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

Keymed Biosciences Co.Ltd54 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Moderate-to-severe Atopic Dermatitis

Interventions

CM326BIOLOGICAL

CM326 injection

PlaceboOTHER

Placebo

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (1)

Peking University People's hospital

Beijing, Beijing Municipality, China

RECRUITING

Outcomes

Primary Outcomes

Incidence of Adverse Events (AE)

Incidence of AEs, including any abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing.

Time frame: Up to week 24

Secondary Outcomes

Pharmacokinetics (PK) parameter: Time to reach peak concentration (Tmax)

Time to reach peak concentration (Tmax)

Time frame: Up to Week 24

Pharmacokinetics (PK) parameter : Peak Plasma concentration (Cmax)

Peak Plasma concentration (Cmax)

Time frame: Up to Week 24

Pharmacokinetics (PK) parameter : Area under the plasma concentration-time curve (AUC)

Area under the plasma concentration-time curve (AUC)

Time frame: Up to Week 24

Pharmacokinetics (PK) parameter : Clearance rate (CL/F)

Clearance rate (CL/F)

Time frame: Up to Week 24

Pharmacokinetics (PK) parameter : Elimination half life (T1/2z)

Elimination half life (T1/2z)

Time frame: Up to Week 24

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

Time frame: Up to Week 24

Pharmacodynamics (PD): Changes from baseline in eosinophil count after CM326 administration

Central Contacts

Qian Jia

CONTACT

+862888610620 qianjia@keymedbio.com

Data from ClinicalTrials.gov

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Changes from baseline in eosinophil count after CM326 administration

Time frame: Up to Week 24

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

Time frame: Up to Week 24

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

Time frame: Up to Week 24

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

Time frame: Up to Week 24

Pharmacodynamics (PD): Changes from baseline in serum periostin concentration after CM326 administration

Changes from baseline in serum periostin concentration after CM326 administration

Time frame: Up to Week 24

Immunogenicity: anti-drug antibody (ADA) and neutralizing antibody (Nab)

Detection of anti-drug antibody (ADA) and neutralizing antibody (Nab)

Time frame: Up to Week 24

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)

Time frame: Up to Week 24

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)

Time frame: Up to Week 24

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

Time frame: Up to Week 24

Proportion of patients with Eczema Area and Severity Index (EASI)-75 (≥75 percent reduction in EASI scores from baseline) at each visit

Time frame: Up to Week 24

Proportion of patients with Eczema Area and Severity Index (EASI)-90 (≥90 percent reduction in EASI scores from baseline) at each visit

Time frame: Up to Week 24

Change from baseline in Eczema Area and Severity Index (EASI) score at each visit

Time frame: Up to Week 24

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)

Time frame: Up to Week 24

Percent change from baseline in Numerical Rating Scale (NRS)

The range of NRS is from 0 (no itch)-10 (worst imaginable itch)

Time frame: Up to Week 24

Body surface area (BSA) of involvement of atopic dermatitis

Change from baseline in percent of BSA

Time frame: Up to Week 24

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

Time frame: Up to Week 24