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PN-943 in Adults With Moderate to Severe Active Ulcerative Colitis (UC)

Primary Purpose

Ulcerative Colitis Chronic Moderate, Ulcerative Colitis Chronic Severe

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
PN-943
Placebo
Sponsored by
Protagonist Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulcerative Colitis Chronic Moderate focused on measuring Inflammatory Bowel Disease (IBD)

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

  1. Male and female subjects age 18 (or the minimum country specific age of consent if >18) to 75 years.
  2. Subject understands the study procedures and agrees to participate in the study by giving written informed consent.
  3. Diagnosis of UC supported by appropriate documentation of biopsy results consistent with UC.
  4. Moderate to severe active UC.
  5. Demonstrated inadequate response, loss of response, or intolerance of at least 1 of oral aminosalicylates (5-ASAs), corticosteroids, immunomodulators, or a biologic (excluding vedolizumab).

Key Exclusion Criteria:

  1. Subject with a current diagnosis of Crohn's disease (CD), indeterminate colitis (IC), microscopic colitis, ischemic colitis, radiation colitis.
  2. History of colonic dysplasia other than completely removed low-grade dysplastic lesion.
  3. History of active bacterial, viral, fungal or mycobacterial infection requiring hospitalization or IV antibiotic/anti-infective treatment within 4 weeks of screening or oral antibiotics/anti-infectives within 2 weeks of screening.
  4. Prior treatment with vedolizumab, natalizumab, or any agent targeting the α4β7 or β1 integrin or planned during the study.
  5. Positive stool test for C. difficile.
  6. Chronic recurrent or serious infection.
  7. Known primary or secondary immunodeficiency.
  8. Pregnant or lactating female or considering becoming pregnant during the study or within 30 days after the last dose of study medication.
  9. History of any major neurological disorders.

Sites / Locations

  • Protagonist Investigational Site
  • Protagonist Investigational Site
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Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

PN-943 450 mg BID

PN-943 150 mg BID

Placebo BID

Arm Description

Oral administration of PN-943 450 mg BID

Oral administration of PN-943 150 mg BID

Oral administration of matching placebo

Outcomes

Primary Outcome Measures

Proportion of subjects achieving clinical remission at Week 12 compared to placebo.
Clinical remission is determined using the Adapted Mayo score (sum of 3 subscores from the Mayo score): Stool frequency subscore (SFS) Rectal bleeding subscore (RBS) Endoscopic subscore (ESS)

Secondary Outcome Measures

Comparison between PN-943 high-dose and low-dose individually to placebo.
Proportion of subjects with endoscopic improvement. Proportion of subjects achieving endoscopic remission. Proportion of subjects with histological improvement. Proportion of subjects achieving histological remission. Proportion of subjects with mucosal healing.

