JP7375252B2 - 結節性痒疹患者における皮膚病変およびそう痒の治療 - Google Patents
結節性痒疹患者における皮膚病変およびそう痒の治療 Download PDFInfo
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Description
本出願は、米国特許法第119(e)条の下、2019年1月28日出願の米国特許仮出願第62/797,803号および2019年2月22日出願の米国特許仮出願第62/809,404号に対する優先権を主張し、これらの内容全体が、参照によって本明細書に組み込まれる。
結節性痒疹(PN)を含む慢性痒疹(CP)を有する対象の皮膚病変およびそう痒を治療するための方法、CPを有する対象における皮膚病変およびそう痒の治療に使用するための薬学的組成物、CPを有する対象における皮膚病変およびそう痒の治療のための薬物の製造におけるネモリズマブまたはその等価物の使用が、本明細書に記載される。
以下の考察は、本開示についての読者の理解を助けるために提供されており、それに対する先行技術の記載または構成を認めるものではない。
結節性痒疹(PN)を含む慢性痒疹(CP)を有する対象における皮膚病変およびそう痒を治療するための方法、PNを含むCPを有する対象における皮膚病変およびそう痒の治療に使用するための薬学的組成物、PNを含むCPを有する対象における皮膚病変およびそう痒の治療のための薬物の製造におけるネモリズマブまたはその等価物の使用が、本明細書に提供される。
[本発明1001]
慢性痒疹(CP)を有する対象における皮膚病変およびそう痒を治療する方法であって、有効量のネモリズマブまたはその等価物を前記対象に投与することを含む、方法。
[本発明1002]
前記対象が、結節性痒疹(PN)を有する、本発明1001の方法。
[本発明1003]
前記対象が、少なくとも約6ヶ月にわたってPNと診断されている、本発明1002の方法。
[本発明1004]
前記対象が、両側分布で身体に少なくとも約20個の小結節を有する、前記本発明のいずれかの方法。
[本発明1005]
前記対象が、上肢に痒疹病変を有する、前記本発明のいずれかの方法。
[本発明1006]
前記そう痒に、数値評価スケール(NRS)の少なくともスコア4が割り当てられている、前記本発明のいずれかの方法。
[本発明1007]
前記そう痒に、数値評価スケール(NRS)の少なくともスコア7が割り当てられている、前記本発明のいずれかの方法。
[本発明1008]
前記対象が、アトピー性皮膚炎を有していない、前記本発明のいずれかの方法。
[本発明1009]
前記有効量のネモリズマブまたはその等価物が、約0.01mg/kg~約0.1mg/kg、約0.1mg/kg~約0.5mg/kg、約0.5mg/kg~約1.5mg/kg、約1.5mg/kg~約2.5mg/kg、または約2.5mg/kg~約10mg/kgである、前記本発明のいずれかの方法。
[本発明1010]
前記有効量のネモリズマブまたはその等価物が、約10mg、約15mg、約20mg、約25mg、約30mg、約35mg、約40mg、約45mg、約50mg、約55mg、約60mg、約65mg、約70mg、約75mg、約80mg、約85mg、約90mgである、前記本発明のいずれかの方法。
[本発明1011]
前記ネモリズマブまたはその等価物が、平坦投薬レジメンに従って投与される、前記本発明のいずれかの方法。
[本発明1012]
前記ネモリズマブまたはその等価物が、負荷投与量レジメンに従って投与される、前記本発明のいずれかの方法。
[本発明1013]
前記ネモリズマブまたはその前記等価物が、局所または非経口経路によって投与される、前記本発明のいずれかの方法。
[本発明1014]
前記ネモリズマブまたはその前記等価物が、皮下投与される、前記本発明のいずれかの方法。
[本発明1015]
前記ネモリズマブまたはその前記等価物が、1週間に1回、2週間に1回、3週間に1回、4週間に1回、5週間に1回、6週間に1回、7週間に1回、または8週間に1回投与される、前記本発明のいずれかの方法。
[本発明1016]
慢性痒疹(CP)を有する対象における皮膚病変およびそう痒の治療に使用するための薬学的組成物であって、ネモリズマブまたはその等価物を含む、薬学的組成物。
[本発明1017]
前記対象が、結節性痒疹(PN)を有する、本発明1016の薬学的組成物。
[本発明1018]
前記対象が、少なくとも約6ヶ月にわたってPNと診断されている、本発明1017の薬学的組成物。
[本発明1019]
前記対象が、両側分布で身体に少なくとも約20個の小結節を有する、本発明1016~1018のいずれかの薬学的組成物。
[本発明1020]
前記対象が、上肢に痒疹病変を有する、本発明1016~1019のいずれかの薬学的組成物。
[本発明1021]
前記そう痒に、数値評価スケール(NRS)の少なくともスコア4が割り当てられている、本発明1016~1020のいずれかの薬学的組成物。
[本発明1022]
前記そう痒に、数値評価スケール(NRS)の少なくともスコア7が割り当てられている、本発明1016~1021のいずれかの薬学的組成物。
[本発明1023]
前記対象が、アトピー性皮膚炎を有していない、本発明1016~1022のいずれかの薬学的組成物。
[本発明1024]
担体をさらに含む、本発明1016~1023のいずれかの薬学的組成物。
[本発明1025]
前記担体が、薬学的に許容される担体である、本発明1024の薬学的組成物。
[本発明1026]
前記ネモリズマブまたはその等価物が、平坦投薬レジメンに従って投与される、本発明1016~1025のいずれかの薬学的組成物。
[本発明1027]
前記ネモリズマブまたはその等価物が、負荷投与量レジメンに従って投与される、本発明1016~1025のいずれかの薬学的組成物。
[本発明1028]
約0.01mg/kg~約0.1mg/kg、約0.1mg/kg~約0.5mg/kg、約0.5mg/kg~約1.5mg/kg、約1.5mg/kg~約2.5mg/kg、または約2.5mg/kg~約10mg/kgのネモリズマブまたはその等価物を含む、本発明1016~1027のいずれかの薬学的組成物。
[本発明1029]
約10mg、約15mg、約20mg、約25mg、約30mg、約35mg、約40mg、約45mg、約50mg、約55mg、約60mg、約65mg、約70mg、約75mg、約80mg、約85mg、約90mgのネモリズマブまたはその等価物を含む、本発明1016~1027のいずれかの薬学的組成物。
[本発明1030]
慢性痒疹(CP)を有する対象における皮膚病変およびそう痒の治療のための薬物の製造における、ネモリズマブまたはその等価物の使用。
[本発明1031]
前記対象が、結節性痒疹(PN)を有する、本発明1030の使用。
[本発明1032]
前記対象が、少なくとも約6ヶ月にわたってPNと診断されている、本発明1031の使用。
[本発明1033]
前記対象が、両側分布で身体に少なくとも約20個の小結節を有する、本発明1030~1032のいずれかの使用。
[本発明1034]
