Status:
ACTIVE_NOT_RECRUITING
Clinical Study to Investigate the Safety, Tolerability, and Pharmacokinetics of GR1603 in SLE
Lead Sponsor:
Genrix (Shanghai) Biopharmaceutical Co., Ltd.
Conditions:
Lupus Erythematosus, Systemic
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
PHASE2
Brief Summary
A Study to Investigate the Tolerability, Safety,Pharmacokinetics and efficacy of GR1603 in subjects with Systemic Lupus Erythematosus ； GR1603 injection is a monoclonal antibody targeting IFNAR1, whic...
Detailed Description
This is a Phase Ib/Ⅱ,double blind, multiple-dose study to evaluate the pharmacokinetics (PK), safety，tolerability and efficacy of intravenously administered GR1603 in participants with active SLE desp...
Eligibility Criteria
Inclusion
- Diagnosis of SLE according to the ACR 1997 ≥24 weeks
- Active moderate to severe SLE
- At least one of these antibodies positive: ANA, anti-dsDNA and anti-Smith.
Exclusion
- Active severe or unstable neuropsychiatric SLE
- Clinically significant laboratory test
- Clinically significant active infection
Key Trial Info
Start Date :
March 8 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 4 2028
Estimated Enrollment :
136 Patients enrolled
Trial Details
Trial ID
NCT06015230
Start Date
March 8 2022
End Date
October 4 2028
Last Update
September 25 2024
Active Locations (1)
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1
Peking union Medical Hosipital
Beijing, Beijing Municipality, China, 100730