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Methods of treating lupus nephritis using interleukin-17 (IL-17) antagonists

A lupus nephritis and antibody technology, applied in antiviral agents, chemical instruments and methods, antibodies, etc., can solve the problems of lack of treatment and unmet medical needs

Pending Publication Date: 2022-07-08
NOVARTIS AG
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0010] Given the severity of the condition and the lack of approved treatments, there is a high unmet medical need for safe and effective long-term therapies (i.e., alone or as add-on therapy) for the treatment of LN

Method used

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  • Methods of treating lupus nephritis using interleukin-17 (IL-17) antagonists
  • Methods of treating lupus nephritis using interleukin-17 (IL-17) antagonists
  • Methods of treating lupus nephritis using interleukin-17 (IL-17) antagonists

Examples

Experimental program
Comparison scheme
Effect test

example 1

[0203] A two-year, phase III randomized, double-blind, parallel-group, placebo-controlled trial to evaluate 300 mg s.c. secukinumab (versus placebo) in combination with SoC therapy in patients with active lupus nephritis safety, efficacy and tolerability.

[0204] Research purposes

[0205] The purpose of this trial was to evaluate subcutaneous (SC) administration of secukinumab 300 mg (compared to placebo) in combination with standard of care therapy (SoC) in patients with active lupus nephritis (ISN / RPS class III or IV, with Efficacy and safety in subjects without coexisting Class V characteristics).

[0206] The background SoC will consist of the following: with mycophenolic acid (MPA) (referring to mycophenolate mofetil or general equivalent) or at equivalent doses (oral) enteric-coated sodium MPA ( or general equivalent), or induction therapy with cyclophosphamide (CYC) (i.v.), followed by maintenance therapy with MPA. In addition, all subjects will receive i.v. and...

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Abstract

The present disclosure relates to methods of treating lupus nephritis (LN) using an IL-17 antagonist, such as secukinumab. Also disclosed herein are IL-17 antibodies, such as IL-17 antagonists such as secukinumab, for use in the treatment of LN patients, as well as medicaments, dosing regimens, pharmaceutical formulations, dosage forms, and kits for use in the disclosed uses and methods.

Description

technical field [0001] The present disclosure relates to methods of treating lupus nephritis (LN) using an IL-17 antagonist (eg, an IL-17 antibody, such as secukinumab). Background technique [0002] LN stands for inflammation of the kidney and is one of the organ-specific disease clinical manifestations of systemic lupus erythematosus (SLE) (Waldman and Madaio (2005) Lupus 14(1):19-24). LN is a chronic inflammatory disease characterized by the production of autoantibodies and other marked immunological abnormalities (Gurevitz et al. (2013) Consult Pharm 28:110-21). The International Society of Nephrology / Renal Pathology Society (ISN / RPS) classification system, which classifies them into six histological categories, has become the standard for the interpretation of kidney biopsies due to their improved correlation with prognosis and treatment outcomes. (Weening et al. (2004) J Am Soc Nephrol. [Journal of the American Society of Nephrology] 15(2):241-50; Markowitz et al. (20...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K39/395
CPCC07K16/244A61K2039/505C07K2317/76A61P13/12A61P37/00A61P31/12A61K2039/54A61K2039/545C07K2317/21C07K2317/34C07K2317/56C07K2317/565C07K2317/90C07K2317/92C07K2317/94
Inventor W·许贝尔S·姆波富L·普里科普
Owner NOVARTIS AG