前記対象が、上肢に痒疹病変を有する、本発明1030~1033のいずれかの使用。
[本発明1035]
前記そう痒に、数値評価スケール(NRS)の少なくともスコア7が割り当てられている、本発明1030~1034のいずれかの使用。
[本発明1036]
前記そう痒に、数値評価スケール(NRS)の少なくともスコア7が割り当てられている、本発明1030~1035のいずれかの使用。
[本発明1037]
前記対象が、アトピー性皮膚炎を有していない、本発明1030~1036のいずれかの使用。
[本発明1038]
前記ネモリズマブまたはその等価物が、平坦投薬レジメンに従って投与される、本発明1030~1037のいずれかの使用。
[本発明1039]
前記ネモリズマブまたはその等価物が、負荷投与量レジメンに従って投与される、本発明1030~1037のいずれかの使用。
[本発明1040]
前記ネモリズマブまたはその等価物が、約0.01mg/kg~約0.1mg/kg、約0.1mg/kg~約0.5mg/kg、約0.5mg/kg~約1.5mg/kg、約1.5mg/kg~約2.5mg/kg、または約2.5mg/kg~約10mg/kgの用量で投与される、本発明1030~1039のいずれかの使用。
[本発明1041]
前記ネモリズマブまたはその等価物が、約10mg、約15mg、約20mg、約25mg、約30mg、約35mg、約40mg、約45mg、約50mg、約55mg、約60mg、約65mg、約70mg、約75mg、約80mg、約85mg、約90mgの用量で投与される、本発明1030~1039のいずれかの使用。
本開示に従う実施形態は、以下により十分に記載される。しかしながら、本開示の態様は、異なる形態で具体化されてもよく、本明細書に明記される実施形態に限定されるものと解釈されるべきではない。むしろ、これらの実施形態は、本開示が徹底的かつ完全であり、本発明の範囲を当業者に十分に伝えるように提供される。本明細書の記載において使用される用語は、特定の実施形態を記載するためのものに過ぎず、限定することは意図されない。
本明細書で使用される場合、単数形「a(1つの)」、「an(1つの)」、および「the(その)」は、単数形のみを指定することが明確に述べられない限り、単数形および複数形の両方を指定する。
「ネモリズマブ」は、IL-31RAに結合するヒト化モノクローナル抗体である。ネモリズマブには、以下のように注釈が付けられる。免疫グロブリンG2-カッパ,抗[ホモサピエンスIL31RA(インターロイキン31受容体サブユニットアルファ)],ヒト化モノクローナル抗体;ガンマ2重鎖(1-445)[ヒト化VH(ホモサピエンスIGHV1-2*02(83.70%)-(IGHD)-IGHJ5*01)[8.8.14](1-121)-ホモサピエンスIGHG2*01(CH1 C10>S(135),R12>K(137),E16>G(141),S17>G(142)(122-219),ヒンジC4>S(223)(220-231),CH2 H30>Q(268)(232-340),CH3 R11>Q(355),Q98>E(419)(341-445))(122-445)],(224-214’)-ジスルフィド(カッパ軽鎖(1’-214’)[ヒト化V-KAPPA(ホモサピエンスIGKV1-39*01(82.10%)-IGKJ4*01)[6.3.9](1’-107’)-ホモサピエンスIGKC*01(108’-214’)]を有する);二量体(227-227”:230-230”)-ビスジスルフィド。ネモリズマブは、以下の位置にジスルフィド架橋を有する。イントラ-H(C23-C104)22-96 148-204 261-321 367-425 22’’-96’’ 148’’-204’’ 261’’-321’’ 367’’-425’’;イントラ-L(C23-C104)23’-88’ 134’-194’ 23’’’-88’’’ 134’’’-194’’’;インター-H-L(h5-CL126)224-214’ 224’’-214’’’;インター-H-H(h8,h11)227-227’’ 230-230’’。ネモリズマブは、以下の位置にN-グリコシル化部位を有する。H CH2 N84.4:297,297’’。ネモリズマブは、H鎖C末端グリシンおよびリジンを欠く(CHS G1>欠失、K2>欠失)。
本明細書では、慢性痒疹(CP)を有する対象における皮膚病変およびそう痒の治療に使用するための薬学的組成物であって、ネモリズマブまたはその等価物を含むか、それからなるか、またはそれから本質的になる、薬学的組成物が提供される。さらに、本開示は、活性成分としてネモリズマブまたはその等価物を含む、CPの治療剤を提供する。
いくつかの実施形態に従うと、結節性痒疹(PN)を有する対象におけるそう痒を治療する方法であって、有効量のネモリズマブまたはその等価物を対象に投与することを含むか、それからなるか、または本質的にそれからなる方法が提供される。
多施設(EUおよび米国の20箇所)、無作為化、二重盲検、プラセボ対照、並行群間研究を、アトピーのバックグラウンドで層別化した2群(1群当たり35人)の約70人の無作為化した患者を含めて実行した。登録した患者は、0.5mg/kgの用量の皮下へのネモリズマブまたはプラセボを、4週間に1回受けた。患者は、以下の基準に基づいて選択した。
1.スクリーニング時に少なくとも18歳の男性または女性。
1.疥癬、虫刺され、限局性神経皮膚炎、乾癬、ざ瘡、毛包炎、習慣性皮膚むしり症、リンパ腫様丘疹症、慢性日光過敏性皮膚炎、疱疹状皮膚炎、スポロトリクム症、水疱症などの、PN以外の別の病態から生じる慢性そう痒。
研究の主要エンドポイントは、4週目でのそう痒NRSのベースライン(BL)からの低減パーセントであった。
表6および7に示されるように、ネモリズマブ治療群およびプラセボ群は、同等の数の、全ての原因による治療下で発現した有害事象(TEAE)、および同等の発生率の、全ての原因による器官別大分類(SOC)によるTEAEを示す。全体的に見て、ネモリズマブは、耐容性が良かった。
SEQUENCE LISTING
<110> Galderma Holding SA
Chugai Seiyaku Kabushiki Kaisha
<120> TREATMENT OF SKIN LESIONS AND PRURITUS IN PRURIGO
NODULARIS PATIENTS
<150> US 62/797,803
<151> 2019-01-28
<150> US 62/809,404
<151> 2019-02-22
<160> 6
<170> PatentIn version 3.5
<210> 1
<211> 662
<212> PRT
<213> Homo sapiens
<400> 1
Met Lys Leu Ser Pro Gln Pro Ser Cys Val Asn Leu Gly Met Met Trp
1 5 10 15
Thr Trp Ala Leu Trp Met Leu Pro Ser Leu Cys Lys Phe Ser Leu Ala
20 25 30
Ala Leu Pro Ala Lys Pro Glu Asn Ile Ser Cys Val Tyr Tyr Tyr Arg
