PF-06823859 ( DrugBank: - )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
50皮膚筋炎/多発性筋炎9

50. 皮膚筋炎/多発性筋炎


臨床試験数 : 182 薬物数 : 229 - (DrugBank : 88) / 標的遺伝子数 : 48 - 標的パスウェイ数 : 147
No.TrialIDDate_
enrollment
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registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
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size
PhaseCountries
1EUCTR2021-004787-10-HU
(EUCTR)
07/03/202229/12/2021An Extension Study for Participants Who Have Completed the Treatment Period of a Qualifying Parent StudyAN OPEN LABEL, LONG-TERM EXTENSION STUDY TO INVESTIGATE THE SAFETY OF PF-06823859 ADMINISTERED TO ADULT PARTICIPANTS =18 AND =80 WITH ACTIVE DERMATOMYOSITIS. Dermatomyositis
MedDRA version: 20.0;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: PF-06823859
Product Code: PF-06823859
INN or Proposed INN: PF-06823859
Other descriptive name: Humanised IgG1K monoclonal antibody against interferon beta
Pfizer Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
20Phase 2United States;Hungary;Spain;Poland;Australia;Germany;Italy
2EUCTR2021-004787-10-PL
(EUCTR)
31/01/202205/01/2022An Extension Study for Participants Who Have Completed the Treatment Period of a Qualifying Parent StudyAN OPEN LABEL, LONG-TERM EXTENSION STUDY TO INVESTIGATE THE SAFETY OF PF-06823859 ADMINISTERED TO ADULT PARTICIPANTS =18 AND =80 WITH ACTIVE DERMATOMYOSITIS. Dermatomyositis
MedDRA version: 20.0;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: PF-06823859
Product Code: PF-06823859
INN or Proposed INN: PF-06823859
Other descriptive name: Humanised IgG1K monoclonal antibody against interferon beta
Pfizer Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
20Phase 2United States;Hungary;Spain;Poland;Australia;Germany;Italy
3NCT05192200
(ClinicalTrials.gov)
December 20, 20211/12/2021An Extension Study for Participants Who Have Completed the Treatment Period of a Qualifying Parent StudyAN OPEN LABEL, LONG-TERM EXTENSION STUDY TO INVESTIGATE THE SAFETY OF PF-06823859 ADMINISTERED TO ADULT PARTICIPANTS =18 AND =80 WITH ACTIVE DERMATOMYOSITIS.DermatomyositisDrug: Anti-Beta Interferon (PF-06823859)PfizerNULLRecruiting18 Years80 YearsAll30Phase 2United States
4EUCTR2020-004228-41-DE
(EUCTR)
28/07/202117/02/2021A placebo-controlled study to evaluate the efficacy, safety and tolerability of PF-06823859 in adult subjects with DermatomyositisA PHASE 2 DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF PF-06823859 IN ADULT SUBJECTS WITH DERMATOMYOSITIS Dermatomyositis
MedDRA version: 20.0;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: PF-06823859
Product Code: PF-06823859
INN or Proposed INN: PF-06823859
Other descriptive name: Humanised IgG1K monoclonal antibody against interferon beta
Pfizer Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
76Phase 2United States;Hungary;Spain;Poland;Germany;Italy
5EUCTR2020-004228-41-HU
(EUCTR)
07/07/202126/03/2021A placebo-controlled study to evaluate the efficacy, safety and tolerability of PF-06823859 in adult subjects with DermatomyositisA PHASE 2 DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF PF-06823859 IN ADULT SUBJECTS WITH DERMATOMYOSITIS Dermatomyositis
MedDRA version: 20.0;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: PF-06823859
Product Code: PF-06823859
INN or Proposed INN: PF-06823859
Other descriptive name: Humanised IgG1K monoclonal antibody against interferon beta
Pfizer Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
76Phase 2United States;Hungary;Spain;Poland;Germany;Italy
6EUCTR2020-004228-41-IT
(EUCTR)
15/06/202107/06/2021A placebo-controlled study to evaluate the efficacy, safety and tolerability of PF-06823859 in adult subjects with DermatomyositisA PHASE 2 DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF PF-06823859 IN ADULT SUBJECTS WITH DERMATOMYOSITIS - - Dermatomyositis
MedDRA version: 20.0;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: PF-06823859
Product Code: [PF-06823859]
Other descriptive name: Humanised IgG1K monoclonal antibody against interferon beta
PFIZER INCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
76Phase 2United States;Hungary;Spain;Poland;Germany;Italy
7EUCTR2020-004228-41-ES
(EUCTR)
28/05/202101/09/2021A placebo-controlled study to evaluate the efficacy, safety and tolerability of PF-06823859 in adult subjects with DermatomyositisA PHASE 2 DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF PF-06823859 IN ADULT SUBJECTS WITH DERMATOMYOSITIS Dermatomyositis
MedDRA version: 20.0;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: PF-06823859
Product Code: PF-06823859
INN or Proposed INN: PF-06823859
Other descriptive name: Humanised IgG1K monoclonal antibody against interferon beta
Pfizer Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
76Phase 2United States;Hungary;Poland;Spain;Germany;Italy
8EUCTR2020-004228-41-PL
(EUCTR)
13/04/202108/03/2021A placebo-controlled study to evaluate the efficacy, safety and tolerability of PF-06823859 in adult subjects with DermatomyositisA PHASE 2 DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF PF-06823859 IN ADULT SUBJECTS WITH DERMATOMYOSITIS Dermatomyositis
MedDRA version: 20.0;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: PF-06823859
Product Code: PF-06823859
INN or Proposed INN: PF-06823859
Other descriptive name: Humanised IgG1K monoclonal antibody against interferon beta
Pfizer Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
76Phase 2United States;Hungary;Spain;Poland;Germany;Italy
9NCT03181893
(ClinicalTrials.gov)
January 23, 20185/6/2017A Study In Adults With Moderate To Severe DermatomyositisA PHASE 2 DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF PF-06823859 IN ADULT SUBJECTS WITH DERMATOMYOSITISDermatomyositisDrug: PF-06823859 low;Drug: Placebo Arm;Drug: PF-06823859 highPfizerNULLActive, not recruiting18 Years80 YearsAll57Phase 2Hungary;United States;Australia;Germany;Italy;Poland;Spain