Phase III Study of GR1802 Injection in Patients With Atopic Dermatitis

Phase 3

Not yet recruiting

• Conditions: Atopic Dermatitis
• Interventions: Biological: placebo; Biological: GR1802 injection

• Registration Number: NCT06216392
• Lead Sponsor: Genrix (Shanghai) Biopharmaceutical Co., Ltd.

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-12
• Study Start: 2024-01
• Study First Submitted: 2024-01-11
• Study First Submitted QC: 2024-01-11
• Last Update Submitted: 2024-01-11
• Study First Posted: 2024-01-22
• Last Update Posted: 2024-01-22
• Primary Completion: 2025-06
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 450

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	placebo	Placebo every two weeks for 16-week treatment. Crossover to GR1802 injection for another 36 weeks
Experimental: GR1802	GR1802 injection	GR1802 injection 300mg every two weeks for 52-week treatment.

Primary Outcome Measures

Name	Time	Method
Proportion of subjects achieving EASI-75 at week 16	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).
Proportion of subjects with IGA score of 0 or 1 and a reduction of IGA score by ≥2 points from baseline at week 16	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).

Secondary Outcome Measures

Name	Time	Method
Changes from baseline in Dermatology Life Quality Index (DLQI)	Baseline up to Week 52	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.
Changes from baseline in Scoring Atopic Dermatitis Index (SCORAD)	Baseline up to Week 52	SCORAD ("SCORing Atopic Dermatitis") is a clinical tool for assessing the severity (i.e., extent, intensity) of atopic dermatitis as objectively as possible.
Percent change of EASI score from baseline	Baseline up to Week 52	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).
Percent change of NRS score from baseline	Baseline up to Week 52	The range of Pruritus Numerical Rating Scale (NRS) is from 0 (no itch)-10 (worst imaginable itch)
Body surface area (BSA) of involvement of atopic dermatitis	Baseline up to Week 52	Change from baseline in percent of BSA
Immunogenicity: anti-drug antibody (ADA) and neutralizing antibody (Nab)	Baseline up to Week 60	anti-drug antibody (ADA) and neutralizing antibody (Nab)
Incidence of adverse events (AEs), abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing.	Baseline up to Week 60	Incidence of adverse events (AEs), abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing.
Changes from baseline in The Patient-Oriented Eczema Measures for Eczema(POEM)	Baseline up to Week 52	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.

Trial Locations

Locations (1)

Huashan Hospital; 🇨🇳 Shanghai, Shanghai, China