This is a multi-center, randomized, double blind, placebo-controlled study to evaluate the efficacy, safety, PK, PD and immumogenicity of GR1802 injection in comparison to placebo in patients with atopic dermatitis. Patients will receive GR1802 injection or Placebo every 2 Weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
450
150mg/1ml. 2 ml every two weeks Route of administration: Subcutaneous
0mg/1ml. 2 ml every two weeks Route of administration: Subcutaneous
Huashan Hospital
Shanghai, Shanghai Municipality, China
Proportion of subjects achieving EASI-75 at week 16
The EASI is a composite index with scores ranging from 0 to 72. Four AD disease characteristics (erythema, thickness \[induration, papulation, edema\], scratching \[excoriation\], and lichenification) will each be assessed for severity by the investigator on a scale of "0" (absent) through "3" (severe).
Time frame: at Week 16
Proportion of subjects with IGA score of 0 or 1 and a reduction of IGA score by ≥2 points from baseline at week 16
IGA is an assessment instrument used in clinical studies to rate the severity of AD globally, based on a 5-point scale ranging from 0 (clear) to 4 (severe).
Time frame: at Week 16
Percent change of EASI score from baseline
The EASI is a composite index with scores ranging from 0 to 72. Four AD disease characteristics (erythema, thickness \[induration, papulation, edema\], scratching \[excoriation\], and lichenification) will each be assessed for severity by the investigator on a scale of "0" (absent) through "3" (severe).
Time frame: Baseline up to Week 52
Percent change of NRS score from baseline
The range of Pruritus Numerical Rating Scale (NRS) is from 0 (no itch)-10 (worst imaginable itch)
Time frame: Baseline up to Week 52
Body surface area (BSA) of involvement of atopic dermatitis
Change from baseline in percent of BSA
Time frame: Baseline up to Week 52
Changes from baseline in Dermatology Life Quality Index (DLQI)
The DLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of AD disease symptoms and treatment on quality of life. It is a 10-question questionnaire with a score of 0 (not at all) to 3 (very much) for each question. A high score is indicative of a poor quality of life.
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Time frame: Baseline up to Week 52
Incidence of adverse events (AEs), abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing.
Incidence of adverse events (AEs), abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing.
Time frame: Baseline up to Week 60
Immunogenicity: anti-drug antibody (ADA) and neutralizing antibody (Nab)
anti-drug antibody (ADA) and neutralizing antibody (Nab)
Time frame: Baseline up to Week 60
Changes from baseline in Scoring Atopic Dermatitis Index (SCORAD)
SCORAD ("SCORing Atopic Dermatitis") is a clinical tool for assessing the severity (i.e., extent, intensity) of atopic dermatitis as objectively as possible.
Time frame: Baseline up to Week 52
Changes from baseline in The Patient-Oriented Eczema Measures for Eczema(POEM)
The Patient Oriented Eczema Measure (POEM) is a tool used for monitoring atopic eczema severity. It focuses on the illness as experienced by the patient.
Time frame: Baseline up to Week 52