PF-06651600 50 mg ( DrugBank: PF-06651600 )


2 diseases
告示番号疾患名(ページ内リンク)臨床試験数
96クローン病9
97潰瘍性大腸炎11

96. クローン病


臨床試験数 : 2,442 薬物数 : 1,278 - (DrugBank : 248) / 標的遺伝子数 : 142 - 標的パスウェイ数 : 209
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2017-003359-43-DE
(EUCTR)
04/10/201819/04/2018A Phase 2a Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PF-06700841 In Subjects With Moderate To Severe Crohn’s DiseaseA Phase 2a, Double-Blind, Randomized, Placebo-Controlled, Parallel Group Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PF-06700841 As Induction And Open Label Extension Treatment In Subjects With Moderate To Severe Crohn’s Disease Moderate To Severe Crohn’s Disease (CD)
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Ritlecitinib 50 mg
Product Code: PF-06651600 50 mg
INN or Proposed INN: PF-06651600
Other descriptive name: PF-06651600-15
Product Name: Brepocitinib 5 mg
Product Code: PF-06700841 5 mg
INN or Proposed INN: PF-06700841
Other descriptive name: PF-06700841-15
Product Name: Brepocitinib 25 mg
Product Code: PF-06700841 25 mg
INN or Proposed INN: PF-06700841
Other descriptive name: PF-06700841-15
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
255Phase 2Serbia;United Arab Emirates;United States;Saudi Arabia;Slovakia;Spain;Ukraine;Lebanon;Russian Federation;Italy;Switzerland;Australia;South Africa;Tunisia;Korea, Republic of;Bosnia and Herzegovina;Czechia;Lithuania;Turkey;Austria;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Georgia;Germany
2EUCTR2017-003359-43-AT
(EUCTR)
24/09/201820/04/2018A Phase 2a Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PF-06700841 In Subjects With Moderate To Severe Crohn’s DiseaseA Phase 2a, Double-Blind, Randomized, Placebo-Controlled, Parallel Group Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PF-06700841 As Induction And Open Label Extension Treatment In Subjects With Moderate To Severe Crohn’s Disease Moderate To Severe Crohn’s Disease (CD)
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Ritlecitinib 50 mg
Product Code: PF-06651600 50 mg
INN or Proposed INN: PF-06651600
Other descriptive name: PF-06651600-15
Product Name: Brepocitinib 5 mg
Product Code: PF-06700841 5 mg
INN or Proposed INN: PF-06700841
Other descriptive name: PF-06700841-15
Product Name: Brepocitinib 25 mg
Product Code: PF-06700841 25 mg
INN or Proposed INN: PF-06700841
Other descriptive name: PF-06700841-15
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
255Phase 2Serbia;United Arab Emirates;United States;Saudi Arabia;Slovakia;Spain;Ukraine;Lebanon;Russian Federation;Italy;Switzerland;Australia;South Africa;Tunisia;Korea, Republic of;Bosnia and Herzegovina;Czechia;Lithuania;Turkey;Austria;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Georgia;Germany
3EUCTR2017-003359-43-HR
(EUCTR)
19/07/201816/05/2019A Phase 2a Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PF-06700841 In Subjects With Moderate To Severe Crohn's Disease A Phase 2a, Double-Blind, Randomized, Placebo-Controlled, Parallel Group Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PF-06700841 As Induction And Open Label Extension Treatment In Subjects With Moderate To Severe Crohn's Disease Moderate To Severe Crohn's Disease (CD)
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: PF-06651600 50 mg
INN or Proposed INN: PF-06651600
Other descriptive name: PF-06651600-15
Product Name: PF-06700841 5 mg
INN or Proposed INN: PF-06700841
Other descriptive name: PF-06700841-15
Product Name: PF-06700841 25 mg
INN or Proposed INN: PF-06700841
Other descriptive name: PF-06700841-15
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
