IFN-Kinoid ( DrugBank: - )

2 diseases
告示番号疾患名（ページ内リンク）臨床試験数
49全身性エリテマトーデス10
50皮膚筋炎／多発性筋炎2

49. 全身性エリテマトーデス

臨床試験数 : 993 /  薬物数 : 702 - (DrugBank : 184) / 標的遺伝子数 : 116 - 標的パスウェイ数 : 200
No.TrialIDDate_
enrollment		Date_
registration		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1EUCTR2015-001341-86-BG
(EUCTR)		10/04/201716/02/2017Phase IIb study of IFN-K in Systemic Lupus ErythematosusA Phase IIb, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Neutralization of the Interferon Gene Signature and the Clinical Efficacy of IFNa-Kinoid in Adult Subjects with Systemic Lupus Erythematosus - Phase IIb study of IFN-K in Systemic Lupus Erythematosus Systemic Lupus Erythematosus
MedDRA version: 19.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		Product Name: IFN-Kinoid
Product Code: IFN-K
INN or Proposed INN: Not yet assigned
Other descriptive name: IFN-Kinoid Drug Substance		Neovacs S.A.NULLNot RecruitingFemale: yes
Male: yes		178Phase 2United States;Serbia;Philippines;Taiwan;Thailand;Spain;Ukraine;Chile;Russian Federation;Colombia;Switzerland;Italy;France;Peru;Tunisia;Moldova, Republic of;Korea, Republic of;Mexico;Argentina;Belgium;Poland;Croatia;Bulgaria;Georgia;Germany
2EUCTR2015-001341-86-ES
(EUCTR)		01/03/201727/12/2016Phase IIb study of IFN-K in Systemic Lupus ErythematosusA Phase IIb, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Neutralization of the Interferon Gene Signature and the Clinical Efficacy of IFNa-Kinoid in Adult Subjects with Systemic Lupus Erythematosus - Phase IIb study of IFN-K in Systemic Lupus Erythematosus Systemic Lupus Erythematosus
MedDRA version: 19.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		Product Name: IFN-Kinoid
Product Code: IFN-K
INN or Proposed INN: Not yet assigned
Other descriptive name: IFN-Kinoid Drug Substance		Neovacs S.A.NULLNot RecruitingFemale: yes
Male: yes		178Phase 2United States;Serbia;Philippines;Taiwan;Thailand;Spain;Ukraine;Chile;Russian Federation;Colombia;Switzerland;Italy;France;Peru;Tunisia;Moldova, Republic of;Korea, Republic of;Mexico;Argentina;Belgium;Poland;Croatia;Bulgaria;Georgia;Germany
3EUCTR2015-001341-86-DE
(EUCTR)		19/11/201501/09/2015Phase IIb study of IFN-K in Systemic Lupus ErythematosusA Phase IIb, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Neutralization of the Interferon Gene Signature and the Clinical Efficacy of IFNa-Kinoid in Adult Subjects with Systemic Lupus Erythematosus - Phase IIb study of IFN-K in Systemic Lupus Erythematosus Systemic Lupus Erythematosus
MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		Product Name: IFN-Kinoid
Product Code: IFN-K
INN or Proposed INN: Not yet assigned
Other descriptive name: IFN-Kinoid Drug Substance		Neovacs S.A.NULLNot RecruitingFemale: yes
Male: yes		178Phase 2Russian Federation;United States;Thailand;Korea, Republic of;Poland;Bulgaria;Chile;France;Serbia;Tunisia;Croatia;Colombia;Argentina;Philippines;Ukraine;Switzerland;Spain;Belgium;Moldova, Republic of;Taiwan;Italy;Mexico;Georgia;Peru;Germany
4EUCTR2015-001341-86-HR
(EUCTR)		23/10/201510/11/2015Phase IIb study of IFN-K in Systemic Lupus ErythematosusA Phase IIb, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Neutralization of the Interferon Gene Signature and the Clinical Efficacy of IFNa-Kinoid in Adult Subjects with Systemic Lupus Erythematosus - Phase IIb study of IFN-K in Systemic Lupus Erythematosus Systemic Lupus Erythematosus;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Name: IFN-Kinoid
Product Code: IFN-K
INN or Proposed INN: Not yet assigned
Other descriptive name: IFN-Kinoid Drug Substance		Neovas S.A.NULLNot RecruitingFemale: yes
Male: yes		178Phase 2Italy;France;Mexico;Argentina;Poland;Belgium;Croatia;Peru;Bulgaria;Georgia;Netherlands;Germany;Moldova, Republic of;Korea, Republic of;United States;Philippines;Taiwan;Spain;Thailand;Russian Federation;Chile;Colombia;Switzerland
5EUCTR2015-001341-86-IT
(EUCTR)		19/09/201510/11/2020Phase IIb study of IFN-K in Systemic Lupus ErythematosusA Phase IIb, Randomized, Double-Blind, Placebo-Controlled Study toEvaluate the Neutralization of the Interferon Gene Signature and theClinical Efficacy of IFNa-Kinoid in Adult Subjects with Systemic LupusErythematosus - IFN-K-002 Systemic Lupus Erythematosus
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		Product Name: IFN-Kinoid
Product Code: IFN-K		NEOVACSNULLNot RecruitingFemale: yes
