This is a randomized, double-blind, placebo-controlled Phase Ib clinical trial evaluating the safety tolerability, pharmacokinetics, immunogenicity and preliminary efficacy of GR2002 Injection in patients with moderate to severe atopic dermatitis. The dosing period was 12 weeks and followed up to 20 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
40
TSLP monoclonal antibody
Peking University People's Hospital
Beijing, Beijing Municipality, China
Adverse events (AEs)
Incidence of AEs.
Time frame: Within 20 weeks
Pharmacokinetics parameters
concentration of GR2002
Time frame: Within 20 weeks
IGA Response
Proportion of subjects with an IGA score of 0-1 and a decrease of ≥2 points from baseline
Time frame: Within 20 weeks
EASI 50/75/90 Response
Proportion of subjects with ≥50%, ≥75%, and ≥90% improvement in EASI score
Time frame: Within 20 weeks
Percentage change in BSA score
Percentage change from baseline in BSA involvement in atopic dermatitis lesions
Time frame: Within 20 weeks
Proportion of Subjects With Weekly Mean Reduction in Daily Peak Pruritus NRS of ≥4/≥3
Proportion of subjects with ≥4/3-point decrease in PP-NRS from baseline
Time frame: Within 20 weeks
immunogenicity
Detection of anti-drug antibody(ADA)
Time frame: Within 20 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.