255 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noSerbia;United States;United Arab Emirates;Saudi Arabia;Slovakia;Spain;Ukraine;Lebanon;Russian Federation;Switzerland;Italy;Australia;South Africa;Tunisia;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;Austria;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Georgia;Germany
4EUCTR2017-003359-43-SK
(EUCTR)
26/06/201819/04/2018A Phase 2a Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PF-06700841 In Subjects With Moderate To Severe Crohn’s DiseaseA Phase 2a, Double-Blind, Randomized, Placebo-Controlled, Parallel Group Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PF-06700841 As Induction And Open Label Extension Treatment In Subjects With Moderate To Severe Crohn’s Disease Moderate To Severe Crohn’s Disease (CD)
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Ritlecitinib 50 mg
Product Code: PF-06651600 50 mg
INN or Proposed INN: PF-06651600
Other descriptive name: PF-06651600-15
Product Name: Brepocitinib 5 mg
Product Code: PF-06700841 5 mg
INN or Proposed INN: PF-06700841
Other descriptive name: PF-06700841-15
Product Name: Brepocitinib 25 mg
Product Code: PF-06700841 25 mg
INN or Proposed INN: PF-06700841
Other descriptive name: PF-06700841-15
Pfizer Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
255Phase 2Serbia;United Arab Emirates;United States;Saudi Arabia;Slovakia;Spain;Ukraine;Lebanon;Russian Federation;Italy;Switzerland;Australia;South Africa;Tunisia;Korea, Republic of;Bosnia and Herzegovina;Czechia;Lithuania;Turkey;Austria;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Georgia;Germany
5EUCTR2017-003359-43-IT
(EUCTR)
05/06/201821/01/2021A Phase 2a Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PF-06700841 In Subjects With Moderate To Severe Crohn's DiseaseA Phase 2a, Double-Blind, Randomized, Placebo-Controlled, Parallel Group Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PF-06700841 As Induction And Open Label Extension Treatment In Subjects With Moderate To Severe Crohn's Disease - nd Moderate To Severe Crohn's Disease (CD)
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: PF-06651600 50 mg
Product Code: [PF-06651600 50 mg]
INN or Proposed INN: PF-06651600
Other descriptive name: PF-06651600-15
Product Name: PF-06700841 5 mg
Product Code: [PF-06700841 5 mg]
INN or Proposed INN: PF-06700841
Other descriptive name: PF-06700841-15
Product Name: PF-06700841 25 mg
Product Code: [PF-06700841 25 mg]
INN or Proposed INN: PF-06700841
Other descriptive name: PF-06700841-15
PFIZER INCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
255Phase 2United States;Czech Republic;Hungary;Slovakia;Belgium;Spain;Poland;Croatia;Lithuania;Austria;Germany;Italy
6EUCTR2017-003359-43-BE
(EUCTR)
28/05/201806/03/2019A Phase 2a Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PF-06700841 In Subjects With Moderate To Severe Crohn’s DiseaseA Phase 2a, Double-Blind, Randomized, Placebo-Controlled, Parallel Group Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PF-06700841 As Induction And Open Label Extension Treatment In Subjects With Moderate To Severe Crohn’s Disease Moderate To Severe Crohn’s Disease (CD)
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Ritlecitinib 50 mg
Product Code: PF-06651600 50 mg
INN or Proposed INN: PF-06651600
Other descriptive name: PF-06651600-15
Product Name: Brepocitinib 5 mg
Product Code: PF-06700841 5 mg
INN or Proposed INN: PF-06700841
Other descriptive name: PF-06700841-15
Product Name: Brepocitinib 25 mg
Product Code: PF-06700841 25 mg
INN or Proposed INN: PF-06700841
Other descriptive name: PF-06700841-15
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
