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

NCT02895100 | Terminated Phase 2 Results DMC

• 1 other identifier: PTG-100-02
• Study Type: interventional
• Target: 98
• Locations: 17 countries
• Sites: 98

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).

Conditions

Ulcerative Colitis

Keywords

ulcerative colitis; inflammatory bowel disease; PROPEL; Propel Study

Outcome Measures

Primary Outcomes (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.

  12 week treatment period

Study Arms (4)

PTG-100 (150 mg QD)

EXPERIMENTAL

Low dose

Drug: PTG-100

PTG-100 (300 mg QD)

EXPERIMENTAL

Medium dose

Drug: PTG-100

PTG-100 (900 mg QD)

EXPERIMENTAL

High dose

Drug: PTG-100

Placebo group

PLACEBO COMPARATOR

Placebo control

Drug: Placebo

Interventions

PTG-100 DRUG

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

PTG-100 (150 mg QD); PTG-100 (300 mg QD); PTG-100 (900 mg QD)

Placebo DRUG

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

Placebo group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Protagonist Therapeutics, Inc.: lead

Study Sites (98)

Site Reference ID/Investigator # 101

Los Angeles, California, 90036, United States

Location

Site Reference ID/Investigator # 102

Los Angeles, California, 90036, United States

Location

Site Reference ID/Investigator # 125

Colorado Springs, Colorado, 80907, United States

Location

Site Reference ID/Investigator # 120

Miami, Florida, 33126, United States

Location

Site Reference ID/Investigator # 106

Port Orange, Florida, 32128, United States

Location

Site Reference ID/Investigator # 115

Saint Augustine, Florida, 32086, United States

Location

Site Reference ID/Investigator # 116

Sweetwater, Florida, 33172, United States

Location

Site Reference ID/Investigator # 100

Atlanta, Georgia, 30607, United States

Location

Site Reference ID/Investigator # 104

Marietta, Georgia, 30060, United States

Location

Site Reference ID/Investigator # 112

Suwanee, Georgia, 30024, United States

Location

Site Reference ID/Investigator # 107

Chicago, Illinois, 60611, United States

Location

Site Reference ID/Investigator # 126

Bastrop, Louisiana, 71220, United States

Location

Site Reference ID/Investigator # 114

Shreveport, Louisiana, 71105, United States

Location

Site Reference ID/Investigator # 117

Chevy Chase, Maryland, 20815, United States

Location

Site Reference ID/Investigator # 109

Great Neck, New York, 11021, United States

Location

Site Reference ID/Investigator # 122

New York, New York, 10065, United States

Location

Site Reference ID/Investigator # 119

Cincinnati, Ohio, 45219, United States

Location

Site Reference ID/Investigator # 110

Hermitage, Tennessee, 37076, United States

Location

Site Reference ID/Investigator # 128

Nashville, Tennessee, 37212, United States

Location

Site Reference ID/Investigator # 118

DeSoto, Texas, 75035, United States

Location

Site Reference ID/Investigator # 113

Richmond, Virginia, 23249, United States

Location

Site Reference ID/Investigator # 901

Murdoch, Western Australia, 6150, Australia

Location

Site Reference ID/Investigator # 908

Herston, 4006, Australia

Location

Site Reference ID/Investigator # 900

South Brisbane, 4101, Australia

Location

Site Reference ID/Investigator # 907

Subiaco, 6008, Australia

Location

Site Reference ID/Investigator # 559

Ghent, 9000, Belgium

Location

Site Reference ID/Investigator # 533

Kortrijk, 8500, Belgium

Location

Site Reference ID/Investigator # 505

Leuven, 3000, Belgium

Location

Site Reference ID/Investigator # 573

Mostar, 88000, Bosnia and Herzegovina

Location

Site Reference ID/Investigator # 571

Tuzla, 3 75000, Bosnia and Herzegovina

Location

Site Reference ID/Investigator # 103

Vancouver, British Columbia, V6Z 2K5, Canada

Location

Site Reference ID/Investigator # 105

London, Ontario, N6A 5A5, Canada

Location

Site Reference ID/Investigator #556

Osijek, 31000, Croatia

Location

Site Reference ID/Investigator # 550

Split, 17 21000, Croatia

Location

Site Reference ID/Investigator # 562

Zagreb, 21 10000, Croatia

Location

Site Reference ID/Investigator # 517

Nový Hradec Králové, 500 12, Czechia

Location

Site Reference ID/Investigator # 539

Zlín, 76275, Czechia

Location

Site Reference ID/Investigator # 560

Berlin, 13353, Germany

Location

Site Reference ID/Investigator # 542

Berlin, 14050, Germany

Location

Site Reference ID/Investigator # 532

Kiel, 24105, Germany

Location

Site Reference ID/Investigator # 506

Leipzig, 4103, Germany

Location

Site Reference ID/Investigator # 572

Mannheim, 68167, Germany

Location

Site Reference ID/Investigator # 538

Münster, 48149, Germany

Location

Site Reference ID/Investigator # 574

Tübingen, 72076, Germany

Location

Site Reference ID/Investigator # 541

Ulm, 89073, Germany

Location

