Trial Outcomes & Findings for Safety and Efficacy Study of PTG-100 in the Treatment of Moderate to Severe Ulcerative Colitis (NCT NCT02895100)

Last Updated: 2025-08-21

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

98 participants

Primary outcome timeframe

12 week treatment period

Results posted on

2025-08-21

Participant Flow

Participant milestones

Participant milestones
Measure	PTG-100 (150 mg QD) Low dose PTG-100: Daily dosing of PTG-100 by subject for a 12 week treatment period.	PTG-100 (300 mg QD) Medium dose PTG-100: Daily dosing of PTG-100 by subject for a 12 week treatment period.	PTG-100 (900 mg QD) High dose PTG-100: Daily dosing of PTG-100 by subject for a 12 week treatment period.	Placebo Group Placebo control Placebo: Daily dosing of Placebo capsules by subject for a 12 week treatment period.
Overall Study STARTED	25	25	23	25
Overall Study COMPLETED	14	14	15	15
Overall Study NOT COMPLETED	11	11	8	10

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PTG-100 (150 mg QD) n=25 Participants Low dose PTG-100: Daily dosing of PTG-100 by subject for a 12 week treatment period.	PTG-100 (300 mg QD) n=25 Participants Medium dose PTG-100: Daily dosing of PTG-100 by subject for a 12 week treatment period.	PTG-100 (900 mg QD) n=23 Participants High dose PTG-100: Daily dosing of PTG-100 by subject for a 12 week treatment period.	Placebo Group n=25 Participants Placebo control Placebo: Daily dosing of Placebo capsules by subject for a 12 week treatment period.	Total n=98 Participants Total of all reporting groups
Age, Continuous	45.2 years STANDARD_DEVIATION 13.8 • n=5 Participants	43.8 years STANDARD_DEVIATION 17 • n=7 Participants	40.6 years STANDARD_DEVIATION 14.1 • n=5 Participants	42.2 years STANDARD_DEVIATION 14.9 • n=4 Participants	43 years STANDARD_DEVIATION 15 • n=21 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	15 Participants n=7 Participants	14 Participants n=5 Participants	10 Participants n=4 Participants	46 Participants n=21 Participants
Sex: Female, Male Male	18 Participants n=5 Participants	10 Participants n=7 Participants	9 Participants n=5 Participants	15 Participants n=4 Participants	52 Participants n=21 Participants
Race/Ethnicity, Customized Race · White	19 Participants n=5 Participants	23 Participants n=7 Participants	22 Participants n=5 Participants	23 Participants n=4 Participants	87 Participants n=21 Participants
Race/Ethnicity, Customized Race · Asian	4 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	5 Participants n=21 Participants
Race/Ethnicity, Customized Race · Black or African American	2 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	5 Participants n=21 Participants
Race/Ethnicity, Customized Race · other	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Weight	77.8 kg STANDARD_DEVIATION 16.3 • n=5 Participants	70.7 kg STANDARD_DEVIATION 15.4 • n=7 Participants	72.3 kg STANDARD_DEVIATION 19.1 • n=5 Participants	69.5 kg STANDARD_DEVIATION 16.1 • n=4 Participants	72.5 kg STANDARD_DEVIATION 16.7 • n=21 Participants
Height	173.2 cm STANDARD_DEVIATION 7.3 • n=5 Participants	169.8 cm STANDARD_DEVIATION 9.7 • n=7 Participants	173.0 cm STANDARD_DEVIATION 9.1 • n=5 Participants	171.1 cm STANDARD_DEVIATION 8.3 • n=4 Participants	171.7 cm STANDARD_DEVIATION 8.6 • n=21 Participants
BMI	25.7 kg/m^2 STANDARD_DEVIATION 4.7 • n=5 Participants	24.5 kg/m^2 STANDARD_DEVIATION 5.2 • n=7 Participants	23.9 kg/m^2 STANDARD_DEVIATION 4.5 • n=5 Participants	23.7 kg/m^2 STANDARD_DEVIATION 4.7 • n=4 Participants	24.5 kg/m^2 STANDARD_DEVIATION 4.8 • n=21 Participants

PRIMARY outcome

Timeframe: 12 week treatment period

Population: All participants who completed 12 weeks of dosing or terminated early.