Full Information

First Posted
August 5, 2020
Last Updated
April 24, 2023
Sponsor
Protagonist Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04504383
Brief Title
PN-943 in Adults With Moderate to Severe Active Ulcerative Colitis (UC)
Official Title
A Phase 2 Randomized, Double-blind, Placebo-controlled, Parallel-group, Multi-center Study to Evaluate the Safety and Efficacy of Oral PN-943 in Subjects With Moderate to Severe Active Ulcerative Colitis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
August 5, 2020 (Actual)
Primary Completion Date
February 16, 2023 (Actual)
Study Completion Date
February 16, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Protagonist Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of the study is to evaluate the safety, tolerability, and clinical efficacy of PN-943 450 mg twice daily [BID] and PN-943 150 mg BID, compared with placebo BID, in subjects with moderate to severe active Ulcerative Colitis (UC).
Detailed Description
The study consists of a 12-week double-blind, placebo-controlled treatment period. Participants will be randomized in a 1:1:1 ratio to PN-943 450 mg BID, PN-943 150 mg BID, or matching placebo BID. Participants who successfully complete the double-blind period may be eligible for an extended treatment period of 40 weeks duration.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis Chronic Moderate, Ulcerative Colitis Chronic Severe
Keywords
Inflammatory Bowel Disease (IBD)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
12-week randomized, double-blind, placebo-controlled, parallel design study in patients with moderate to severe active UC. It will be followed by 40 weeks of Extended Active Treatment.
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
169 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PN-943 450 mg BID
Arm Type
Experimental
Arm Description
Oral administration of PN-943 450 mg BID
Arm Title
PN-943 150 mg BID
Arm Type
Experimental
Arm Description
Oral administration of PN-943 150 mg BID
Arm Title
Placebo BID
Arm Type
Placebo Comparator
Arm Description
Oral administration of matching placebo
Intervention Type
Drug
Intervention Name(s)
PN-943
Intervention Description
Administered by the oral route BID for the duration of the study.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered by the oral route BID for 12 weeks.
Primary Outcome Measure Information:
Title
Proportion of subjects achieving clinical remission at Week 12 compared to placebo.
Description
Clinical remission is determined using the Adapted Mayo score (sum of 3 subscores from the Mayo score): Stool frequency subscore (SFS) Rectal bleeding subscore (RBS) Endoscopic subscore (ESS)
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Comparison between PN-943 high-dose and low-dose individually to placebo.
Description
Proportion of subjects with endoscopic improvement. Proportion of subjects achieving endoscopic remission. Proportion of subjects with histological improvement. Proportion of subjects achieving histological remission. Proportion of subjects with mucosal healing.
Time Frame
Week 12
Other Pre-specified Outcome Measures:
Title
Proportion of subjects achieving clinical remission at Week 52.
Description
Clinical remission is determined using the Adapted Mayo score (sum of 3 subscores from the Mayo score): Stool frequency subscore (SFS) Rectal bleeding subscore (RBS) Endoscopic subscore (ESS)
Time Frame
Week 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: Male and female subjects age 18 (or the minimum country specific age of consent if >18) to 75 years. Subject understands the study procedures and agrees to participate in the study by giving written informed consent. Diagnosis of UC supported by appropriate documentation of biopsy results consistent with UC. Moderate to severe active UC. Demonstrated inadequate response, loss of response, or intolerance of at least 1 of oral aminosalicylates (5-ASAs), corticosteroids, immunomodulators, or a biologic (excluding vedolizumab). Key Exclusion Criteria: Subject with a current diagnosis of Crohn's disease (CD), indeterminate colitis (IC), microscopic colitis, ischemic colitis, radiation colitis. History of colonic dysplasia other than completely removed low-grade dysplastic lesion. History of active bacterial, viral, fungal or mycobacterial infection requiring hospitalization or IV antibiotic/anti-infective treatment within 4 weeks of screening or oral antibiotics/anti-infectives within 2 weeks of screening. Prior treatment with vedolizumab, natalizumab, or any agent targeting the α4β7 or β1 integrin or planned during the study. Positive stool test for C. difficile. Chronic recurrent or serious infection. Known primary or secondary immunodeficiency. Pregnant or lactating female or considering becoming pregnant during the study or within 30 days after the last dose of study medication. History of any major neurological disorders.
