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

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ClinicalTrials.gov Identifier: NCT02895100
Recruitment Status : Terminated (Data Monitoring Committee discontinued the trial due to futility-based outcome)
First Posted : September 9, 2016
Results First Posted : March 22, 2021
Last Update Posted : March 22, 2021
Sponsor:
Information provided by (Responsible Party):
Protagonist Therapeutics, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Ulcerative Colitis
Interventions Drug: PTG-100
Drug: Placebo
Enrollment 100
Recruitment Details  
Pre-assignment Details  
Arm/Group Title PTG-100 (150 mg QD) PTG-100 (300 mg QD) PTG-100 (900 mg QD) Placebo Group
Hide Arm/Group Description

Low dose

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

Medium dose

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

High dose

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

Placebo control

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

Period Title: Overall Study
Started 25 25 23 25
Completed 14 14 15 15
Not Completed 11 11 8 10
Arm/Group Title PTG-100 (150 mg QD) PTG-100 (300 mg QD) PTG-100 (900 mg QD) Placebo Group Total
Hide Arm/Group Description

Low dose

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

Medium dose

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

High dose

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

Placebo control

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

Total of all reporting groups
Overall Number of Baseline Participants 25 25 23 25 98
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 25 participants 25 participants 23 participants 25 participants 98 participants
45.2  (13.8) 43.8  (17) 40.6  (14.1) 42.2  (14.9) 43  (15)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 25 participants 23 participants 25 participants 98 participants
Female
7
  28.0%
15
  60.0%
14
  60.9%
10
  40.0%
46
  46.9%
Male
18
  72.0%
10
  40.0%
9
  39.1%
15
  60.0%
52
  53.1%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Race Number Analyzed 25 participants 25 participants 23 participants 25 participants 98 participants
White 19 23 22 23 87
Asian 4 1 0 0 5
Black or African American 2 0 1 2 5
other 0 1 0 0 1
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 25 participants 25 participants 23 participants 25 participants 98 participants
77.8  (16.3) 70.7  (15.4) 72.3  (19.1) 69.5  (16.1) 72.5  (16.7)
Height  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 25 participants 25 participants 23 participants 25 participants 98 participants
173.2  (7.3) 169.8  (9.7) 173.0  (9.1) 171.1  (8.3) 171.7  (8.6)
BMI  
Mean (Standard Deviation)
Unit of measure:  Kg/m2
Number Analyzed 25 participants 25 participants 23 participants 25 participants 98 participants
25.7  (4.7) 24.5  (5.2) 23.9  (4.5) 23.7  (4.7) 24.5  (4.8)
1.Primary Outcome
Title Proportion of Subjects Receiving PTG-100 With Clinical Remission at Week 12 Compared With Placebo
Hide Description 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.
Time Frame 12 week treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who completed 12 weeks of dosing or terminated early.
Arm/Group Title PTG-100 (150 mg QD) PTG-100 (300 mg QD) PTG-100 (900 mg QD) Placebo Group
Hide Arm/Group Description:

Low dose

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

Medium dose

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

High dose

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

Placebo control

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

Overall Number of Participants Analyzed 16 16 16 17
Measure Type: Count of Participants
Unit of Measure: Participants
1
   6.3%
2
  12.5%
3
  18.8%
4
  23.5%
Time Frame Day 0 to Week 12
Adverse Event Reporting Description At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
 
Arm/Group Title PTG-100 (150 mg QD) PTG-100 (300 mg QD) PTG-100 (900 mg QD) Placebo Group
Hide Arm/Group Description

