Safety and Efficacy Study of OMS906 in Patients With C3G and ICGN (NCT06209736) | Clinical Trial Compass
RecruitingPhase 2
Safety and Efficacy Study of OMS906 in Patients With C3G and ICGN
Lithuania, New Zealand, Poland20 participantsStarted 2024-03-01
Plain-language summary
The purpose of this study is to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of OMS906 in patients with C3 Glomerulopathy (C3G) and Idiopathic Immune Complex-Mediated Glomerulonephritis (ICGN)
Who can participate
Age range18 Years – 99 Years
SexALL
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Inclusion criteria
✓. Male or female adults 18 years and older.
✓. Competent to provide informed consent and has completed informed consent procedures.
✓. Diagnosis of C3G, including dense deposit disease, or ICGN confirmed by biopsy within 36 months of screening.
✓. Two 24-hour UPCR ≥ 0.8 gm/gm with the 2 collections separated by 14 - 28 days.
✓. GFR estimated by the CKD-EPI equation ≥ 45 mL/min/1.73 m2.
✓. Serum C3 concentration less than the lower limit of laboratory normal during screening.
✓. Must be on stable maximally tolerated or allowed dose of ACE inhibitor or ARB for at least 90 days.
✓. If receiving a sodium-glucose co-transporter-2 (SGLT-2) inhibitor, must be on a stable dose for at least 90 days.
Exclusion criteria
✕. History of major organ transplant or hematopoietic stem cell/marrow transplant.
✕. Have known congenital deficiency of any of complement factors C1q, C1r, C1s, C2 or C4.
✕. Have rapidly progressing glomerulonephritis defined as a 50% or greater decline in the eGFR within 3 months with renal biopsy findings of glomerular crescent formation seen in at least 50% of glomeruli.
✕. Have renal biopsy findings showing interstitial fibrosis/tubular atrophy of more than 50%.
What they're measuring
1
To assess OMS906 5mg/kg IV administration at 4-week intervals in patients with C3G and ICGN.
✕. Immunodeficiency or treatment with immunosuppressive agents (except mycophenolate mofetil or corticosteroids at the prednisone equivalent of ≤ 7.5 mg/day in patients with C3G only) within 90 days of screening.
✕. Treatment with rituximab within 6 months of screening.
✕. Resting blood pressure \> 140/90 mmHg during screening.
✕. History of any active malignancy within 5 years of screening except non-melanoma skin cancers.