PRA023 ( DrugBank: - )


3 diseases
告示番号疾患名(ページ内リンク)臨床試験数
51全身性強皮症3
96クローン病4
97潰瘍性大腸炎6

51. 全身性強皮症


臨床試験数 : 525 薬物数 : 565 - (DrugBank : 148) / 標的遺伝子数 : 114 - 標的パスウェイ数 : 217
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2021-005206-10-DE
(EUCTR)
19/07/202207/04/2022A study of PRA023 in patients with Systemic Sclerosis Associated with Interstitial Lung DiseaseA Double Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of PRA023 in Subjects with Systemic Sclerosis Associated with Interstitial Lung Disease (SSc-ILD) - The ATHENA-SSc-ILD Study Systemic sclerosis associated with interstitial lung disease
MedDRA version: 21.0;Level: LLT;Classification code 10025109;Term: Lung involvement in systemic sclerosis;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: PRA023
INN or Proposed INN: tulisokibart
Other descriptive name: PRA023
Prometheus Biosciences, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Phase 2United States;Spain;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Norway;Germany;Netherlands
2EUCTR2021-005206-10-ES
(EUCTR)
12/04/202202/02/2022A study of PRA023 in patients with Systemic Sclerosis Associated with Interstitial Lung Disease.A Double Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of PRA023 in Subjects with Systemic Sclerosis Associated with Interstitial Lung Disease (SSc-ILD). - The ATHENA-SSc-ILD Study. Systemic sclerosis associated with interstitial lung disease.
MedDRA version: 21.0;Level: LLT;Classification code 10025109;Term: Lung involvement in systemic sclerosis;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: PRA023
INN or Proposed INN: Not yet assigned
Other descriptive name: PRA023
Prometheus Biosciences, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Phase 2United States;Spain;Israel;United Kingdom;Italy;Switzerland;France;Hungary;Canada;Belgium;Poland;Australia;Germany;Netherlands;Norway
3NCT05270668
(ClinicalTrials.gov)
February 22, 202227/2/2022Phase 2 Safety and Efficacy Study of PRA023 in Subjects With Systemic Sclerosis Associated With Interstitial Lung Disease (SSc-ILD)A Double Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of PRA023 in Subjects With Systemic Sclerosis Associated With Interstitial Lung Disease (SSc-ILD)Diffuse Cutaneous Systemic Sclerosis;Interstitial Lung DiseaseDrug: PRA023 IV;Device: Companion diagnostic ( CDx);Drug: PlaceboPrometheus Biosciences, Inc.NULLRecruiting18 YearsN/AAll100Phase 2United States;Australia;Belgium;Canada;France;Germany;Hungary;Israel;Italy;Netherlands;Norway;Poland;Spain;Switzerland;United Kingdom

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
1EUCTR2021-000092-37-BE
(EUCTR)
17/12/202113/09/2021A study of PRA023 in patients with Crohn's DiseaseA Phase 2a, Multi-Center, Open-Label Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of PRA023 in Subjects with Moderately to Severely Active Crohn’s Disease Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: PRA023
INN or Proposed INN: Not yet assigned
Other descriptive name: PRA023
Prometheus Biosciences, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
50Phase 2United States;France;Czechia;Czech Republic;Canada;Poland;Belgium;Ukraine;Australia;Russian Federation;Georgia
2EUCTR2021-000092-37-PL
(EUCTR)
19/11/202117/08/2021A study of PRA023 in patients with Crohn's DiseaseA Phase 2a, Multi-Center, Open-Label Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of PRA023 in Subjects with Moderately to Severely Active Crohn’s Disease Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: PRA023
INN or Proposed INN: Not yet assigned
Other descriptive name: PRA023
Prometheus Biosciences, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
50Phase 2France;United States;Czechia;Czech Republic;Canada;Belgium;Poland;Ukraine;Australia;Russian Federation;Georgia
3EUCTR2021-000092-37-CZ
(EUCTR)
03/11/202107/06/2021A study of PRA023 in patients with Crohn's DiseaseA Phase 2a, Multi-Center, Open-Label Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of PRA023 in Subjects with Moderately to Severely Active Crohn’s Disease Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: PRA023
INN or Proposed INN: Not yet assigned
Other descriptive name: PRA023
Prometheus Biosciences, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
50Phase 2France;United States;Czechia;Czech Republic;Canada;Belgium;Poland;Australia;Georgia
4NCT05013905
(ClinicalTrials.gov)
July 28, 202113/8/2021A Phase 2a Safety and Efficacy Open-Label Study of PRA023 in Subjects With Moderately to Severely Active Crohn's DiseaseA Phase 2a, Multi-Center, Open-Label Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of PRA023 in Subjects With Moderately to Severely Active Crohn's DiseaseCrohn DiseaseDrug: PRA023 IV;Device: Companion diagnostic (CDx)Prometheus Biosciences, Inc.NULLActive, not recruiting18 YearsN/AAll50Phase 2United States;Australia;Belgium;Canada;Czechia;France;Georgia;Poland;Ukraine

