentration (Tmax)	Time to reach peak concentration (Tmax)	Up to Week 24
Secondary	Pharmacokinetics (PK) parameter : Peak Plasma concentration (Cmax)	Peak Plasma concentration (Cmax)	Up to Week 24
Secondary	Pharmacokinetics (PK) parameter : Area under the plasma concentration-time curve (AUC)	Area under the plasma concentration-time curve (AUC)	Up to Week 24
Secondary	Pharmacokinetics (PK) parameter : Clearance rate (CL/F)	Clearance rate (CL/F)	Up to Week 24
Secondary	Pharmacokinetics (PK) parameter : Elimination half life (T1/2z)	Elimination half life (T1/2z)	Up to Week 24
Secondary	Pharmacodynamics (PD): Changes from baseline in serum thymus activation regulation chemokine (TARC) concentration after CM326 administration	Changes from baseline in serum thymus activation regulation chemokine (TARC) concentration after CM326 administration	Up to Week 24
Secondary	Pharmacodynamics (PD): Changes from baseline in eosinophil count after CM326 administration	Changes from baseline in eosinophil count after CM326 administration	Up to Week 24
Secondary	Pharmacodynamics (PD): Changes from baseline in serum total immunoglobulin E (IgE) concentration after CM326 administration	Changes from baseline in serum total immunoglobulin E (IgE) concentration after CM326 administration	Up to Week 24
Secondary	Pharmacodynamics (PD): Changes from baseline in plasma interleukin-5 (IL-5) concentration after CM326 administration	Changes from baseline in plasma interleukin-5 (IL-5) concentration after CM326 administration	Up to Week 24
Secondary	Pharmacodynamics (PD): Changes from baseline in plasma interleukin-13 (IL-13) concentration after CM326 administration	Changes from baseline in plasma interleukin-13 (IL-13) concentration after CM326 administration	Up to Week 24
Secondary	Pharmacodynamics (PD): Changes from baseline in serum periostin concentration after CM326 administration	Changes from baseline in serum periostin concentration after CM326 administration	Up to Week 24
Secondary	Immunogenicity: anti-drug antibody (ADA) and neutralizing antibody (Nab)	Detection of anti-drug antibody (ADA) and neutralizing antibody (Nab)	Up to Week 24
Secondary	Proportion of patients with Investigator's Global Assessment (IGA) score = 0-1 at each visit	IGA is a 6-point scale ranging from 0 (clear) to 5 (very severe)	Up to Week 24
Secondary	Proportion of patients with IGA reduction from baseline of =2 points at each visit	IGA is a 6-point scale ranging from 0 (clear) to 5 (very severe)	Up to Week 24
Secondary	Proportion of patients with Eczema Area and Severity Index (EASI)-50 (=50 percent reduction in EASI scores from baseline) at each visit	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	Up to Week 24
Secondary	Proportion of patients with Eczema Area and Severity Index (EASI)-75 (=75 percent reduction in EASI scores from baseline) at each visit	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	Up to Week 24
Secondary	Proportion of patients with Eczema Area and Severity Index (EASI)-90 (=90 percent reduction in EASI scores from baseline) at each visit	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	Up to Week 24
Secondary	Change from baseline in Eczema Area and Severity Index (EASI) score at each visit	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	Up to Week 24
Secondary	Proportion of patients with reduction of Pruritus Numerical Rating Scale (NRS) of =3 and =4 points from baseline	The range of NRS is from 0 (no itch)-10 (worst imaginable itch)	Up to Week 24
Secondary	Percent change from baseline in Numerical Rating Scale (NRS)	The range of NRS is from 0 (no itch)-10 (worst imaginable itch)	Up to Week 24
Secondary	Body surface area (BSA) of involvement of atopic dermatitis	Change from baseline in percent of BSA	Up to Week 24
Secondary	Changes from baseline in Dermatology Life Quality Index (DLQI) at each visit	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	Up to Week 24