97. Ulcerative colitis Clinical trials / Disease details


Clinical trials : 2,630 Drugs : 1,459 - (DrugBank : 265) / Drug target genes : 144 - Drug target pathways : 202

  
6 trials found
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