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A Phase 2 Safety and Efficacy Study of PRA023 in Subjects With Moderately to Severely Active Ulcerative Colitis (ARTEMIS-UC)

Primary Purpose

Ulcerative Colitis

Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
PRA023 IV
Companion Diagnostic (CDx) Testing
Placebo
Sponsored by
Prometheus Biosciences, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulcerative Colitis focused on measuring ARTEMIS-UC, ARTEMIS, Ulcerative Colitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Confirmed diagnosis of ulcerative colitis (UC)
  • Moderately to severely active UC as defined by 3-component Modified Mayo score
  • Must have corticosteroid dependence or have had no response, insufficient response, loss of response, and/or intolerance to at least one of the following therapies: corticosteroid, immunosuppressants, or an approved anti-TNF, anti-integrin, anti-IL12/23, JAK inhibitor, S1PR modulator.
  • Able to provide written informed consent and understand and comply with the requirements of the study.

Exclusion Criteria:

  • WOCBP and men with female partners of childbearing potential who are unwilling or unable to use two highly effective methods of contraception to avoid pregnancy for the entire study period and for up to 12 weeks after the last dose of study drug
  • Diagnosis of Crohn's disease or indeterminate colitis
  • Current evidence of fulminant colitis, toxic megacolon, bowel perforation, total proctocoloectomy or partial colectomy
  • Current or impending need for colostomy or ileostomy
  • Surgical bowel resection within 3 months before screening
  • Past or current evidence of definite low-grade or high-grade colonic dysplasia not completely removed
  • Subjects in the opinion of the investigator are at an unacceptable risk for participation in the study
  • Subjects who meet the protocol criteria for important laboratory exclusion criteria

Sites / Locations

  • Prometheus Biosciences Selected Center
  • Prometheus Biosciences Selected Site
  • Prometheus Biosciences Selected Site
  • Prometheus Biosciences Selected Site
  • Prometheus Biosciences Selected Site
  • Prometheus Biosciences Selected Site
  • Prometheus Biosciences Selected Site
  • Prometheus Biosciences Selected Site
  • Prometheus Biosciences Selected Site
  • Prometheus Biosciences Selected Site
  • Prometheus Biosciences Selected Site
  • Prometheus Biosciences Selected Site
  • Prometheus Biosciences Selected Site
  • Prometheus Biosciences Selected Site
  • Prometheus Biosciences Selected Site
  • Prometheus Biosciences Selected Site
  • Prometheus Biosciences Selected Site
  • Prometheus Biosciences Selected Site
  • Prometheus Biosciences Selected Site
  • Prometheus Biosciences Selected Site
  • Prometheus Biosciences Selected Site
  • Prometheus Biosciences Selected Site
  • Prometheus Biosciences Selected Site
  • Prometheus Biosciences Selected Site
  • Prometheus Biosciences Selected Site
  • Prometheus Biosciences Selected Site
  • Prometheus Biosciences Selected Site
  • Prometheus Biosciences Selected Site
  • Prometheus Biosciences Selected Site
  • Prometheus Biosciences Selected Site
  • Prometheus Biosciences Selected Site
  • Prometheus Biosciences Selected Site
  • Prometheus Biosciences Selected Site
  • Prometheus Biosciences Selected Site
  • Prometheus Biosciences Selected Site
  • Prometheus Biosciences Selected Site
  • Prometheus Biosciences Selected Site
  • Prometheus Biosciences Selected Site
  • Prometheus Biosciences Selected Site
  • Prometheus Biosciences Selected Site
  • Prometheus Biosciences Selected Site
  • Prometheus Biosciences Selected Site
  • Prometheus Biosciences Selected Site
  • Prometheus Biosciences Selected Site
  • Prometheus Biosciences Selected Site
  • Prometheus Biosciences Selected Site
  • Prometheus Biosciences Selected Site
  • Prometheus Biosciences Selected Site
  • Prometheus Biosciences Selected Site
  • Prometheus Biosciences Selected Site
  • Prometheus Biosciences Selected Site
  • Prometheus Biosciences Selected Site
  • Prometheus Biosciences Selected Site
  • Prometheus Biosciences Selected Site
  • Prometheus Biosciences Selected Site
  • Prometheus Biosciences Selected Site
  • Prometheus Biosciences Selected Site
  • Prometheus Biosciences Selected Site
  • Prometheus Biosciences Selected Center
  • Prometheus Biosciences Selected Site
  • Prometheus Biosciences Selected Site
  • Prometheus Biosciences Selected Site
  • Prometheus Biosciences Selected Site
  • Prometheus Biosciences Selected Site
  • Prometheus Biosciences Selected Site
  • Prometheus Biosciences Selected Site
  • Prometheus Biosciences Selected Site
  • Prometheus Biosciences Selected Site
  • Prometheus Biosciences Selected Site
  • Prometheus Biosciences Selected Site
  • Prometheus Biosciences Selected Site
  • Prometheus Biosciences Selected Site
  • Prometheus Biosciences Selected Site
  • Prometheus Biosciences Selected Site
  • Prometheus Biosciences Selected Site
  • Prometheus Biosciences Selected Site
  • Prometheus Biosciences Selected Site
  • Prometheus Biosciences Selected Site
  • Prometheus Biosciences Selected Site
  • Prometheus Biosciences Selected Site
  • Prometheus Biosciences Selected Site
  • Prometheus Biosciences Selected Site
  • Prometheus Biosciences Selected Site #2
  • Prometheus Biosciences Selected Site
  • Prometheus Biosciences Selected Site
  • Prometheus Biosciences Selected Site
  • Prometheus Biosciences Selected Site
  • Prometheus Biosciences Selected Sites

