Peking union Medical Hosipital
Beijing, Beijing Municipality, 100730, China
Active, Not Recruiting
NCT Number: NCT06015230
Clinical Study to Investigate the Safety, Tolerability, and Pharmacokinetics of GR1603 in SLE
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.
Active, Not Recruiting
This study is active but is not currently recruiting participants.
Notify MeKey information
Conditions
Age range
18 year–70 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 1 / Phase 2
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
low dose GR1603 in phase Ⅰb
Biological6 subjects in GR1603 low dose，2 subjects in placebo
high dose GR1603 in phaseⅠb
Biological6 subjects in GR1603 high dose，2 subjects in placebo
low dose GR1603 in phase Ⅱ
Biologicallow dose GR1603 monthly
high dose GR1603 in phase Ⅱ
Biologicalhigh dose GR1603 monthly
Placebo in phase Ⅱ
BiologicalPlacebo
Primary outcomes
-
Adverse events(phase Ib)
Time frame: 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)
Time frame: 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
Secondary outcomes
-
Cmax(phaseⅠb）
Time frame: up to week 16
Pharmacokinetic indices
-
AUC0-t(phaseⅠb）
Time frame: up to week 16
Pharmacokinetic indices
-
AUC0-∞(phaseⅠb）
Time frame: up to week 16
Pharmacokinetic indices
-
AUCss(phaseⅠb）
Time frame: up to week 16
Pharmacokinetic indices
-
Tmax(phaseⅠb）
Time frame: up to week 16
Pharmacokinetic indices
-
t1/2z(phaseⅠb）
Time frame: up to week 16
Pharmacokinetic indices
-
Vz(phaseⅠb）
Time frame: up to week 16
Pharmacokinetic indices
-
CLz(phaseⅠb）
Time frame: up to week 16
Pharmacokinetic indices
-
Number of participants who achieved SRI (4)(phase Ⅱ)
Time frame: 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;
-
Number of participants who achieved BICLA response(phase Ⅱ)
Time frame: 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
-
Number of participants with a ≥50% reduction in CLASI activity score (phase Ⅱ)
Time frame: up to week 28
CLASI:Cutaneous Lupus Erythematosus Disease Area and Severity Index
-
Flare rate(phase Ⅱ）
Time frame: 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
Sponsors and collaborators
Lead sponsor
Genrix (Shanghai) Biopharmaceutical Co., Ltd.
Industry
Registry information
Official study title
A Phase Ⅰb/Ⅱ, Randomized, Double-blind, Placebo-controlled Study to Investigate the Tolerability, Safety,Pharmacokinetics and Efficacy of an Intravenous Treatment Regimen of GR1603 in Subjects with Systemic Lupus Erythematosus
Important dates
- Study start
- 2022
- Primary completion
- 2028
- Study completion
- 2028
- First posted
- Aug 29, 2023
- Registry last updated
- Sep 25, 2024
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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