Clinical trial NCT05186922: The Study of CM326 in Patients With Moderate-to-severe Atopic Dermatitis
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Moderate-to-severe Atopic Dermatitis
Lead sponsor: Keymed Biosciences Co.Ltd
Sponsor class: INDUSTRY
First posted: 2022-01-11
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of Adverse Events (AE)
timeFrame: Up to week 24
Secondary outcomes:
measure: Pharmacokinetics (PK) parameter: Time to reach peak concentration (Tmax)
timeFrame: Up to Week 24
measure: Pharmacokinetics (PK) parameter : Peak Plasma concentration (Cmax)
timeFrame: Up to Week 24
measure: Pharmacokinetics (PK) parameter : Area under the plasma concentration-time curve (AUC)
timeFrame: Up to Week 24
measure: Pharmacokinetics (PK) parameter : Clearance rate (CL/F)
timeFrame: Up to Week 24
measure: Pharmacokinetics (PK) parameter : Elimination half life (T1/2z)
timeFrame: Up to Week 24
measure: Pharmacodynamics (PD): Changes from baseline in serum thymus activation regulation chemokine (TARC) concentration after CM326 administration
timeFrame: Up to Week 24
measure: Pharmacodynamics (PD): Changes from baseline in eosinophil count after CM326 administration
timeFrame: Up to Week 24
measure: Pharmacodynamics (PD): Changes from baseline in serum total immunoglobulin E (IgE) concentration after CM326 administration
timeFrame: Up to Week 24
measure: Pharmacodynamics (PD): Changes from baseline in plasma interleukin-5 (IL-5) concentration after CM326 administration
timeFrame: Up to Week 24
measure: Pharmacodynamics (PD): Changes from baseline in plasma interleukin-13 (IL-13) concentration after CM326 administration
timeFrame: Up to Week 24
measure: Pharmacodynamics (PD): Changes from baseline in serum periostin concentration after CM326 administration
timeFrame: Up to Week 24
measure: Immunogenicity: anti-drug antibody (ADA) and neutralizing antibody (Nab)
timeFrame: Up to Week 24
measure: Proportion of patients with Investigator's Global Assessment (IGA) score = 0-1 at each visit
timeFrame: Up to Week 24
measure: Proportion of patients with IGA reduction from baseline of ≥2 points at each visit
timeFrame: Up to Week 24
measure: Proportion of patients with Eczema Area and Severity Index (EASI)-50 (≥50 percent reduction in EASI scores from baseline) at each visit
timeFrame: Up to Week 24
measure: Proportion of patients with Eczema Area and Severity Index (EASI)-75 (≥75 percent reduction in EASI scores from baseline) at each visit
timeFrame: Up to Week 24
measure: Proportion of patients with Eczema Area and Severity Index (EASI)-90 (≥90 percent reduction in EASI scores from baseline) at each visit
timeFrame: Up to Week 24
measure: Change from baseline in Eczema Area and Severity Index (EASI) score at each visit
timeFrame: Up to Week 24
measure: Proportion of patients with reduction of Pruritus Numerical Rating Scale (NRS) of ≥3 and ≥4 points from baseline
timeFrame: Up to Week 24
measure: Percent change from baseline in Numerical Rating Scale (NRS)
timeFrame: Up to Week 24
measure: Body surface area (BSA) of involvement of atopic dermatitis
timeFrame: Up to Week 24
measure: Changes from baseline in Dermatology Life Quality Index (DLQI) at each visit
timeFrame: Up to Week 24
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's hospital
state: Beijing
Study officials:
References: