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

April 24, 2023 updated by: Protagonist Therapeutics, Inc.

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

169

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Innsbruck, Austria, 6020
        • Protagonist Investigational Site
      • Salzburg, Austria, 5020
        • Protagonist Investigational Site
      • Vienna, Austria, 1090
        • Protagonist Investigational Site
  • Bulgaria
      • Sofia, Bulgaria, 1303
        • Protagonist Investigational Site
      • Sofia, Bulgaria, 1407
        • Protagonist Investigational Site
  • Canada
    • British Columbia
      • Kelowna, British Columbia, Canada, V1Y 4N7
        • Protagonist Investigational Site
      • Vancouver, British Columbia, Canada, V6K 2K5
        • Protagonist Investigational Site
      • West Vancouver, British Columbia, Canada, V7T 1C5
        • Protagonist Investigational Site
    • Ontario
      • North Bay, Ontario, Canada, P1B 2H3
        • Protagonist Investigational Site
      • Toronto, Ontario, Canada, M5T 3A9
        • Protagonist Investigational Site
      • Vaughan, Ontario, Canada, L4L 4Y7
        • Protagonist Investigational Site
  • Georgia
      • Tbilisi, Georgia, 0141
        • Protagonist Investigational Site
      • Tbilisi, Georgia, 0144
        • Protagonist Investigational Site
      • Tbilisi, Georgia, 0159
        • Protagonist Investigational Site
      • Tbilisi, Georgia, 0160
        • Protagonist Investigational Site
      • Tbilisi, Georgia, 0186
        • Protagonist Investigational Site
  • Germany
      • Berlin, Germany, 14050
        • Protagonist Investigational Site
      • Berlin, Germany, 14163
        • Protagonist Investigational Site
      • Kiel, Germany, 24105
        • Protagonist Investigational Site
      • Tuebingen, Germany, 72076
        • Protagonist Investigational Site
  • Hungary
      • Budapest, Hungary, H-1033
        • Protagonist Investigational Site
      • Debrecen, Hungary, 4025
        • Protagonist Investigational Site
      • Székesfehérvár, Hungary, 8000
        • Protagonist Investigational Site
  • Italy
      • Castellana Grotte, Italy, 70013
        • Protagonist Investigational Site
      • Modena, Italy, 41124
        • Protagonist Investigational Site
      • Negrar, Italy, 37024
        • Protagonist Investigational Site
      • Padova, Italy, 35128
        • Protagonist Investigational Site
      • Roma, Italy, 00152
        • Protagonist Investigational Site
      • Roma, Italy, 00168
        • Protagonist Investigational Site
      • San Giovanni Rotondo, Italy, 71013
        • Protagonist Investigational Site
  • Korea, Republic of
      • Busan, Korea, Republic of, 48079
        • Protagonist Investigational Site
      • Busan, Korea, Republic of, 49201
        • Protagonist Investigational Site
      • Daegu, Korea, Republic of, 42415
        • Protagonist Investigational Site
      • Daegu, Korea, Republic of, 42601
        • Protagonist Investigational Site
      • Daejeon, Korea, Republic of, 34943
        • Protagonist Investigational Site
      • Seoul, Korea, Republic of, 06351
        • Protagonist Investigational Site
      • Seoul, Korea, Republic of, 06591
        • Protagonist Investigational Site
      • Seoul, Korea, Republic of, 06973
        • Protagonist Investigational Site
  • Poland
      • Bydgoszcz, Poland, 85-079
        • Protagonist Investigational Site
      • Bydgoszcz, Poland, 85794
        • Protagonist Investigational Site
      • Czestochowa, Poland, 42-200
        • Protagonist Investigational Site
      • Czestochowa, Poland, 42217
        • Protagonist Investigational Site
      • Katowice, Poland, 40-748
        • Protagonist Investigational Site
      • Kraków, Poland, 31-501
        • Protagonist Investigational Site
      • Ksawerów, Poland, 95-054
        • Protagonist Investigational Site
      • Lublin, Poland, 20-582
        • Protagonist Investigational Site
      • Nowy Targ, Poland, 34-400
        • Protagonist Investigational Site
      • Piotrków Trybunalski, Poland, 97-300
        • Protagonist Investigational Site
      • Poznań, Poland, 60-529
        • Protagonist Investigational Site
      • Poznań, Poland, 61-441
