Clinical Study to Investigate the Safety, Tolerability, and Pharmacokinetics of GR1603 in SLE

Lupus Erythematosus, Systemic Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06015230
• Other study ID #: GR1603-002
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: March 8, 2022
• Est. completion date: October 4, 2028

Study information

• Verified date: June 2023
• Source: Genrix (Shanghai) Biopharmaceutical Co., Ltd.
• Contact: xiaofeng zeng, PHD
• Phone: 010-69154186
• Email: xiaofeng.zeng[@]cstar.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 136
• Est. completion date: October 4, 2028
• Est. primary completion date: June 10, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic

Intervention

Biological:
• low dose GR1603 in phase ?b
6 subjects in GR1603 low dose,2 subjects in placebo
• high dose GR1603 in phase?b
6 subjects in GR1603 high dose,2 subjects in placebo
• low dose GR1603 in phase ?
low dose GR1603 monthly
• high dose GR1603 in phase ?
high dose GR1603 monthly
• Placebo in phase ?
Placebo

Locations

Country	Name	City	State
China	Peking union Medical Hosipital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Genrix (Shanghai) Biopharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Number of participants who achieved BICLA response (phase ?)	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
Secondary	Cmax(phase?b)	Pharmacokinetic indices	up to week 16
Secondary	AUC0-t(phase?b)	Pharmacokinetic indices	up to week 16
Secondary	AUC0-8(phase?b)	Pharmacokinetic indices	up to week 16
Secondary	AUCss(phase?b)	Pharmacokinetic indices	up to week 16
Secondary	Tmax(phase?b)	Pharmacokinetic indices	up to week 16
Secondary	t1/2z(phase?b)	Pharmacokinetic indices	up to week 16
Secondary	Vz(phase?b)	Pharmacokinetic indices	up to week 16
Secondary	CLz(phase?b)	Pharmacokinetic indices	up to week 16
Secondary	Number of participants who achieved SRI (4)(phase ?)	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
Secondary	Number of participants who achieved BICLA response(phase ?)	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
Secondary	Number of participants with a =50% reduction in CLASI activity score (phase ?)	CLASI:Cutaneous Lupus Erythematosus Disease Area and Severity Index	up to week 28
Secondary	Flare rate(phase ?)	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