255Phase 2Serbia;United Arab Emirates;United States;Saudi Arabia;Slovakia;Spain;Ukraine;Lebanon;Russian Federation;Italy;Switzerland;Australia;South Africa;Tunisia;Korea, Republic of;Bosnia and Herzegovina;Czechia;Lithuania;Turkey;Austria;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Georgia;Germany
7EUCTR2017-003359-43-LT
(EUCTR)
24/05/201817/04/2018A Phase 2a Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PF-06700841 In Subjects With Moderate To Severe Crohn’s Disease A Phase 2a, Double-Blind, Randomized, Placebo-Controlled, Parallel Group Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PF-06700841 As Induction And Open Label Extension Treatment In Subjects With Moderate To Severe Crohn’s Disease Moderate To Severe Crohn’s Disease (CD)
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: PF-06651600 50 mg
INN or Proposed INN: PF-06651600
Other descriptive name: PF-06651600-15
Product Name: PF-06700841 5 mg
INN or Proposed INN: PF-06700841
Other descriptive name: PF-06700841-15
Product Name: PF-06700841 25 mg
INN or Proposed INN: PF-06700841
Other descriptive name: PF-06700841-15
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot Recruiting Female: yes
Male: yes
255 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noSerbia;United States;United Arab Emirates;Saudi Arabia;Slovakia;Spain;Ukraine;Lebanon;Russian Federation;Switzerland;Italy;Australia;South Africa;Tunisia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;Austria;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Georgia;Germany
8EUCTR2017-003359-43-PL
(EUCTR)
23/05/201824/04/2018A Phase 2a Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PF-06700841 In Subjects With Moderate To Severe Crohn’s DiseaseA Phase 2a, Double-Blind, Randomized, Placebo-Controlled, Parallel Group Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PF-06700841 As Induction And Open Label Extension Treatment In Subjects With Moderate To Severe Crohn’s Disease Moderate To Severe Crohn’s Disease (CD)
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Ritlecitinib 50 mg
Product Code: PF-06651600 50 mg
INN or Proposed INN: PF-06651600
Other descriptive name: PF-06651600-15
Product Name: Brepocitinib 5 mg
Product Code: PF-06700841 5 mg
INN or Proposed INN: PF-06700841
Other descriptive name: PF-06700841-15
Product Name: Brepocitinib 25 mg
Product Code: PF-06700841 25 mg
INN or Proposed INN: PF-06700841
Other descriptive name: PF-06700841-15
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
255Phase 2Serbia;United States;United Arab Emirates;Saudi Arabia;Slovakia;Spain;Ukraine;Lebanon;Russian Federation;Switzerland;Italy;Australia;South Africa;Tunisia;Korea, Republic of;Bosnia and Herzegovina;Czechia;Lithuania;Turkey;Austria;Czech Republic;Hungary;Canada;Poland;Belgium;Croatia;Georgia;Germany
9EUCTR2017-003359-43-ES
(EUCTR)
25/04/201827/04/2018A Phase 2a Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PF-06700841 In Subjects With Moderate To Severe Crohn’s DiseaseA Phase 2a, Double-Blind, Randomized, Placebo-Controlled, Parallel Group Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PF-06700841 As Induction And Open Label Extension Treatment In Subjects With Moderate To Severe Crohn’s Disease Moderate To Severe Crohn’s Disease (CD)
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: PF-06651600 50 mg
INN or Proposed INN: PF-06651600
Other descriptive name: PF-06651600-15
Product Name: PF-06700841 5 mg
INN or Proposed INN: PF-06700841
Other descriptive name: PF-06700841-15
Product Name: PF-06700841 25 mg
INN or Proposed INN: PF-06700841
Other descriptive name: PF-06700841-15
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
255Phase 2Serbia;Belarus;United States;United Arab Emirates;Saudi Arabia;Slovakia;Spain;Ukraine;Lebanon;Russian Federation;Israel;Switzerland;Italy;Australia;South Africa;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;Austria;Czech Republic;Hungary;Canada;Poland;Belgium;Croatia;Georgia;Germany;New Zealand