Facility Information:
Facility Name
Protagonist Investigational Site
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Protagonist Investigational Site
City
Garden Grove
State/Province
California
ZIP/Postal Code
92845
Country
United States
Facility Name
Protagonist Investigational Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90036
Country
United States
Facility Name
Protagonist Investigational Site
City
Murrieta
State/Province
California
ZIP/Postal Code
92563
Country
United States
Facility Name
Protagonist Investigational Site
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Facility Name
Protagonist Investigational Site
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Facility Name
Protagonist Investigational Site
City
Kissimmee
State/Province
Florida
ZIP/Postal Code
34741
Country
United States
Facility Name
Protagonist Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
Facility Name
Protagonist Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33175
Country
United States
Facility Name
Protagonist Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Facility Name
Protagonist Investigational site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32819
Country
United States
Facility Name
Protagonist Investigational Site
City
Saint Augustine
State/Province
Florida
ZIP/Postal Code
32086
Country
United States
Facility Name
Protagonist Investigational Site
City
Wesley Chapel
State/Province
Florida
ZIP/Postal Code
33544
Country
United States
Facility Name
Protagonist Investigational Site
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
Protagonist Investigational Site
City
Glen Burnie
State/Province
Maryland
ZIP/Postal Code
21061
Country
United States
Facility Name
Protagonist Investigational Site
City
Chesterfield
State/Province
Michigan
ZIP/Postal Code
48047
Country
United States
Facility Name
Protagonist Investigational Site
City
Troy
State/Province
Michigan
ZIP/Postal Code
48098
Country
United States
Facility Name
Protagonist Investigational Site
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
Protagonist Investigational Site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Protagonist Investigational Site
City
Englewood
State/Province
New Jersey
ZIP/Postal Code
07631
Country
United States
Facility Name
Protagonist Investigational Site
City
North Massapequa
State/Province
New York
ZIP/Postal Code
11758
Country
United States
Facility Name
Protagonist Investigational Site
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210
Country
United States
Facility Name
Protagonist Investigational Site
City
Norman
State/Province
Oklahoma
ZIP/Postal Code
73071
Country
United States
Facility Name
Protagonist Investigational Site
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
Facility Name
Protagonist Investigational Site
City
Orangeburg
State/Province
South Carolina
ZIP/Postal Code
29118
Country
United States
Facility Name
Protagonist Investigational Site
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States
Facility Name
Protagonist Investigational Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78742
Country
United States
Facility Name
Protagonist Investigational site
City
Garland
State/Province
Texas
ZIP/Postal Code
75044
Country
United States
Facility Name
Protagonist Investigational Site
City
Pasadena
State/Province
Texas
ZIP/Postal Code
77505
Country
United States
Facility Name
Protagonist Investigational Site
City
Spring
State/Province
Texas
ZIP/Postal Code
77388
Country
United States
Facility Name
Protagonist Investigational site
City
Lynchburg
State/Province
Virginia
ZIP/Postal Code
24502
Country
United States
Facility Name
Protagonist Investigational Site
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
Facility Name
Protagonist Investigational Site
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Facility Name
Protagonist Investigational Site
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Facility Name
Protagonist Investigational Site
City
Sofia
ZIP/Postal Code
1303
Country
Bulgaria
Facility Name
Protagonist Investigational Site
City
Sofia
ZIP/Postal Code
1407
Country
Bulgaria
Facility Name
Protagonist Investigational Site
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1Y 4N7
Country
Canada
Facility Name
Protagonist Investigational Site
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6K 2K5
Country
Canada
Facility Name
Protagonist Investigational Site
City
West Vancouver
State/Province
British Columbia
ZIP/Postal Code
V7T 1C5
Country
Canada
Facility Name
Protagonist Investigational Site
City
North Bay
State/Province
Ontario
ZIP/Postal Code
P1B 2H3
Country
Canada
Facility Name
Protagonist Investigational Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 3A9
Country
Canada
Facility Name
Protagonist Investigational Site
City
Vaughan
State/Province
Ontario
ZIP/Postal Code
L4L 4Y7
Country
Canada
Facility Name
Protagonist Investigational Site
City
Tbilisi
ZIP/Postal Code
0141
Country
Georgia
Facility Name
Protagonist Investigational Site
City
Tbilisi
ZIP/Postal Code
0144
Country
Georgia
Facility Name
Protagonist Investigational Site
City
Tbilisi
ZIP/Postal Code
0159
Country
Georgia
Facility Name
Protagonist Investigational Site
City
Tbilisi
ZIP/Postal Code
0160
Country
Georgia
Facility Name
Protagonist Investigational Site
City
Tbilisi
ZIP/Postal Code
0186
Country
Georgia
Facility Name
Protagonist Investigational Site
City
Berlin
ZIP/Postal Code
14050
Country
Germany
Facility Name
Protagonist Investigational Site
City
Berlin
ZIP/Postal Code
14163
Country
Germany
Facility Name
Protagonist Investigational Site
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Facility Name
Protagonist Investigational Site
City
Tuebingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Protagonist Investigational Site
City
Budapest
ZIP/Postal Code
H-1033
Country
Hungary
Facility Name
Protagonist Investigational Site
City
Debrecen
ZIP/Postal Code
4025
Country
Hungary
Facility Name
Protagonist Investigational Site
City
Székesfehérvár
ZIP/Postal Code
8000
Country
Hungary
Facility Name
Protagonist Investigational Site
City
Castellana Grotte
ZIP/Postal Code
70013
Country
Italy
Facility Name
Protagonist Investigational Site
City
Modena
ZIP/Postal Code
41124
Country
Italy
Facility Name
Protagonist Investigational Site
City
Negrar
ZIP/Postal Code
37024
Country
Italy
Facility Name
Protagonist Investigational Site
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
Protagonist Investigational Site
City
Roma
ZIP/Postal Code
00152
Country
Italy
Facility Name
Protagonist Investigational Site
City
Roma
ZIP/Postal Code
00168
Country
Italy
Facility Name
Protagonist Investigational Site
City
San Giovanni Rotondo
ZIP/Postal Code
71013
Country
Italy
Facility Name
Protagonist Investigational Site
City
Busan
ZIP/Postal Code
48079
Country
Korea, Republic of
Facility Name
Protagonist Investigational Site
City
Busan
ZIP/Postal Code
49201
Country
Korea, Republic of
Facility Name
Protagonist Investigational Site
City
Daegu
ZIP/Postal Code
42415
Country
Korea, Republic of
Facility Name
Protagonist Investigational Site
City
Daegu
ZIP/Postal Code
42601
Country
Korea, Republic of
Facility Name
Protagonist Investigational Site
City
Daejeon
ZIP/Postal Code
34943
Country
Korea, Republic of
Facility Name
Protagonist Investigational Site
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Protagonist Investigational Site
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Facility Name
Protagonist Investigational site
City
Seoul
ZIP/Postal Code
06973
Country
Korea, Republic of
Facility Name
Protagonist Investigational Site
City
Poznań
State/Province
Wielkopolskie
ZIP/Postal Code
60-848
Country
Poland
Facility Name
Protagonist Investigational Site
City
Bydgoszcz
ZIP/Postal Code
85-079
Country
Poland
Facility Name
Protagonist Investigational Site
City
Bydgoszcz
ZIP/Postal Code
85794
Country
Poland
Facility Name
Protagonist Investigational Site
City
Czestochowa
ZIP/Postal Code
42-200
Country
Poland
Facility Name
Protagonist Investigational Site
City
Czestochowa
ZIP/Postal Code
42217
Country
Poland
Facility Name
Protagonist Investigational Site
City
Katowice
ZIP/Postal Code
40-748
Country
Poland
Facility Name
Protagonist Investigational Site
City
Kraków
ZIP/Postal Code
31-501
Country
Poland
Facility Name
Protagonist Investigational Site
City
Ksawerów
ZIP/Postal Code
95-054
Country
Poland
Facility Name
Protagonist Investigational Site
City
Lublin
ZIP/Postal Code
20-582
Country
Poland
Facility Name
Protagonist Investigational Site
City
Nowy Targ
ZIP/Postal Code
34-400
Country
Poland
Facility Name
Protagonist Investigational Site
City
Piotrków Trybunalski