Male: yes		178Phase 2United States;Philippines;Taiwan;Spain;Thailand;Korea, Democratic People's Republic of;Russian Federation;Chile;Colombia;Italy;France;Mexico;Argentina;Poland;Belgium;Croatia;Peru;Bulgaria;Georgia;Netherlands;Germany;Moldova, Republic of;Korea, Republic of
6EUCTR2015-001341-86-BE
(EUCTR)		07/09/201503/09/2015Phase IIb study of IFN-K in Systemic Lupus ErythematosusA Phase IIb, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Neutralization of the Interferon Gene Signature and the Clinical Efficacy of IFNa-Kinoid in Adult Subjects with Systemic Lupus Erythematosus - Phase IIb study of IFN-K in Systemic Lupus Erythematosus Systemic Lupus Erythematosus
MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		Product Name: IFN-Kinoid
Product Code: IFN-K
INN or Proposed INN: Not yet assigned
Other descriptive name: IFN-Kinoid Drug Substance		Neovacs S.A.NULLNot RecruitingFemale: yes
Male: yes		178Phase 2Russian Federation;United States;Thailand;Korea, Republic of;Poland;Bulgaria;Chile;France;Serbia;Tunisia;Croatia;Colombia;Argentina;Philippines;Ukraine;Switzerland;Spain;Belgium;Moldova, Republic of;Taiwan;Italy;Mexico;Georgia;Peru;Germany
7EUCTR2009-012059-47-DE
(EUCTR)		12/08/201021/01/2010A phase I-II, randomized, double-blind, placebo-controlled, dose escalation study of Neovacs’ IFNa-Kinoid in adult subjects with Systemic Lupus Erythematosus. - IFN-Kinoid in Systemic Lupus ErythematosusA phase I-II, randomized, double-blind, placebo-controlled, dose escalation study of Neovacs’ IFNa-Kinoid in adult subjects with Systemic Lupus Erythematosus. - IFN-Kinoid in Systemic Lupus Erythematosus Systemic Lupus Erythematosus (SLE)
MedDRA version: 12.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus		Product Name: IFN-a2b Kinoid
Product Code: IFN-K
INN or Proposed INN: Not assigned yet
Other descriptive name: IFN-a 2b Kinoid Drug Substance		Neovacs SANULLNot RecruitingFemale: yes
Male: yes		28Phase 1;Phase 2France;Belgium;Bulgaria;Germany
8EUCTR2009-012059-47-FR
(EUCTR)		07/05/201002/02/2010A phase I-II, randomized, observer-blind, placebo-controlled, dose escalation study to evaluate the safety and immune responses of various doses of Neovacs’ IFNa-Kinoid in adult patients with Systemic Lupus Erythematosus. - IFN-Kinoid in Systemic Lupus ErythematosusA phase I-II, randomized, observer-blind, placebo-controlled, dose escalation study to evaluate the safety and immune responses of various doses of Neovacs’ IFNa-Kinoid in adult patients with Systemic Lupus Erythematosus. - IFN-Kinoid in Systemic Lupus Erythematosus Systemic Lupus Erythematosus (SLE)
MedDRA version: 12.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus 		Product Name: IFN-a2b Kinoid
Product Code: IFN-K
INN or Proposed INN: Not assigned yet
Other descriptive name: IFN-a 2b Kinoid Drug Substance		Neovacs SANULLNot Recruiting Female: yes
Male: yes		28 Human pharmacology (Phase 1): yes Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance;Belgium;Bulgaria;Germany
9EUCTR2009-012059-47-BG
(EUCTR)		23/04/201015/04/2010A phase I-II, randomized, double-blind, placebo-controlled, dose escalation study of Neovacs’ IFNa-Kinoid in adult subjects with Systemic Lupus Erythematosus.A phase I-II, randomized, double-blind, placebo-controlled, dose escalation study of Neovacs’ IFNa-Kinoid in adult subjects with Systemic Lupus Erythematosus. - IFN-Kinoid in Systemic Lupus Erythematosus Systemic Lupus Erythematosus (SLE)
MedDRA version: 14.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders		Product Name: IFN-a2b Kinoid
Product Code: IFN-K
INN or Proposed INN: Not assigned yet
Other descriptive name: IFN-a 2b Kinoid Drug Substance		Neovacs SANULLNot RecruitingFemale: yes
Male: yes		28Phase 1;Phase 2France;Belgium;Bulgaria;Germany
10EUCTR2009-012059-47-BE
(EUCTR)		28/01/201005/01/2010A phase I-II, randomized, double-blind, placebo-controlled, dose escalation study of Neovacs’ IFNa-Kinoid in adult subjects with Systemic Lupus Erythematosus. - IFN-Kinoid in Systemic Lupus ErythematosusA phase I-II, randomized, double-blind, placebo-controlled, dose escalation study of Neovacs’ IFNa-Kinoid in adult subjects with Systemic Lupus Erythematosus. - IFN-Kinoid in Systemic Lupus Erythematosus Systemic Lupus Erythematosus (SLE)
MedDRA version: 14.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders		Product Name: IFN-a2b Kinoid
Product Code: IFN-K
INN or Proposed INN: Not assigned yet
Other descriptive name: IFN-a 2b Kinoid Drug Substance		Neovacs SANULLNot RecruitingFemale: yes
Male: yes		28Phase 1;Phase 2France;Belgium;Bulgaria;Germany