Outcome measures

Outcome measures
Measure	PTG-100 (150 mg QD) n=16 Participants Low dose PTG-100: Daily dosing of PTG-100 by subject for a 12 week treatment period.	PTG-100 (300 mg QD) n=16 Participants Medium dose PTG-100: Daily dosing of PTG-100 by subject for a 12 week treatment period.	PTG-100 (900 mg QD) n=16 Participants High dose PTG-100: Daily dosing of PTG-100 by subject for a 12 week treatment period.	Placebo Group n=17 Participants Placebo control Placebo: Daily dosing of Placebo capsules by subject for a 12 week treatment period.
Proportion of Subjects Receiving PTG-100 With Clinical Remission at Week 12 Compared With Placebo	1 Participants	2 Participants	3 Participants	4 Participants

Adverse Events

PTG-100 (150 mg QD)

Serious events: 2 serious events

Other events: 7 other events

Deaths: 0 deaths

PTG-100 (300 mg QD)

Serious events: 2 serious events

Other events: 11 other events

Deaths: 0 deaths

PTG-100 (900 mg QD)

Serious events: 1 serious events

Other events: 14 other events

Deaths: 0 deaths

Placebo Group

Serious events: 1 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	PTG-100 (150 mg QD) n=25 participants at risk Low dose PTG-100: Daily dosing of PTG-100 by subject for a 12 week treatment period.	PTG-100 (300 mg QD) n=25 participants at risk Medium dose PTG-100: Daily dosing of PTG-100 by subject for a 12 week treatment period.	PTG-100 (900 mg QD) n=23 participants at risk High dose PTG-100: Daily dosing of PTG-100 by subject for a 12 week treatment period.	Placebo Group n=25 participants at risk Placebo control Placebo: Daily dosing of Placebo capsules by subject for a 12 week treatment period.
Infections and infestations Perirectal Abscess	4.0% 1/25 • Number of events 1 • Day 0 to Week 12 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.	0.00% 0/25 • Day 0 to Week 12 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.	0.00% 0/23 • Day 0 to Week 12 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.	0.00% 0/25 • Day 0 to Week 12 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.
Gastrointestinal disorders Ulcerative Colitis Flare	4.0% 1/25 • Number of events 1 • Day 0 to Week 12 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.	0.00% 0/25 • Day 0 to Week 12 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.	0.00% 0/23 • Day 0 to Week 12 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.	0.00% 0/25 • Day 0 to Week 12 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.
Gastrointestinal disorders Colitis Ulcerative	0.00% 0/25 • Day 0 to Week 12 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.	0.00% 0/25 • Day 0 to Week 12 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.	4.3% 1/23 • Number of events 1 • Day 0 to Week 12 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.	0.00% 0/25 • Day 0 to Week 12 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.
Pregnancy, puerperium and perinatal conditions Pregnancy	0.00% 0/25 • Day 0 to Week 12 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.	4.0% 1/25 • Number of events 1 • Day 0 to Week 12 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.	0.00% 0/23 • Day 0 to Week 12 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.	0.00% 0/25 • Day 0 to Week 12 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.
Gastrointestinal disorders Intestinal ischemia	0.00% 0/25 • Day 0 to Week 12 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.	0.00% 0/25 • Day 0 to Week 12 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.	0.00% 0/23 • Day 0 to Week 12 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.	4.0% 1/25 • Number of events 1 • Day 0 to Week 12 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.
Gastrointestinal disorders Exacerbation of Ulcerative Colitis	0.00% 0/25 • Day 0 to Week 12 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.	4.0% 1/25 • Number of events 1 • Day 0 to Week 12 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.	0.00% 0/23 • Day 0 to Week 12 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.	0.00% 0/25 • Day 0 to Week 12 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.

Other adverse events

Additional Information

Director Clinical Development

Protagonist Therapeutics, Inc

Phone: (+1) 888-899-1543

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER