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

NCT ID: NCT02895100

Last Updated: 2025-08-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 98 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-31
• Study Completion Date: 2018-03-26

Brief 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).

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.

Conditions

Ulcerative Colitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

PTG-100 (150 mg QD)

Low dose

Group Type: EXPERIMENTAL

PTG-100

Intervention Type: DRUG

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

PTG-100 (300 mg QD)

Medium dose

Group Type: EXPERIMENTAL

PTG-100

Intervention Type: DRUG

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

PTG-100 (900 mg QD)

High dose

Group Type: EXPERIMENTAL

PTG-100

Intervention Type: DRUG

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

Placebo group

Placebo control

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

PTG-100

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Protagonist Therapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Director Clinical Development

Role: STUDY_DIRECTOR

Protagonist Therapeutics, Inc.

Locations

Site Reference ID/Investigator # 101

Los Angeles, California, United States

Site Reference ID/Investigator # 102

Los Angeles, California, United States

Site Reference ID/Investigator # 125

Colorado Springs, Colorado, United States

Site Reference ID/Investigator # 120

Miami, Florida, United States

Site Reference ID/Investigator # 106

Port Orange, Florida, United States

Site Reference ID/Investigator # 115

Saint Augustine, Florida, United States

Site Reference ID/Investigator # 116

Sweetwater, Florida, United States

Site Reference ID/Investigator # 100

Atlanta, Georgia, United States

Site Reference ID/Investigator # 104

Marietta, Georgia, United States

Site Reference ID/Investigator # 112

Suwanee, Georgia, United States

Site Reference ID/Investigator # 107

Chicago, Illinois, United States

Site Reference ID/Investigator # 126

Bastrop, Louisiana, United States

Site Reference ID/Investigator # 114

Shreveport, Louisiana, United States

Site Reference ID/Investigator # 117

Chevy Chase, Maryland, United States

Site Reference ID/Investigator # 109

Great Neck, New York, United States

Site Reference ID/Investigator # 122

New York, New York, United States

Site Reference ID/Investigator # 119

Cincinnati, Ohio, United States

Site Reference ID/Investigator # 110

Hermitage, Tennessee, United States

Site Reference ID/Investigator # 128

Nashville, Tennessee, United States

Site Reference ID/Investigator # 118

DeSoto, Texas, United States

Site Reference ID/Investigator # 113

Richmond, Virginia, United States

Site Reference ID/Investigator # 901

Murdoch, Western Australia, Australia

Site Reference ID/Investigator # 908

Herston, , Australia

Site Reference ID/Investigator # 900

South Brisbane, , Australia

Site Reference ID/Investigator # 907

Subiaco, , Australia

Site Reference ID/Investigator # 559

Ghent, , Belgium

Site Reference ID/Investigator # 533

Kortrijk, , Belgium

Site Reference ID/Investigator # 505

Leuven, , Belgium

Site Reference ID/Investigator # 573

Mostar, , Bosnia and Herzegovina

Site Reference ID/Investigator # 571

Tuzla, , Bosnia and Herzegovina

Site Reference ID/Investigator # 103

Vancouver, British Columbia, Canada

Site Reference ID/Investigator # 105

London, Ontario, Canada

Site Reference ID/Investigator #556

Osijek, , Croatia

Site Reference ID/Investigator # 550

Split, , Croatia

Site Reference ID/Investigator # 562

Zagreb, , Croatia

Site Reference ID/Investigator # 517

Nový Hradec Králové, , Czechia

Site Reference ID/Investigator # 539

Zlín, , Czechia

Site Reference ID/Investigator # 560

Berlin, , Germany

Site Reference ID/Investigator # 542

