Safety and Efficacy Study of PTG-100 in the Treatment of Moderate to Severe Ulcerative Colitis

September 24, 2021 updated by: Protagonist Therapeutics, Inc.

A Phase 2b Randomised, Double-blind, Placebo-controlled, Parallel, Adaptive 2-Stage, Multi-Centre Study to Evaluate the Safety and Efficacy of Oral PTG-100 Induction in Subjects With Moderate to Severe Active Ulcerative Colitis

The main objectives of this study are to evaluate the efficacy, safety, and tolerability of daily doses of PTG-100 in subjects with moderate to severe ulcerative colitis (UC).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

This is a Phase II multi-centre, double blind, randomised, placebo-controlled, clinical study to evaluate the efficacy, safety, and tolerability of an oral peptide, PTG-100, administered as capsules for 12 weeks in subjects with moderate to severe UC.

Following screening procedures and confirmation of subject eligibility, subjects will be randomised 1:1:1:1 to one of three daily doses of PTG-100 (150, 300 or 900 mg) or placebo. Stratification will be based on subjects' prior treatment with anti-TNF agents, with a maximum of 50% of subjects with prior unsuccessful anti-TNF agent treatments. Subjects will be treated with study drug for 12 weeks. Sigmoidoscopies will be performed at the Screening Visit and on Week 12. A final Follow Up Visit will occur on Week 16, when subject has been off study treatment for 4 weeks. Clinical, safety, pharmacokinetic (PK) and pharmacodynamic (PD) parameters will be evaluated on an ongoing basis during the 16 week study.

Study Type

Interventional

Enrollment (Actual)

