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Safe and effective method of treating psoriasis with Anti-il-23 specific antibody

A psoriasis, antibody technology, applied in the direction of antibody medical ingredients, medical preparations with non-active ingredients, medical preparations containing active ingredients, etc.

Pending Publication Date: 2021-09-14
JANSSEN BIOTECH INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although the etiology of psoriasis has not been clearly defined, gene and protein analyzes have shown that IL-12, IL-23, and their downstream molecules are overexpressed in psoriatic lesions, and some may be associated with the severity of psoriatic disease

Method used

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  • Safe and effective method of treating psoriasis with Anti-il-23 specific antibody
  • Safe and effective method of treating psoriasis with Anti-il-23 specific antibody
  • Safe and effective method of treating psoriasis with Anti-il-23 specific antibody

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0219] Example 1: Evaluation of CNTO 1959 (guselkumab) and secukinumab for the treatment of moderate to severe plaque silver A phase 3 multicenter randomized double-blind study of comparative efficacy in psoriasis

[0220] Research design :

[0221] ●Phase 3 randomized double-blind multicenter active comparator study in subjects with moderate to severe plaque psoriasis including 2 parallel treatment arms: guselkumab 100 mg and secukinumab 300mg.

[0222] Randomization: At week 0, approximately 1040 subjects meeting all inclusion and exclusion criteria are planned to be randomized in a 1:1 ratio to the 2 arms based on permuted block randomization using stratification by study site 1 of:

[0223] ○ Group I (n=520): Guselkumab, 100 mg, SC, administered at weeks 0, 4, 12, 20, and then every 8 weeks until week 44.

[0224] ○ Group II (n=520): secukinumab, 300 mg, SC, administered at weeks 0, 1, 2, 3, and 4, and then every 4 weeks until week 44.

[0225] ●Treatment Duratio...

Embodiment 2

[0301] Example 2 - Evaluation of anti-IL-23 and anti-IL-17A on IL-17F levels and IL-17F levels of immune cell populations in skin and serum Effect of treatment on IL-22 levels

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Abstract

A method of treating psoriasis in a patient by administering an IL-23 specific antibody, e.g., guselkumab, in a clinically proven safe and clinically proven effective amount and the patient achieves PASI90, PASI100 or IGA 0 or 1 score as measured 16, 24, 32, 40 and 48 weeks after initial treatment and the patient achieves higher efficacy than a patient treated with the secukinumab antibody.

Description

[0001] Reference Sequence Listing Submitted Electronically [0002] This application contains a Sequence Listing that has been electronically filed in ASCII format and is hereby incorporated by reference in its entirety. Said ASCII copy was created on November 19, 2019, named PCTSEQUENCELISTING.txt, and was 80,004 bytes in size. technical field [0003] The present invention relates to methods of treating psoriasis with antibodies that bind human IL-23 protein. In particular, the present invention relates to methods of administering anti-IL-23 specific antibodies and specific pharmaceutical compositions of antibodies (e.g., guselkumab) that are safe and effective in patients with psoriasis . Background technique [0004] Interleukin (IL)-12 is a secreted heterodimeric cytokine consisting of 2 disulfide-linked glycosylated protein subunits, named p35 and p40 according to their approximate molecular weights. IL-12 is primarily produced by antigen-presenting cells and drive...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K39/395C07K16/24A61K9/08
CPCA61P17/06A61K45/06C07K16/244A61K2039/545C07K2317/21C07K2317/76A61K2039/505C07K16/241C07K2317/565A61K39/39591A61K47/26A61K47/22A61K39/395
Inventor J·安格萨那P·布兰尼根S·德普里莫S·弗拉文S·李X·刘E·蒙诺兹B·兰达佐
Owner JANSSEN BIOTECH INC
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