Trial Outcomes & Findings for Efficacy and Safety of Trichuris Suis Ova (TSO) as Compared to Placebo (NCT NCT01576471)
NCT ID: NCT01576471
Last Updated: 2017-06-29
Results Overview
CDAI \>= 100 point reduction from baseline
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
250 participants
Primary outcome timeframe
12 weeks
Results posted on
2017-06-29
Participant Flow
Participant milestones
| Measure |
Placebo
Placebo: Placebo: dose every 2 weeks X 10 weeks (up to 6 total doses)
|
TSO 7500
Trichuris suis ova (TSO): TSO 7500: 7500 embryonated, viable TSO every 2 weeks X 10 weeks (up to 6 total doses)
|
|---|---|---|
|
Overall Study
STARTED
|
125
|
125
|
|
Overall Study
COMPLETED
|
117
|
116
|
|
Overall Study
NOT COMPLETED
|
8
|
9
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy and Safety of Trichuris Suis Ova (TSO) as Compared to Placebo
Baseline characteristics by cohort
| Measure |
Placebo
n=125 Participants
Placebo: Placebo: dose every 2 weeks X 10 weeks (up to 6 total doses)
|
TSO 7500
n=125 Participants
Trichuris suis ova (TSO): TSO 7500: 7500 embryonated, viable TSO every 2 weeks X 10 weeks (up to 6 total doses)
|
Total
n=250 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
125 Participants
n=99 Participants
|
125 Participants
n=107 Participants
|
250 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
38.6 years
STANDARD_DEVIATION 1.07 • n=99 Participants
|
40.9 years
STANDARD_DEVIATION 1.04 • n=107 Participants
|
39.8 years
STANDARD_DEVIATION 0.75 • n=206 Participants
|
|
Sex: Female, Male
Female
|
61 Participants
n=99 Participants
|
71 Participants
n=107 Participants
|
132 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
64 Participants
n=99 Participants
|
54 Participants
n=107 Participants
|
118 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
15 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
110 Participants
n=99 Participants
|
112 Participants
n=107 Participants
|
222 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
112 Participants
n=99 Participants
|
117 Participants
n=107 Participants
|
229 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
125 participants
n=99 Participants
|
125 participants
n=107 Participants
|
250 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: all patients randomized and treated with at least 1 dose of study medication
CDAI \>= 100 point reduction from baseline
Outcome measures
| Measure |
Placebo
n=125 Participants
Placebo: Placebo: dose every 2 weeks X 10 weeks (up to 6 total doses)
|
TSO 7500
n=125 Participants
Trichuris suis ova (TSO): TSO 7500: 7500 embryonated, viable TSO every 2 weeks X 10 weeks (up to 6 total doses)
|
|---|---|---|
|
Evaluate the Effects of TSO on the Induction of Response in Crohn's Disease, as Measured Primarily by Crohn's Disease Activity Index (CDAI)
|
55 Participants
|
58 Participants
|
Adverse Events
Placebo
Serious events: 6 serious events
Other events: 27 other events
Deaths: 0 deaths
TSO 7500
Serious events: 3 serious events
Other events: 31 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=125 participants at risk
Placebo: Placebo: dose every 2 weeks X 10 weeks (up to 6 total doses)
|
TSO 7500
n=125 participants at risk
Trichuris suis ova (TSO): TSO 7500: 7500 embryonated, viable TSO every 2 weeks X 10 weeks (up to 6 total doses)
|
|---|---|---|
|
Gastrointestinal disorders
Food Poisoning
|
0.80%
1/125 • Number of events 1 • 12 weeks
no difference
|
0.00%
0/125 • 12 weeks
no difference
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
0.80%
1/125 • Number of events 1 • 12 weeks
no difference
|
0.00%
0/125 • 12 weeks
no difference
|
|
Gastrointestinal disorders
Crohn's Disease
|
1.6%
2/125 • Number of events 2 • 12 weeks
no difference
|
0.80%
1/125 • Number of events 1 • 12 weeks
no difference
|
|
Infections and infestations
Abscess Intestinal
|
0.00%
0/125 • 12 weeks
no difference
|
0.80%
1/125 • Number of events 1 • 12 weeks
no difference
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/125 • 12 weeks
no difference
|
0.80%
1/125 • Number of events 1 • 12 weeks
no difference
|
|
Renal and urinary disorders
Calculus ureteric
|
0.80%
1/125 • Number of events 1 • 12 weeks
no difference
|
0.00%
0/125 • 12 weeks
no difference
|
|
Renal and urinary disorders
Hydronephrosis
|
0.80%
1/125 • Number of events 1 • 12 weeks
no difference
|
0.00%
0/125 • 12 weeks
no difference
|
|
Vascular disorders
Vein disorder
|
0.80%
1/125 • Number of events 1 • 12 weeks
no difference
|
0.00%
0/125 • 12 weeks
no difference
|
Other adverse events
| Measure |
Placebo
n=125 participants at risk
Placebo: Placebo: dose every 2 weeks X 10 weeks (up to 6 total doses)
|
TSO 7500
n=125 participants at risk
Trichuris suis ova (TSO): TSO 7500: 7500 embryonated, viable TSO every 2 weeks X 10 weeks (up to 6 total doses)
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
5.6%
7/125 • Number of events 7 • 12 weeks
no difference
|
8.0%
10/125 • Number of events 10 • 12 weeks
no difference
|
|
Gastrointestinal disorders
Abdominal Pain
|
11.2%
14/125 • Number of events 14 • 12 weeks
no difference
|
11.2%
14/125 • Number of events 14 • 12 weeks
no difference
|
|
Gastrointestinal disorders
Crohn's Disease
|
4.8%
6/125 • Number of events 6 • 12 weeks
no difference
|
5.6%
7/125 • Number of events 7 • 12 weeks
no difference
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee As specified in each clinical trial agreement
- Publication restrictions are in place
Restriction type: OTHER