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

A Randomized, Placebo-controlled, Patient and Investigator Blinded, Study Investigating the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Multiple Doses of CFZ533 in Patients With Moderately Active Proliferative Lupus Nephritis

ClinicalTrials.gov Identifier: NCT03610516

Novartis Reference Number: CCFZ533X2202

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

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.

Condition 
Lupus Nephritis
Phase 
Phase 2
Overall status 
Recruiting
Enrollment count 
60 participants
Start date 
Sep 12, 2018
Completion date 
Mar 17, 2021
Gender 
All
Age(s)
18 Years - 75 Years (Adult, Older Adult)

Interventions

Drug
CFZ533
multiple doses of CFZ533 intravenous infusion
Drug
Placebo
multiple doses of placebo intravenous infusion

Eligibility Criteria

Key Inclusion Criteria:

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)
Subjects must have a body mass index (BMI) within the range of 18 - 40 kg/m2 at screening visit
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
Presence of antinuclear autoantibody (ANA titer ≥ 1:80) at screening
Morning UPCR ≥ 0.5 at screening visit and baseline visit

At least one of the following:

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
Patient must have sufficient kidney function as estimated by eGFR ˃ 30mL/min/1.73 m2 at screening and baseline visits (Levey et al 2009)
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 2012.
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:

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.
Hypoalbuminemia (serum albumin of less than 2.0 g/dL)

Patients who have received:

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

Patients who are at significant risk for the thromboembolic events based on the following:

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
Have had signs or symptoms of a clinically significant systemic viral, bacterial or fungal infection within 30 days prior to randomization
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

United States
Novartis Investigative Site
Recruiting
Columbus, 43210
Ohio
United States
Argentina
Novartis Investigative Site
Recruiting
Ciudad Autonoma de Bs As, C1015ABO
-
Argentina
Novartis Investigative Site
Recruiting
Cordoba, X5000JHQ
-
Argentina
Novartis Investigative Site
Recruiting
Cordoba, X5016KEH
-
Argentina
China
Novartis Investigative Site
Recruiting
Changsha, 410008
Hunan
China
Novartis Investigative Site
Recruiting
Beijing, 100730
-
China
Novartis Investigative Site
Recruiting
Shanghai, 200127
-
China
Germany
Novartis Investigative Site
Recruiting
Berlin, 13353
-
Germany
Novartis Investigative Site
Completed
Kirchheim, 73230
-
Germany
Novartis Investigative Site
Recruiting
Mainz, 55131
-
Germany
Hong Kong
Novartis Investigative Site
Recruiting
HongKong,
-
Hong Kong
Hungary
Novartis Investigative Site
Recruiting
Debrecen, 4032
-
Hungary
Korea, Republic of
Novartis Investigative Site
Recruiting
Seoul, 06591
Seocho Gu
Korea, Republic of
Novartis Investigative Site
Recruiting
Seoul, 03080
-
Korea, Republic of
Russian Federation
Novartis Investigative Site
Completed
Ekaterinburg, 620028
-
Russian Federation
Novartis Investigative Site
Completed
Moscow, 115522
-
Russian Federation
Novartis Investigative Site
Recruiting
Rostov on Don, 344022
-
Russian Federation
Novartis Investigative Site
Recruiting
St-Petersburg, 197022
-
Russian Federation
Novartis Investigative Site
Recruiting
Yaroslavl, 150062
-
Russian Federation
Taiwan
Novartis Investigative Site
Recruiting
Taichung, 40447
-
Taiwan
Novartis Investigative Site
Recruiting
Taichung, 40705
-
Taiwan
Novartis Investigative Site
Recruiting
Taipei, 10048
-
Taiwan
Tunisia
Novartis Investigative Site
Recruiting
Tunis, 1007
Tunisie
Tunisia
Novartis Investigative Site
Recruiting
Tunis, 1008
-
Tunisia
Turkey
Novartis Investigative Site
Withdrawn
Ankara, 06230
-
Turkey
Novartis Investigative Site
Recruiting
Ankara, 06560
-
Turkey
Novartis Investigative Site
Recruiting
Kocaeli, 41380
-
Turkey

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
1-888-669-6682
Name: 
Novartis Pharmaceuticals
Phone: 
+41613241111
Email: 

Have a question?

Call 1-999-669-6682 or email [email protected]