97. 潰瘍性大腸炎


臨床試験数 : 2,630 薬物数 : 1,459 - (DrugBank : 265) / 標的遺伝子数 : 144 - 標的パスウェイ数 : 202
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2016-003708-29-BG
(EUCTR)
20/04/201817/01/2018Study to evaluate the effectiveness of oral PF-06651600 and PF-06700841 in subjects with moderate to severe ulcerative colitis, a disease characterized by continuous inflammation that is localized to the colonA Phase 2B, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Dose Ranging Study of Oral PF-06651600 and PF-06700841 as Induction and Chronic Therapy in Subjects with Moderate to Severe Ulcerative Colitis - Vibrato Moderate to severe Ulcerative Colitis (UC)
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Ritlecitinib 10 mg
Product Code: PF-06651600 10 mg
INN or Proposed INN: PF-06651600
Other descriptive name: PF-06651600-15
Product Name: Ritlecitinib 50 mg
Product Code: PF-06651600 50 mg
INN or Proposed INN: PF-06651600
Other descriptive name: PF-06651600-15
Product Name: Ritlecitinib 5 mg
Product Code: PF-06700841 5 mg
INN or Proposed INN: PF-06700841
Other descriptive name: PF-06700841-15
Product Name: Brepocitinib 25 mg
Product Code: PF-06700841 25 mg
INN or Proposed INN: PF-06700841
Other descriptive name: PF-06700841-15
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
318Phase 2Serbia;United States;Czechia;Slovakia;Spain;Ukraine;Lithuania;Turkey;Austria;Israel;Russian Federation;Italy;Hungary;Canada;Poland;Romania;Denmark;Bulgaria;Georgia;Netherlands;Germany;Korea, Republic of
2EUCTR2016-003708-29-NL
(EUCTR)
09/11/201719/07/2017Study to evaluate the effectiveness of oral PF-06651600 and PF-06700841 in subjects with moderate to severe ulcerative colitis, a disease characterized by continuous inflammation that is localized to the colonA Phase 2B, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Dose Ranging Study of Oral PF-06651600 and PF-06700841 as Induction and Chronic Therapy in Subjects with Moderate to Severe Ulcerative Colitis - Vibrato Moderate to severe Ulcerative Colitis (UC)
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: PF-06651600 10 mg
INN or Proposed INN: PF-06651600
Other descriptive name: PF-06651600-15
Product Code: PF-06651600 50 mg
INN or Proposed INN: PF-06651600
Other descriptive name: PF-06651600-15
Product Code: PF-06700841 5 mg
INN or Proposed INN: PF-06700841
Other descriptive name: PF-06700841-15
Product Code: PF-06700841 25 mg
INN or Proposed INN: PF-06700841
Other descriptive name: PF-06700841-15
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
360Phase 2Serbia;Slovakia;Spain;Ukraine;Ireland;Turkey;Lithuania;Austria;Russian Federation;Israel;Italy;Czech Republic;Hungary;Canada;Poland;Romania;Denmark;Bulgaria;Georgia;Netherlands;Germany;Korea, Republic of;United States
3EUCTR2016-003708-29-IT
(EUCTR)
01/09/201722/01/2021Study to evaluate the effectiveness of oral PF-06651600 and PF-06700841 in subjects with moderate to severe ulcerative colitis, a disease characterized by continuous inflammation that is localized to the colonA Phase 2B, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Dose Ranging Study of Oral PF-06651600 and PF-06700841 as Induction and Chronic Therapy in Subjects with Moderate to Severe Ulcerative Colitis - Vibrato Moderate to severe Ulcerative Colitis (UC)
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: PF-06651600 10 mg
Product Code: [PF-06651600 10 mg]
INN or Proposed INN: PF-06651600
Other descriptive name: PF-06651600-15
Product Name: PF-06651600 50 mg
Product Code: [PF-06651600 50 mg]
INN or Proposed INN: PF-06651600
Other descriptive name: PF-06651600-15