35 40 45
Lys Asn Leu Thr Cys Thr Trp Ser Pro Gly Lys Glu Thr Ser Tyr Thr
50 55 60
Gln Tyr Thr Val Lys Arg Thr Tyr Ala Phe Gly Glu Lys His Asp Asn
65 70 75 80
Cys Thr Thr Asn Ser Ser Thr Ser Glu Asn Arg Ala Ser Cys Ser Phe
85 90 95
Phe Leu Pro Arg Ile Thr Ile Pro Asp Asn Tyr Thr Ile Glu Val Glu
100 105 110
Ala Glu Asn Gly Asp Gly Val Ile Lys Ser His Met Thr Tyr Trp Arg
115 120 125
Leu Glu Asn Ile Ala Lys Thr Glu Pro Pro Lys Ile Phe Arg Val Lys
130 135 140
Pro Val Leu Gly Ile Lys Arg Met Ile Gln Ile Glu Trp Ile Lys Pro
145 150 155 160
Glu Leu Ala Pro Val Ser Ser Asp Leu Lys Tyr Thr Leu Arg Phe Arg
165 170 175
Thr Val Asn Ser Thr Ser Trp Met Glu Val Asn Phe Ala Lys Asn Arg
180 185 190
Lys Asp Lys Asn Gln Thr Tyr Asn Leu Thr Gly Leu Gln Pro Phe Thr
195 200 205
Glu Tyr Val Ile Ala Leu Arg Cys Ala Val Lys Glu Ser Lys Phe Trp
210 215 220
Ser Asp Trp Ser Gln Glu Lys Met Gly Met Thr Glu Glu Glu Ala Pro
225 230 235 240
Cys Gly Leu Glu Leu Trp Arg Val Leu Lys Pro Ala Glu Ala Asp Gly
245 250 255
Arg Arg Pro Val Arg Leu Leu Trp Lys Lys Ala Arg Gly Ala Pro Val
260 265 270
Leu Glu Lys Thr Leu Gly Tyr Asn Ile Trp Tyr Tyr Pro Glu Ser Asn
275 280 285
Thr Asn Leu Thr Glu Thr Met Asn Thr Thr Asn Gln Gln Leu Glu Leu
290 295 300
His Leu Gly Gly Glu Ser Phe Trp Val Ser Met Ile Ser Tyr Asn Ser
305 310 315 320
Leu Gly Lys Ser Pro Val Ala Thr Leu Arg Ile Pro Ala Ile Gln Glu
325 330 335
Lys Ser Phe Gln Cys Ile Glu Val Met Gln Ala Cys Val Ala Glu Asp
340 345 350
Gln Leu Val Val Lys Trp Gln Ser Ser Ala Leu Asp Val Asn Thr Trp
355 360 365
Met Ile Glu Trp Phe Pro Asp Val Asp Ser Glu Pro Thr Thr Leu Ser
370 375 380
Trp Glu Ser Val Ser Gln Ala Thr Asn Trp Thr Ile Gln Gln Asp Lys
385 390 395 400
Leu Lys Pro Phe Trp Cys Tyr Asn Ile Ser Val Tyr Pro Met Leu His
405 410 415
Asp Lys Val Gly Glu Pro Tyr Ser Ile Gln Ala Tyr Ala Lys Glu Gly
420 425 430
Val Pro Ser Glu Gly Pro Glu Thr Lys Val Glu Asn Ile Gly Val Lys
435 440 445
Thr Val Thr Ile Thr Trp Lys Glu Ile Pro Lys Ser Glu Arg Lys Gly
450 455 460
Ile Ile Cys Asn Tyr Thr Ile Phe Tyr Gln Ala Glu Gly Gly Lys Gly
465 470 475 480
Phe Ser Lys Thr Val Asn Ser Ser Ile Leu Gln Tyr Gly Leu Glu Ser
485 490 495
Leu Lys Arg Lys Thr Ser Tyr Ile Val Gln Val Met Ala Ser Thr Ser
500 505 510
Ala Gly Gly Thr Asn Gly Thr Ser Ile Asn Phe Lys Thr Leu Ser Phe
515 520 525
Ser Val Phe Glu Ile Ile Leu Ile Thr Ser Leu Ile Gly Gly Gly Leu
530 535 540
Leu Ile Leu Ile Ile Leu Thr Val Ala Tyr Gly Leu Lys Lys Pro Asn
545 550 555 560
Lys Leu Thr His Leu Cys Trp Pro Thr Val Pro Asn Pro Ala Glu Ser
565 570 575
Ser Ile Ala Thr Trp His Gly Asp Asp Phe Lys Asp Lys Leu Asn Leu
580 585 590
Lys Glu Ser Asp Asp Ser Val Asn Thr Glu Asp Arg Ile Leu Lys Pro
595 600 605
Cys Ser Thr Pro Ser Asp Lys Leu Val Ile Asp Lys Leu Val Val Asn
610 615 620
Phe Gly Asn Val Leu Gln Glu Ile Phe Thr Asp Glu Ala Arg Thr Gly
625 630 635 640
Gln Glu Asn Asn Leu Gly Gly Glu Lys Asn Gly Thr Arg Ile Leu Ser
645 650 655
Ser Cys Pro Thr Ser Ile
660
<210> 2
<211> 732
<212> PRT
<213> Homo sapiens
<400> 2
Met Met Trp Thr Trp Ala Leu Trp Met Leu Pro Ser Leu Cys Lys Phe
1 5 10 15