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
1EUCTR2021-000091-11-BE
(EUCTR)
09/12/202127/07/2021A study of PRA023 in patients with Ulcerative ColitisA Phase 2, Multi-Center, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Induction Therapy with PRA023 in Subjects with Moderately to Severely Active Ulcerative Colitis Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: PRA023
INN or Proposed INN: Not yet assigned
Other descriptive name: PRA023
Prometheus Biosciences, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
170Phase 2United States;Czechia;Ukraine;Israel;Russian Federation;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Australia;Georgia
2EUCTR2021-000091-11-IT
(EUCTR)
08/11/202102/09/2021A study of efficacy of PRA023 in patients with Ulcerative ColitisA Phase 2, Multi-Center, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Induction Therapy with PRA023 in Subjects with Moderately to Severely Active Ulcerative Colitis - ARTEMIS-UC Study Ulcerative Colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Product Name: PRA023
Product Code: [PRA023]
Other descriptive name: PRA023
Prometheus Biosciences Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
170Phase 2Belarus;United States;Czechia;Ukraine;Israel;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Australia;Georgia;Bulgaria
3EUCTR2021-000091-11-CZ
(EUCTR)
20/10/202122/04/2021A study of PRA023 in patients with Ulcerative ColitisA Phase 2, Multi-Center, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Induction Therapy with PRA023 in Subjects with Moderately to Severely Active Ulcerative Colitis Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: PRA023
INN or Proposed INN: Not yet assigned
Other descriptive name: PRA023
Prometheus Biosciences, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
170Phase 2United States;Czechia;Ukraine;Russian Federation;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Australia;Bulgaria;Georgia
4EUCTR2021-000091-11-HU
(EUCTR)
13/09/202117/04/2021A study of PRA023 in patients with Ulcerative ColitisA Phase 2, Multi-Center, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Induction Therapy with PRA023 in Subjects with Moderately to Severely Active Ulcerative Colitis Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: PRA023
INN or Proposed INN: Not yet assigned
Other descriptive name: PRA023
Prometheus Biosciences, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
170Phase 2Belarus;United States;Czechia;Ukraine;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Australia;Georgia
5EUCTR2021-000091-11-PL
(EUCTR)
06/08/202120/05/2021A study of PRA023 in patients with Ulcerative ColitisA Phase 2, Multi-Center, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Induction Therapy with PRA023 in Subjects with Moderately to Severely Active Ulcerative Colitis Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: PRA023
INN or Proposed INN: Not yet assigned
Other descriptive name: PRA023
Prometheus Biosciences, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
170Phase 2United States;Czechia;Ukraine;Israel;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Australia;Georgia
6NCT04996797
(ClinicalTrials.gov)
July 14, 20212/8/2021A Phase 2 Safety and Efficacy Study of PRA023 in Subjects With Moderately to Severely Active Ulcerative ColitisA Phase 2, Multi-Center, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Induction Therapy With PRA023 in Subjects With Moderately to Severely Active Ulcerative ColitisUlcerative ColitisDrug: PRA023 IV;Device: Companion Diagnostic (CDx) Testing;Other: PlaceboPrometheus Biosciences, Inc.NULLActive, not recruiting18 YearsN/AAll170Phase 2United States;Australia;Belgium;Canada;Czechia;France;Georgia;Hungary;Israel;Italy;Poland;United Kingdom