98

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

  • Australia
      • Herston, Australia, 4006
        • Site Reference ID/Investigator # 908
      • South Brisbane, Australia, 4101
        • Site Reference ID/Investigator # 900
      • Subiaco, Australia, 6008
        • Site Reference ID/Investigator # 907
    • Western Australia
      • Murdoch, Western Australia, Australia, 6150
        • Site Reference ID/Investigator # 901
  • Belgium
      • Gent, Belgium, 9000
        • Site Reference ID/Investigator # 559
      • Kortrijk, Belgium, 8500
        • Site Reference ID/Investigator # 533
      • Leuven, Belgium, 3000
        • Site Reference ID/Investigator # 505
  • Bosnia and Herzegovina
      • Mostar, Bosnia and Herzegovina, 88000
        • Site Reference ID/Investigator # 573
      • Tuzla, Bosnia and Herzegovina, 3 75000
        • Site Reference ID/Investigator # 571
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 2K5
        • Site Reference ID/Investigator # 103
    • Ontario
      • London, Ontario, Canada, N6A 5A5
        • Site Reference ID/Investigator # 105
  • Croatia
      • Osijek, Croatia, 31000
        • Site Reference ID/Investigator #556
      • Split, Croatia, 17 21000
        • Site Reference ID/Investigator # 550
      • Zagreb, Croatia, 21 10000
        • Site Reference ID/Investigator # 562
  • Czechia
      • Nový Hradec Králové, Czechia, 500 12
        • Site Reference ID/Investigator # 517
      • Zlín, Czechia, 76275
        • Site Reference ID/Investigator # 539
  • Germany
      • Berlin, Germany, 13353
        • Site Reference ID/Investigator # 560
      • Berlin, Germany, 14050
        • Site Reference ID/Investigator # 542
      • Kiel, Germany, 24105
        • Site Reference ID/Investigator # 532
      • Leipzig, Germany, 4103
        • Site Reference ID/Investigator # 506
      • Mannheim, Germany, 68167
        • Site Reference ID/Investigator # 572
      • Münster, Germany, 48149
        • Site Reference ID/Investigator # 538
      • Tuebingen, Germany, 72076
        • Site Reference ID/Investigator # 574
      • Ulm, Germany, 89073
        • Site Reference ID/Investigator # 541
  • Hungary
      • Budapest, Hungary, 1036
        • Site Reference ID/Investigator # 554
      • Budapest, Hungary, 1125
        • Site Reference ID/Investigator # 558
      • Debrecen, Hungary, 4032
        • Site Reference ID/Investigator # 552
      • Eger, Hungary, 3300
        • Site Reference ID/Investigator # 567
      • Kistarcsa, Hungary, 2143
        • Site Reference ID/Investigator # 557
      • Mosonmagyaróvár, Hungary, 9200
        • Site Reference ID/Investigator # 544
      • Sopron, Hungary, 9400
        • Site Reference ID/Investigator # 563
  • Korea, Republic of
      • Daegu, Korea, Republic of, 42415
        • Site Reference ID/Investigator # 906
      • Seoul, Korea, Republic of, 06591
        • Site Reference ID/Investigator # 905
      • Seoul, Korea, Republic of, 3722
        • Site Reference ID/Investigator # 904
  • Latvia
      • Riga, Latvia, 1002
        • Site Reference ID/Investigator # 501
      • Riga, Latvia, LV-1002
        • Site Reference ID/Investigator # 545
  • Netherlands
      • Amsterdam, Netherlands, 1105
        • Site Reference ID/Investigator # 568
  • New Zealand
      • Dunedin, New Zealand, 9016
        • Site Reference ID/Investigator # 903
      • Newton, New Zealand, 6021
        • Site Reference ID/Investigator # 902
  • Poland
      • Kielce, Poland, 25-364
        • Site Reference ID/Investigator # 529
      • Krakow, Poland, 31-531
        • Site Reference ID/Investigator # 540
      • Kraków, Poland, 31-530
        • Site Reference ID/Investigator # 576
      • Ksawerów, Poland, 95-054
        • Site Reference ID/Investigator # 512
      • Lodz, Poland, 90-153
        • Site Reference ID/Investigator # 530
      • Lodz, Poland, 90-302
        • Site Reference ID/Investigator # 518
      • Poznań, Poland, 61-845
        • Site Reference ID/Investigator # 577
      • Sopot, Poland, 81-756
        • Site Reference ID/Investigator # 546
      • Warszawa, Poland, 00-632
        • Site Reference ID/Investigator # 513
      • Wloclawek, Poland, 87-806
        • Site Reference ID/Investigator # 531
  • Russian Federation
      • Kazan', Russian Federation, 420029
        • Site Reference ID/Investigator # 553
      • Moscow, Russian Federation, 125412
        • Site Reference ID/Investigator # 524
