Omega Research Group | Omega Research Orlando, LLC
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Phase 1b, open-label study of CLN-978 administered subcutaneously in patients with Moderate to Severe Systemic Lupus Erythematosus (SLE).
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Inclusion criteria
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: 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 ≥8 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.
If on corticosteroid and/or antimalarial, the dose must be stable prior to day 1.
Laboratory parameters including the following:
Part B only: For patients who were treated in Part A and did not experience dose-limiting toxicity (DLT) or discontinue CLN-978 treatment due to AEs are eligible for retreatment at a higher dose or longer schedule in Part B if they otherwise meet eligibility criteria and at least 90 days have passed since the last dose of CLN-978.
Exclusion criteria
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.
Evidence of hepatitis B, hepatitis C (HCV) infection, human immunodeficiency virus (HIV), Epstein-Barr virus (EBV), or cytomegalovirus (CMV) infection.
History of splenectomy.
Prior treatment with the following:
Live or attenuated vaccine within 28 days prior to screening or during screening.
Active, clinically significant bacterial, viral, fungal, mycobacterial, parasitic, or other infection, including SARS-CoV-2 infection, within 14 days before Day 1.
Active or latent tuberculosis (TB) evidenced by a positive or indeterminant Interferon Gamma Release Assay (IGRA), unless the patient has documented previous completion of TB treatment and no current clinical indication of TB.
Any condition for which, in the opinion of the Investigator and/or Sponsor, would not be in the best interest of the patient to participate in the study or that could prevent, limit, or confound any protocol-defined assessment.
Primary purpose
Allocation
Interventional model
Masking
24 participants in 2 patient groups
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Central trial contact
Meagan Sardinha
Data sourced from clinicaltrials.gov
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