        • Protagonist Investigational Site
      • Rzeszów, Poland, 35-326
        • Protagonist Investigational Site
      • Sopot, Poland, 81-756
        • Protagonist Investigational Site
      • Swidnica, Poland, 58-100
        • Protagonist Investigational Site
      • Toruń, Poland, 87-100
        • Protagonist Investigational Site
      • Tychy, Poland, 43-100
        • Protagonist Investigational Site
      • Warsaw, Poland, 00-635
        • Protagonist Investigational Site
      • Warsaw, Poland, 00-728
        • Protagonist Investigational Site
      • Warszawa, Poland, 00-332
        • Protagonist Investigational Site
      • Wrocław, Poland, 50449
        • Protagonist Investigational Site
      • Wrocław, Poland, 51-162
        • Protagonist Investigational Site
      • Wrocław, Poland, 51-685
        • Protagonist Investigational Site
      • Wrocław, Poland, 52210
        • Protagonist Investigational Site
      • Włocławek, Poland, 87-800
        • Protagonist Investigational Site
      • Łódź, Poland, 90-349
        • Protagonist Investigational Site
      • Łódź, Poland, 90-644
        • Protagonist Investigational Site
    • Wielkopolskie
      • Poznań, Wielkopolskie, Poland, 60-848
        • Protagonist Investigational Site
  • Russian Federation
      • Chelyabinsk, Russian Federation, 454076
        • Protagonist Investigational Site
      • Moscow, Russian Federation, 105554
        • Protagonist Investigational Site
      • Novosibirsk, Russian Federation, 630087
        • Protagonist Investigational Site
      • Novosibirsk, Russian Federation
        • Protagonist Investigational Site
      • Perm, Russian Federation, 614068
        • Protagonist Investigational Site
      • Pyatigorsk, Russian Federation, 357500
        • Protagonist Investigational Site
      • Saint Petersburg, Russian Federation, 196143
        • Protagonist Investigational Site
      • Saint Petersburg, Russian Federation, 196257
        • Protagonist Investigational Site
      • Saint Petersburg, Russian Federation, 197089
        • Protagonist Investigational Site
      • Saint Petersburg, Russian Federation, 197110
        • Protagonist Investigational Site
      • Samara, Russian Federation, 443029
        • Protagonist Investigational Site
      • Saratow, Russian Federation, 410053
        • Protagonist Investigational Site
      • Stavropol', Russian Federation, 355000
        • Protagonist Investigational Site
      • Tomsk, Russian Federation, 634063
        • Protagonist Investigational Site
      • Tyumen, Russian Federation, 625026
        • Protagonist Investigational Site
  • Serbia
      • Zrenjanin, Serbia, 23000
        • Protagonist Investigational Site
  • Ukraine
      • Ivano-Frankivs'k, Ukraine, 76018
        • Protagonist Investigational Site
      • Kherson, Ukraine, 73000
        • Protagonist Investigational Site
      • Kyiv, Ukraine, 01030
        • Protagonist Investigational Site
      • Kyiv, Ukraine, 01103
        • Protagonist Investigational Site
      • Kyiv, Ukraine, 04073
        • Protagonist Investigational Site
      • Lviv, Ukraine, 79007
        • Protagonist Investigational Site
      • Vinnytsia, Ukraine, 21000
        • Protagonist Investigational Site
      • Vinnytsia, Ukraine, 21018
        • Protagonist Investigational Site
      • Zhytomyr, Ukraine, 10003
        • Protagonist Investigational Site
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85712
        • Protagonist Investigational Site
    • California
      • Garden Grove, California, United States, 92845
        • Protagonist Investigational Site
      • Los Angeles, California, United States, 90036
        • Protagonist Investigational Site
      • Murrieta, California, United States, 92563
        • Protagonist Investigational Site
      • San Francisco, California, United States, 94158
        • Protagonist Investigational Site
    • Colorado
      • Colorado Springs, Colorado, United States, 80907
        • Protagonist Investigational Site
    • Florida
      • Kissimmee, Florida, United States, 34741
        • Protagonist Investigational Site
      • Miami, Florida, United States, 33125
        • Protagonist Investigational Site
      • Miami, Florida, United States, 33175
        • Protagonist Investigational Site