Low dose

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

Medium dose

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

High dose

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

Placebo control

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

All-Cause Mortality
PTG-100 (150 mg QD) PTG-100 (300 mg QD) PTG-100 (900 mg QD) Placebo Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/25 (0.00%)      0/25 (0.00%)      0/23 (0.00%)      0/25 (0.00%)    
Hide Serious Adverse Events
PTG-100 (150 mg QD) PTG-100 (300 mg QD) PTG-100 (900 mg QD) Placebo Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/25 (8.00%)      2/25 (8.00%)      1/23 (4.35%)      1/25 (4.00%)    
Gastrointestinal disorders         
Ulcerative Colitis Flare  1  1/25 (4.00%)  1 0/25 (0.00%)  0 0/23 (0.00%)  0 0/25 (0.00%)  0
Colitis Ulcerative  1  0/25 (0.00%)  0 0/25 (0.00%)  0 1/23 (4.35%)  1 0/25 (0.00%)  0
Intestinal ischemia  1  0/25 (0.00%)  0 0/25 (0.00%)  0 0/23 (0.00%)  0 1/25 (4.00%)  1
Exacerbation of Ulcerative Colitis  1  0/25 (0.00%)  0 1/25 (4.00%)  1 0/23 (0.00%)  0 0/25 (0.00%)  0
Infections and infestations         
Perirectal Abscess  1  1/25 (4.00%)  1 0/25 (0.00%)  0 0/23 (0.00%)  0 0/25 (0.00%)  0
Pregnancy, puerperium and perinatal conditions         
Pregnancy  1  0/25 (0.00%)  0 1/25 (4.00%)  1 0/23 (0.00%)  0 0/25 (0.00%)  0
1
Term from vocabulary, MedDRA 21.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
PTG-100 (150 mg QD) PTG-100 (300 mg QD) PTG-100 (900 mg QD) Placebo Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/25 (28.00%)      11/25 (44.00%)      14/23 (60.87%)      11/25 (44.00%)    
Blood and lymphatic system disorders         
Anemia  1  0/25 (0.00%)  0 2/25 (8.00%)  2 1/23 (4.35%)  1 1/25 (4.00%)  1
Blood Creatinine Increased  1  0/25 (0.00%)  0 0/25 (0.00%)  0 0/23 (0.00%)  0 1/25 (4.00%)  1
Endocrine disorders         
Adrenal Insufficiency  1  0/25 (0.00%)  0 0/25 (0.00%)  0 0/23 (0.00%)  0 1/25 (4.00%)  1
Gastrointestinal disorders         
Colitis Ulcerative  1  3/25 (12.00%)  3 2/25 (8.00%)  2 3/23 (13.04%)  3 0/25 (0.00%)  0
Abdominal Pain  1  0/25 (0.00%)  0 2/25 (8.00%)  2 0/23 (0.00%)  0 0/25 (0.00%)  0
Dyspepsia  1  1/25 (4.00%)  1 1/25 (4.00%)  1 0/23 (0.00%)  0 0/25 (0.00%)  0
Anal Fistula  1  1/25 (4.00%)  0/25 (0.00%)  0 0/23 (0.00%)  0 0/25 (0.00%)  0
General disorders         
Fatigue  1  0/25 (0.00%)  0 0/25 (0.00%)  0 2/23 (8.70%)  2 1/25 (4.00%)  1
Back Pain  1  0/25 (0.00%)  0 0/25 (0.00%)  0 1/23 (4.35%)  1 0/25 (0.00%)  0
Immune system disorders         
Pyrexia  1  1/25 (4.00%)  1 0/25 (0.00%)  0 0/23 (0.00%)  0 1/25 (4.00%)  1
Infections and infestations         
Nasopharyngitis  1  0/25 (0.00%)  0 3/25 (12.00%)  3 0/23 (0.00%)  0 1/25 (4.00%)  1
Musculoskeletal and connective tissue disorders         
Arthralgia  1  0/25 (0.00%)  0 0/25 (0.00%)  0 2/23 (8.70%)  2 0/25 (0.00%)  0
Arthritis  1  0/25 (0.00%)  0 2/25 (8.00%)  2 0/23 (0.00%)  0 0/25 (0.00%)  0
Alveolar Osteitis  1  1/25 (4.00%)  1 0/25 (0.00%)  0 0/23 (0.00%)  0 0/25 (0.00%)  0
Articular Disc Disorder  1  0/25 (0.00%)  0 0/25 (0.00%)  0 1/23 (4.35%)  1 0/25 (0.00%)  0
Asthenia  1  0/25 (0.00%)  0 0/25 (0.00%)  0 0/23 (0.00%)  0 1/25 (4.00%)  1
Nervous system disorders         
Headache  1  0/25 (0.00%)  0 0/25 (0.00%)  0 4/23 (17.39%)  4 2/25 (8.00%)  2
Renal and urinary disorders         
Urinary Tract Infection  1  0/25 (0.00%)  0 0/25 (0.00%)  0 0/23 (0.00%)  0 1/25 (4.00%)  1
Respiratory, thoracic and mediastinal disorders         
Upper Respiratory Tract Infection  1  0/25 (0.00%)  0 0/25 (0.00%)  0 0/23 (0.00%)  0 1/25 (4.00%)  1
1
Term from vocabulary, MedDRA 21.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
 
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Director Clinical Development
Organization: Protagonist Therapeutics, Inc
Phone: (+1) 888-899-1543
EMail: ptgxclintrials@ptgx-inc.com
Layout table for additonal information
Responsible Party: Protagonist Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02895100    
Other Study ID Numbers: PTG-100-02
First Submitted: September 4, 2016
First Posted: September 9, 2016
Results First Submitted: February 22, 2021
Results First Posted: March 22, 2021
Last Update Posted: March 22, 2021