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

NCT ID: NCT05186922

Last Updated: 2022-03-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-17
• Study Completion Date: 2023-01-31

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.

Conditions

Moderate-to-severe Atopic Dermatitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

CM326 55 mg, once every two weeks (Q2W)

55mg for 6 doses, every 2 weeks, subcutaneous (SC)

Group Type: EXPERIMENTAL

CM326

Intervention Type: BIOLOGICAL

CM326 injection

CM326 110 mg, once every two weeks (Q2W)

110mg for 6 doses, every 2 weeks, subcutaneous (SC)

Group Type: EXPERIMENTAL

CM326

Intervention Type: BIOLOGICAL

CM326 injection

CM326 110 mg, once every four weeks (Q4W)

110mg for 3 doses, every 4 weeks, subcutaneous (SC)

Group Type: EXPERIMENTAL

CM326

Intervention Type: BIOLOGICAL

CM326 injection

CM326 220 mg, once every two weeks (Q2W)

220mg for 6 doses, every 2 weeks, subcutaneous (SC)

Group Type: EXPERIMENTAL

CM326

Intervention Type: BIOLOGICAL

CM326 injection

CM326 220 mg, once every four weeks (Q4W)

220mg for 3 doses, every 4 weeks, subcutaneous (SC)

Group Type: EXPERIMENTAL

CM326

Intervention Type: BIOLOGICAL

CM326 injection

Placebo

Placebo for 6 doses, every 2 weeks, subcutaneous (SC) and placebo for 3 doses, every 4 weeks, subcutaneous (SC)

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Placebo

Interventions

CM326

CM326 injection

Intervention Type: BIOLOGICAL

Placebo

Placebo

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Keymed Biosciences Co.Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Peking University People's hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Qian Jia

Role: CONTACT

qianjia@keymedbio.com

+862888610620

Facility Contacts

Jianzhong Zhang

Role: primary

Other Identifiers

CM326AD001

Identifier Type: -

Identifier Source: org_study_id