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

Cohort 1 PRA023

Cohort 1 Placebo

CDx+ Expansion Cohort PRA023

CDx+ Expansion Cohort Placebo

Arm Description

Participants randomized to receive PRA023 administered by intravenous (IV) infusion.

Participant randomized to receive placebo administered by intravenous (IV) infusion.

Participants randomized to receive PRA023 administered by intravenous (IV) infusion.

Participant randomized to receive placebo administered by intravenous (IV) infusion.

Outcomes

Primary Outcome Measures

Induction of clinical remission
Proportion of participants achieving induction of clinical remission
Safety and tolerability
Incidence of AE, SAE, AE leading to discontinuation

Secondary Outcome Measures

Induction of endoscopic improvement
Proportion of participants achieving induction of endoscopic improvement
Induction of clinical response
Proportion of participants achieving induction of clinical response
Induction of clinical remission in CDx+ participants
Proportion of CDx+ participants achieving induction of clinical remission
Induction of histologic remission
Proportion of participants achieving induction of histologic remission
Induction of histologic-endoscopic mucosal improvement
Proportion of participants achieving induction of histologic- endoscopic mucosal improvement
Induction of endoscopic improvement in CDx+ participants
Proportion of CDx+ participants achieving induction of endoscopic improvement
Induction of clinical response in CDx+ participants
Proportion of CDx+ participants achieving induction of clinical response
Induction of histologic remission in CDx+ participants
Proportion of CDx+ participants achieving induction of histologic remission
Induction of histologic-endoscopic mucosal improvement in CDx+ participants
Proportion of CDx+ participants achieving induction of histologic-endoscopic mucosal
Clinical remission in CDx+ vs. CDx- participants
Proportion of of CDx+ vs. CDx- participants achieving clinical remission
Induction of mucosal healing
Proportion of participants achieving induction of mucosal healing
Induction of mucosal healing in CDx+ participants
Proportion of CDx+ participants achieving induction of mucosal healing
Change in IBDQ
Change from Baseline in IBDQ through Week 12
Change in IBDQ in CDx+ participants
Change from Baseline in IBDQ through Week 12 in CDx+ participants
Induction of Clinical remission in CDx+ participants per alternative algorithm
Proportion of CDx+ participants per alternative algorithm achieving induction of Clinical remission