ZIP/Postal Code
97-300
Country
Poland
Facility Name
Protagonist Investigational Site
City
Poznań
ZIP/Postal Code
60-529
Country
Poland
Facility Name
Protagonist Investigational Site
City
Poznań
ZIP/Postal Code
61-441
Country
Poland
Facility Name
Protagonist Investigational Site
City
Rzeszów
ZIP/Postal Code
35-326
Country
Poland
Facility Name
Protagonist Investigational Site
City
Sopot
ZIP/Postal Code
81-756
Country
Poland
Facility Name
Protagonist Investigational Site
City
Swidnica
ZIP/Postal Code
58-100
Country
Poland
Facility Name
Protagonist Investigational Site
City
Toruń
ZIP/Postal Code
87-100
Country
Poland
Facility Name
Protagonist Investigational Site
City
Tychy
ZIP/Postal Code
43-100
Country
Poland
Facility Name
Protagonist Investigational Site
City
Warsaw
ZIP/Postal Code
00-635
Country
Poland
Facility Name
Protagonist Investigational Site
City
Warsaw
ZIP/Postal Code
00-728
Country
Poland
Facility Name
Protagonist Investigational Site
City
Warszawa
ZIP/Postal Code
00-332
Country
Poland
Facility Name
Protagonist Investigational Site
City
Wrocław
ZIP/Postal Code
50449
Country
Poland
Facility Name
Protagonist Investigational Site
City
Wrocław
ZIP/Postal Code
51-162
Country
Poland
Facility Name
Protagonist Investigational Site
City
Wrocław
ZIP/Postal Code
51-685
Country
Poland
Facility Name
Protagonist Investigational Site
City
Wrocław
ZIP/Postal Code
52210
Country
Poland
Facility Name
Protagonist Investigational Site
City
Włocławek
ZIP/Postal Code
87-800
Country
Poland
Facility Name
Protagonist Investigational Site
City
Łódź
ZIP/Postal Code
90-349
Country
Poland
Facility Name
Protagonist Investigational Site
City
Łódź
ZIP/Postal Code
90-644
Country
Poland
Facility Name
Protagonist Investigational Site
City
Chelyabinsk
ZIP/Postal Code
454076
Country
Russian Federation
Facility Name
Protagonist Investigational Site
City
Moscow
ZIP/Postal Code
105554
Country
Russian Federation
Facility Name
Protagonist Investigational Site
City
Novosibirsk
ZIP/Postal Code
630087
Country
Russian Federation
Facility Name
Protagonist Investigational Site
City
Novosibirsk
Country
Russian Federation
Facility Name
Protagonist Investigational Site
City
Perm
ZIP/Postal Code
614068
Country
Russian Federation
Facility Name
Protagonist Investigational Site
City
Pyatigorsk
ZIP/Postal Code
357500
Country
Russian Federation
Facility Name
Protagonist Investigational Site
City
Saint Petersburg
ZIP/Postal Code
196143
Country
Russian Federation
Facility Name
Protagonist Investigational Site
City
Saint Petersburg
ZIP/Postal Code
196257
Country
Russian Federation
Facility Name
Protagonist Investigational Site
City
Saint Petersburg
ZIP/Postal Code
197089
Country
Russian Federation
Facility Name
Protagonist Investigational Site
City
Saint Petersburg
ZIP/Postal Code
197110
Country
Russian Federation
Facility Name
Protagonist Investigational Site
City
Samara
ZIP/Postal Code
443029
Country
Russian Federation
Facility Name
Protagonist Investigational Site
City
Saratow
ZIP/Postal Code
410053
Country
Russian Federation
Facility Name
Protagonist Investigational Site
City
Stavropol'
ZIP/Postal Code
355000
Country
Russian Federation
Facility Name
Protagonist Investigational Site
City
Tomsk
ZIP/Postal Code
634063
Country
Russian Federation
Facility Name
Protagonist Investigational Site
City
Tyumen
ZIP/Postal Code
625026
Country
Russian Federation
Facility Name
Protagonist Investigational Site
City
Zrenjanin
ZIP/Postal Code
23000
Country
Serbia
Facility Name
Protagonist Investigational Site
City
Ivano-Frankivs'k
ZIP/Postal Code
76018
Country
Ukraine
Facility Name
Protagonist Investigational Site
City
Kherson
ZIP/Postal Code
73000
Country
Ukraine
Facility Name
Protagonist Investigational Site
City
Kyiv
ZIP/Postal Code
01030
Country
Ukraine
Facility Name
Protagonist Investigational Site
City
Kyiv
ZIP/Postal Code
01103
Country
Ukraine
Facility Name
Protagonist Investigational Site
City
Kyiv
ZIP/Postal Code
04073
Country
Ukraine
Facility Name
Protagonist Investigational Site
City
Lviv
ZIP/Postal Code
79007
Country
Ukraine
Facility Name
Protagonist Investigational Site
City
Vinnytsia
ZIP/Postal Code
21000
Country
Ukraine
Facility Name
Protagonist Investigational Site
City
Vinnytsia
ZIP/Postal Code
21018
Country
Ukraine
Facility Name
Protagonist Investigational Site
City
Zhytomyr
ZIP/Postal Code
10003
Country
Ukraine

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

PN-943 in Adults With Moderate to Severe Active Ulcerative Colitis (UC)

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