Safety and Efficacy of Combination Belimumab and Voclosporin in the Treatment of Proliferative Fo… (NCT07225387) | Clinical Trial Compass
RecruitingPhase 4
Safety and Efficacy of Combination Belimumab and Voclosporin in the Treatment of Proliferative Forms of Lupus Glomerulopathy: Synergy Trial
United States30 participantsStarted 2024-10-01
Plain-language summary
This is a Phase IV, open-label, randomized trial to determine whether the combination of Belimumab (BEL) and Voclosporin (VCS), plus background therapy with Mycophenolate Mofetil (MMF), improves the proportion of patients with proliferative lupus nephritis achieving complete renal response (CRR) compared to proportion of patients achieving CRR from recent clinical trials. This protocol will additionally determine whether combination therapy using Belimumab (BEL) and Voclosporin (VCS) facilitates rapid discontinuation of MMF.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. Signed Informed Consent Form
✓. Age 18-80 years at time of signing Informed Consent Form
✓. Ability to comply with the study protocol, in the investigator's judgment
✓. A diagnosis of SLE by any one of the following criteria: European League Against Rheumatism/ American College of Rheumatology/Systemic Lupus International Collaborating Clinics (EULAR/ACR/SLICC)
✓. ISN/RPS 2003 Class III, Class IV, Class III/V or Class IV/V Lupus Nephritis diagnosed and meet one of these criteria:
✓. UPCR must be \>750 mg/gm from a 24 hour urine collection during screening. If the UPCR does not exceed 750 mg/gm, it may be repeated once during the screening period.
✓. Resting systolic blood pressure \<150 mm Hg and resting diastolic blood pressure \<90 mm Hg.
✓. Subject must be on maximum tolerated ACEi or ARB therapy as adjudicated by the site PI for ≥4 weeks prior to randomization.
Exclusion criteria
What they're measuring
1
Primary Outcome Measure: Day 360 (12 Month) Outcome
. Pancreatitis or gastrointestinal hemorrhage within 6 months prior to screening.
✕. Active unhealed peptic ulcer within 3 months prior to screening. If an ulcer has healed and the subject is on adequate therapy, the subject may be randomized. 9. Positive human immunodeficiency virus (HIV) infection. 10. In the opinion of the Investigator, clinically significant drug or alcohol abuse 2 years prior to screening.