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50. 皮膚筋炎／多発性筋炎

臨床試験数 : 194 /  薬物数 : 244 - (DrugBank : 89) / 標的遺伝子数 : 50 - 標的パスウェイ数 : 151
No.TrialIDDate_
enrollment		Date_
registration		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1NCT02980198
(ClinicalTrials.gov)		May 3, 201725/11/2016Study of IFN-K in DermatomyositisA Phase IIa, Single Blind, Randomized, Study to Evaluate the Safety, the Immunogenicity, and the Clinical and Biological Efficacy of IFNa-Kinoid (IFN-K) in Adult Subjects With DermatomyositisDermatomyositisBiological: IFN-Kinoid;Other: Placebo;Other: ISA 51NeovacsNULLWithdrawn18 Years65 YearsAll0Phase 2France;Germany;Italy;Switzerland;United Kingdom
2EUCTR2016-000137-52-DE
(EUCTR)		26/07/201606/06/2016Phase IIa exploratory study to assess the safety and effect of IFNa-Kinoid (IFN-K) in adult patients with DermatomyositisA Phase IIa, Single Blind, Randomized, Study to Evaluate the Safety, the Immunogenicity, and the Clinical and Biological Efficacy of IFNa-Kinoid (IFN-K) in Adult Subjects with Dermatomyositis. Dermatomyositis
MedDRA version: 19.1;Level: PT;Classification code 10012503;Term: Dermatomyositis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		Product Name: IFNa-Kinoid
Product Code: IFN-K
INN or Proposed INN: Not yet assigned
Other descriptive name: IFN-Kinoid Drug Substance		Neovacs SANULLNot Recruiting Female: yes
Male: yes		30 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance;Germany;Italy;United Kingdom;Switzerland

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