Ser Leu Ala Ala Leu Pro Ala Lys Pro Glu Asn Ile Ser Cys Val Tyr
20 25 30
Tyr Tyr Arg Lys Asn Leu Thr Cys Thr Trp Ser Pro Gly Lys Glu Thr
35 40 45
Ser Tyr Thr Gln Tyr Thr Val Lys Arg Thr Tyr Ala Phe Gly Glu Lys
50 55 60
His Asp Asn Cys Thr Thr Asn Ser Ser Thr Ser Glu Asn Arg Ala Ser
65 70 75 80
Cys Ser Phe Phe Leu Pro Arg Ile Thr Ile Pro Asp Asn Tyr Thr Ile
85 90 95
Glu Val Glu Ala Glu Asn Gly Asp Gly Val Ile Lys Ser His Met Thr
100 105 110
Tyr Trp Arg Leu Glu Asn Ile Ala Lys Thr Glu Pro Pro Lys Ile Phe
115 120 125
Arg Val Lys Pro Val Leu Gly Ile Lys Arg Met Ile Gln Ile Glu Trp
130 135 140
Ile Lys Pro Glu Leu Ala Pro Val Ser Ser Asp Leu Lys Tyr Thr Leu
145 150 155 160
Arg Phe Arg Thr Val Asn Ser Thr Ser Trp Met Glu Val Asn Phe Ala
165 170 175
Lys Asn Arg Lys Asp Lys Asn Gln Thr Tyr Asn Leu Thr Gly Leu Gln
180 185 190
Pro Phe Thr Glu Tyr Val Ile Ala Leu Arg Cys Ala Val Lys Glu Ser
195 200 205
Lys Phe Trp Ser Asp Trp Ser Gln Glu Lys Met Gly Met Thr Glu Glu
210 215 220
Glu Ala Pro Cys Gly Leu Glu Leu Trp Arg Val Leu Lys Pro Ala Glu
225 230 235 240
Ala Asp Gly Arg Arg Pro Val Arg Leu Leu Trp Lys Lys Ala Arg Gly
245 250 255
Ala Pro Val Leu Glu Lys Thr Leu Gly Tyr Asn Ile Trp Tyr Tyr Pro
260 265 270
Glu Ser Asn Thr Asn Leu Thr Glu Thr Met Asn Thr Thr Asn Gln Gln
275 280 285
Leu Glu Leu His Leu Gly Gly Glu Ser Phe Trp Val Ser Met Ile Ser
290 295 300
Tyr Asn Ser Leu Gly Lys Ser Pro Val Ala Thr Leu Arg Ile Pro Ala
305 310 315 320
Ile Gln Glu Lys Ser Phe Gln Cys Ile Glu Val Met Gln Ala Cys Val
325 330 335
Ala Glu Asp Gln Leu Val Val Lys Trp Gln Ser Ser Ala Leu Asp Val
340 345 350
Asn Thr Trp Met Ile Glu Trp Phe Pro Asp Val Asp Ser Glu Pro Thr
355 360 365
Thr Leu Ser Trp Glu Ser Val Ser Gln Ala Thr Asn Trp Thr Ile Gln
370 375 380
Gln Asp Lys Leu Lys Pro Phe Trp Cys Tyr Asn Ile Ser Val Tyr Pro
385 390 395 400
Met Leu His Asp Lys Val Gly Glu Pro Tyr Ser Ile Gln Ala Tyr Ala
405 410 415
Lys Glu Gly Val Pro Ser Glu Gly Pro Glu Thr Lys Val Glu Asn Ile
420 425 430
Gly Val Lys Thr Val Thr Ile Thr Trp Lys Glu Ile Pro Lys Ser Glu
435 440 445
Arg Lys Gly Ile Ile Cys Asn Tyr Thr Ile Phe Tyr Gln Ala Glu Gly
450 455 460
Gly Lys Gly Phe Ser Lys Thr Val Asn Ser Ser Ile Leu Gln Tyr Gly
465 470 475 480
Leu Glu Ser Leu Lys Arg Lys Thr Ser Tyr Ile Val Gln Val Met Ala
485 490 495
Ser Thr Ser Ala Gly Gly Thr Asn Gly Thr Ser Ile Asn Phe Lys Thr
500 505 510
Leu Ser Phe Ser Val Phe Glu Ile Ile Leu Ile Thr Ser Leu Ile Gly
515 520 525
Gly Gly Leu Leu Ile Leu Ile Ile Leu Thr Val Ala Tyr Gly Leu Lys
530 535 540
Lys Pro Asn Lys Leu Thr His Leu Cys Trp Pro Thr Val Pro Asn Pro
545 550 555 560
Ala Glu Ser Ser Ile Ala Thr Trp His Gly Asp Asp Phe Lys Asp Lys
565 570 575
Leu Asn Leu Lys Glu Ser Asp Asp Ser Val Asn Thr Glu Asp Arg Ile
580 585 590
Leu Lys Pro Cys Ser Thr Pro Ser Asp Lys Leu Val Ile Asp Lys Leu
595 600 605
Val Val Asn Phe Gly Asn Val Leu Gln Glu Ile Phe Thr Asp Glu Ala
610 615 620
Arg Thr Gly Gln Glu Asn Asn Leu Gly Gly Glu Lys Asn Gly Tyr Val
625 630 635 640
Thr Cys Pro Phe Arg Pro Asp Cys Pro Leu Gly Lys Ser Phe Glu Glu
645 650 655
Leu Pro Val Ser Pro Glu Ile Pro Pro Arg Lys Ser Gln Tyr Leu Arg
660 665 670