Full Information

First Posted
August 2, 2021
Last Updated
July 27, 2023
Sponsor
Prometheus Biosciences, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04996797
Brief Title
A Phase 2 Safety and Efficacy Study of PRA023 in Subjects With Moderately to Severely Active Ulcerative Colitis
Acronym
ARTEMIS-UC
Official Title
A 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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 14, 2021 (Actual)
Primary Completion Date
May 23, 2023 (Actual)
Study Completion Date
August 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Prometheus Biosciences, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to assess the safety and efficacy of PRA023 in participants with moderately to severely active Ulcerative Colitis. The purpose of Cohort 2 of the study is to assess the safety and efficacy of PRA023 in participants with moderately to severely active ulcerative colitis who are companion diagnostic positive. After the completion of the 12-week induction, all participants have the option to continue in the open-label extension for another 38 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis
Keywords
ARTEMIS-UC, ARTEMIS, Ulcerative Colitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
170 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1 PRA023
Arm Type
Experimental
Arm Description
Participants randomized to receive PRA023 administered by intravenous (IV) infusion.
Arm Title
Cohort 1 Placebo
Arm Type
Placebo Comparator
Arm Description
Participant randomized to receive placebo administered by intravenous (IV) infusion.
Arm Title
CDx+ Expansion Cohort PRA023
Arm Type
Experimental
Arm Description
Participants randomized to receive PRA023 administered by intravenous (IV) infusion.
Arm Title
CDx+ Expansion Cohort Placebo
Arm Type
Placebo Comparator
Arm Description
Participant randomized to receive placebo administered by intravenous (IV) infusion.
Intervention Type
Drug
Intervention Name(s)
PRA023 IV
Intervention Description
PRA023 administered by IV infusion
Intervention Type
Device
Intervention Name(s)
Companion Diagnostic (CDx) Testing
Intervention Description
PRA023 CDx Genotyping Assay
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo administered by IV infusion
Primary Outcome Measure Information:
Title
Induction of clinical remission
Description
Proportion of participants achieving induction of clinical remission
Time Frame
Week 12
Title
Safety and tolerability
Description
Incidence of AE, SAE, AE leading to discontinuation
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Induction of endoscopic improvement
Description
Proportion of participants achieving induction of endoscopic improvement
Time Frame
Week 12
Title
Induction of clinical response
Description
Proportion of participants achieving induction of clinical response
Time Frame
Week 12
Title
Induction of clinical remission in CDx+ participants
Description
Proportion of CDx+ participants achieving induction of clinical remission
Time Frame
Week 12
Title
Induction of histologic remission
Description
Proportion of participants achieving induction of histologic remission
Time Frame
Week 12
Title
Induction of histologic-endoscopic mucosal improvement
Description
Proportion of participants achieving induction of histologic- endoscopic mucosal improvement
Time Frame
Week 12
Title
Induction of endoscopic improvement in CDx+ participants
Description
Proportion of CDx+ participants achieving induction of endoscopic improvement
Time Frame
Week 12
Title
Induction of clinical response in CDx+ participants
Description
Proportion of CDx+ participants achieving induction of clinical response
Time Frame
Week 12
Title
Induction of histologic remission in CDx+ participants
Description
Proportion of CDx+ participants achieving induction of histologic remission
Time Frame
Week 12
Title
Induction of histologic-endoscopic mucosal improvement in CDx+ participants
Description
Proportion of CDx+ participants achieving induction of histologic-endoscopic mucosal
Time Frame
Week 12
Title
Clinical remission in CDx+ vs. CDx- participants
Description
Proportion of of CDx+ vs. CDx- participants achieving clinical remission
Time Frame
Week 12
Title
Induction of mucosal healing
Description
Proportion of participants achieving induction of mucosal healing
Time Frame
Week 12
Title
Induction of mucosal healing in CDx+ participants
Description
Proportion of CDx+ participants achieving induction of mucosal healing
Time Frame
Week 12
Title
Change in IBDQ
Description
Change from Baseline in IBDQ through Week 12
Time Frame
Week 12
Title
Change in IBDQ in CDx+ participants
Description
Change from Baseline in IBDQ through Week 12 in CDx+ participants
Time Frame
Week 12
Title
Induction of Clinical remission in CDx+ participants per alternative algorithm
Description
Proportion of CDx+ participants per alternative algorithm achieving induction of Clinical remission
Time Frame
Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Confirmed diagnosis of ulcerative colitis (UC) Moderately to severely active UC as defined by 3-component Modified Mayo score Must have corticosteroid dependence or have had no response, insufficient response, loss of response, and/or intolerance to at least one of the following therapies: corticosteroid, immunosuppressants, or an approved anti-TNF, anti-integrin, anti-IL12/23, JAK inhibitor, S1PR modulator. Able to provide written informed consent and understand and comply with the requirements of the study. Exclusion Criteria: WOCBP and men with female partners of childbearing potential who are unwilling or unable to use two highly effective methods of contraception to avoid pregnancy for the entire study period and for up to 12 weeks after the last dose of study drug Diagnosis of Crohn's disease or indeterminate colitis Current evidence of fulminant colitis, toxic megacolon, bowel perforation, total proctocoloectomy or partial colectomy Current or impending need for colostomy or ileostomy Surgical bowel resection within 3 months before screening Past or current evidence of definite low-grade or high-grade colonic dysplasia not completely removed Subjects in the opinion of the investigator are at an unacceptable risk for participation in the study Subjects who meet the protocol criteria for important laboratory exclusion criteria
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prometheus Biosciences
Organizational Affiliation
Clinicaltrials Call center
Official's Role
Study Director
Facility Information:
Facility Name
Prometheus Biosciences Selected Center
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Prometheus Biosciences Selected Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
Prometheus Biosciences Selected Site
City
Sun City
State/Province
Arizona
ZIP/Postal Code
85351
Country
United States
Facility Name
Prometheus Biosciences Selected Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90045
Country
United States
Facility Name
Prometheus Biosciences Selected Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Prometheus Biosciences Selected Site
City
San Diego
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Prometheus Biosciences Selected Site
City
Bristol
State/Province
Connecticut
ZIP/Postal Code
06010
Country
United States
Facility Name
Prometheus Biosciences Selected Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30010
Country
United States
Facility Name
Prometheus Biosciences Selected Site
City
Arlington Heights
State/Province
Illinois
ZIP/Postal Code
60005
Country
United States
Facility Name
Prometheus Biosciences Selected Site
City
Glenview
State/Province
Illinois
ZIP/Postal Code
60026
Country
United States
Facility Name
Prometheus Biosciences Selected Site
City
Gurnee
State/Province
Illinois
ZIP/Postal Code
60031
Country
United States
Facility Name
Prometheus Biosciences Selected Site
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Prometheus Biosciences Selected Site
City
Liberty
State/Province
Kansas
ZIP/Postal Code
64098
Country
United States
Facility Name
Prometheus Biosciences Selected Site
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
Facility Name
