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

Keymed Biosciences

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Moderate-to-severe Atopic Dermatitis

Treatments: Biological: CM326; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05186922

CM326AD001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 54 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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54 participants in 6 patient groups, including a placebo group

CM326 55 mg, once every two weeks (Q2W)

Experimental group

Description:

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

Treatment:

Biological: CM326

CM326 110 mg, once every two weeks (Q2W)

Experimental group

Description:

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

Treatment:

Biological: CM326

CM326 110 mg, once every four weeks (Q4W)

Experimental group

Description:

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

Treatment:

Biological: CM326

CM326 220 mg, once every two weeks (Q2W)

Experimental group

Description:

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

Treatment:

Biological: CM326

CM326 220 mg, once every four weeks (Q4W)

Experimental group

Description:

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

Treatment:

Biological: CM326

Placebo

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo