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

Primary Purpose

Ulcerative Colitis

Status

Terminated

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

PTG-100

Placebo

About this trial

This is an interventional treatment trial for Ulcerative Colitis focused on measuring ulcerative colitis, inflammatory bowel disease, PROPEL, Propel Study

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Arm Label

PTG-100 (150 mg QD)

PTG-100 (300 mg QD)

PTG-100 (900 mg QD)

Placebo group

Arm Description

Low dose

Medium dose

High dose

Placebo control

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT02895100

First Posted

September 4, 2016

Last Updated

September 24, 2021

Sponsor

Protagonist Therapeutics, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02895100

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2021

Overall Recruitment Status

Terminated

Why Stopped

Data Monitoring Committee discontinued the trial due to futility-based outcome

Study Start Date

December 2016 (undefined)

Primary Completion Date

March 26, 2018 (Actual)

Study Completion Date

March 26, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Protagonist Therapeutics, Inc.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ulcerative Colitis

Keywords

ulcerative colitis, inflammatory bowel disease, PROPEL, Propel Study

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

98 (Actual)

8. Arms, Groups, and Interventions

Arm Title

PTG-100 (150 mg QD)

Arm Type

Experimental

Arm Description

Low dose

Arm Title

PTG-100 (300 mg QD)

Arm Type

Experimental

Arm Description

Medium dose

Arm Title

PTG-100 (900 mg QD)

Arm Type

Experimental

Arm Description

High dose

Arm Title

Placebo group

Arm Type

Placebo Comparator

Arm Description

Placebo control

Intervention Type

Drug

Intervention Name(s)

PTG-100

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

Time Frame

12 week treatment period

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Director Clinical Development

Organizational Affiliation

Protagonist Therapeutics, Inc.

Official's Role

Study Director

Facility Information:

