Phase III Study of GR1802 Injection in Patients With Atopic Dermatitis

A Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Phase 3 Trial Evaluating the Efficacy, Safety, and Immunogenicity of GR1802 Injection in Patients With Moderate to Severe Atopic Dermatitis

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 Overview

• Status: Not yet recruiting
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Biological: GR1802 injection; Biological: placebo

• Study Type: Interventional
• Enrollment (Estimated): 450
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Jinhua Xu, PhD.; Phone Number: 021-52889999; Email: xjhhsyy@163.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200000
      • Huashan Hospital
      • Contact: Jinhua Xu, PhD.; Phone Number: +86-021-52889999; Email: luhanyu@genrixbio.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental: GR1802; GR1802 injection 300mg every two weeks for 52-week treatment.	Biological: GR1802 injection; 150mg/1ml. 2 ml every two weeks Route of administration: Subcutaneous
Placebo Comparator: Placebo; Placebo every two weeks for 16-week treatment. Crossover to GR1802 injection for another 36 weeks	Biological: placebo; 0mg/1ml. 2 ml every two weeks Route of administration: Subcutaneous

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Body surface area (BSA) of involvement of atopic dermatitis	Change from baseline in percent of BSA	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.	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.	Baseline up to Week 60
Immunogenicity: anti-drug antibody (ADA) and neutralizing antibody (Nab)	anti-drug antibody (ADA) and neutralizing antibody (Nab)	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.	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.	Baseline up to Week 52

Collaborators and Investigators

• Sponsor: Genrix (Shanghai) Biopharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2024
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: January 11, 2024
• First Submitted That Met QC Criteria: January 11, 2024
• First Posted (Actual): January 22, 2024

Study Record Updates

• Last Update Posted (Actual): January 22, 2024
• Last Update Submitted That Met QC Criteria: January 11, 2024
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic
• Other Study ID Numbers: GR1802-004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No