Ser Arg Met Pro Glu Gly Thr Arg Pro Glu Ala Lys Glu Gln Leu Leu
675 680 685
Phe Ser Gly Gln Ser Leu Val Pro Asp His Leu Cys Glu Glu Gly Ala
690 695 700
Pro Asn Pro Tyr Leu Lys Asn Ser Val Thr Ala Arg Glu Phe Leu Val
705 710 715 720
Ser Glu Lys Leu Pro Glu His Thr Lys Gly Glu Val
725 730
<210> 3
<211> 716
<212> PRT
<213> Mus musculus
<400> 3
Met Trp Thr Leu Ala Leu Trp Ala Phe Ser Phe Leu Cys Lys Phe Ser
1 5 10 15
Leu Ala Val Leu Pro Thr Lys Pro Glu Asn Ile Ser Cys Val Phe Tyr
20 25 30
Phe Asp Arg Asn Leu Thr Cys Thr Trp Arg Pro Glu Lys Glu Thr Asn
35 40 45
Asp Thr Ser Tyr Ile Val Thr Leu Thr Tyr Ser Tyr Gly Lys Ser Asn
50 55 60
Tyr Ser Asp Asn Ala Thr Glu Ala Ser Tyr Ser Phe Pro Arg Ser Cys
65 70 75 80
Ala Met Pro Pro Asp Ile Cys Ser Val Glu Val Gln Ala Gln Asn Gly
85 90 95
Asp Gly Lys Val Lys Ser Asp Ile Thr Tyr Trp His Leu Ile Ser Ile
100 105 110
Ala Lys Thr Glu Pro Pro Ile Ile Leu Ser Val Asn Pro Ile Cys Asn
115 120 125
Arg Met Phe Gln Ile Gln Trp Lys Pro Arg Glu Lys Thr Arg Gly Phe
130 135 140
Pro Leu Val Cys Met Leu Arg Phe Arg Thr Val Asn Ser Ser Arg Trp
145 150 155 160
Thr Glu Val Asn Phe Glu Asn Cys Lys Gln Val Cys Asn Leu Thr Gly
165 170 175
Leu Gln Ala Phe Thr Glu Tyr Val Leu Ala Leu Arg Phe Arg Phe Asn
180 185 190
Asp Ser Arg Tyr Trp Ser Lys Trp Ser Lys Glu Glu Thr Arg Val Thr
195 200 205
Met Glu Glu Val Pro His Val Leu Asp Leu Trp Arg Ile Leu Glu Pro
210 215 220
Ala Asp Met Asn Gly Asp Arg Lys Val Arg Leu Leu Trp Lys Lys Ala
225 230 235 240
Arg Gly Ala Pro Val Leu Glu Lys Thr Phe Gly Tyr His Ile Gln Tyr
245 250 255
Phe Ala Glu Asn Ser Thr Asn Leu Thr Glu Ile Asn Asn Ile Thr Thr
260 265 270
Gln Gln Tyr Glu Leu Leu Leu Met Ser Gln Ala His Ser Val Ser Val
275 280 285
Thr Ser Phe Asn Ser Leu Gly Lys Ser Gln Glu Ala Ile Leu Arg Ile
290 295 300
Pro Asp Val His Glu Lys Thr Phe Gln Tyr Ile Lys Ser Met Lys Ala
305 310 315 320
Tyr Ile Ala Glu Pro Leu Leu Val Val Asn Trp Gln Ser Ser Ile Pro
325 330 335
Ala Val Asp Thr Trp Ile Val Glu Trp Leu Pro Glu Ala Ala Met Ser
340 345 350
Lys Phe Pro Ala Leu Ser Trp Glu Ser Val Ser Gln Val Thr Asn Trp
355 360 365
Thr Ile Glu Gln Asp Lys Leu Lys Pro Phe Thr Cys Tyr Asn Ile Ser
370 375 380
Val Tyr Pro Val Leu Gly His Arg Val Gly Glu Pro Tyr Ser Ile Gln
385 390 395 400
Ala Tyr Ala Lys Glu Gly Thr Pro Leu Lys Gly Pro Glu Thr Arg Val
405 410 415
Glu Asn Ile Gly Leu Arg Thr Ala Thr Ile Thr Trp Lys Glu Ile Pro
420 425 430
Lys Ser Ala Arg Asn Gly Phe Ile Asn Asn Tyr Thr Val Phe Tyr Gln
435 440 445
Ala Glu Gly Gly Lys Glu Leu Ser Lys Thr Val Asn Ser His Ala Leu
450 455 460
Gln Cys Asp Leu Glu Ser Leu Thr Arg Arg Thr Ser Tyr Thr Val Trp
465 470 475 480
Val Met Ala Ser Thr Arg Ala Gly Gly Thr Asn Gly Val Arg Ile Asn
485 490 495
Phe Lys Thr Leu Ser Ile Ser Val Phe Glu Ile Val Leu Leu Thr Ser
500 505 510
Leu Val Gly Gly Gly Leu Leu Leu Leu Ser Ile Lys Thr Val Thr Phe
515 520 525
Gly Leu Arg Lys Pro Asn Arg Leu Thr Pro Leu Cys Cys Pro Asp Val
530 535 540
Pro Asn Pro Ala Glu Ser Ser Leu Ala Thr Trp Leu Gly Asp Gly Phe
545 550 555 560
Lys Lys Ser Asn Met Lys Glu Thr Gly Asn Ser Gly Asp Thr Glu Asp
565 570 575
Val Val Leu Lys Pro Cys Pro Val Pro Ala Asp Leu Ile Asp Lys Leu
