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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02895100




Registration number
NCT02895100
Ethics application status
Date submitted
4/09/2016
Date registered
9/09/2016

Titles & IDs
Public title
Safety and Efficacy Study of PTG-100 in the Treatment of Moderate to Severe Ulcerative Colitis
Scientific 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
Secondary ID [1] 0 0
PTG-100-02
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ulcerative Colitis 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - PTG-100
Treatment: Drugs - Placebo

Experimental: PTG-100 (150 mg QD) - Low dose

Experimental: PTG-100 (300 mg QD) - Medium dose

Experimental: PTG-100 (900 mg QD) - High dose

Placebo comparator: Placebo group - Placebo control


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

Treatment: Drugs: Placebo
Daily dosing of Placebo capsules by subject for a 12 week treatment period.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of Subjects Receiving PTG-100 With Clinical Remission at Week 12 Compared With Placebo
Timepoint [1] 0 0
12 week treatment period

Eligibility
Key inclusion 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
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
26/03/2018
Sample size
Target
Accrual to date
Final
98
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Site Reference ID/Investigator # 901 - Murdoch
Recruitment hospital [2] 0 0
Site Reference ID/Investigator # 908 - Herston
Recruitment hospital [3] 0 0
Site Reference ID/Investigator # 900 - South Brisbane
Recruitment hospital [4] 0 0
Site Reference ID/Investigator # 907 - Subiaco
Recruitment postcode(s) [1] 0 0
6150 - Murdoch
Recruitment postcode(s) [2] 0 0
4006 - Herston
Recruitment postcode(s) [3] 0 0
4101 - South Brisbane
Recruitment postcode(s) [4] 0 0
6008 - Subiaco
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
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United States of America
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Florida
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United States of America
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Georgia
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United States of America
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Illinois
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United States of America
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Louisiana
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United States of America
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Maryland
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United States of America
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New York
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United States of America
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Ohio
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United States of America
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Tennessee
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United States of America
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Texas
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United States of America
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Virginia
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Belgium
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Gent
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Belgium
State/province [14] 0 0
Kortrijk
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Belgium
State/province [15] 0 0
Leuven
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Bosnia and Herzegovina
State/province [16] 0 0
Mostar
Country [17] 0 0
Bosnia and Herzegovina
State/province [17] 0 0
Tuzla
Country [18] 0 0
Canada
State/province [18] 0 0
British Columbia
Country [19] 0 0
Canada
State/province [19] 0 0
Ontario
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Croatia
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Osijek
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Croatia
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Split
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Croatia
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Zagreb
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Czechia
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Nový Hradec Králové
Country [24] 0 0
Czechia
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Zlín
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Germany
State/province [25] 0 0
Berlin
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Germany
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Kiel
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Germany
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Leipzig
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Germany
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Mannheim
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Germany
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Münster
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Germany
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Tuebingen
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Germany
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Ulm
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Hungary
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Budapest
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Hungary
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Debrecen
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Hungary
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Eger
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Hungary
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Kistarcsa
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Hungary
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Mosonmagyaróvár
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Hungary
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Sopron
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Korea, Republic of
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Daegu
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Korea, Republic of
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Seoul
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Latvia
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Riga
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Netherlands
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Amsterdam
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New Zealand
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Dunedin
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New Zealand
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Newton
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Poland
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Kielce
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Krakow
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Kraków
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Ksawerów
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Lodz
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Poznan
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Sopot
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Poland
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Warszawa
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Poland
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Wloclawek
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Russian Federation
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Kazan'
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Russian Federation
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Moscow
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Russian Federation
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Moskva
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Russian Federation
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Novosibirsk
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Russian Federation
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Rostov-na-Donu
Country [58] 0 0
Russian Federation
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Saint Petersburg
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Russian Federation
State/province [59] 0 0
Samara
Country [60] 0 0
Russian Federation
State/province [60] 0 0
Ufa
Country [61] 0 0
Russian Federation
State/province [61] 0 0
Yaroslavl
Country [62] 0 0
Serbia
State/province [62] 0 0
Belgrade
Country [63] 0 0
Serbia
State/province [63] 0 0
Kragujevac
Country [64] 0 0
Serbia
State/province [64] 0 0
Niš
Country [65] 0 0
Serbia
State/province [65] 0 0
Zvezdara
Country [66] 0 0
Ukraine
State/province [66] 0 0
Chernivtsi
Country [67] 0 0
Ukraine
State/province [67] 0 0
Ivano-Frankivs'k
Country [68] 0 0
Ukraine
State/province [68] 0 0
Kharkiv
Country [69] 0 0
Ukraine
State/province [69] 0 0
Kharkov
Country [70] 0 0
Ukraine
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Kiev
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Ukraine
State/province [71] 0 0
Kyiv
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Ukraine
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L'viv
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Ukraine
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Odessa
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Ukraine
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Uzhgorod
Country [75] 0 0
Ukraine
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Vinnytsya
Country [76] 0 0
Ukraine
State/province [76] 0 0
Zaporizhzhya

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Protagonist Therapeutics, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Director Clinical Development
Address 0 0
Protagonist Therapeutics, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT02895100