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Treatment of cutaneous lupus erythematosus

A lupus erythematosus, skin technology, applied in the field of treatment of cutaneous lupus erythematosus, can solve problems such as unmet medical needs

Pending Publication Date: 2021-12-21
LEO PHARMA AS
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0011] Therefore, there is an unmet medical need for new treatments for cutaneous lupus erythematosus with high efficacy and an attractive safety profile

Method used

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  • Treatment of cutaneous lupus erythematosus
  • Treatment of cutaneous lupus erythematosus
  • Treatment of cutaneous lupus erythematosus

Examples

Experimental program
Comparison scheme
Effect test

Embodiment

[0126] Clinical Trials

[0127] The clinical trial was a multicentre, double-blind, randomized, vehicle-controlled phase 2a trial in adult subjects with DLE, with topical twice-daily application of a compound of formula (I) formulated as a cream at 20 mg / g and vehicle cream for 6 weeks. Each subject must have at least 2 DLE target lesions with active disease. The 2 target lesions will be randomized 1:1 to active ingredient treatment and vehicle treatment.

[0128] treatment period

[0129] At baseline (Day 1). Treatment assignment to the 2 target lesions will be randomized (1:1) to drug cream 20 mg / g and vehicle. Treatments will be given twice daily for 6 weeks. The first administration of investigational medicinal product (IMP) will be performed at the trial site on Day 1 when all baseline assessments have been performed. Subsequent IMP administrations will be performed by the subject at home.

[0130] During the 6-week treatment period, subjects will return to the ...

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Abstract

The present invention relates to the treatment of cutaneous lupus erythematosus. The problem to be solved by the invention is to provide a new pharmaceutical use of 3-[(3S,4R)-3-methyl-6-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1,6-diazaspiro[3.4]octan-1- yl]-3-oxopropanenitrile. A therapeutic or preventive agent cutaneous lupus erythematosus, containing 3-[(3S,4R)-3-methyl-6-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)- 1,6-diazaspiro[3.4]octan-1-yl]-3-oxopropanenitrile as an active ingredient, and a pharmaceutical formulation thereof.

Description

[0001] field of invention [0002] The present invention relates to digotinib (3-[(3S,4R)-3-methyl-6-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1,6-diazepine New pharmaceutical uses of spiro[3.4]oct-1-yl]-3-oxopropionitrile). In another aspect, the invention relates to the treatment of cutaneous lupus erythematosus. In yet another aspect, the present invention relates to new topical pharmaceutical formulations comprising digotinib. [0003] Background of the invention [0004] Lupus erythematosus is an inflammatory autoimmune disease that may affect only the skin (cutaneous lupus erythematosus, CLE), but may also include severe systemic organ involvement (systemic lupus erythematosus, SLE). CLE can be acute, subacute, or chronic. Discoid lupus erythematosus (DLE) is the most common form of chronic CLE, accounting for 80% of all cases. [0005] Discoid lupus erythematosus (DLE) is an autoimmune disease affecting the skin with erythematous, scaly, localized lesions. Over time, these ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/519A61K9/00A61P37/00
CPCA61K31/519A61P37/00A61K9/06A61K9/0014A61K47/06C07D487/10A61K47/10A61K47/12A61K9/10
Inventor J·尼尔森G·P·佩德森H·莫滕森C·桑德P·K·雷费尔
Owner LEO PHARMA AS