Phase III Study of GR1802 Injection in Patients With Atopic Dermatitis

NCT06216392 | Unknown Phase 3

• 1 other identifier: GR1802-004
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 1

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.

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• Percent change of EASI score from baseline

  Baseline up to Week 52

• Percent change of NRS score from baseline

  Baseline up to Week 52

• Body surface area (BSA) of involvement of atopic dermatitis

  Baseline up to Week 52

• Changes from baseline in Dermatology Life Quality Index (DLQI)

  Baseline up to Week 52

• Incidence of adverse events (AEs), abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing.

  Baseline up to Week 60

Study Arms (2)

Experimental: GR1802

EXPERIMENTAL

GR1802 injection 300mg every two weeks for 52-week treatment.

Biological: GR1802 injection

Placebo

PLACEBO COMPARATOR

Placebo every two weeks for 16-week treatment. Crossover to GR1802 injection for another 36 weeks

Biological: placebo

Interventions

GR1802 injection BIOLOGICAL

150mg/1ml. 2 ml every two weeks Route of administration: Subcutaneous

Experimental: GR1802

placebo BIOLOGICAL

0mg/1ml. 2 ml every two weeks Route of administration: Subcutaneous

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Inadequate response or intolerance to topical glucocorticoid therapy for AD within 6 months prior to screening.

You may not qualify if:

• Not enough washing-out period for previous therapy.
• Concurrent disease/status which may potentially affect the efficacy/safety judgement.
• Abnormal laboratory test results at screening that, in the judgment of the investigator, may affect the subject's ability to complete the trial.
• Women who are pregnant or breastfeeding, or planning to become pregnant, breastfeeding during the study.
• Other

Sponsors & Collaborators

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

Study Sites (1)

Huashan Hospital

Shanghai, Shanghai Municipality, 200000, China

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Central Study Contacts

Jinhua Xu, PhD.

CONTACT

021-52889999; xjhhsyy@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2024
• First Posted: January 22, 2024
• Study Start: January 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: January 1, 2026
• Last Updated: January 22, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)