For Healthcare Professionals

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

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About the study

This study is 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.
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

  1. Men and women with systemic lupus erythematosus (SLE) aged ≥ 18 years and ≤ 75 years at screening, fulfilling at least 4 out of 11 criteria for SLE as defined by the American College of Rheumatology (Tan at al 1982, revised by Hochberg 1997)
  2. Subjects must have a body mass index (BMI) within the range of 18
  3. 40 kg/m2 at screening visit
  4. Histological diagnosis of proliferative lupus nephritis World Health Organization (WHO) ISN/RPS (Weening et al 2004) Class III or IV within 5 years of screening
  5. Presence of antinuclear autoantibody (ANA titer ≥ 1:80) at screening
  6. Morning UPCR ≥ 0.5 at screening visit and baseline visit
  7. At least one of the following:
  8. low complement level (C3 ˂ 0.9 g/L) or (C4 ˂ 0.1 g/L), and/or
  9. elevated anti-dsDNA (≥ 30 IU/mL), and/or
  10. 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
  11. Patient must have sufficient kidney function as estimated by eGFR ˃ 30mL/min/1.73 m2 at screening and baseline visits (Levey et al 2009)
  12. Patient must have active disease as defined by proteinuria and additional symptoms as above despite standard of care therapy for LN as considered appropriate by the treating physician (e.g., corticosteroids and/or immunosuppressive or immunomodulatory treatments such as mycophenolate, azathioprine, methotrexate or hydroxychloroquine). For guidance, see published guidelines such as Bertsias et all 2012 and Hahn et al
  13. Women of childbearing potential (defined as all women physiologically capable of becoming pregnant) must use highly effective methods of contraception during dosing and until study completion. Key

EXCLUSION CRITERIA

  1. Any glomerulonephritis other than WHO Class III or IV lupus nephritis. Patients with proliferative nephritis (Class III or IV) who, in addition, have overlapping histological signs for other glomerulonephritis, e.g., Class V, are eligible at the investigator´s discretion.
  2. Hypoalbuminemia (serum albumin of less than 2.0 g/dL)
  3. Patients who have received:
  4. oral or i.v. cyclophosphamide within 3 months prior to randomization
  5. i.v. corticosteroid bolus (dose ˃ 1 mg/kg) within 3 months prior to randomization
  6. 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
  7. belimumab within 6 months prior to randomization
  8. any other biologic drug or an investigational drug within one months or five times the half-life, whichever is longer prior to randomization
  9. any calcineurin inhibitor (e.g., tacrolimus or cyclosporin A) within 3 months prior to randomization
  10. Patients who are at significant risk for the thromboembolic events based on the following:
  11. history of either thrombosis or 3 or more spontaneous abortions
  12. 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
  13. Have had signs or symptoms of a clinically significant systemic viral, bacterial or fungal infection within 30 days prior to randomization
  14. Live vaccines within 4 weeks of the first study drug infusion Other protocol-defined inclusion/exclusion criteria may apply. -
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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.
Phone iconCall 1-888-669-6682Email iconEmail Study Center

Study’s details


Contition

Lupus Nephritis

Age

18+

Phase

Phase 2

Participants needed

57

Est. Completion Date

Jul 2023

Treatment type

Interventional


Sponsor

Novartis

ClinicalTrials.gov identifier

NCT03610516

Study number

CCFZ533X2202

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