      • Miami, Florida, United States, 33180
        • Protagonist Investigational Site
      • Orlando, Florida, United States, 32819
        • Protagonist Investigational Site
      • Saint Augustine, Florida, United States, 32086
        • Protagonist Investigational Site
      • Wesley Chapel, Florida, United States, 33544
        • Protagonist Investigational Site
    • Louisiana
      • Metairie, Louisiana, United States, 70006
        • Protagonist Investigational Site
    • Maryland
      • Glen Burnie, Maryland, United States, 21061
        • Protagonist Investigational Site
    • Michigan
      • Chesterfield, Michigan, United States, 48047
        • Protagonist Investigational Site
      • Troy, Michigan, United States, 48098
        • Protagonist Investigational Site
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • Protagonist Investigational Site
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Protagonist Investigational Site
    • New Jersey
      • Englewood, New Jersey, United States, 07631
        • Protagonist Investigational Site
    • New York
      • North Massapequa, New York, United States, 11758
        • Protagonist Investigational Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28210
        • Protagonist Investigational Site
    • Oklahoma
      • Norman, Oklahoma, United States, 73071
        • Protagonist Investigational Site
      • Oklahoma City, Oklahoma, United States, 73103
        • Protagonist Investigational Site
    • South Carolina
      • Orangeburg, South Carolina, United States, 29118
        • Protagonist Investigational Site
    • Tennessee
      • Nashville, Tennessee, United States, 37212
        • Protagonist Investigational Site
    • Texas
      • Austin, Texas, United States, 78742
        • Protagonist Investigational Site
      • Garland, Texas, United States, 75044
        • Protagonist Investigational Site
      • Pasadena, Texas, United States, 77505
        • Protagonist Investigational Site
      • Spring, Texas, United States, 77388
        • Protagonist Investigational Site
    • Virginia
      • Lynchburg, Virginia, United States, 24502
        • Protagonist Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PN-943 450 mg BID
Oral administration of PN-943 450 mg BID
Drug: PN-943
Administered by the oral route BID for the duration of the study.
Experimental: PN-943 150 mg BID
Oral administration of PN-943 150 mg BID
Drug: PN-943
Administered by the oral route BID for the duration of the study.
Placebo Comparator: Placebo BID
Oral administration of matching placebo
Drug: Placebo
Administered by the oral route BID for 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of subjects achieving clinical remission at Week 12 compared to placebo.
Time Frame: Week 12

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)
Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison between PN-943 high-dose and low-dose individually to placebo.
Time Frame: Week 12
  1. Proportion of subjects with endoscopic improvement.
  2. Proportion of subjects achieving endoscopic remission.
  3. Proportion of subjects with histological improvement.
  4. Proportion of subjects achieving histological remission.
  5. Proportion of subjects with mucosal healing.
Week 12

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of subjects achieving clinical remission at Week 52.
Time Frame: Week 52

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)
Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Protagonist Therapeutics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 5, 2020

Primary Completion (Actual)

February 16, 2023

Study Completion (Actual)

February 16, 2023

Study Registration Dates

First Submitted

August 5, 2020

First Submitted That Met QC Criteria

August 5, 2020

First Posted (Actual)

August 7, 2020

Study Record Updates

Last Update Posted (Actual)

April 25, 2023

Last Update Submitted That Met QC Criteria

April 24, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PN-943-03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Ulcerative Colitis Chronic Moderate

Clinical Trials on PN-943

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Sweden

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe