CompletedPhase 2

Safety, Pharmacokinetics and Preliminary Efficacy Study of CFZ533 in Patients With Lupus Nephritis.

Argentina, China57 participantsStarted 2018-09-12

Plain-language summary

This study was to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary therapeutic efficacy of multiple doses of CFZ533 anti-CD40 monoclonal antibody in patients with moderately active lupus nephritis.

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. low complement level (C3 ˂ 0.9 g/L) or (C4 ˂ 0.1 g/L), and/or
✓. elevated anti-dsDNA (≥ 30 IU/mL), and/or
✓. urine sediment consistent with active proliferative LN such as presence of cellular (granular or red blood cell) casts or hematuria ( ˃5 red blood cells per high power field) if other causes such as menstrual bleeding are excluded

Exclusion criteria

✕. oral or i.v. cyclophosphamide within 3 months prior to randomization
✕. i.v. corticosteroid bolus (dose ˃ 1 mg/kg) within 3 months prior to randomization
✕. rituximab or other B cell depleting agent within 12 months. for patients who received such treatment earlier, B cell count should be within normal ranges prior to randomization
✕. belimumab within 6 months prior to randomization
✕. any other biologic drug or an investigational drug within one months or five times the half-life, whichever is longer prior to randomization
✕. any calcineurin inhibitor (e.g., tacrolimus or cyclosporin A) within 3 months prior to randomization
✕. history of either thrombosis or 3 or more spontaneous abortions
✕. presence of lupus anticoagulant or prolonged activated partial thromboplastin time (aPTT) and no prophylactic treatment with aspirin or anticoagulants as per local standard of care

What they're measuring

Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

Timeframe: Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 49 weeks.

Ratio to Baseline in Urinary Protein Creatinine Ratio (UPCR)

Timeframe: Baseline, Day 169

Trial details

NCT IDNCT03610516

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-06-29

Results submitted2024-06-13

View on ClinicalTrials.gov More Lupus Nephritis trials