Berlin, , Germany

Site Reference ID/Investigator # 532

Kiel, , Germany

Site Reference ID/Investigator # 506

Leipzig, , Germany

Site Reference ID/Investigator # 572

Mannheim, , Germany

Site Reference ID/Investigator # 538

Münster, , Germany

Site Reference ID/Investigator # 574

Tübingen, , Germany

Site Reference ID/Investigator # 541

Ulm, , Germany

Site Reference ID/Investigator # 554

Budapest, , Hungary

Site Reference ID/Investigator # 558

Budapest, , Hungary

Site Reference ID/Investigator # 552

Debrecen, , Hungary

Site Reference ID/Investigator # 567

Eger, , Hungary

Site Reference ID/Investigator # 557

Kistarcsa, , Hungary

Site Reference ID/Investigator # 544

Mosonmagyaróvár, , Hungary

Site Reference ID/Investigator # 563

Sopron, , Hungary

Site Reference ID/Investigator # 501

Riga, , Latvia

Site Reference ID/Investigator # 545

Riga, , Latvia

Site Reference ID/Investigator # 568

Amsterdam, , Netherlands

Site Reference ID/Investigator # 903

Dunedin, , New Zealand

Site Reference ID/Investigator # 902

Newton, , New Zealand

Site Reference ID/Investigator # 529

Kielce, , Poland

Site Reference ID/Investigator # 576

Krakow, , Poland

Site Reference ID/Investigator # 540

Krakow, , Poland

Site Reference ID/Investigator # 512

Ksawerów, , Poland

Site Reference ID/Investigator # 530

Lodz, , Poland

Site Reference ID/Investigator # 518

Lodz, , Poland

Site Reference ID/Investigator # 577

Poznan, , Poland

Site Reference ID/Investigator # 546

Sopot, , Poland

Site Reference ID/Investigator # 513

Warsaw, , Poland

Site Reference ID/Investigator # 531

Włocławek, , Poland

Site Reference ID/Investigator # 553

Kazan', , Russia

Site Reference ID/Investigator # 524

Moscow, , Russia

Site Reference ID/Investigator # 536

Moskva, , Russia

Site Reference ID/Investigator # 515

Novosibirsk, , Russia

Site Reference ID/Investigator # 526

Rostov-on-Don, , Russia

Site Reference ID/Investigator # 514

Saint Petersburg, , Russia

Site Reference ID/Investigator # 522

Saint Petersburg, , Russia

Site Reference ID/Investigator # 555

Saint Petersburg, , Russia

Site Reference ID/Investigator # 523

Samara, , Russia

Site Reference ID/Investigator # 551

Ufa, , Russia

Site Reference ID/Investigator # 525

Yaroslavl, , Russia

Site Reference ID/Investigator # 521

Belgrade, , Serbia

Site Reference ID/Investigator # 575

Belgrade, , Serbia

Site Reference ID/Investigator # 566

Belgrade, , Serbia

Site Reference ID/Investigator # 500

Kragujevac, , Serbia

Site Reference ID/Investigator # 543

Niš, , Serbia

Site Reference ID/Investigator # 502

Zvezdara, , Serbia

Site Reference ID/Investigator # 906

Daegu, , South Korea

Site Reference ID/Investigator # 905

Seoul, , South Korea

Site Reference ID/Investigator # 904

Seoul, , South Korea

Site Reference ID/Investigator # 510

Chernivtsi, , Ukraine

Site Reference ID/Investigator # 535

Ivano-Frankivsk, , Ukraine

Site Reference ID/Investigator # 509

Kharkiv, , Ukraine

Site Reference ID/Investigator # 508

Kharkiv, , Ukraine

Site Reference ID/Investigator # 549

Kiev, , Ukraine

Site Reference ID/Investigator # 565

Kyiv, , Ukraine

Site Reference ID/Investigator # 534

Lviv, , Ukraine

Site Reference ID/Investigator # 520

Odesa, , Ukraine

Site Reference ID/Investigator # 504

Uzhhorod, , Ukraine

Site Reference ID/Investigator # 507

Vinnytsia, , Ukraine

Site Reference ID/Investigator # 547

Zaporizhzhya, , Ukraine

Countries

United States; Australia; Belgium; Bosnia and Herzegovina; Canada; Croatia; Czechia; Germany; Hungary; Latvia; Netherlands; New Zealand; Poland; Russia; Serbia; South Korea; Ukraine

References

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.

Reference Type: DERIVED

PMID: 34474038 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

PTG-100-02

Identifier Type: -

Identifier Source: org_study_id