AzTrials
AzTrials

Ulcerative ColitisPhase 2NCT02895100

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

A Phase 2 study testing PTG-100 in people with Ulcerative Colitis, run by Protagonist Therapeutics, Inc. at 98 sites in 17 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

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). Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Ulcerative Colitis
What is being tested?
PTG-100
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
98 participants
Where
98 sitesin 17 countries
Study dates
Dec 2016to 26 Mar 2018
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 17Show fewer
  • 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.

Trial locations and contacts

98 sites in 17 countries.

98 sites in 17 countries

United States21 sites

  • Site Reference ID/Investigator # 100

    Atlanta, Georgia, 30607

  • Site Reference ID/Investigator # 126

    Bastrop, Louisiana, 71220

  • Site Reference ID/Investigator # 117

    Chevy Chase, Maryland, 20815

  • Site Reference ID/Investigator # 107

    Chicago, Illinois, 60611

  • Site Reference ID/Investigator # 119

    Cincinnati, Ohio, 45219

  • Site Reference ID/Investigator # 125

    Colorado Springs, Colorado, 80907

  • Site Reference ID/Investigator # 118

    DeSoto, Texas, 75035

  • Site Reference ID/Investigator # 109

    Great Neck, New York, 11021

  • Site Reference ID/Investigator # 110

    Hermitage, Tennessee, 37076

  • Site Reference ID/Investigator # 101

    Los Angeles, California, 90036

  • Site Reference ID/Investigator # 102

    Los Angeles, California, 90036

  • Site Reference ID/Investigator # 104

    Marietta, Georgia, 30060

  • Site Reference ID/Investigator # 120

    Miami, Florida, 33126

  • Site Reference ID/Investigator # 128

    Nashville, Tennessee, 37212

  • Site Reference ID/Investigator # 122

    New York, New York, 10065

  • Site Reference ID/Investigator # 106

    Port Orange, Florida, 32128

  • Site Reference ID/Investigator # 113

    Richmond, Virginia, 23249

  • Site Reference ID/Investigator # 115

    Saint Augustine, Florida, 32086

  • Site Reference ID/Investigator # 114

    Shreveport, Louisiana, 71105

  • Site Reference ID/Investigator # 112

    Suwanee, Georgia, 30024

  • Site Reference ID/Investigator # 116

    Sweetwater, Florida, 33172

Other trials in United States

Russia11 sites

  • Site Reference ID/Investigator # 553

    Kazan', 420029

  • Site Reference ID/Investigator # 524

    Moscow, 125412

  • Site Reference ID/Investigator # 536

    Moskva, 127015

  • Site Reference ID/Investigator # 515

    Novosibirsk, 630117

  • Site Reference ID/Investigator # 526

    Rostov-on-Don, 344022

  • Site Reference ID/Investigator # 514

    Saint Petersburg, 191186

  • Site Reference ID/Investigator # 522

    Saint Petersburg, 195067

  • Site Reference ID/Investigator # 555

    Saint Petersburg, 195257

  • Site Reference ID/Investigator # 523

    Samara, 443093

  • Site Reference ID/Investigator # 551

    Ufa, 450071

  • Site Reference ID/Investigator # 525

    Yaroslavl, 150000

Other trials in Russia

Ukraine11 sites

  • Site Reference ID/Investigator # 510

    Chernivtsi, 3110

  • Site Reference ID/Investigator # 535

    Ivano-Frankivsk, 76018

  • Site Reference ID/Investigator # 509

    Kharkiv, 6100

  • Site Reference ID/Investigator # 508

    Kharkiv, 61039

  • Site Reference ID/Investigator # 549

    Kiev

  • Site Reference ID/Investigator # 565

    Kyiv, 2232

  • Site Reference ID/Investigator # 534

    Lviv, 79059

  • Site Reference ID/Investigator # 520

    Odesa, 65025

  • Site Reference ID/Investigator # 504

    Uzhhorod, 88000

  • Site Reference ID/Investigator # 507

    Vinnytsia, 21018

  • Site Reference ID/Investigator # 547

    Zaporizhzhya, 609065

Other trials in Ukraine

Poland10 sites

  • Site Reference ID/Investigator # 529

    Kielce, 25-364

  • Site Reference ID/Investigator # 576

    Krakow, 31-530

  • Site Reference ID/Investigator # 540

    Krakow, 31-531

  • Site Reference ID/Investigator # 512

    Ksawerów, 95-054

  • Site Reference ID/Investigator # 530

    Lodz, 90-153

  • Site Reference ID/Investigator # 518

    Lodz, 90-302

  • Site Reference ID/Investigator # 577

    Poznan, 61-845

  • Site Reference ID/Investigator # 546

    Sopot, 81-756

  • Site Reference ID/Investigator # 513

    Warsaw, 00-632

  • Site Reference ID/Investigator # 531

    Włocławek, 87-806

Other trials in Poland

Germany8 sites

  • Site Reference ID/Investigator # 560

    Berlin, 13353

  • Site Reference ID/Investigator # 542

    Berlin, 14050

  • Site Reference ID/Investigator # 532

    Kiel, 24105

  • Site Reference ID/Investigator # 506

    Leipzig, 4103

  • Site Reference ID/Investigator # 572

    Mannheim, 68167

  • Site Reference ID/Investigator # 538

    Münster, 48149

  • Site Reference ID/Investigator # 574

    Tübingen, 72076

  • Site Reference ID/Investigator # 541

    Ulm, 89073

Other trials in Germany

Hungary7 sites

  • Site Reference ID/Investigator # 554

    Budapest, 1036

  • Site Reference ID/Investigator # 558

    Budapest, 1125

  • Site Reference ID/Investigator # 552

    Debrecen, 4032

  • Site Reference ID/Investigator # 567

    Eger, 3300

