Trial Outcomes & Findings for Vedolizumab Monotherapy Vs Combination Therapy With Tacrolimus in UC (NCT NCT02954159)
NCT ID: NCT02954159
Last Updated: 2020-09-03
Results Overview
Steroid-free clinical response at week 6 after starting vedolizumab, defined as a reduction in the Mayo Clinic score of at least 3 points and a decrease of at least 30% from the baseline score, with a decrease of at least 1 point on the rectal bleeding subscale or an absolute rectal bleeding score of 0 or 1 while off steroids.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
4 participants
Primary outcome timeframe
week 6
Results posted on
2020-09-03
Participant Flow
Participant milestones
| Measure |
Treatment Arm
vedolizumab at standard regimen with concomitant induction treatment of tacrolimus (starting 0.05 mg per Kg twice daily)
Tacrolimus: Oral tacrolimus tablet starting at 0.05mg/kg twice daily, with dose adjustments aiming for serum trough levels of 10-15 ng/ml during the first 2 weeks, and 5-10ng/ml subsequently.
Vedolizumab: Intravenous Vedolizumab 300 mg at week 0, 2 and 6 followed by the same dose every 8 weeks. This drug will be given as per standard of care.
|
Placebo Arm
vedolizumab at standard regimen with placebo.
Vedolizumab: Intravenous Vedolizumab 300 mg at week 0, 2 and 6 followed by the same dose every 8 weeks. This drug will be given as per standard of care.
Placebo: Patients will be randomized 1:1 in Treatment arm (receive Tacrolimus) and Placebo Arm.
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
2
|
|
Overall Study
COMPLETED
|
1
|
1
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Treatment Arm
vedolizumab at standard regimen with concomitant induction treatment of tacrolimus (starting 0.05 mg per Kg twice daily)
Tacrolimus: Oral tacrolimus tablet starting at 0.05mg/kg twice daily, with dose adjustments aiming for serum trough levels of 10-15 ng/ml during the first 2 weeks, and 5-10ng/ml subsequently.
Vedolizumab: Intravenous Vedolizumab 300 mg at week 0, 2 and 6 followed by the same dose every 8 weeks. This drug will be given as per standard of care.
|
Placebo Arm
vedolizumab at standard regimen with placebo.
Vedolizumab: Intravenous Vedolizumab 300 mg at week 0, 2 and 6 followed by the same dose every 8 weeks. This drug will be given as per standard of care.
Placebo: Patients will be randomized 1:1 in Treatment arm (receive Tacrolimus) and Placebo Arm.
|
|---|---|---|
|
Overall Study
Study ended prematurely due to low enrol
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Vedolizumab Monotherapy Vs Combination Therapy With Tacrolimus in UC
Baseline characteristics by cohort
| Measure |
Treatment Arm
n=2 Participants
vedolizumab at standard regimen with concomitant induction treatment of tacrolimus (starting 0.05 mg per Kg twice daily)
Tacrolimus: Oral tacrolimus tablet starting at 0.05mg/kg twice daily, with dose adjustments aiming for serum trough levels of 10-15 ng/ml during the first 2 weeks, and 5-10ng/ml subsequently.
Vedolizumab: Intravenous Vedolizumab 300 mg at week 0, 2 and 6 followed by the same dose every 8 weeks. This drug will be given as per standard of care.
|
Placebo Arm
n=2 Participants
vedolizumab at standard regimen with placebo.
Vedolizumab: Intravenous Vedolizumab 300 mg at week 0, 2 and 6 followed by the same dose every 8 weeks. This drug will be given as per standard of care.
Placebo: Patients will be randomized 1:1 in Treatment arm (receive Tacrolimus) and Placebo Arm.
|
Total
n=4 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: week 6Population: Data not collected
Steroid-free clinical response at week 6 after starting vedolizumab, defined as a reduction in the Mayo Clinic score of at least 3 points and a decrease of at least 30% from the baseline score, with a decrease of at least 1 point on the rectal bleeding subscale or an absolute rectal bleeding score of 0 or 1 while off steroids.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: week 14Population: Data not collected
Steroid-free clinical response at week 14 after starting vedolizumab.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Screening, Week 2, 6, 8, 14, 30Population: Data not collected
total score on assessment
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Screening, Week 6, 14, 30Population: Data not collected
total score on assessment
Outcome measures
Outcome data not reported
Adverse Events
Treatment Arm
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo Arm
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment Arm
n=2 participants at risk
vedolizumab at standard regimen with concomitant induction treatment of tacrolimus (starting 0.05 mg per Kg twice daily)
Tacrolimus: Oral tacrolimus tablet starting at 0.05mg/kg twice daily, with dose adjustments aiming for serum trough levels of 10-15 ng/ml during the first 2 weeks, and 5-10ng/ml subsequently.