Site Reference ID/Investigator # 554

Budapest, 1036, Hungary

Location

Site Reference ID/Investigator # 558

Budapest, 1125, Hungary

Location

Site Reference ID/Investigator # 552

Debrecen, 4032, Hungary

Location

Site Reference ID/Investigator # 567

Eger, 3300, Hungary

Location

Site Reference ID/Investigator # 557

Kistarcsa, 2143, Hungary

Location

Site Reference ID/Investigator # 544

Mosonmagyaróvár, 9200, Hungary

Location

Site Reference ID/Investigator # 563

Sopron, 9400, Hungary

Location

Site Reference ID/Investigator # 501

Riga, 1002, Latvia

Location

Site Reference ID/Investigator # 545

Riga, LV-1002, Latvia

Location

Site Reference ID/Investigator # 568

Amsterdam, 1105, Netherlands

Location

Site Reference ID/Investigator # 903

Dunedin, 9016, New Zealand

Location

Site Reference ID/Investigator # 902

Newton, 6021, New Zealand

Location

Site Reference ID/Investigator # 529

Kielce, 25-364, Poland

Location

Site Reference ID/Investigator # 576

Krakow, 31-530, Poland

Location

Site Reference ID/Investigator # 540

Krakow, 31-531, Poland

Location

Site Reference ID/Investigator # 512

Ksawerów, 95-054, Poland

Location

Site Reference ID/Investigator # 530

Lodz, 90-153, Poland

Location

Site Reference ID/Investigator # 518

Lodz, 90-302, Poland

Location

Site Reference ID/Investigator # 577

Poznan, 61-845, Poland

Location

Site Reference ID/Investigator # 546

Sopot, 81-756, Poland

Location

Site Reference ID/Investigator # 513

Warsaw, 00-632, Poland

Location

Site Reference ID/Investigator # 531

Włocławek, 87-806, Poland

Location

Site Reference ID/Investigator # 553

Kazan', 420029, Russia

Location

Site Reference ID/Investigator # 524

Moscow, 125412, Russia

Location

Site Reference ID/Investigator # 536

Moskva, 127015, Russia

Location

Site Reference ID/Investigator # 515

Novosibirsk, 630117, Russia

Location

Site Reference ID/Investigator # 526

Rostov-on-Don, 344022, Russia

Location

Site Reference ID/Investigator # 514

Saint Petersburg, 191186, Russia

Location

Site Reference ID/Investigator # 522

Saint Petersburg, 195067, Russia

Location

Site Reference ID/Investigator # 555

Saint Petersburg, 195257, Russia

Location

Site Reference ID/Investigator # 523

Samara, 443093, Russia

Location

Site Reference ID/Investigator # 551

Ufa, 450071, Russia

Location

Site Reference ID/Investigator # 525

Yaroslavl, 150000, Russia

Location

Site Reference ID/Investigator # 521

Belgrade, 0 11080, Serbia

Location

Site Reference ID/Investigator # 575

Belgrade, 11000, Serbia

Location

Site Reference ID/Investigator # 566

Belgrade, 11080, Serbia

Location

Site Reference ID/Investigator # 500

Kragujevac, 12 34111, Serbia

Location

Site Reference ID/Investigator # 543

Niš, 18105, Serbia

Location

Site Reference ID/Investigator # 502

Zvezdara, 0 11050, Serbia

Location

Site Reference ID/Investigator # 906

Daegu, 42415, South Korea

Location

Site Reference ID/Investigator # 905

Seoul, 06591, South Korea

Location

Site Reference ID/Investigator # 904

Seoul, 3722, South Korea

Location

Site Reference ID/Investigator # 510

Chernivtsi, 3110, Ukraine

Location

Site Reference ID/Investigator # 535

Ivano-Frankivsk, 76018, Ukraine

Location

Site Reference ID/Investigator # 509

Kharkiv, 6100, Ukraine

Location

Site Reference ID/Investigator # 508

Kharkiv, 61039, Ukraine

Location

Site Reference ID/Investigator # 549

Kiev, Ukraine

Location

Site Reference ID/Investigator # 565

Kyiv, 2232, Ukraine

Location

Site Reference ID/Investigator # 534

Lviv, 79059, Ukraine

Location

Site Reference ID/Investigator # 520

Odesa, 65025, Ukraine

Location

Site Reference ID/Investigator # 504

Uzhhorod, 88000, Ukraine

Location

Site Reference ID/Investigator # 507

Vinnytsia, 21018, Ukraine

Location

Site Reference ID/Investigator # 547

Zaporizhzhya, 609065, Ukraine

Location

Related Publications (1)

• 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.

  PMID: 34474038 DERIVED

MeSH Terms

Conditions

Colitis, Ulcerative; Inflammatory Bowel Diseases

Interventions

PTG-100 peptide

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases; Intestinal Diseases

Results Point of Contact

• Title: Director Clinical Development
• Organization: Protagonist Therapeutics, Inc

ptgxclintrials@ptgx-inc.com

(+1) 888-899-1543

Study Officials

• Director Clinical Development

  Protagonist Therapeutics, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2016
• First Posted: September 9, 2016
• Study Start: December 1, 2016
• Primary Completion: March 26, 2018
• Study Completion: March 26, 2018
• Last Updated: August 21, 2025
• Results First Posted: March 22, 2021

Record last verified: 2021-09

Locations

AU (4); HU (7); US (21); CZ (2); CA (2); KR (3); BE (3); BO (2); SE (6); PL (10); NL (1); RU (11); DE (8); NZ (2); CR (3); LA (2); UA (11)