Back to resultsClinical Study to Investigate the Safety, Tolerability, and Pharmacokinetics of GR1603 in SLE
Primary Purpose
Lupus Erythematosus, Systemic
Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
low dose GR1603 in phase Ⅰb
high dose GR1603 in phaseⅠb
low dose GR1603 in phase Ⅱ
high dose GR1603 in phase Ⅱ
Placebo in phase Ⅱ
Sponsored by
About this trial
This is an interventional treatment trial for Lupus Erythematosus, Systemic focused on measuring IFNR, Autoimmune Diseases, SLE
Eligibility Criteria
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
Sites / Locations
- Peking union Medical HosipitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
Treatment group 1-Ⅰb
Treatment group 2-Ⅰb
treatment group 3-Ⅱ
treatment group 4-Ⅱ
treatment group 5-Ⅱ
Arm Description
6 subjects in GR1603 low dose，2 subjects in placebo
6 subjects in GR1603 high dose，2 subjects in placebo
low dose GR1603 monthly
high dose GR1603 monthly
placebo
Outcomes
Primary Outcome Measures
Adverse events(phase Ib)
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)
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 Outcome Measures
Cmax(phaseⅠb）
Pharmacokinetic indices
AUC0-t(phaseⅠb）
Pharmacokinetic indices
AUC0-∞(phaseⅠb）
Pharmacokinetic indices
AUCss(phaseⅠb）
Pharmacokinetic indices
Tmax(phaseⅠb）
Pharmacokinetic indices
t1/2z(phaseⅠb）
Pharmacokinetic indices
Vz(phaseⅠb）
Pharmacokinetic indices
CLz(phaseⅠb）
Pharmacokinetic indices
Number of participants who achieved SRI (4)(phase Ⅱ)
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)
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)
CLASI:Cutaneous Lupus Erythematosus Disease Area and Severity Index
Flare rate(phase Ⅱ）
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
Full Information
NCT ID
NCT06015230
First Posted
June 1, 2023
Last Updated
August 22, 2023
Sponsor
Genrix (Shanghai) Biopharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT06015230
Brief Title
Clinical Study to Investigate the Safety, Tolerability, and Pharmacokinetics of GR1603 in SLE
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 8, 2022 (Actual)
Primary Completion Date
June 10, 2028 (Anticipated)
Study Completion Date
October 4, 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genrix (Shanghai) Biopharmaceutical Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lupus Erythematosus, Systemic
Keywords
IFNR, Autoimmune Diseases, SLE
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
136 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment group 1-Ⅰb
Arm Type
Experimental
Arm Description
6 subjects in GR1603 low dose，2 subjects in placebo
Arm Title
Treatment group 2-Ⅰb
Arm Type
Experimental
Arm Description
6 subjects in GR1603 high dose，2 subjects in placebo
Arm Title
treatment group 3-Ⅱ
Arm Type
Experimental
Arm Description
low dose GR1603 monthly
Arm Title
treatment group 4-Ⅱ
Arm Type
Experimental
Arm Description
high dose GR1603 monthly
Arm Title
treatment group 5-Ⅱ
Arm Type
Placebo Comparator
Arm Description
placebo
Intervention Type
Biological
Intervention Name(s)
low dose GR1603 in phase Ⅰb
Intervention Description
6 subjects in GR1603 low dose，2 subjects in placebo
Intervention Type
Biological
Intervention Name(s)
high dose GR1603 in phaseⅠb
Intervention Description
6 subjects in GR1603 high dose，2 subjects in placebo
Intervention Type
Biological
Intervention Name(s)
low dose GR1603 in phase Ⅱ
Intervention Description
low dose GR1603 monthly
Intervention Type
Biological
Intervention Name(s)
high dose GR1603 in phase Ⅱ
Intervention Description
high dose GR1603 monthly
Intervention Type
Biological
Intervention Name(s)
Placebo in phase Ⅱ
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Adverse events(phase Ib)
Description
to characterise the safety and tolerability of GR1603,including abnormal vital signs,laboratory tests,electrocardiogram and physical examination
Time Frame
up to week 16
Title
Number of participants who achieved BICLA response (phase Ⅱ)
Description
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
Time Frame
week 24
Secondary Outcome Measure Information:
Title
Cmax(phaseⅠb）
Description
Pharmacokinetic indices
Time Frame
up to week 16
Title
AUC0-t(phaseⅠb）
Description
Pharmacokinetic indices
Time Frame
up to week 16
Title
AUC0-∞(phaseⅠb）
Description
Pharmacokinetic indices
Time Frame
up to week 16
Title
AUCss(phaseⅠb）
Description
Pharmacokinetic indices
Time Frame
up to week 16
Title
Tmax(phaseⅠb）
Description
Pharmacokinetic indices
Time Frame
up to week 16
Title
t1/2z(phaseⅠb）
Description
Pharmacokinetic indices
Time Frame
up to week 16
Title
Vz(phaseⅠb）
Description
Pharmacokinetic indices
Time Frame
up to week 16
Title
CLz(phaseⅠb）
Description
Pharmacokinetic indices
Time Frame
up to week 16
Title
Number of participants who achieved SRI (4)(phase Ⅱ)
Description
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;
Time Frame
up to week 28
Title
Number of participants who achieved BICLA response(phase Ⅱ)
Description
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
Time Frame
up to week 28
Title
Number of participants with a ≥50% reduction in CLASI activity score (phase Ⅱ)
Description
CLASI:Cutaneous Lupus Erythematosus Disease Area and Severity Index
Time Frame
up to week 28
Title
Flare rate(phase Ⅱ）
Description
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
Time Frame
up to week 28
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
xiaofeng zeng, PHD
Phone
010-69154186
Email
xiaofeng.zeng@cstar.org.cn
First Name & Middle Initial & Last Name or Official Title & Degree
juan huang, MD
Phone
18842664061
Email
huangjuan@genrixbio.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
xiaofeng zeng, PHD
Organizational Affiliation
Peking Union Medical College Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking union Medical Hosipital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
jiali tian, MD
Phone
010-69154186
Email
tianjiali@pumch.cn
First Name & Middle Initial & Last Name & Degree
xiaofeng zeng, PHD
12. IPD Sharing Statement
Learn more about this trial
Clinical Study to Investigate the Safety, Tolerability, and Pharmacokinetics of GR1603 in SLE
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