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

Genrix (Shanghai) Biopharmaceutical

Status and phase: Active, not recruiting; Phase 2; Phase 1

Conditions: Lupus Erythematosus, Systemic

Treatments: Biological: high dose GR1603 in phaseⅠb; Biological: low dose GR1603 in phase Ⅰb; Biological: low dose GR1603 in phase Ⅱ; Biological: high dose GR1603 in phase Ⅱ; Biological: Placebo in phase Ⅱ

Study type: Interventional

Funder types: Industry

Identifiers

NCT06015230

GR1603-002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 136 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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136 participants in 5 patient groups, including a placebo group

Treatment group 1-Ⅰb

Experimental group

Description:

6 subjects in GR1603 low dose，2 subjects in placebo

Treatment:

Biological: low dose GR1603 in phase Ⅰb

Treatment group 2-Ⅰb

Experimental group

Description:

6 subjects in GR1603 high dose，2 subjects in placebo

Treatment:

Biological: high dose GR1603 in phaseⅠb

treatment group 3-Ⅱ

Experimental group

Description:

low dose GR1603 monthly

Treatment:

Biological: low dose GR1603 in phase Ⅱ

treatment group 4-Ⅱ

Experimental group

Description:

high dose GR1603 monthly

Treatment:

Biological: high dose GR1603 in phase Ⅱ

treatment group 5-Ⅱ

Placebo Comparator group

Description:

placebo

Treatment:

Biological: Placebo in phase Ⅱ