Clinical trial NCT06216392: Phase III Study of GR1802 Injection in Patients With Atopic Dermatitis
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Atopic Dermatitis
Lead sponsor: Genrix (Shanghai) Biopharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-01-22
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Proportion of subjects achieving EASI-75 at week 16
timeFrame: at Week 16
measure: Proportion of subjects with IGA score of 0 or 1 and a reduction of IGA score by ≥2 points from baseline at week 16
timeFrame: at Week 16
Secondary outcomes:
measure: Percent change of EASI score from baseline
timeFrame: Baseline up to Week 52
measure: Percent change of NRS score from baseline
timeFrame: Baseline up to Week 52
measure: Body surface area (BSA) of involvement of atopic dermatitis
timeFrame: Baseline up to Week 52
measure: Changes from baseline in Dermatology Life Quality Index (DLQI)
timeFrame: Baseline up to Week 52
measure: Incidence of adverse events (AEs), abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing.
timeFrame: Baseline up to Week 60
measure: Immunogenicity: anti-drug antibody (ADA) and neutralizing antibody (Nab)
timeFrame: Baseline up to Week 60
measure: Changes from baseline in Scoring Atopic Dermatitis Index (SCORAD)
timeFrame: Baseline up to Week 52
measure: Changes from baseline in The Patient-Oriented Eczema Measures for Eczema(POEM)
timeFrame: Baseline up to Week 52
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Huashan Hospital
state: Shanghai
Study officials:
References: