IFN-Kinoid Drug Substance ( 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5
50皮膚筋炎/多発性筋炎1

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-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

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
1EUCTR2016-000137-52-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