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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06216392
Other study ID # GR1802-004
Secondary ID
Status Not yet recruiting
Phase Phase 3
First received
Last updated
Start date January 2024
Est. completion date January 2026

Study information

Verified date December 2023
Source Genrix (Shanghai) Biopharmaceutical Co., Ltd.
Contact Jinhua Xu, PhD.
Phone 021-52889999
Email xjhhsyy@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 450
Est. completion date January 2026
Est. primary completion date June 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: 1. Diagnosed with AD according to Williams criteria with a history of at least 12 months before Screening, with below requirements: 1) EASI score =16 at Screening and Baseline; 2) IGA score =3 at Screening and Baseline; 3) =10% BSA of AD involvement at Screening and Baseline; 4) Pruritus NRS average score =4 at Baseline. 2. Inadequate response or intolerance to topical glucocorticoid therapy for AD within 6 months prior to screening. Exclusion Criteria: 1. Not enough washing-out period for previous therapy. 2. Concurrent disease/status which may potentially affect the efficacy/safety judgement. 3. Abnormal laboratory test results at screening that, in the judgment of the investigator, may affect the subject's ability to complete the trial. 4. Women who are pregnant or breastfeeding, or planning to become pregnant, breastfeeding during the study. 5. Other

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
GR1802 injection
150mg/1ml. 2 ml every two weeks Route of administration: Subcutaneous
placebo
0mg/1ml. 2 ml every two weeks Route of administration: Subcutaneous

Locations

Country Name City State
China Huashan Hospital Shanghai Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Genrix (Shanghai) Biopharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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). at Week 16
Primary 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). at Week 16
Secondary 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). Baseline up to Week 52
Secondary Percent change of NRS score from baseline The range of Pruritus Numerical Rating Scale (NRS) is from 0 (no itch)-10 (worst imaginable itch) Baseline up to Week 52
Secondary Body surface area (BSA) of involvement of atopic dermatitis Change from baseline in percent of BSA Baseline up to Week 52
Secondary 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. Baseline up to Week 52
Secondary 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. Baseline up to Week 60
Secondary Immunogenicity: anti-drug antibody (ADA) and neutralizing antibody (Nab) anti-drug antibody (ADA) and neutralizing antibody (Nab) Baseline up to Week 60
Secondary 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. Baseline up to Week 52
Secondary 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. Baseline up to Week 52
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