Product Name: PF-06700841 5 mg
Product Code: [PF-06700841 5 mg]
INN or Proposed INN: PF-06700841
Other descriptive name: PF-06700841-15
Product Name: PF-06700841 25 mg
Product Code: [PF-06700841 25 mg]
INN or Proposed INN: PF-06700841
Other descriptive name: PF-06700841-15
PFIZER INCNULLNot RecruitingFemale: yes
Male: yes
360Phase 2Serbia;United States;Czechia;Slovakia;Spain;Ukraine;Lithuania;Turkey;Austria;Israel;Russian Federation;Italy;Hungary;Canada;Poland;Romania;Denmark;Georgia;Bulgaria;Netherlands;Germany;Korea, Republic of
4EUCTR2016-003708-29-AT
(EUCTR)
07/08/201724/04/2017Study to evaluate the effectiveness of oral PF-06651600 and PF-06700841 in subjects with moderate to severe ulcerative colitis, a disease characterized by continuous inflammation that is localized to the colonA Phase 2B, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Dose Ranging Study of Oral PF-06651600 and PF-06700841 as Induction and Chronic Therapy in Subjects with Moderate to Severe Ulcerative Colitis - Vibrato Moderate to severe Ulcerative Colitis (UC)
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: PF-06651600 10 mg
INN or Proposed INN: PF-06651600
Other descriptive name: PF-06651600-15
Product Code: PF-06651600 50 mg
INN or Proposed INN: PF-06651600
Other descriptive name: PF-06651600-15
Product Code: PF-06700841 5 mg
INN or Proposed INN: PF-06700841
Other descriptive name: PF-06700841-15
Product Code: PF-06700841 25 mg
INN or Proposed INN: PF-06700841
Other descriptive name: PF-06700841-15
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
360Phase 2United States;Serbia;Slovakia;Spain;Ukraine;Lithuania;Turkey;Austria;Russian Federation;Israel;Italy;Czech Republic;Hungary;Canada;Poland;Romania;Denmark;Bulgaria;Georgia;Germany;Netherlands;Korea, Republic of
5EUCTR2016-003708-29-DE
(EUCTR)
07/08/201724/04/2017A Phase 2B, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Dose Ranging Study of Oral PF-06651600 and PF-06700841 as Induction and Chronic Therapy in Subjects with Moderate to Severe Ulcerative Colitis - Vibrato A Phase 2B, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Dose Ranging Study of Oral PF-06651600 and PF-06700841 as Induction and Chronic Therapy in Subjects with Moderate to Severe Ulcerative Colitis - Vibrato Moderate to severe Ulcerative Colitis (UC)
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Ritlecitinib 10 mg
Product Code: PF-06651600 10 mg
INN or Proposed INN: PF-06651600
Other descriptive name: PF-06651600-15
Product Name: Ritlecitinib 50 mg
Product Code: PF-06651600 50 mg
INN or Proposed INN: PF-06651600
Other descriptive name: PF-06651600-15
Product Name: Brepocitinib 5 mg
Product Code: PF-06700841 5 mg
INN or Proposed INN: PF-06700841
Other descriptive name: PF-06700841-15
Product Name: Brepocitinib 25 mg
Product Code: PF-06700841 25 mg
INN or Proposed INN: PF-06700841
Other descriptive name: PF-06700841-15
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
318Phase 2Serbia;United States;Czechia;Slovakia;Spain;Ukraine;Lithuania;Turkey;Austria;Israel;Russian Federation;Italy;Hungary;Canada;Poland;Romania;Denmark;Georgia;Bulgaria;Netherlands;Germany;Korea, Republic of
6EUCTR2016-003708-29-HU
(EUCTR)
30/06/201711/05/2017Study to evaluate the effectiveness of oral PF-06651600 and PF-06700841 in subjects with moderate to severe ulcerative colitis, a disease characterized by continuous inflammation that is localized to the colonA Phase 2B, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Dose Ranging Study of Oral PF-06651600 and PF-06700841 as Induction and Chronic Therapy in Subjects with Moderate to Severe Ulcerative Colitis - Vibrato Moderate to severe Ulcerative Colitis (UC)