  • Site Reference ID/Investigator # 557

    Kistarcsa, 2143

  • Site Reference ID/Investigator # 544

    Mosonmagyaróvár, 9200

  • Site Reference ID/Investigator # 563

    Sopron, 9400

Other trials in Hungary

Serbia6 sites

  • Site Reference ID/Investigator # 521

    Belgrade, 0 11080

  • Site Reference ID/Investigator # 575

    Belgrade, 11000

  • Site Reference ID/Investigator # 566

    Belgrade, 11080

  • Site Reference ID/Investigator # 500

    Kragujevac, 12 34111

  • Site Reference ID/Investigator # 543

    Niš, 18105

  • Site Reference ID/Investigator # 502

    Zvezdara, 0 11050

Other trials in Serbia

Australia4 sites

  • Site Reference ID/Investigator # 908

    Herston, 4006

  • Site Reference ID/Investigator # 901

    Murdoch, Western Australia, 6150

  • Site Reference ID/Investigator # 900

    South Brisbane, 4101

  • Site Reference ID/Investigator # 907

    Subiaco, 6008

Other trials in Australia

Belgium3 sites

  • Site Reference ID/Investigator # 559

    Ghent, 9000

  • Site Reference ID/Investigator # 533

    Kortrijk, 8500

  • Site Reference ID/Investigator # 505

    Leuven, 3000

Other trials in Belgium

Croatia3 sites

  • Site Reference ID/Investigator #556

    Osijek, 31000

  • Site Reference ID/Investigator # 550

    Split, 17 21000

  • Site Reference ID/Investigator # 562

    Zagreb, 21 10000

Other trials in Croatia

South Korea3 sites

  • Site Reference ID/Investigator # 906

    Daegu, 42415

  • Site Reference ID/Investigator # 905

    Seoul, 06591

  • Site Reference ID/Investigator # 904

    Seoul, 3722

Other trials in South Korea

Bosnia and Herzegovina2 sites

  • Site Reference ID/Investigator # 573

    Mostar, 88000

  • Site Reference ID/Investigator # 571

    Tuzla, 3 75000

Other trials in Bosnia and Herzegovina

Canada2 sites

  • Site Reference ID/Investigator # 105

    London, Ontario, N6A 5A5

  • Site Reference ID/Investigator # 103

    Vancouver, British Columbia, V6Z 2K5

Other trials in Canada

Czechia2 sites

  • Site Reference ID/Investigator # 517

    Nový Hradec Králové, 500 12

  • Site Reference ID/Investigator # 539

    Zlín, 76275

Other trials in Czechia

Latvia2 sites

  • Site Reference ID/Investigator # 501

    Riga, 1002

  • Site Reference ID/Investigator # 545

    Riga, LV-1002

Other trials in Latvia

New Zealand2 sites

  • Site Reference ID/Investigator # 903

    Dunedin, 9016

  • Site Reference ID/Investigator # 902

    Newton, 6021

Other trials in New Zealand

Netherlands1 site

  • Site Reference ID/Investigator # 568

    Amsterdam, 1105

Other trials in Netherlands

About this study

Official title: 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).

Read the 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.

Being tested
PTG-100, Placebo
Keywords
ulcerative colitis, inflammatory bowel disease, PROPEL, Propel Study
Medical subject headings
Colitis, Ulcerative, Inflammatory Bowel Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PTG-100Drug

    Daily dosing of PTG-100 by subject for a 12 week treatment period.

  • PlaceboDrug

    Daily dosing of Placebo capsules by subject for a 12 week treatment period.

Study groups in NCT02895100
Study groupRoleWhat they receive
PTG-100 (150 mg QD)ExperimentalLow dose
Receives: Drug: PTG-100
PTG-100 (300 mg QD)ExperimentalMedium dose
Receives: Drug: PTG-100
PTG-100 (900 mg QD)ExperimentalHigh dose
Receives: Drug: PTG-100
Placebo groupPlacebo comparatorPlacebo control
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of Subjects Receiving PTG-100 With Clinical Remission at Week 12 Compared With Placebo

    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.

    Measured: 12 week treatment period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Sep 2016 (estimated)
  2. Study startDec 2016
  3. Primary completion26 Mar 2018
  4. Study completion26 Mar 2018

Why it stopped: Data Monitoring Committee discontinued the trial due to futility-based outcome

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
98 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02895100
Sponsor's protocol ID
PTG-100-02
Status last verified
Sep 2021
First submitted
4 Sep 2016
Last updated
21 Aug 2025
Data monitoring committee
Yes
Individual data sharing
Undecided

Publications

  • Sandborn WJ, Mattheakis LC, Modi NB, Pugatch D, Bressler B, Lee S, Bhandari R, Kanwar B, Shames R, D'Haens G, Schreiber S, Danese S, Feagan B, Pai RK, Liu DY, Gupta S. PTG-100, an Oral alpha4beta7 Antagonist Peptide: Preclinical Development and Phase 1 and 2a Studies in Ulcerative Colitis. Gastroenterology. 2021 Dec;161(6):1853-1864.e10. doi: 10.1053/j.gastro.2021.08.045. Epub 2021 Aug 30.

    PubMed 34474038

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PTG-100 in people with Ulcerative Colitis, run by Protagonist Therapeutics, Inc. at 98 sites in 17 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 21 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 98 sites in United States, Russia, Ukraine, Poland, Germany and 12 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of Subjects Receiving PTG-100 With Clinical Remission at Week 12 Compared With Placebo (time frame: 12 week treatment period). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02895100, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in