CFZ533

DRUG11 trials

Sponsors

Novartis Pharmaceuticals, Novartis

Conditions

Graves' DiseaseHidradenitis SuppurativaKidney TransplantationLiver Transplant RejectionLupus NephritisMyasthenia Gravis, GeneralizedRheumatoid ArthritisSjogren syndrome

Phase 1

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Dose CFZ533 in Rheumatoid Arthritis Patients

CompletedNCT02089087

Novartis PharmaceuticalsRheumatoid Arthritis

Start: 2013-01-07End: 2017-02-03Updated: 2020-12-11

CCFZ533X2201 - PoC Study in de Novo Renal Transplantation

CompletedNCT02217410

Novartis PharmaceuticalsKidney Transplantation

Start: 2015-02-05End: 2017-11-29Updated: 2021-09-28

Phase 2

Safety,Tolerability,Pharmacokinetics and Efficacy of CFZ533 in Moderate to Severe Myasthenia Gravis

CompletedNCT02565576

Novartis PharmaceuticalsMyasthenia Gravis, Generalized

Start: 2015-09-29End: 2017-12-19Updated: 2021-01-05

A Study to Evaluate the Safety and Effect of CFZ533 on Patients With Graves' Disease

CompletedNCT02713256

Novartis PharmaceuticalsGraves' Disease

Start: 2016-04-19End: 2017-04-24Updated: 2021-01-05

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

CompletedNCT03610516

Novartis PharmaceuticalsLupus Nephritis

Start: 2018-09-12End: 2023-06-29Updated: 2024-10-09

Study the Efficacy and Safety of VAY736 and CFZ533 in SLE Patients

CompletedNCT03656562

Novartis PharmaceuticalsSystemic Lupus Erythematosus (SLE)

Start: 2018-12-19End: 2025-04-28Updated: 2025-10-07

Study of Efficacy, Safety, Tolerability, Pharmacokinetic (PK) and Pharmacodynamic (PD) of an Anti-CD40 Monoclonal Antibody, CFZ533, in Liver Transplant Recipients With Additional 12-month Follow-up and Long-term Extension

TerminatedNCT03781414

Novartis PharmaceuticalsLiver Transplant Rejection

Start: 2019-10-07End: 2023-04-20Updated: 2025-05-16

Study of Efficacy and Safety of Investigational Treatments in Patients With Moderate to Severe Hidradenitis Suppurativa

Active, not recruitingNCT03827798

Novartis PharmaceuticalsHidradenitis Suppurativa

Start: 2019-02-27End: 2026-12-11Updated: 2026-02-06

Study of Safety and Efficacy of Multiple Doses of CFZ533 in Two Distinct Populations of Patients With Sjogren's Syndrome

CompletedNCT03905525

Novartis PharmaceuticalsSjögren Syndrome

Start: 2019-10-01End: 2023-06-06Updated: 2023-09-15

Study of Safety and Efficacy of CFZ533 in Type 1 Diabetes Pediatric and Young Adult Subjects

CompletedNCT04129528

Novartis PharmaceuticalsType 1 Diabetes Mellitus

Start: 2019-11-08End: 2024-06-04Updated: 2025-04-08

A TWINSS extension trial to evaluate the safety and tolerability of CFZ533 (iscalimab) at two dose levels administered subcutaneously in patients with Sjögren*s Syndrome

Active, not recruitingNL-OMON51920

NovartisSjogren syndrome

Start: 2021-11-09Target: 8Updated: 2024-08-19

Related Papers

Efficacy, pharmacokinetics and safety of iscalimab (CFZ533) in patients with proliferative lupus nephritis: a randomised, double-blind, placebo-controlled, phase II study.

PubMed2025-08-143 citations

PREEXISTING ANTIBODIES AGAINST VACCINE ANTIGENS ARE PRESERVED IN PATIENTS WITH SYSTEMIC LUPUS ERYTHEMATOSUS AND SJÖGREN’S DISEASE UPON IANALUMAB TREATMENT WHILE AUTOANTIBODIES DECLINE

The Journal of Rheumatology2025-05-201 citations

IANALUMAB’S DUAL MODE OF ACTION: TARGETING B CELLS THROUGH ENHANCED B CELL DEPLETION AND BLOCKADE OF B CELL-ACTIVATING FACTOR RECEPTOR SIGNALING

The Journal of Rheumatology2025-05-20

Safety and efficacy of subcutaneous iscalimab (CFZ533) in two distinct populations of patients with Sjögren's disease (TWINSS): week 24 results of a randomised, double-blind, placebo-controlled, phase 2b dose-ranging study.

2024-07-3125 citations

P41 Assessment of cognitive function in a randomized, placebo-controlled, interventional trial conducted in patients with moderate-to-severe systemic lupus erythematosus (SLE)

Poster presentations2024-03-01

Registered trials on novel therapies for myasthenia gravis: a cross-sectional study on ClinicalTrials.gov.

2024-01-243 citations

Ianalumab, a Novel Anti-B-Cell Activating Factor (BAFF) Receptor (BAFF-R) Monoclonal Antibody (mAb) in Development for Immune Thrombocytopenia (ITP) and Warm Autoimmune Hemolytic Anemia (wAIHA), Has Demonstrated a Favorable Safety Profile in Sjögren's Syndrome (SjS), Systemic Lupus Erythematosus (SLE) and Chronic Lymphocytic Leukemia (CLL)

Blood2023-11-025 citations

PHASE 2 STUDY DESIGN EVALUATING EFFICACY, SAFETY, PHARMACOKINETICS AND PHARMACODYNAMICS OF THE ANTI-CD40 MONOCLONAL ANTIBODY CFZ533 (ISCALIMAB) IN DE NOVO LIVER TRANSPLANT RECIPIENTS: THE CONTRAIL I STUDY

Transplantation2020-08-281 citations

CD40 Inhibition with CFZ533 - A New, Fully Human, Non-Depleting, Fc Silent mAB - Improves Renal Allograft Function While Demonstrating Comparable Efficacy vs. Tacrolimus in De-Novo CNI-Free Kidney Transplant Recipients

Transplantation2018-07-019 citations