      • Moskva, Russian Federation, 127015
        • Site Reference ID/Investigator # 536
      • Novosibirsk, Russian Federation, 630117
        • Site Reference ID/Investigator # 515
      • Rostov-na-Donu, Russian Federation, 344022
        • Site Reference ID/Investigator # 526
      • Saint Petersburg, Russian Federation, 191186
        • Site Reference ID/Investigator # 514
      • Saint Petersburg, Russian Federation, 195067
        • Site Reference ID/Investigator # 522
      • Saint Petersburg, Russian Federation, 195257
        • Site Reference ID/Investigator # 555
      • Samara, Russian Federation, 443093
        • Site Reference ID/Investigator # 523
      • Ufa, Russian Federation, 450071
        • Site Reference ID/Investigator # 551
      • Yaroslavl, Russian Federation, 150000
        • Site Reference ID/Investigator # 525
  • Serbia
      • Belgrade, Serbia, 0 11080
        • Site Reference ID/Investigator # 521
      • Belgrade, Serbia, 11000
        • Site Reference ID/Investigator # 575
      • Belgrade, Serbia, 11080
        • Site Reference ID/Investigator # 566
      • Kragujevac, Serbia, 12 34111
        • Site Reference ID/Investigator # 500
      • Niš, Serbia, 18105
        • Site Reference ID/Investigator # 543
      • Zvezdara, Serbia, 0 11050
        • Site Reference ID/Investigator # 502
  • Ukraine
      • Chernivtsi, Ukraine, 3110
        • Site Reference ID/Investigator # 510
      • Ivano-Frankivs'k, Ukraine, 76018
        • Site Reference ID/Investigator # 535
      • Kharkiv, Ukraine, 61039
        • Site Reference ID/Investigator # 508
      • Kharkov, Ukraine, 6100
        • Site Reference ID/Investigator # 509
      • Kiev, Ukraine
        • Site Reference ID/Investigator # 549
      • Kyiv, Ukraine, 2232
        • Site Reference ID/Investigator # 565
      • L'viv, Ukraine, 79059
        • Site Reference ID/Investigator # 534
      • Odessa, Ukraine, 65025
        • Site Reference ID/Investigator # 520
      • Uzhgorod, Ukraine, 88000
        • Site Reference ID/Investigator # 504
      • Vinnytsya, Ukraine, 21018
        • Site Reference ID/Investigator # 507
      • Zaporizhzhya, Ukraine, 609065
        • Site Reference ID/Investigator # 547
  • United States
    • California
      • Los Angeles, California, United States, 90036
        • Site Reference ID/Investigator # 101
      • Los Angeles, California, United States, 90036
        • Site Reference ID/Investigator # 102
    • Colorado
      • Colorado Springs, Colorado, United States, 80907
        • Site Reference ID/Investigator # 125
    • Florida
      • Miami, Florida, United States, 33126
        • Site Reference ID/Investigator # 120
      • Port Orange, Florida, United States, 32128
        • Site Reference ID/Investigator # 106
      • Saint Augustine, Florida, United States, 32086
        • Site Reference ID/Investigator # 115
      • Sweetwater, Florida, United States, 33172
        • Site Reference ID/Investigator # 116
    • Georgia
      • Atlanta, Georgia, United States, 30607
        • Site Reference ID/Investigator # 100
      • Marietta, Georgia, United States, 30060
        • Site Reference ID/Investigator # 104
      • Suwanee, Georgia, United States, 30024
        • Site Reference ID/Investigator # 112
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Site Reference ID/Investigator # 107
    • Louisiana
      • Bastrop, Louisiana, United States, 71220
        • Site Reference ID/Investigator # 126
      • Shreveport, Louisiana, United States, 71105
        • Site Reference ID/Investigator # 114
    • Maryland
      • Chevy Chase, Maryland, United States, 20815
        • Site Reference ID/Investigator # 117
    • New York
      • Great Neck, New York, United States, 11021
        • Site Reference ID/Investigator # 109
      • New York, New York, United States, 10065
        • Site Reference ID/Investigator # 122
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Site Reference ID/Investigator # 119
    • Tennessee
      • Hermitage, Tennessee, United States, 37076
        • Site Reference ID/Investigator # 110
      • Nashville, Tennessee, United States, 37212
        • Site Reference ID/Investigator # 128
    • Texas
      • DeSoto, Texas, United States, 75035
        • Site Reference ID/Investigator # 118
    • Virginia
      • Richmond, Virginia, United States, 23249
        • Site Reference ID/Investigator # 113

