Efficacy and Safety of Vedolizumab Intravenous (IV) in the Treatment of Primary Sclerosing Cholangitis in Subjects With Underlying Inflammatory Bowel Disease
|ClinicalTrials.gov Identifier: NCT03035058|
Recruitment Status : Withdrawn
First Posted : January 27, 2017
Last Update Posted : March 8, 2017
|Condition or disease||Intervention/treatment||Phase|
|Primary Sclerosing Cholangitis Inflammatory Bowel Disease||Drug: Vedolizumab Drug: Placebo||Phase 3|
The drug being tested in this study is called vedolizumab. Vedolizumab is being tested to treat people who have non-end-stage primary sclerosing cholangitis (PSC) with underlying inflammatory bowel disease (IBD). This study will look at changes in fibrosis staging in people who take vedolizumab.
The study will enroll approximately 258 patients. Participants will be randomly assigned (by chance, like flipping a coin) to one of the three treatment groups in ratio 1:1:1—which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need):
- Vedolizumab 300 mg once every 4 weeks (Q4W)
- Vedolizumab 300 mg once every 8 weeks (Q8W)
- Placebo (dummy inactive pill) - this is a tablet that looks like the study drug but has no active ingredient
All participants will be administered vedolizumab or placebo via intravenous infusion
This multi-center trial will be conducted worldwide. The overall time to participate in this study is up to 124 weeks. Participants will make multiple visits to the clinic and will be contacted by telephone 6 months after last dose of study drug for a follow-up assessment.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Randomized, Global, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Vedolizumab IV for the Treatment of Primary Sclerosing Cholangitis, With Underlying Inflammatory Bowel Disease|
|Study Start Date :||February 2017|
|Estimated Primary Completion Date :||September 2020|
|Estimated Study Completion Date :||January 2021|
Experimental: Vedolizumab IV 300 mg Q4W
Vedolizumab 300 mg, intravenous (IV), once at Day 1 and Week 2; followed by vedolizumab 300 mg, IV, once every 4 weeks (Q4W) starting from Week 6 to Week 102.
Vedolizumab intravenous infusion
Experimental: Vedolizumab IV 300 mg Q8W + Placebo
Vedolizumab 300 mg, IV, once at Day 1 and Week 2; followed by vedolizumab 300 mg, IV, once every 8 weeks (Q8W) starting from Week 6 to Week 102 (and placebo, IV, Q8W starting from Week 10 to Week 98.
Vedolizumab intravenous infusion
Placebo Comparator: Placebo
Vedolizumab placebo-matching, IV, at Day 1 and Week 2; followed by Vedolizumab placebo-matching, IV, Q4W starting from Week 6 to Week 102.
- Percentage of Participants with No Worsening in Ishak Fibrosis Staging Score from Baseline to Week 106 Visit [ Time Frame: Baseline and Week 106 ]Assessments will be performed from liver biopsies with histology assessed by 2 independent blinded central readers for Ishak fibrosis staging score. Ishak fibrosis staging scoring is as follows: 0=No fibrosis, 1=Fibrous expansion of some portal areas with or without septa, 2=Fibrous expansion of most portal areas with or without septa, 3=Fibrous expansion of most portal areas with occasional portal to portal bridging, 4=Fibrous expansion of portal areas with marked bridging (portal to portal and/or portal to central), 5=Marked bridging with occasional nodules (incomplete cirrhosis), 6=Cirrhosis, probable or definitive. A negative change from Baseline indicates improvement.
- Percentage of Participants with a ≥35% Reduction in Serum Alkaline Phosphatase (ALP) from Baseline to Week 106 Visit [ Time Frame: Baseline and Week 106 ]Blood will be collected and ALP will be assessed as part of the serum chemistry testing.
- Change in Ishak Necroinflammatory Grading Score from Baseline to the Week 106 Visit [ Time Frame: Baseline and Week 106 ]Assessments will be performed from liver biopsies with histology assessed by 2 independent blinded central readers for Ishak fibrosis staging score. Ishak necroinflammatory grading score is based on assessments from 4 subscales: (A) Periportal or periseptal interface hepatitis (piecemeal necrosis) 5-point subscale (0=Absent to 4=Severe), (B) Confluent necrosis 7-point subscale (0=Absent to 6=Panacinar or multiacinar necrosis), (C) Focal (spotty) lytic necrosis, apoptosis and focal inflammation 5-point subscale (0=Absent to 4=More than ten foci per times 10 objective), and (D) Portal inflammation (0=Absent to 4=Marked, all portal areas). A negative change from Baseline indicates improvement.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03035058
|Study Director:||Medical Director Clinical Science||Takeda|