Clinical Study to Investigate the Safety, Tolerability, and Pharmacokinetics of GR1603 in SLE
- Conditions
- Lupus Erythematosus, Systemic
- Interventions
- Biological: low dose GR1603 in phase ⅠbBiological: low dose GR1603 in phase ⅡBiological: high dose GR1603 in phase ⅡBiological: Placebo in phase ⅡBiological: high dose GR1603 in phaseⅠb
- Registration Number
- NCT06015230
- Lead Sponsor
- Genrix (Shanghai) Biopharmaceutical Co., Ltd.
- 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, which can block IFNAR binding to type I interferons such as IFNα and be used to treat systemic lupus erythematosus.
- 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 despite receiving standard of care .
Phase Ib is a multi-dose escalation phase in which 16 subjects are scheduled to enroll.
A total of 120 subjects were randomly assigned to GR1603 injection low dose group, high dose group or placebo group in phase Ⅱ.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 136
- 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.
- Active severe or unstable neuropsychiatric SLE
- Clinically significant laboratory test
- Clinically significant active infection
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment group 1-Ⅰb low dose GR1603 in phase Ⅰb 6 subjects in GR1603 low dose，2 subjects in placebo treatment group 3-Ⅱ low dose GR1603 in phase Ⅱ low dose GR1603 monthly treatment group 4-Ⅱ high dose GR1603 in phase Ⅱ high dose GR1603 monthly treatment group 5-Ⅱ Placebo in phase Ⅱ placebo Treatment group 2-Ⅰb high dose GR1603 in phaseⅠb 6 subjects in GR1603 high dose，2 subjects in placebo
- Primary Outcome Measures
Name Time Method 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
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
- Secondary Outcome Measures
Name Time Method AUC0-∞(phaseⅠb） up to week 16 Pharmacokinetic indices
Cmax(phaseⅠb） up to week 16 Pharmacokinetic indices
AUC0-t(phaseⅠb） up to week 16 Pharmacokinetic indices
AUCss(phaseⅠb） up to week 16 Pharmacokinetic indices
Vz(phaseⅠb） up to week 16 Pharmacokinetic indices
t1/2z(phaseⅠb） up to week 16 Pharmacokinetic indices
CLz(phaseⅠb） up to week 16 Pharmacokinetic indices
Tmax(phaseⅠb） up to week 16 Pharmacokinetic indices
Number of participants who achieved BICLA response(phase Ⅱ) up to week 28 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
Flare rate(phase Ⅱ） up to week 28 A flare was defined as either 1 or more new BILAG-2004 A or 2 or more new BILAG-2004 B items compared to the previous visit
Number of participants with a ≥50% reduction in CLASI activity score (phase Ⅱ) up to week 28 CLASI:Cutaneous Lupus Erythematosus Disease Area and Severity Index
Number of participants who achieved SRI (4)(phase Ⅱ) up to week 28 An SRI (4) responder defined as a participant who had a reduction in baseline Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score of greater than or equal to 4 points;
Trial Locations
- Locations (1)
Peking union Medical Hosipital
🇨🇳Beijing, Beijing, China