Prometheus Biosciences Selected Site
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
Facility Name
Prometheus Biosciences Selected Site
City
Chesterfield
State/Province
Michigan
ZIP/Postal Code
48047
Country
United States
Facility Name
Prometheus Biosciences Selected Site
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Prometheus Biosciences Selected Site
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Prometheus Biosciences Selected Site
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Prometheus Biosciences Selected Site
City
Dublin
State/Province
Ohio
ZIP/Postal Code
43016
Country
United States
Facility Name
Prometheus Biosciences Selected Site
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
Prometheus Biosciences Selected Site
City
Bedford
State/Province
Texas
ZIP/Postal Code
76022
Country
United States
Facility Name
Prometheus Biosciences Selected Site
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79424
Country
United States
Facility Name
Prometheus Biosciences Selected Site
City
Mansfield
State/Province
Texas
ZIP/Postal Code
76063
Country
United States
Facility Name
Prometheus Biosciences Selected Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Prometheus Biosciences Selected Site
City
Southlake
State/Province
Texas
ZIP/Postal Code
76092
Country
United States
Facility Name
Prometheus Biosciences Selected Site
City
Tyler
State/Province
Texas
ZIP/Postal Code
75702
Country
United States
Facility Name
Prometheus Biosciences Selected Site
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
Facility Name
Prometheus Biosciences Selected Site
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Prometheus Biosciences Selected Site
City
Woodville
State/Province
Adelaide
Country
Australia
Facility Name
Prometheus Biosciences Selected Site
City
Kingswood
State/Province
New South Wales
ZIP/Postal Code
2747
Country
Australia
Facility Name
Prometheus Biosciences Selected Site
City
Old Toongabbie
State/Province
New South Wales
ZIP/Postal Code
NSW 2146
Country
Australia
Facility Name
Prometheus Biosciences Selected Site
City
South Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Facility Name
Prometheus Biosciences Selected Site
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
Prometheus Biosciences Selected Site
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Prometheus Biosciences Selected Site
City
Fitzroy
State/Province
Victoria
ZIP/Postal Code
VIC 3065
Country
Australia
Facility Name
Prometheus Biosciences Selected Site
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
VIC 3065
Country
Australia
Facility Name
Prometheus Biosciences Selected Site
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Prometheus Biosciences Selected Site
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Prometheus Biosciences Selected Site
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4Z6
Country
Canada
Facility Name
Prometheus Biosciences Selected Site
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z2K5
Country
Canada
Facility Name
Prometheus Biosciences Selected Site
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 1V7
Country
Canada
Facility Name
Prometheus Biosciences Selected Site
City
North York
State/Province
Ontario
ZIP/Postal Code
M6A 3B4
Country
Canada
Facility Name
Prometheus Biosciences Selected Site
City
Brno
Country
Czechia
Facility Name
Prometheus Biosciences Selected Site
City
Hradec Králové
Country
Czechia
Facility Name
Prometheus Biosciences Selected Site
City
Olomouc
ZIP/Postal Code
779 00
Country
Czechia
Facility Name
Prometheus Biosciences Selected Site
City
Slaný
Country
Czechia
Facility Name
Prometheus Biosciences Selected Site
City
Clichy
ZIP/Postal Code
92110
Country
France
Facility Name
Prometheus Biosciences Selected Site
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Prometheus Biosciences Selected Site
City
Nice
ZIP/Postal Code
06202
Country
France
Facility Name
Prometheus Biosciences Selected Site
City
Pierre-Bénite
ZIP/Postal Code
69495
Country
France
Facility Name
Prometheus Biosciences Selected Site
City