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: PF-06651600 10 mg
INN or Proposed INN: PF-06651600
Other descriptive name: PF-06651600-15
Product Code: PF-06651600 50 mg
INN or Proposed INN: PF-06651600
Other descriptive name: PF-06651600-15
Product Code: PF-06700841 5 mg
INN or Proposed INN: PF-06700841
Other descriptive name: PF-06700841-15
Product Code: PF-06700841 25 mg
INN or Proposed INN: PF-06700841
Other descriptive name: PF-06700841-15
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
360 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noSerbia;United States;Slovakia;Spain;Ukraine;Lithuania;Turkey;Austria;Russian Federation;Israel;Italy;Hungary;Czech Republic;Canada;Poland;Romania;Denmark;Bulgaria;Georgia;Netherlands;Germany;Korea, Republic of
7EUCTR2016-003708-29-DK
(EUCTR)
27/06/201721/04/2017Study to evaluate the effectiveness of oral PF-06651600 and PF-06700841 in subjects with moderate to severe ulcerative colitis, a disease characterized by continuous inflammation that is localized to the colonA Phase 2B, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Dose Ranging Study of Oral PF-06651600 and PF-06700841 as Induction and Chronic Therapy in Subjects with Moderate to Severe Ulcerative Colitis - Vibrato Moderate to severe Ulcerative Colitis (UC)
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Ritlecitinib 10 mg
Product Code: PF-06651600 10 mg
INN or Proposed INN: PF-06651600
Other descriptive name: PF-06651600-15
Product Name: Ritlecitinib 50 mg
Product Code: PF-06651600 50 mg
INN or Proposed INN: PF-06651600
Other descriptive name: PF-06651600-15
Product Name: Brepocitinib 5 mg
Product Code: PF-06700841 5 mg
INN or Proposed INN: PF-06700841
Other descriptive name: PF-06700841-15
Product Name: Brepocitinib 25 mg
Product Code: PF-06700841 25 mg
INN or Proposed INN: PF-06700841
Other descriptive name: PF-06700841-15
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
318Phase 2Serbia;United States;Czechia;Slovakia;Spain;Ukraine;Lithuania;Turkey;Austria;Israel;Russian Federation;Italy;Hungary;Canada;Poland;Romania;Denmark;Georgia;Bulgaria;Netherlands;Germany;Korea, Republic of
8EUCTR2016-003708-29-PL
(EUCTR)
07/06/201726/04/2017Study to evaluate the effectiveness of oral PF-06651600 and PF-06700841 in subjects with moderate to severe ulcerative colitis, a disease characterized by continuous inflammation that is localized to the colonA Phase 2B, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Dose Ranging Study of Oral PF-06651600 and PF-06700841 as Induction and Chronic Therapy in Subjects with Moderate to Severe Ulcerative Colitis - Vibrato Moderate to severe Ulcerative Colitis (UC)
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Ritlecitinib 10 mg
Product Code: PF-06651600 10 mg
INN or Proposed INN: PF-06651600
Other descriptive name: PF-06651600-15
Product Name: Ritlecitinib 50 mg
Product Code: PF-06651600 50 mg
INN or Proposed INN: PF-06651600
Other descriptive name: PF-06651600-15
Product Name: Brepocitinib 5 mg
Product Code: PF-06700841 5 mg
INN or Proposed INN: PF-06700841
Other descriptive name: PF-06700841-15
Product Name: Brepocitinib 25 mg
Product Code: PF-06700841 25 mg
INN or Proposed INN: PF-06700841
Other descriptive name: PF-06700841-15
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
318Phase 2Serbia;United States;Czechia;Slovakia;Spain;Ukraine;Lithuania;Turkey;Austria;Israel;Russian Federation;Italy;Hungary;Canada;Poland;Romania;Denmark;Georgia;Bulgaria;Netherlands;Germany;Korea, Republic of
9EUCTR2016-003708-29-LT
(EUCTR)
