A Study of KZR-616 in Patients With SLE With and Without Lupus Nephritis (NCT03393013) | Clinical Trial Compass
CompletedPhase 1/2
A Study of KZR-616 in Patients With SLE With and Without Lupus Nephritis
United States69 participantsStarted 2018-02-20
Plain-language 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).
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
What they're measuring
1
Phase 1b: Number of Patients Who Experienced at Least One Treatment-Related Treatment-Emergent Adverse Event
Timeframe: 25 weeks
2
Phase 2: Number of Patients With Lupus Nephritis With a 50% Reduction in UPCR