Phase 1
Completed N=52
Study of EQ001 (Itolizumab) in Systemic Lupus Erythematosus With or Without Active Proliferative Nephritis
Lupus Erythematosus · Lupus Nephritis
Source: ClinicalTrials.gov NCT04128579 ↗
Enrolled (actual)
52
Serious AEs
5.8%
Results posted
Apr 2025
Primary outcomePrimary: Number of Treatment Emergent Adverse Events — 0; 17; 2; 4 Participants
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Treatment Emergent Adverse Events |
0; 17; 2; 4; 3; 8 | — |
| SECONDARY To Characterize the PK of Itolizumab |
— | — |
| SECONDARY CD6 Receptor Occupancy |
— | — |
Eligibility Criteria
Type A Cohort Key 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
Type B Cohort Key Inclusion Criteria:
- Is male or female, age ≥ 18 and ≤ 75 years
- Has a diagnosis of SLE
- Kidney biopsy with a histologic diagnosis of LN Classes III or IV (+/- V)
- Has a urine protein to creatinine ratio of > 1000 mg/g
- Requires induction treatment due to newly diagnosed LN or relapsing/flaring disease or has an incomplete response to current treatment
- Has adequate hematologic function
- Restricted SLE treatments are stable and/or washed out
- Most recent eGFR ≥ 40 mL/min/1.73m2
- Has evidence of serologic activity
Key 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
Data sourced from ClinicalTrials.gov (NCT04128579). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.