580 585 590
Val Val Asn Phe Glu Asn Phe Leu Glu Val Val Leu Thr Glu Glu Ala
595 600 605
Gly Lys Gly Gln Ala Ser Ile Leu Gly Gly Glu Ala Asn Glu Tyr Val
610 615 620
Thr Ser Pro Ser Arg Pro Asp Gly Pro Pro Gly Lys Ser Phe Lys Glu
625 630 635 640
Pro Ser Val Leu Thr Glu Val Ala Ser Glu Asp Ser His Ser Thr Cys
645 650 655
Ser Arg Met Ala Asp Glu Ala Tyr Ser Glu Leu Ala Arg Gln Pro Ser
660 665 670
Ser Ser Cys Gln Ser Pro Gly Leu Ser Pro Pro Arg Glu Asp Gln Ala
675 680 685
Gln Asn Pro Tyr Leu Lys Asn Ser Val Thr Thr Arg Glu Phe Leu Val
690 695 700
His Glu Asn Ile Pro Glu His Ser Lys Gly Glu Val
705 710 715
<210> 4
<211> 735
<212> PRT
<213> Macaca fascicularis
<400> 4
Met Met Trp Thr Trp Ala Leu Trp Met Phe Pro Leu Leu Cys Lys Phe
1 5 10 15
Gly Leu Ala Ala Leu Pro Ala Lys Pro Glu Asn Ile Ser Cys Val Tyr
20 25 30
Tyr Tyr Arg Lys Asn Leu Thr Cys Thr Trp Ser Pro Gly Lys Glu Thr
35 40 45
Ser Tyr Thr Gln Tyr Thr Ala Lys Arg Thr Tyr Ala Phe Gly Lys Lys
50 55 60
His Asp Asn Cys Thr Thr Ser Ser Ser Thr Ser Glu Asn Arg Ala Ser
65 70 75 80
Cys Ser Phe Phe Leu Pro Arg Ile Thr Ile Pro Asp Asn Tyr Thr Ile
85 90 95
Glu Val Glu Ala Glu Asn Gly Asp Gly Val Ile Lys Ser Asp Met Thr
100 105 110
Cys Trp Arg Leu Glu Asp Ile Ala Lys Thr Glu Pro Pro Glu Ile Phe
115 120 125
Ser Val Lys Pro Val Leu Gly Ile Lys Arg Met Ile Arg Ile Glu Trp
130 135 140
Ile Lys Pro Glu Leu Ala Pro Val Ser Ser Asp Leu Lys Tyr Ala Leu
145 150 155 160
Arg Phe Arg Thr Val Asn Ser Thr Ser Trp Met Glu Val Asn Phe Ala
165 170 175
Lys Asn Arg Lys Asp Thr Asn Gln Thr Tyr Asn Leu Met Gly Leu Gln
180 185 190
Ala Phe Thr Glu Tyr Val Val Ala Leu Arg Cys Ala Val Lys Glu Ser
195 200 205
Lys Phe Trp Ser Asp Trp Ser Gln Glu Lys Met Gly Met Thr Glu Glu
210 215 220
Glu Ala Pro Cys Gly Leu Glu Leu Trp Arg Val Leu Lys Pro Thr Glu
225 230 235 240
Val Asp Gly Arg Arg Pro Val Arg Leu Leu Trp Lys Lys Ala Arg Gly
245 250 255
Ala Pro Val Leu Glu Lys Thr Leu Gly Tyr Asn Ile Trp Tyr Phe Pro
260 265 270
Glu Asn Asn Thr Asn Leu Thr Glu Thr Val Asn Thr Thr Asn Gln Gln
275 280 285
Leu Glu Leu His Leu Gly Gly Glu Ser Tyr Trp Val Ser Met Ile Ser
290 295 300
Tyr Asn Ser Leu Gly Lys Ser Pro Val Thr Thr Leu Arg Ile Pro Ala
305 310 315 320
Ile Gln Glu Lys Ser Phe Arg Cys Ile Glu Val Met Gln Ala Cys Leu
325 330 335
Ala Glu Asp Gln Leu Val Val Lys Trp Gln Ser Ser Ala Leu Asp Val
340 345 350
Asn Thr Trp Met Ile Glu Trp Phe Pro Asp Met Asp Ser Glu His Pro
355 360 365
Thr Leu Ser Trp Glu Ser Val Ser Gln Ala Thr Asn Trp Thr Ile Gln
370 375 380
Gln Asp Lys Leu Lys Pro Phe Trp Cys Tyr Asn Ile Ser Val Tyr Pro
385 390 395 400
Met Leu His Asp Lys Val Gly Glu Pro Tyr Ser Ile Gln Ala Tyr Ala
405 410 415
Lys Glu Gly Ile Pro Ser Lys Gly Pro Glu Thr Lys Val Glu Asn Ile
420 425 430
Gly Val Lys Thr Val Thr Ile Thr Trp Lys Glu Ile Pro Lys Ser Glu
435 440 445
Arg Lys Gly Ile Ile Cys Asn Tyr Thr Ile Phe Tyr Gln Ala Glu Gly
450 455 460
Gly Lys Gly Phe Ser Lys Thr Val Asn Ser Ser Ile Leu Gln Tyr Gly
465 470 475 480
Leu Glu Ser Leu Lys Arg Lys Thr Ser Tyr Thr Val Arg Val Met Ala
485 490 495
Ser Thr Ser Ala Gly Gly Ile Asn Gly Thr Ser Ile Asn Phe Lys Thr
500 505 510
