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

• Register: ClinicalTrials.gov
• Last refreshed on: 11 March 2024
• Main ID: NCT04128579
• Date of registration: 30/09/2019
• Prospective Registration: Yes
• Primary sponsor: Equillium
• Public title: Study of EQ001 (Itolizumab) in Systemic Lupus Erythematosus With or Without Active Proliferative Nephritis EQUALISE
• Scientific title: A Phase 1b Multiple Ascending-dose Study of EQ001 in Subjects With Systemic Lupus Erythematosus With or Without Active Proliferative Lupus Nephritis
• Date of first enrolment: October 1, 2019
• Target sample size: 55
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT04128579
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Sequential Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

India, Poland, United States

Contacts

• Name: Kenneth Kalunian, MD
• Affiliation: UCSD

Key inclusion & exclusion criteria

Type A Cohort Key Inclusion Criteria:

1. Is male or female, age = 18 and = 75 years

2. 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

3. Received at least 1 immunosuppressive or immunomodulatory treatment for SLE at any
time in the past or currently

4. Has documented elevation of antinuclear antibodies (ANA) in the past or during
Screening

5. Restricted SLE treatments are stable and/or washed out

6. During Screening, has adequate hematologic function

Type B Cohort Key Inclusion Criteria:

1. Is male or female, age = 18 and = 75 years

2. Has a diagnosis of SLE

3. Kidney biopsy with a histologic diagnosis of LN Classes III or IV (+/- V)

4. Has a urine protein to creatinine ratio of > 1000 mg/g

5. Requires induction treatment due to newly diagnosed LN or relapsing/flaring disease or
has an incomplete response to current treatment

6. Has adequate hematologic function

7. Restricted SLE treatments are stable and/or washed out

8. Most recent eGFR = 40 mL/min/1.73m2

9. Has evidence of serologic activity

Key Exclusion Criteria:

1. Acute or chronic infections requiring systemic antibacterial, antifungal, or antiviral
therapy

2. Positive for hepatitis B virus (HBV), hepatitis C virus (HCV), or HIV

3. Active TB or a positive TB test



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Lupus Erythematosus

Lupus Nephritis

Intervention(s)

Drug: Itolizumab [Bmab 600]

Primary Outcome(s)

Incidence of Treatment Emergent Adverse Events [Time Frame: Type A up to Day 57 or Type B up to Day 253]

Secondary Outcome(s)

To characterize the PK of itolizumab [Time Frame: Type A up to Day 57 or Type B up to Day 253]

CD6 receptor occupancy [Time Frame: Type A up to Day 57 or Type B up to Day 253]

Secondary ID(s)

EQ001-19-002

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Biocon Limited