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Clinical Trials in China / NCT06015230
Active, not recruiting Phase 1/2

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

NCT06015230 · tracked via the Priya Life Science China tracker
Sponsor
Genrix (Shanghai) Biopharmaceutical Co., Ltd
Phase
Phase 1/2
Started
2022-03-08
Last updated
2024-09-25

Condition(s) studied

Lupus Erythematosus, Systemic

Investigational drug(s) / intervention(s)

low dose GR1603 in phase Ⅰbhigh dose GR1603 in phaseⅠblow dose GR1603 in phase Ⅱhigh dose GR1603 in phase ⅡPlacebo in phase Ⅱ

low dose GR1603 in phase Ⅰb: 6 subjects in GR1603 low dose，2 subjects in placebo

high dose GR1603 in phaseⅠb: 6 subjects in GR1603 high dose，2 subjects in placebo

low dose GR1603 in phase Ⅱ: low dose GR1603 monthly

high dose GR1603 in phase Ⅱ: high dose GR1603 monthly

Placebo in phase Ⅱ: Placebo

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Adverse events(phase Ib) — 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) — 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

Trial sites (1)

FacilityCityRegionStatus
Peking union Medical Hosipital Beijing Beijing Municipality

More Genrix (Shanghai) Biopharmaceutical Co., Ltd. trials in China

A Study of GR1803 Injection Versus Daratumumab, Pomalidomide, and Dexamethasone (DPd) in Participants With Relapsed or Refractory Multiple Myeloma Recruiting
A Study to Evaluate the Safety, Immunogenicity, and Pharmacokinetics of GR2303 in Healthy Adult Recruiting
A Study of GR1803 Injection in Combination With Anti-CD38 Monoclonal Antibody for the Treatment of Participants With Multiple Myeloma Starting soon
GR1803 Injection in Patients With Relapsed/Refractory Multiple Myeloma Active, not recruiting
A Clinical Trial of Multiple Doses of GR2301 Injection in Healthy Adult Trial Participants in China. Starting soon

Other trials for the same condition

A Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus Erythematosus Recruiting
A Research Study to Evaluate the Effects of a New Oral Medicine Called Cenerimod in Adults With Systemic Lupus Erythematosus Active, not recruiting
Vunakizumab for the Treatment of Mild to Moderate Systemic Lupus Erythematosus Recruiting
A Study of Outcomes in Chinese Patients Treated With Anifrolumab Who Have Active Mod-severe Systemic Lupus Erythematosus Recruiting
A Study to Learn About the Safety of Litifilimab (BIIB059) Injections and Whether They Can Improve Symptoms of Adult Participants Who Have Systemic Lupus Erythematosus Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06015230 on ClinicalTrials.gov ↗ ← All trials in China