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

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria include:

  • Male and female subjects age 18 to 80 years, inclusive
  • Diagnosis of UC for at least 2 months prior to screening
  • Moderate to severe active UC as defined by Mayo Score of 6 to 12 inclusive (range of 0-12) at baseline with endoscopy score of at least 2 (range 0-3)
  • Subject must have had an inadequate response, loss of response to or intolerance to at least of of the following medications: immunomodulators, TNF-alpha antagonists or corticosteroids
  • Subject is unlikely to conceive, as defined by one of the following: a) subject is male, b) subject is surgically sterilized female, c) subject is post-menopausal female >= 45 years of age with clinical documentation of menopause, or d) subject is woman of child bearing potential (WOCBP) and agrees to abstain from heterosexual activity, use adequate hormonal contraception or use double barrier contraception.
  • For WOCBP, a negative pregnancy test at screening and within 24 hours of first dose of study medication

Exclusion Criteria include:

  • Subject has Crohn's Disease (CD), indeterminate colitis (IC) or presence or history of fistula with CD
  • History of toxic megacolon, abdominal abscess, symptomatic colonic stricture or stoma; history or is at imminent risk of colectomy
  • History or current evidence of colonic dysplasia or adenomatous colonic polyps
  • Current bacterial or parasitic pathogenic enteric infection, including Clostridium difficile, infection with hepatitis B or C virus, infection with human immunodeficiency virus, infection requiring hospitalisation or intravenous antimicrobial therapy, or opportunistic infection within 6 months, any infection requiring antimicrobial therapy within 2 weeks, history of more than one episode of herpes zoster or any episode of disseminated zoster
  • Live virus vaccination within one month prior to screening
  • Subject has a concurrent clinically significant, unstable, or uncontrolled cardiovascular, pulmonary, hepatic, renal, gastrointestinal, genitourinary, hematological, coagulation, immunological, endocrine/metabolic, or other medical disorder that, in the opinion of the investigator, might confound the study results or poses additional risk to the subject
  • Known primary or secondary immunodeficiency
  • History of myocardial infarction, unstable angina, transient ischaemic attack, decompensated heart failure requiring hospitalisation, congestive heart failure (NYHA Class 3 or 4), uncontrolled arrhythmias, cardiac revascularisation, stroke, uncontrolled hypertension, or uncontrolled diabetes within 6 months of screening
  • Clinically meaningful laboratory abnormalities at screening
  • Pregnant or lactating females
  • Any surgical procedure requiring general anaesthesia within one month prior to screening, or planned elective surgery during the study
  • History of malignant neoplasms or carcinoma in situ within 5 years prior to screening
  • History of any major neurological disorders, as judged by the Investigator, or positive progressive multifocal leukoencephalopathy (PML) subjective symptom checklist
  • Current or recent history of alcohol dependence or illicit drug use within 1 year prior to screening.
  • Subject is mentally or legally incapacitated at the time of screening visit or has a history of clinically significant psychiatric disorders that would impact the subject's ability to participate in the trial according to the investigator
  • Unable to attend study visits or comply with procedures
  • Concurrent participation in any other interventional study.

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
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: PTG-100 (150 mg QD)
Low dose
Drug: PTG-100
Daily dosing of PTG-100 by subject for a 12 week treatment period.
EXPERIMENTAL: PTG-100 (300 mg QD)
Medium dose
Drug: PTG-100
Daily dosing of PTG-100 by subject for a 12 week treatment period.
EXPERIMENTAL: PTG-100 (900 mg QD)
High dose
Drug: PTG-100
Daily dosing of PTG-100 by subject for a 12 week treatment period.
PLACEBO_COMPARATOR: Placebo group
Placebo control
Drug: Placebo
Daily dosing of Placebo capsules by subject for a 12 week treatment period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of Subjects Receiving PTG-100 With Clinical Remission at Week 12 Compared With Placebo
Time Frame: 12 week treatment period
The primary efficacy endpoint for this study was the proportion of subjects receiving PTG-100 with clinical remission at Week 12. Clinical remission was defined using the Mayo subscores of stool frequency, rectal bleeding, and endoscopy.
12 week treatment period

Collaborators and Investigators

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

Sponsor

Protagonist Therapeutics, Inc.

Investigators

  • Study Director: Director Clinical Development, Protagonist Therapeutics, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

December 1, 2016

Primary Completion (ACTUAL)

March 26, 2018

Study Completion (ACTUAL)

March 26, 2018

Study Registration Dates

First Submitted

September 4, 2016

First Submitted That Met QC Criteria

September 4, 2016

First Posted (ESTIMATE)

September 9, 2016

Study Record Updates

Last Update Posted (ACTUAL)

October 22, 2021

Last Update Submitted That Met QC Criteria

September 24, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PTG-100-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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.

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