Leu Ser Phe Ser Val Phe Glu Ile Ile Leu Ile Thr Ser Leu Ile Gly
515 520 525
Gly Gly Leu Leu Ile Leu Ile Ile Leu Thr Val Ala Tyr Gly Leu Lys
530 535 540
Lys Pro Asn Lys Leu Thr His Leu Cys Trp Pro Ser Val Pro Asn Pro
545 550 555 560
Ala Glu Ser Ser Ile Ala Thr Trp Arg Gly Asp Asp Phe Lys Asp Lys
565 570 575
Leu Asn Leu Lys Glu Ser Asp Asp Ser Val Asn Thr Glu Asp Arg Ile
580 585 590
Leu Lys Pro Cys Ser Thr Pro Ser Asp Lys Leu Val Ile Asp Lys Ser
595 600 605
Val Val Asn Phe Gly Asn Val Leu Gln Glu Met Phe Thr Asp Glu Ala
610 615 620
Arg Thr Gly Gln Glu Asn Asn Leu Gly Gly Glu Lys Asn Glu Tyr Val
625 630 635 640
Thr His Pro Phe Arg Ala Asp Cys Pro Leu Gly Lys Ser Phe Glu Glu
645 650 655
Leu Pro Val Ser Pro Glu Ile Pro Pro Arg Lys Ser Gln Tyr Leu Arg
660 665 670
Ser Arg Met Pro Glu Gly Thr Cys Leu Glu Ala Glu Glu Gln Leu Leu
675 680 685
Val Ser Gly Gln Ser Leu Glu Ser Leu Ala Pro Asp His Val Arg Glu
690 695 700
Ala Ala Ala Pro Asn Pro Tyr Leu Lys Asn Ser Val Thr Thr Arg Glu
705 710 715 720
Phe Leu Val Ser Gln Lys Leu Pro Glu His Thr Lys Gly Glu Val
725 730 735
<210> 5
<211> 445
<212> PRT
<213> Artificial Sequence
<220>
<223> Nemolizumab heavy chain amino acid sequence
<400> 5
Gln Val Gln Leu Val Gln Ser Gly Ala Glu Val Lys Lys Pro Gly Ala
1 5 10 15
Ser Val Lys Val Ser Cys Lys Ala Ser Gly Tyr Thr Phe Thr Gly Tyr
20 25 30
Ile Met Asn Trp Val Arg Gln Ala Pro Gly Gln Gly Leu Glu Trp Met
35 40 45
Gly Leu Ile Asn Pro Tyr Asn Gly Gly Thr Asp Tyr Asn Pro Gln Phe
50 55 60
Gln Asp Arg Val Thr Ile Thr Ala Asp Lys Ser Thr Ser Thr Ala Tyr
65 70 75 80
Met Glu Leu Ser Ser Leu Arg Ser Glu Asp Thr Ala Val Tyr Tyr Cys
85 90 95
Ala Arg Asp Gly Tyr Asp Asp Gly Pro Tyr Thr Leu Glu Thr Trp Gly
100 105 110
Gln Gly Thr Leu Val Thr Val Ser Ser Ala Ser Thr Lys Gly Pro Ser
115 120 125
Val Phe Pro Leu Ala Pro Ser Ser Lys Ser Thr Ser Gly Gly Thr Ala
130 135 140
Ala Leu Gly Cys Leu Val Lys Asp Tyr Phe Pro Glu Pro Val Thr Val
145 150 155 160
Ser Trp Asn Ser Gly Ala Leu Thr Ser Gly Val His Thr Phe Pro Ala
165 170 175
Val Leu Gln Ser Ser Gly Leu Tyr Ser Leu Ser Ser Val Val Thr Val
180 185 190
Pro Ser Ser Asn Phe Gly Thr Gln Thr Tyr Thr Cys Asn Val Asp His
195 200 205
Lys Pro Ser Asn Thr Lys Val Asp Lys Thr Val Glu Arg Lys Ser Cys
210 215 220
Val Glu Cys Pro Pro Cys Pro Ala Pro Pro Val Ala Gly Pro Ser Val
225 230 235 240
Phe Leu Phe Pro Pro Lys Pro Lys Asp Thr Leu Met Ile Ser Arg Thr
245 250 255
Pro Glu Val Thr Cys Val Val Val Asp Val Ser Gln Glu Asp Pro Glu
260 265 270
Val Gln Phe Asn Trp Tyr Val Asp Gly Val Glu Val His Asn Ala Lys
275 280 285
Thr Lys Pro Arg Glu Glu Gln Phe Asn Ser Thr Phe Arg Val Val Ser
290 295 300
Val Leu Thr Val Val His Gln Asp Trp Leu Asn Gly Lys Glu Tyr Lys
305 310 315 320
Cys Lys Val Ser Asn Lys Gly Leu Pro Ala Pro Ile Glu Lys Thr Ile
325 330 335
Ser Lys Thr Lys Gly Gln Pro Arg Glu Pro Gln Val Tyr Thr Leu Pro
340 345 350
Pro Ser Gln Glu Glu Met Thr Lys Asn Gln Val Ser Leu Thr Cys Leu
355 360 365
Val Lys Gly Phe Tyr Pro Ser Asp Ile Ala Val Glu Trp Glu Ser Asn
370 375 380
Gly Gln Pro Glu Asn Asn Tyr Lys Thr Thr Pro Pro Met Leu Asp Ser
385 390 395 400
Asp Gly Ser Phe Phe Leu Tyr Ser Lys Leu Thr Val Asp Lys Ser Arg
