low dose GR1603 in phase Ⅰbhigh dose GR1603 in phaseⅠblow dose GR1603 in phase Ⅱhigh dose GR1603 in phase ⅡPlacebo in phase Ⅱ
low dose GR1603 in phase Ⅰb: 6 subjects in GR1603 low dose，2 subjects in placebo
high dose GR1603 in phaseⅠb: 6 subjects in GR1603 high dose，2 subjects in placebo
low dose GR1603 in phase Ⅱ: low dose GR1603 monthly
high dose GR1603 in phase Ⅱ: high dose GR1603 monthly
Placebo in phase Ⅱ: Placebo
Study 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, which can block IFNAR binding to type I interferons such as IFNα and be used to treat systemic lupus erythematosus.
Eligibility
Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
Inclusion Criteria:
* 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 Criteria:
* Active severe or unstable neuropsychiatric SLE
* Clinically significant laboratory test
* Clinically significant active infection
Primary outcome measure(s)
Adverse events(phase Ib) — up to week 16 to characterise the safety and tolerability of GR1603,including abnormal vital signs,laboratory tests,electrocardiogram and physical examination
Number of participants who achieved BICLA response (phase Ⅱ) — week 24 BICLA respnse:reduction of all baseline BILAG-2004 A to B/C/D and baseline BILAG-2004 B to C/D, and no BILAG-2004 worsening in other organ systems, as defined by ≥1 new BILAG-2004 A or ≥2 new BILAG-2004 B
Trial sites (1)
Facility
City
Region
Status
Peking union Medical Hosipital
Beijing
Beijing Municipality
More Genrix (Shanghai) Biopharmaceutical Co., Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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