Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group 1-Ⅰb | Experimental | 6 subjects in GR1603 low dose，2 subjects in placebo |
|
| Treatment group 2-Ⅰb | Experimental | 6 subjects in GR1603 high dose，2 subjects in placebo |
|
| treatment group 3-Ⅱ | Experimental | low dose GR1603 monthly |
|
| treatment group 4-Ⅱ | Experimental | high dose GR1603 monthly |
|
| treatment group 5-Ⅱ | Placebo Comparator | placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| low dose GR1603 in phase Ⅰb | Biological | 6 subjects in GR1603 low dose，2 subjects in placebo |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events(phase Ib) | to characterise the safety and tolerability of GR1603,including abnormal vital signs,laboratory tests,electrocardiogram and physical examination | up to week 16 |
| 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 | week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax(phaseⅠb） | Pharmacokinetic indices | up to week 16 |
| AUC0-t(phaseⅠb） | Pharmacokinetic indices | up to week 16 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| xiaofeng zeng, PHD | Peking Union Medical College Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking union Medical Hosipital | Beijing | Beijing Municipality | 100730 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| high dose GR1603 in phaseⅠb | Biological | 6 subjects in GR1603 high dose，2 subjects in placebo |
|
| low dose GR1603 in phase Ⅱ | Biological | low dose GR1603 monthly |
|
| high dose GR1603 in phase Ⅱ | Biological | high dose GR1603 monthly |
|
| Placebo in phase Ⅱ | Biological | Placebo |
|
| AUC0-∞(phaseⅠb） | Pharmacokinetic indices | up to week 16 |
| AUCss(phaseⅠb） | Pharmacokinetic indices | up to week 16 |
| Tmax(phaseⅠb） | Pharmacokinetic indices | up to week 16 |
| t1/2z(phaseⅠb） | Pharmacokinetic indices | up to week 16 |
| Vz(phaseⅠb） | Pharmacokinetic indices | up to week 16 |
| CLz(phaseⅠb） | Pharmacokinetic indices | up to week 16 |
| 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; | up to week 28 |
| 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 | up to week 28 |
| Number of participants with a ≥50% reduction in CLASI activity score (phase Ⅱ) | CLASI:Cutaneous Lupus Erythematosus Disease Area and Severity Index | up to week 28 |
| 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 | up to week 28 |
| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| D001327 | Autoimmune Diseases |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D007154 | Immune System Diseases |
Not provided
Not provided