Facility Name

Site Reference ID/Investigator # 101

City

Los Angeles

State/Province

California

ZIP/Postal Code

90036

Country

United States

Facility Name

Site Reference ID/Investigator # 102

City

Los Angeles

State/Province

California

ZIP/Postal Code

90036

Country

United States

Facility Name

Site Reference ID/Investigator # 125

City

Colorado Springs

State/Province

Colorado

ZIP/Postal Code

80907

Country

United States

Facility Name

Site Reference ID/Investigator # 120

City

Miami

State/Province

Florida

ZIP/Postal Code

33126

Country

United States

Facility Name

Site Reference ID/Investigator # 106

City

Port Orange

State/Province

Florida

ZIP/Postal Code

32128

Country

United States

Facility Name

Site Reference ID/Investigator # 115

City

Saint Augustine

State/Province

Florida

ZIP/Postal Code

32086

Country

United States

Facility Name

Site Reference ID/Investigator # 116

City

Sweetwater

State/Province

Florida

ZIP/Postal Code

33172

Country

United States

Facility Name

Site Reference ID/Investigator # 100

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30607

Country

United States

Facility Name

Site Reference ID/Investigator # 104

City

Marietta

State/Province

Georgia

ZIP/Postal Code

30060

Country

United States

Facility Name

Site Reference ID/Investigator # 112

City

Suwanee

State/Province

Georgia

ZIP/Postal Code

30024

Country

United States

Facility Name

Site Reference ID/Investigator # 107

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

Facility Name

Site Reference ID/Investigator # 126

City

Bastrop

State/Province

Louisiana

ZIP/Postal Code

71220

Country

United States

Facility Name

Site Reference ID/Investigator # 114

City

Shreveport

State/Province

Louisiana

ZIP/Postal Code

71105

Country

United States

Facility Name

Site Reference ID/Investigator # 117

City

Chevy Chase

State/Province

Maryland

ZIP/Postal Code

20815

Country

United States

Facility Name

Site Reference ID/Investigator # 109

City

Great Neck

State/Province

New York

ZIP/Postal Code

11021

Country

United States

Facility Name

Site Reference ID/Investigator # 122

City

New York

State/Province

New York

ZIP/Postal Code

10065

Country

United States

Facility Name

Site Reference ID/Investigator # 119

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45219

Country

United States

Facility Name

Site Reference ID/Investigator # 110

City

Hermitage

State/Province

Tennessee

ZIP/Postal Code

37076

Country

United States

Facility Name

Site Reference ID/Investigator # 128

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37212

Country

United States

Facility Name

Site Reference ID/Investigator # 118

City

DeSoto

State/Province

Texas

ZIP/Postal Code

75035

Country

United States

Facility Name

Site Reference ID/Investigator # 113

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23249

Country

United States

Facility Name

Site Reference ID/Investigator # 901

City

Murdoch

State/Province

Western Australia

ZIP/Postal Code

6150

Country

Australia

Facility Name

Site Reference ID/Investigator # 908

City

Herston

ZIP/Postal Code

4006

Country

Australia

Facility Name

Site Reference ID/Investigator # 900

City

South Brisbane

ZIP/Postal Code

4101

Country

Australia

Facility Name

Site Reference ID/Investigator # 907

City

Subiaco

ZIP/Postal Code

6008

Country

Australia

Facility Name

Site Reference ID/Investigator # 559

City

Gent

ZIP/Postal Code

9000

Country

Belgium

Facility Name

Site Reference ID/Investigator # 533

City

Kortrijk

ZIP/Postal Code

8500

Country

Belgium

Facility Name

Site Reference ID/Investigator # 505

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

Facility Name

Site Reference ID/Investigator # 573

City

Mostar

ZIP/Postal Code

88000

Country

Bosnia and Herzegovina

Facility Name

Site Reference ID/Investigator # 571

City

Tuzla

ZIP/Postal Code

3 75000

Country

Bosnia and Herzegovina

Facility Name

Site Reference ID/Investigator # 103

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V6Z 2K5

Country

Canada

Facility Name

Site Reference ID/Investigator # 105

City

London

State/Province

Ontario

ZIP/Postal Code

N6A 5A5

Country

Canada

Facility Name

Site Reference ID/Investigator #556

City

Osijek

ZIP/Postal Code

31000

Country

Croatia

Facility Name

Site Reference ID/Investigator # 550

City

Split

ZIP/Postal Code

17 21000

Country

Croatia

Facility Name

Site Reference ID/Investigator # 562

City

Zagreb

ZIP/Postal Code

21 10000

Country

Croatia

Facility Name

Site Reference ID/Investigator # 517

City

Nový Hradec Králové

ZIP/Postal Code

500 12

Country

Czechia

Facility Name

Site Reference ID/Investigator # 539

City

Zlín

ZIP/Postal Code

76275

Country

Czechia

Facility Name

Site Reference ID/Investigator # 560

City

Berlin

ZIP/Postal Code

13353

Country

Germany

Facility Name

Site Reference ID/Investigator # 542

City

Berlin

ZIP/Postal Code

14050

Country

Germany

Facility Name

Site Reference ID/Investigator # 532

City

Kiel

ZIP/Postal Code

24105

Country

Germany

Facility Name

Site Reference ID/Investigator # 506

City

Leipzig

ZIP/Postal Code

4103

Country

Germany

Facility Name

Site Reference ID/Investigator # 572

City

Mannheim

ZIP/Postal Code

68167

Country

Germany

Facility Name

Site Reference ID/Investigator # 538

City

Münster

ZIP/Postal Code

48149

Country

Germany

Facility Name

Site Reference ID/Investigator # 574

City

Tuebingen

ZIP/Postal Code

72076

Country

Germany

Facility Name

Site Reference ID/Investigator # 541

City

Ulm

ZIP/Postal Code

89073

Country

Germany

Facility Name

Site Reference ID/Investigator # 554

City

Budapest

ZIP/Postal Code

1036

Country

Hungary

Facility Name

Site Reference ID/Investigator # 558

City

Budapest

ZIP/Postal Code

1125

Country

Hungary

Facility Name

Site Reference ID/Investigator # 552

City

Debrecen

ZIP/Postal Code

4032

Country