405 410 415
Trp Gln Glu Gly Asn Val Phe Ser Cys Ser Val Met His Glu Ala Leu
420 425 430
His Asn His Tyr Thr Gln Lys Ser Leu Ser Leu Ser Pro
435 440 445
<210> 6
<211> 214
<212> PRT
<213> Artificial Sequence
<220>
<223> Nemolizumab light chain amino acid sequence
<400> 6
Asp Ile Gln Met Thr Gln Ser Pro Ser Ser Leu Ser Ala Ser Val Gly
1 5 10 15
Asp Arg Val Thr Ile Thr Cys Gln Ala Ser Glu Asp Ile Tyr Ser Phe
20 25 30
Val Ala Trp Tyr Gln Gln Lys Pro Gly Lys Ala Pro Lys Leu Leu Ile
35 40 45
Tyr Asn Ala Gln Thr Glu Ala Gln Gly Val Pro Ser Arg Phe Ser Gly
50 55 60
Ser Gly Ser Gly Thr Asp Phe Thr Leu Thr Ile Ser Ser Leu Gln Pro
65 70 75 80
Glu Asp Phe Ala Thr Tyr Tyr Cys Gln His His Tyr Asp Ser Pro Leu
85 90 95
Thr Phe Gly Gly Gly Thr Lys Val Glu Ile Lys Arg Thr Val Ala Ala
100 105 110
Pro Ser Val Phe Ile Phe Pro Pro Ser Asp Glu Gln Leu Lys Ser Gly
115 120 125
Thr Ala Ser Val Val Cys Leu Leu Asn Asn Phe Tyr Pro Arg Glu Ala
130 135 140
Lys Val Gln Trp Lys Val Asp Asn Ala Leu Gln Ser Gly Asn Ser Gln
145 150 155 160
Glu Ser Val Thr Glu Gln Asp Ser Lys Asp Ser Thr Tyr Ser Leu Ser
165 170 175
Ser Thr Leu Thr Leu Ser Lys Ala Asp Tyr Glu Lys His Lys Val Tyr
180 185 190
Ala Cys Glu Val Thr His Gln Gly Leu Ser Ser Pro Val Thr Lys Ser
195 200 205
Phe Asn Arg Gly Glu Cys
210
Claims (26)
- 結節性痒疹(PN)を有する対象における皮膚病変およびそう痒の治療に使用するための薬学的組成物であって、前記対象が、アトピー性皮膚炎を有しておらず、ネモリズマブを含む、薬学的組成物。
- 結節性痒疹(PN)を有する対象における皮膚病変およびそう痒の治療に使用するための薬学的組成物であって、ネモリズマブを含む、薬学的組成物。
- 前記対象が、少なくとも約6ヶ月にわたってPNと診断されている、請求項2に記載の薬学的組成物。
- 前記対象が、両側分布で身体に少なくとも約20個の小結節を有する、請求項2または3に記載の薬学的組成物。
- 前記対象が、上肢に痒疹病変を有する、請求項1~4のいずれか一項に記載の薬学的組成物。
- 前記そう痒に、数値評価スケール(NRS)の少なくともスコア4が割り当てられている、請求項1~5のいずれか一項に記載の薬学的組成物。
- 前記そう痒に、数値評価スケール(NRS)の少なくともスコア7が割り当てられている、請求項1~6のいずれか一項に記載の薬学的組成物。
- 前記対象が、アトピー性皮膚炎を有していない、請求項2~4のいずれか一項に記載の薬学的組成物。
- 担体をさらに含む、請求項1~8のいずれか一項に記載の薬学的組成物。
- 前記担体が、薬学的に許容される担体である、請求項9に記載の薬学的組成物。
- 前記薬学的組成物が、前記ネモリズマブが、平坦投薬レジメンに従って対象に投与されるように用いられることを特徴とする、請求項1~10のいずれか一項に記載の薬学的組成物。
- 前記薬学的組成物が、前記ネモリズマブが、負荷投与量レジメンに従って投与されるように用いられることを特徴とする、請求項1~10のいずれか一項に記載の薬学的組成物。
- 前記薬学的組成物が、1週間に1回、2週間に1回、3週間に1回、4週間に1回、5週間に1回、6週間に1回、7週間に1回、または8週間に1回、対象に投与されるように用いられることを特徴とする、請求項1~12のいずれか一項に記載の薬学的組成物。
- 前記薬学的組成物が、4週間に1回、対象に投与されるように用いられることを特徴とする、請求項1~13のいずれか一項に記載の薬学的組成物。
- 結節性痒疹(PN)を有する対象における皮膚病変およびそう痒の治療のための薬剤の製造における、ネモリズマブの使用であって、前記対象が、アトピー性皮膚炎を有しておらず、該薬剤が、ネモリズマブを含む、使用。
- 結節性痒疹(PN)を有する対象における皮膚病変およびそう痒の治療のための薬剤の製造における、ネモリズマブの使用であって、該薬剤が、ネモリズマブを含む、使用。
- 前記対象が、少なくとも約6ヶ月にわたってPNと診断されている、請求項16に記載の使用。
- 前記対象が、両側分布で身体に少なくとも約20個の小結節を有する、請求項16または17に記載の使用。
- 前記対象が、上肢に痒疹病変を有する、請求項15~18のいずれか一項に記載の使用。
- 前記そう痒に、数値評価スケール(NRS)の少なくともスコア4が割り当てられている、請求項15~19のいずれか一項に記載の使用。
- 前記そう痒に、数値評価スケール(NRS)の少なくともスコア7が割り当てられている、請求項15~20のいずれか一項に記載の使用。
- 前記対象が、アトピー性皮膚炎を有していない、請求項16~18のいずれか一項に記載の使用。
- 該薬剤が、前記ネモリズマブが、平坦投薬レジメンに従って対象に投与されるように用いられることを特徴とする、請求項15~22のいずれか一項に記載の使用。
- 該薬剤が、前記ネモリズマブが、負荷投与量レジメンに従って対象に投与されるように用いられることを特徴とする、請求項15~22のいずれか一項に記載の使用。
- 該薬剤が、1週間に1回、2週間に1回、3週間に1回、4週間に1回、5週間に1回、6週間に1回、7週間に1回、または8週間に1回、対象に投与されるように用いられることを特徴とする、請求項15~24のいずれか一項に記載の使用。
- 該薬剤が、4週間に1回、対象に投与されるように用いられることを特徴とする、請求項15~25のいずれか一項に記載の使用。
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