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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT02895100
Ethics application status
Date submitted
4/09/2016
Date registered
9/09/2016
Date last updated
7/03/2019

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
Primary outcome [2] 0 0
Proportion of subjects with at least 1 adverse event (AE) comparing individual PTG-100 dosing groups with placebo - An adverse event is any undesirable experience associated with the use of a medical product in a patient.
Timepoint [2] 0 0
Up to approximately 16 weeks
Secondary outcome [1] 0 0
Proportion of subjects with endoscopic response at Week 12 (defined as an endoscopic subscore of 0 or 1) - Mayo endoscopic subscore is one of the Mayo score components and its value ranges from 0 to 3 points
Timepoint [1] 0 0
12 week treatment period
Secondary outcome [2] 0 0
Proportion of subjects with clinical response at Week 12 (defined as at least 1 point and 30% reduction from baseline in rectal bleeding and stool frequency subscores) - Mayo stool frequency and rectal bleeding subscores are two of the Mayo score components and each subscore value ranges from 0 to 3 points
Timepoint [2] 0 0
12 week treatment period
Secondary outcome [3] 0 0
Mean change in endoscopy subscore from baseline to Week 12 - Mayo endoscopic subscore is one of the Mayo score components and its value ranges from 0 to 3 points
Timepoint [3] 0 0
12 week treatment period
Secondary outcome [4] 0 0
Mean change in rectal bleeding and stool frequency subscores from baseline to Weeks 2, 4, 6, 8, 10, 12, and 16 - Mayo stool frequency and rectal bleeding subscores are two of the Mayo score components and each subscore value ranges from 0 to 3 points
Timepoint [4] 0 0
12 week treatment period
Secondary outcome [5] 0 0
Proportion of subjects with endoscopic remission at Week 12 (defined as an endoscopic subscore of 0) - Mayo endoscopic subscore is one of the Mayo score components and its value ranges from 0 to 3 points
Timepoint [5] 0 0
12 week treatment period
Secondary outcome [6] 0 0
Mean change in Mayo Score from baseline to Week 12 - The Complete Mayo Score is the sum of 4 subscores (stool frequency, rectal bleeding, endoscopic findings, physician's global assessment. Each subscore ranges from 0 to 3, with the higher value indicating more severe disease. The total Complete Mayo Score ranges from 0 to 12.
Timepoint [6] 0 0
12 week treatment period
Secondary outcome [7] 0 0
Mean change in Partial Mayo Score from baseline to Weeks 2, 4, 6, 8, 12, and 16 - The Partial Mayo Score is the sum of 3 subscores (stool frequency, rectal bleeding, physician's global assessment. Each subscore ranges from 0 to 3, with the higher value indicating more severe disease. The Partial Mayo Score ranges from 0 to 9.
Timepoint [7] 0 0
12 week treatment period
Secondary outcome [8] 0 0
Mean change in fecal calprotectin levels from baseline to Weeks 6 and 12 - Fecal calprotectin is used to detect inflammation in the intestines. For patients with ulcerative colitis (UC), it is a measure of the activity and severity of UC.
Timepoint [8] 0 0
12 week treatment period
Secondary outcome [9] 0 0
Mean change in Inflammatory Bowel Disease Questionnaire (IBDQ) score from baseline to Week 12 - IBDQ is a widely used questionnaire for health-related quality of life assessment in patients with inflammatory bowel diseases (IBDs)
Timepoint [9] 0 0
12 week treatment period
Secondary outcome [10] 0 0
Proportion of subjects developing antidrug antibodies (ADA) - ADA are antibodies which may develop as a result of an immunological reaction to a pharmaceutical agent. ADAs may inactivate the therapeutic effects of a drug and, in rare cases, cause adverse effects.
Timepoint [10] 0 0
16 week study duration
Secondary outcome [11] 0 0
Frequency and type of adverse events (AE) (affecting = 5% of subjects) - An adverse event is any undesirable experience associated with the use of a medical product in a patient.
Timepoint [11] 0 0
16 week study duration

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
Gender
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
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Louisiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Maryland
Country [8] 0 0
United States of America
State/province [8] 0 0
New York
Country [9] 0 0
United States of America
State/province [9] 0 0
Ohio
Country [10] 0 0
United States of America
State/province [10] 0 0
Tennessee
Country [11] 0 0
United States of America
State/province [11] 0 0
Texas
Country [12] 0 0
United States of America
State/province [12] 0 0
Virginia
Country [13] 0 0
Belgium
State/province [13] 0 0
Gent
Country [14] 0 0
Belgium
State/province [14] 0 0
Kortrijk
Country [15] 0 0
Belgium
State/province [15] 0 0
Leuven
Country [16] 0 0
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
Country [20] 0 0
Croatia
State/province [20] 0 0
Osijek
Country [21] 0 0
Croatia
State/province [21] 0 0
Split
Country [22] 0 0
Croatia
State/province [22] 0 0
Zagreb
Country [23] 0 0
Czechia
State/province [23] 0 0
Nový Hradec Králové
Country [24] 0 0
Czechia
State/province [24] 0 0
Zlín
Country [25] 0 0
Germany
State/province [25] 0 0
Berlin
Country [26] 0 0
Germany
State/province [26] 0 0
Kiel
Country [27] 0 0
Germany
State/province [27] 0 0
Leipzig
Country [28] 0 0
Germany
State/province [28] 0 0
Mannheim
Country [29] 0 0
Germany
State/province [29] 0 0
Münster
Country [30] 0 0
Germany
State/province [30] 0 0
Tuebingen
Country [31] 0 0
Germany
State/province [31] 0 0
Ulm
Country [32] 0 0
Hungary
State/province [32] 0 0
Budapest
Country [33] 0 0
Hungary
State/province [33] 0 0
Debrecen
Country [34] 0 0
Hungary
State/province [34] 0 0
Eger
Country [35] 0 0
Hungary
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Kistarcsa
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Hungary
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Mosonmagyaróvár
Country [37] 0 0
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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Poland
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Lodz
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Poznan
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Poland
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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
Country [53] 0 0
Russian Federation
State/province [53] 0 0
Kazan'
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Russian Federation
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Moscow
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Russian Federation
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Moskva
Country [56] 0 0
Russian Federation
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Novosibirsk
Country [57] 0 0
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
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Samara
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Russian Federation
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Ufa
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Russian Federation
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Yaroslavl
Country [62] 0 0
Serbia
State/province [62] 0 0
Belgrade
Country [63] 0 0
Serbia
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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
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Kharkiv
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Ukraine
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Kharkov
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Ukraine
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Kiev
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Ukraine
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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
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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
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).
Trial website
https://clinicaltrials.gov/show/NCT02895100
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bittoo Kanwar, MD
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

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT02895100