Saint-Priest-en-Jarez
ZIP/Postal Code
42270
Country
France
Facility Name
Prometheus Biosciences Selected Site
City
Vandœuvre-lès-Nancy
ZIP/Postal Code
54511
Country
France
Facility Name
Prometheus Biosciences Selected Site
City
Tbilisi
Country
Georgia
Facility Name
Prometheus Biosciences Selected Site
City
Győr
State/Province
Gyor-Moson-Sopron
ZIP/Postal Code
9024
Country
Hungary
Facility Name
Prometheus Biosciences Selected Site
City
Bekescsaba
ZIP/Postal Code
5600
Country
Hungary
Facility Name
Prometheus Biosciences Selected Site
City
Budapest
ZIP/Postal Code
1062
Country
Hungary
Facility Name
Prometheus Biosciences Selected Site
City
Budapest
ZIP/Postal Code
1088
Country
Hungary
Facility Name
Prometheus Biosciences Selected Center
City
Budapest
ZIP/Postal Code
1135
Country
Hungary
Facility Name
Prometheus Biosciences Selected Site
City
Afula
ZIP/Postal Code
18341
Country
Israel
Facility Name
Prometheus Biosciences Selected Site
City
Be'er Sheva
ZIP/Postal Code
84100
Country
Israel
Facility Name
Prometheus Biosciences Selected Site
City
H̱olon
ZIP/Postal Code
58100
Country
Israel
Facility Name
Prometheus Biosciences Selected Site
City
Jerusalem
ZIP/Postal Code
91031
Country
Israel
Facility Name
Prometheus Biosciences Selected Site
City
Petah tikva
ZIP/Postal Code
49414
Country
Israel
Facility Name
Prometheus Biosciences Selected Site
City
Bologna
State/Province
Emilia-Romagna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Prometheus Biosciences Selected Site
City
Milano
State/Province
Milan
ZIP/Postal Code
20132
Country
Italy
Facility Name
Prometheus Biosciences Selected Site
City
Milano
State/Province
Milan
ZIP/Postal Code
20157
Country
Italy
Facility Name
Prometheus Biosciences Selected Site
City
Roma
State/Province
Rome
ZIP/Postal Code
00168
Country
Italy
Facility Name
Prometheus Biosciences Selected Site
City
Poznań
State/Province
Greater Poland
ZIP/Postal Code
61-441
Country
Poland
Facility Name
Prometheus Biosciences Selected Site
City
Wloclawek
State/Province
Kuuavian-Pomeranian
ZIP/Postal Code
87-800
Country
Poland
Facility Name
Prometheus Biosciences Selected Site
City
Kraków
State/Province
Lesser Poland
ZIP/Postal Code
31-009
Country
Poland
Facility Name
Prometheus Biosciences Selected Site
City
Wrocław
State/Province
Lower Silesian
ZIP/Postal Code
40-211
Country
Poland
Facility Name
Prometheus Biosciences Selected Site
City
Wrocław
State/Province
Lower Silesian
ZIP/Postal Code
540144
Country
Poland
Facility Name
Prometheus Biosciences Selected Site
City
Warszawa
State/Province
Masovia
ZIP/Postal Code
04-730
Country
Poland
Facility Name
Prometheus Biosciences Selected Site
City
Katowice
State/Province
Silesian
ZIP/Postal Code
40-211
Country
Poland
Facility Name
Prometheus Biosciences Selected Site
City
Kraków
Country
Poland
Facility Name
Prometheus Biosciences Selected Site
City
Lublin
ZIP/Postal Code
20-362
Country
Poland
Facility Name
Prometheus Biosciences Selected Site
City
Lublin
ZIP/Postal Code
20-607
Country
Poland
Facility Name
Prometheus Biosciences Selected Site
City
Rzeszów
Country
Poland
Facility Name
Prometheus Biosciences Selected Site
City
Sopot
Country
Poland
Facility Name
Prometheus Biosciences Selected Site
City
Szczecin
Country
Poland
Facility Name
Prometheus Biosciences Selected Site
City
Toruń
Country
Poland
Facility Name
Prometheus Biosciences Selected Site #2
City
Warsaw
Country
Poland
Facility Name
Prometheus Biosciences Selected Site
City
Warsaw
Country
Poland
Facility Name
Prometheus Biosciences Selected Site
City
Wrocław
Country
Poland
Facility Name
Prometheus Biosciences Selected Site
City
Łódź
ZIP/Postal Code
93-357
Country
Poland
Facility Name
Prometheus Biosciences Selected Site
City
Prescot
State/Province
Merseyside
ZIP/Postal Code
L34 1BH
Country
United Kingdom
Facility Name
Prometheus Biosciences Selected Sites
City
London
ZIP/Postal Code
E11 1NR
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

A Phase 2 Safety and Efficacy Study of PRA023 in Subjects With Moderately to Severely Active Ulcerative Colitis

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