Vedolizumab: Intravenous Vedolizumab 300 mg at week 0, 2 and 6 followed by the same dose every 8 weeks. This drug will be given as per standard of care.
|
Placebo Arm
n=2 participants at risk
vedolizumab at standard regimen with placebo.
Vedolizumab: Intravenous Vedolizumab 300 mg at week 0, 2 and 6 followed by the same dose every 8 weeks. This drug will be given as per standard of care.
Placebo: Patients will be randomized 1:1 in Treatment arm (receive Tacrolimus) and Placebo Arm.
|
|---|---|---|
|
Gastrointestinal disorders
Increase in severity of UC symptoms
|
50.0%
1/2 • Number of events 1 • 20 months, 13 days
|
0.00%
0/2 • 20 months, 13 days
|
Other adverse events
| Measure |
Treatment Arm
n=2 participants at risk
vedolizumab at standard regimen with concomitant induction treatment of tacrolimus (starting 0.05 mg per Kg twice daily)
Tacrolimus: Oral tacrolimus tablet starting at 0.05mg/kg twice daily, with dose adjustments aiming for serum trough levels of 10-15 ng/ml during the first 2 weeks, and 5-10ng/ml subsequently.
Vedolizumab: Intravenous Vedolizumab 300 mg at week 0, 2 and 6 followed by the same dose every 8 weeks. This drug will be given as per standard of care.
|
Placebo Arm
n=2 participants at risk
vedolizumab at standard regimen with placebo.
Vedolizumab: Intravenous Vedolizumab 300 mg at week 0, 2 and 6 followed by the same dose every 8 weeks. This drug will be given as per standard of care.
Placebo: Patients will be randomized 1:1 in Treatment arm (receive Tacrolimus) and Placebo Arm.
|
|---|---|---|
|
Nervous system disorders
Intermittent tremor
|
0.00%
0/2 • 20 months, 13 days
|
50.0%
1/2 • Number of events 1 • 20 months, 13 days
|
|
Renal and urinary disorders
clinically significant elevated creatinine
|
50.0%
1/2 • Number of events 1 • 20 months, 13 days
|
0.00%
0/2 • 20 months, 13 days
|
|
Endocrine disorders
clinically significant low phosphorus
|
50.0%
1/2 • Number of events 1 • 20 months, 13 days
|
0.00%
0/2 • 20 months, 13 days
|
|
Endocrine disorders
clinically significant low magnesium
|
50.0%
1/2 • Number of events 1 • 20 months, 13 days
|
0.00%
0/2 • 20 months, 13 days
|
|
Skin and subcutaneous tissue disorders
rash
|
0.00%
0/2 • 20 months, 13 days
|
0.00%
0/2 • 20 months, 13 days
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/2 • 20 months, 13 days
|
50.0%
1/2 • Number of events 1 • 20 months, 13 days
|
|
Gastrointestinal disorders
Emesis
|
0.00%
0/2 • 20 months, 13 days
|
50.0%
1/2 • Number of events 1 • 20 months, 13 days
|
|
General disorders
increased pain
|
50.0%
1/2 • Number of events 1 • 20 months, 13 days
|
0.00%
0/2 • 20 months, 13 days
|
|
Gastrointestinal disorders
increased diarrhea
|
50.0%
1/2 • Number of events 1 • 20 months, 13 days
|
0.00%
0/2 • 20 months, 13 days
|
|
Gastrointestinal disorders
increase in severity of UC symptoms
|
50.0%
1/2 • Number of events 1 • 20 months, 13 days
|
0.00%
0/2 • 20 months, 13 days
|
Additional Information
Andres Yarur, MD; Principal Investigator
Medical College Of Wisconsin
Phone: 414-955-6858
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place