Phase 1b, open-label study of CLN-978 administered subcutaneously in patients with Moderate to Severe Systemic Lupus Erythematosus (SLE).
Diagnosis of SLE at least 24 weeks prior to Screening and meet 2019 EULAR / ACR Classification Criteria at screening.
Presence of one or more of the following autoantibodies documented during screening or in the previous 12 months before screening: positive anti-nuclear antibody (ANA) test (≥1:80); anti dsDNA above the upper limit of normal (ULN); anti-Sm above the ULN.
Active SLE disease, as demonstrated by a SLEDAI total score ≥6 at screening.
Inadequate response to at least 2 of the following treatments: oral corticosteroid, antimalarials, conventional immunosuppressants, or biologics. At least one of the failed treatments should be an immunosuppressive or biologic standard-of care agent.
Active inflammatory disease other than SLE. Thyroiditis or secondary Sjogren's syndrome is allowed.
Considered at high risk for thrombosis.
Rapidly progressive glomerulonephritis, and/or urine protein/creatinine >3 mg/mg (339 mg/mmol).
Active severe neuropsychiatric/CNS manifestations of SLE.
Sequential
CLN-978
DrugSpecified dose on specified days
Safety and tolerability
Incidence and severity of adverse events (AEs)/adverse events of special interest (AESIs)/serious adverse events (SAEs)
Pharmacokinetics
Serum concentrations of CLN-978
Immunogenicity
Level of anti-drug antibodies
Pharmacodynamics-related biomarker
Levels of total B lymphocytes in the peripheral blood
hybrid Systemic Lupus Erythematosus Disease Activity Index (hSLEDAI)
Change in hybrid Systemic Lupus Erythematosus Disease Activity Index (hSLEDAI) score on a scale of 0 to12 with a higher score meaning worse outcome
Physicians Global Assessment
Change in Physicians Global Assessment (PGA) score on a scale of 0 to 3 with a higher score indicating worse outcome
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