Phase III Study of GR1802 Injection in Patients With Atopic Dermatitis

Atopic Dermatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06216392
• Other study ID #: GR1802-004
• Status: Not yet recruiting
• Phase: Phase 3
• 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
• 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

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

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