06/06/201718/04/2017Study to evaluate the effectiveness of oral PF-06651600 and PF-06700841 in subjects with moderate to severe ulcerative colitis, a disease characterized by continuous inflammation that is localized to the colonA Phase 2B, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Dose Ranging Study of Oral PF-06651600 and PF-06700841 as Induction and Chronic Therapy in Subjects with Moderate to Severe Ulcerative Colitis - Vibrato Moderate to severe Ulcerative Colitis (UC)
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: PF-06651600 10 mg
INN or Proposed INN: PF-06651600
Other descriptive name: PF-06651600-15
Product Code: PF-06651600 50 mg
INN or Proposed INN: PF-06651600
Other descriptive name: PF-06651600-15
Product Code: PF-06700841 5 mg
INN or Proposed INN: PF-06700841
Other descriptive name: PF-06700841-15
Product Code: PF-06700841 25 mg
INN or Proposed INN: PF-06700841
Other descriptive name: PF-06700841-15
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot Recruiting Female: yes
Male: yes
360 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noSerbia;United States;Slovakia;Spain;Ukraine;Lithuania;Turkey;Austria;Russian Federation;Israel;Italy;Hungary;Czech Republic;Canada;Poland;Romania;Denmark;Bulgaria;Georgia;Netherlands;Germany;Korea, Republic of
10EUCTR2016-003708-29-ES
(EUCTR)
22/05/201731/05/2017Study to evaluate the effectiveness of oral PF-06651600 and PF-06700841 in subjects with moderate to severe ulcerative colitis, a disease characterized by continuous inflammation that is localized to the colonA Phase 2B, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Dose Ranging Study of Oral PF-06651600 and PF-06700841 as Induction and Chronic Therapy in Subjects with Moderate to Severe Ulcerative Colitis - Vibrato Moderate to severe Ulcerative Colitis (UC)
MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: PF-06651600 10 mg
INN or Proposed INN: PF-06651600
Other descriptive name: PF-06651600-15
Product Code: PF-06651600 50 mg
INN or Proposed INN: PF-06651600
Other descriptive name: PF-06651600-15
Product Code: PF-06700841 5 mg
INN or Proposed INN: PF-06700841
Other descriptive name: PF-06700841-15
Product Code: PF-06700841 25 mg
INN or Proposed INN: PF-06700841
Other descriptive name: PF-06700841-15
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
360Phase 2United States;Serbia;Philippines;Slovakia;Spain;Ukraine;Turkey;Lithuania;Austria;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Bulgaria;Norway;Netherlands;Germany;Korea, Republic of
11EUCTR2016-003708-29-SK
(EUCTR)
18/04/201724/02/2017Study to evaluate the effectiveness of oral PF-06651600 and PF-06700841 in subjects with moderate to severe ulcerative colitis, a disease characterized by continuous inflammation that is localized to the colonA Phase 2B, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Dose Ranging Study of Oral PF-06651600 and PF-06700841 as Induction and Chronic Therapy in Subjects with Moderate to Severe Ulcerative Colitis - Vibrato Moderate to severe Ulcerative Colitis (UC)
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Ritlecitinib 10 mg
Product Code: PF-06651600 10 mg
INN or Proposed INN: PF-06651600
Other descriptive name: PF-06651600-15
Product Name: Ritlecitinib 50 mg
Product Code: PF-06651600 50 mg
INN or Proposed INN: PF-06651600
Other descriptive name: PF-06651600-15
Product Name: Brepocitinib 5 mg
Product Code: PF-06700841 5 mg
INN or Proposed INN: PF-06700841
Other descriptive name: PF-06700841-15
Product Name: Brepocitinib 25 mg
Product Code: PF-06700841 25 mg
INN or Proposed INN: PF-06700841
Other descriptive name: PF-06700841-15
Pfizer Inc.NULLNot RecruitingFemale: yes
Male: yes
318Phase 2Serbia;United States;Slovakia;Spain;Ukraine;Lithuania;Turkey;Austria;Israel;Russian Federation;Italy;Hungary;Canada;Poland;Romania;Denmark;Georgia;Bulgaria;Netherlands;Germany;Korea, Republic of