CompletedPhase 1

Study of EQ001 (Itolizumab) in Systemic Lupus Erythematosus With or Without Active Proliferative Nephritis

United States52 participantsStarted 2019-10-01

Plain-language summary

This is a multi-center study to evaluate the safety, tolerability, PK, PD, and clinical activity of itolizumab (EQ001) in subjects with Systemic Lupus Erythematosus with or without Active Proliferative Lupus Nephritis

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. Is male or female, age ≥ 18 and ≤ 75 years
✓. Has previously been documented to have met or currently meets Systemic Lupus International Collaborating Clinics (SLICC) and/or American College of Rheumatology (ACR) criteria for SLE
✓. Received at least 1 immunosuppressive or immunomodulatory treatment for SLE at any time in the past or currently
✓. Has documented elevation of antinuclear antibodies (ANA) in the past or during Screening
✓. Restricted SLE treatments are stable and/or washed out
✓. During Screening, has adequate hematologic function
✓. Is male or female, age ≥ 18 and ≤ 75 years
✓. Has a diagnosis of SLE

Exclusion criteria

✕. Acute or chronic infections requiring systemic antibacterial, antifungal, or antiviral therapy
✕. Positive for hepatitis B virus (HBV), hepatitis C virus (HCV), or HIV
✕. Active TB or a positive TB test

What they're measuring

Number of Treatment Emergent Adverse Events

Timeframe: Type A up to Day 57 or Type B up to Day 253

Trial details

NCT IDNCT04128579

SponsorEquillium

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-11-16

Results submitted2025-03-06

View on ClinicalTrials.gov More Lupus Erythematosus trials