Status:
COMPLETED
A Study of KZR-616 in Patients With SLE With and Without Lupus Nephritis
Lead Sponsor:
Kezar Life Sciences, Inc.
Conditions:
Lupus Nephritis
Systemic Lupus Erythematosus
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief Summary
This was a Phase 1b/2, multi-center study in which patients received KZR-616, administered as a subcutaneous (SC) injection weekly for 13 weeks (Phase 1b) or 24 weeks (Phase 2).
Detailed Description
This was a Phase 1b/2, open-label, multi-center study in which patients received zetomipzomib administered as a SC injection weekly for either 13 weeks (Phase 1b) or for 24 weeks (Phase 2). In both ph...
Eligibility Criteria
Inclusion
- Key
- 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
- 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
Key Trial Info
Start Date :
February 20 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 4 2022
Estimated Enrollment :
69 Patients enrolled
Trial Details
Trial ID
NCT03393013
Start Date
February 20 2018
End Date
August 4 2022
Last Update
November 18 2025
Active Locations (36)
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1
Academic Medical Research Institute
Los Angeles, California, United States, 990022
2
Inland Rheumatology Clinical Trials, Inc.
Upland, California, United States, 91786
3
SouthCoast Research Center, Inc.
Miami, Florida, United States, 33136
4
Hope Clinical Trials, Inc.
Miami, Florida, United States, 33165