Hungary

Facility Name

Site Reference ID/Investigator # 567

City

Eger

ZIP/Postal Code

3300

Country

Hungary

Facility Name

Site Reference ID/Investigator # 557

City

Kistarcsa

ZIP/Postal Code

2143

Country

Hungary

Facility Name

Site Reference ID/Investigator # 544

City

Mosonmagyaróvár

ZIP/Postal Code

9200

Country

Hungary

Facility Name

Site Reference ID/Investigator # 563

City

Sopron

ZIP/Postal Code

9400

Country

Hungary

Facility Name

Site Reference ID/Investigator # 906

City

Daegu

ZIP/Postal Code

42415

Country

Korea, Republic of

Facility Name

Site Reference ID/Investigator # 905

City

Seoul

ZIP/Postal Code

06591

Country

Korea, Republic of

Facility Name

Site Reference ID/Investigator # 904

City

Seoul

ZIP/Postal Code

3722

Country

Korea, Republic of

Facility Name

Site Reference ID/Investigator # 501

City

Riga

ZIP/Postal Code

1002

Country

Latvia

Facility Name

Site Reference ID/Investigator # 545

City

Riga

ZIP/Postal Code

LV-1002

Country

Latvia

Facility Name

Site Reference ID/Investigator # 568

City

Amsterdam

ZIP/Postal Code

1105

Country

Netherlands

Facility Name

Site Reference ID/Investigator # 903

City

Dunedin

ZIP/Postal Code

9016

Country

New Zealand

Facility Name

Site Reference ID/Investigator # 902

City

Newton

ZIP/Postal Code

6021

Country

New Zealand

Facility Name

Site Reference ID/Investigator # 529

City

Kielce

ZIP/Postal Code

25-364

Country

Poland

Facility Name

Site Reference ID/Investigator # 540

City

Krakow

ZIP/Postal Code

31-531

Country

Poland

Facility Name

Site Reference ID/Investigator # 576

City

Kraków

ZIP/Postal Code

31-530

Country

Poland

Facility Name

Site Reference ID/Investigator # 512

City

Ksawerów

ZIP/Postal Code

95-054

Country

Poland

Facility Name

Site Reference ID/Investigator # 530

City

Lodz

ZIP/Postal Code

90-153

Country

Poland

Facility Name

Site Reference ID/Investigator # 518

City

Lodz

ZIP/Postal Code

90-302

Country

Poland

Facility Name

Site Reference ID/Investigator # 577

City

Poznań

ZIP/Postal Code

61-845

Country

Poland

Facility Name

Site Reference ID/Investigator # 546

City

Sopot

ZIP/Postal Code

81-756

Country

Poland

Facility Name

Site Reference ID/Investigator # 513

City

Warszawa

ZIP/Postal Code

00-632

Country

Poland

Facility Name

Site Reference ID/Investigator # 531

City

Wloclawek

ZIP/Postal Code

87-806

Country

Poland

Facility Name

Site Reference ID/Investigator # 553

City

Kazan'

ZIP/Postal Code

420029

Country

Russian Federation

Facility Name

Site Reference ID/Investigator # 524

City

Moscow

ZIP/Postal Code

125412

Country

Russian Federation

Facility Name

Site Reference ID/Investigator # 536

City

Moskva

ZIP/Postal Code

127015

Country

Russian Federation

Facility Name

Site Reference ID/Investigator # 515

City

Novosibirsk

ZIP/Postal Code

630117

Country

Russian Federation

Facility Name

Site Reference ID/Investigator # 526

City

Rostov-na-Donu

ZIP/Postal Code

344022

Country

Russian Federation

Facility Name

Site Reference ID/Investigator # 514

City

Saint Petersburg

ZIP/Postal Code

191186

Country

Russian Federation

Facility Name

Site Reference ID/Investigator # 522

City

Saint Petersburg

ZIP/Postal Code

195067

Country

Russian Federation

Facility Name

Site Reference ID/Investigator # 555

City

Saint Petersburg

ZIP/Postal Code

195257

Country

Russian Federation

Facility Name

Site Reference ID/Investigator # 523

City

Samara

ZIP/Postal Code

443093

Country

Russian Federation

Facility Name

Site Reference ID/Investigator # 551

City

Ufa

ZIP/Postal Code

450071

Country

Russian Federation

Facility Name

Site Reference ID/Investigator # 525

City

Yaroslavl

ZIP/Postal Code

150000

Country

Russian Federation

Facility Name

Site Reference ID/Investigator # 521

City

Belgrade

ZIP/Postal Code

0 11080

Country

Serbia

Facility Name

Site Reference ID/Investigator # 575

City

Belgrade

ZIP/Postal Code

11000

Country

Serbia

Facility Name

Site Reference ID/Investigator # 566

City

Belgrade

ZIP/Postal Code

11080

Country

Serbia

Facility Name

Site Reference ID/Investigator # 500

City

Kragujevac

ZIP/Postal Code

12 34111

Country

Serbia

Facility Name

Site Reference ID/Investigator # 543

City

Niš

ZIP/Postal Code

18105

Country

Serbia

Facility Name

Site Reference ID/Investigator # 502

City

Zvezdara

ZIP/Postal Code

0 11050

Country

Serbia

Facility Name

Site Reference ID/Investigator # 510

City

Chernivtsi

ZIP/Postal Code

3110

Country

Ukraine

Facility Name

Site Reference ID/Investigator # 535

City

Ivano-Frankivs'k

ZIP/Postal Code

76018

Country

Ukraine

Facility Name

Site Reference ID/Investigator # 508

City

Kharkiv

ZIP/Postal Code

61039

Country

Ukraine

Facility Name

Site Reference ID/Investigator # 509

City

Kharkov

ZIP/Postal Code

6100

Country

Ukraine

Facility Name

Site Reference ID/Investigator # 549

City

Kiev

Country

Ukraine

Facility Name

Site Reference ID/Investigator # 565

City

Kyiv

ZIP/Postal Code

2232

Country

Ukraine

Facility Name

Site Reference ID/Investigator # 534

City

L'viv

ZIP/Postal Code

79059

Country

Ukraine

Facility Name

Site Reference ID/Investigator # 520

City

Odessa

ZIP/Postal Code

65025

Country

Ukraine

Facility Name

Site Reference ID/Investigator # 504

City

Uzhgorod

ZIP/Postal Code

88000

Country

Ukraine

Facility Name

Site Reference ID/Investigator # 507

City

Vinnytsya

ZIP/Postal Code

21018

Country

Ukraine

Facility Name

Site Reference ID/Investigator # 547

City

Zaporizhzhya

ZIP/Postal Code

609065

Country

Ukraine

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

34474038

Citation

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.

Results Reference

derived

Learn more about this trial

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

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

Ulcerative Colitis

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial