Last updated: February 21, 2022
Sponsor: Keymed Biosciences Co.Ltd
Overall Status: Active - Recruiting
Phase
1/2
Condition
Rash
Allergy
Atopic Dermatitis
Treatment
N/AClinical Study ID
NCT05186922
CM326AD001
Ages 18-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 andbaseline
- The weekly mean score of daily peaks in pruritus NRS at baseline ≥4
- Provide signed informed consent
Exclusion
Exclusion Criteria:
- Not enough washing-out period for previous therapy.
- Presence of other concomitant and poorly controlled serious diseases or recurrentchronic diseases, including but not limited to active infections, cardiovascular andcerebrovascular 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 aspartateaminotransferase (AST) or alanine aminotransferase (ALT) level > 2 times of upperlimit of normal (ULN), total bilirubin >1.5 times of upper limit of normal (ULN) orserum creatinine level > upper limit of normal (ULN).
- Womens who are pregnant or breastfeeding, or who plan to become pregnant during thestudy.
Study Design
Total Participants: 54
Study Start date:
February 17, 2022
Estimated Completion Date:
January 31, 2023
Study Description
Connect with a study center
Peking University People's hospital
Beijing, Beijing
ChinaActive - Recruiting

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