A Study of KZR-616 in Patients With SLE With and Without Lupus Nephritis

Key Inclusion Criteria

Phase 1b:

• Fulfilled the 2012 Systemic Lupus International Collaborating Clinics (SLICC) classification for SLE
• Had a positive antinuclear antibody (ANA) titer, anti-double stranded DNA (dsDNA) antibody titer, or a positive anti-Smith antibody titer
• Had active SLE (as indicated by Systemic Lupus Erythematosus Disease Activity Index 2000 [SLEDAI-2K] score ≥4), and
• Had received at least 1 prior therapy for SLE

Phase 2:

• Had active proliferative LN (Class III or IV, with or without Class V disease)
• Had a UPCR ≥1.0 measured in 24-hour urine collection
• Had a histologic diagnosis of LN on renal biopsy within the prior 2 years; for biopsies > 1 year before the Screening visit, one of the following must also be present at screening: low C3, low C4, or anti-ds-DNA elevated to above normal range
• Fulfilled the 2012 SLICC classification for SLE
• Had a positive ANA titer, anti-dsDNA antibody titer, or anti-Smith antibody titer, and
• Were currently receiving ≥1 immunosuppressive agent at a stable dose and route of administration for ≥8 weeks. If the patient is also on corticosteroids then must be on a stable dose for ≥ 2 weeks prior to Baseline

Key Exclusion Criteria

Phase 1b:

• Current or medical history of:
• Central nervous system manifestations by autoimmune disease
• Overlapping autoimmune condition that may affect study assessments/outcomes
• Antiphospholipid syndrome with history of thromboembolic event of within the 52 weeks prior to Screening
• Malignancy of any type, with exceptions for in situ cancer that has been completely excised and certain cancers >5 years ago
• Positive test at Screening for HIV, hepatitis B/C
• Major surgery within 4 weeks before signing informed consent form or planned major surgery during the study period

Phase 2:

• Current or medical history of:
• Central nervous system manifestations of SLE
• Overlapping autoimmune condition that may affect study assessments/outcomes
• Antiphospholipid syndrome with history of thromboembolic event of within the 52 weeks prior to Screening
• Malignancy of any type within the last 5 years, with exceptions for appropriately excised and cured cervical carcinoma in situ or excised basal or squamous cell carcinomas of the skin
• Has received dialysis within the 52 weeks prior to Screening
• Positive test at Screening for HIV, hepatitis B/C
• Major surgery within 12 weeks before signing informed consent form or planned major surgery during the study period
• Use of investigational therapy or device, and/or participation in an investigational trial <8 weeks or 5 half-lives, whichever is longer, prior to Baseline; Patients who participated in Phase 1b of KZR-616-002 are excluded from Phase 2