Status:
NOT_YET_RECRUITING
Phase III Study of GR1802 Injection in Patients With Atopic Dermatitis
Lead Sponsor:
Genrix (Shanghai) Biopharmaceutical Co., Ltd.
Conditions:
Atopic Dermatitis
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
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 ato...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
January 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
450 Patients enrolled
Trial Details
Trial ID
NCT06216392
Start Date
January 1 2024
End Date
January 1 2026
Last Update
January 22 2024
Active Locations (1)
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1
Huashan Hospital
Shanghai, Shanghai Municipality, China, 200000