A Study of Vedolizumab With Tofacitinib in Adults With Ulcerative Colitis (UC)
ConditionUlcerative Colitis
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-65
SponsorTakeda
About this trial
The main aim of this study is to learn about the effect of treatment with vedolizumab IV (vedolizumab) together with tofacitinib in adults with moderate and severe ulcerative colitis (UC). Another aim is to learn about treatment with vedolizumab alone after the double treatment.
All participants will receive vedolizumab together with tofacitinib for 8 weeks and will be checked for response. Participants who show a response to the treatment after 8 weeks will be treated with vedolizumab alone for an additional 44 weeks.
Each participant will be followed up for at least 26 weeks after the last dose of vedolizumab.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Has a confirmed diagnosis of UC established at least 3 months prior to screening, by clinical and endoscopic evidence and corroborated by a histopathology report.
Has moderately to severely active UC as determined by a complete Mayo score [including PGA] of 6 to 12 with a rectal bleeding subscore ≥1 and a centrally assessed endoscopic subscore ≥2 at screening.
Has evidence of UC extending proximally to the rectum [≥15 centimeter (cm) of involved colon].
Participants with extensive colitis or pancolitis of >8 years duration or left sided colitis >12 years duration must have documented evidence that a surveillance colonoscopy was performed within 12 months of the initial screening visit.
Disqualifiers
Acute severe UC.
The participant has had extensive colonic resection, subtotal or total colectomy.
The participant has clinical evidence of abdominal abscess or toxic megacolon.
The participant has an ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine.
Trial design
Design model
Single group
Treatments tested in this trial
Vedolizumab
DrugVedolizumab IV infusions
Tofacitinib
DrugTofacitinib Tablets
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: Vedolizumab 300 mg + Tofacitinib 10 mgExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Percentage of Participants Achieving Clinical Remission at Week 8 Based on Complete Mayo Score
Clinical remission based on complete Mayo Score is where a participant achieves complete Mayo Score ≤2 points with no individual subscore \>1 at Week 8. The complete Mayo Clinic Score includes 4 variables: Stool frequency, rectal bleeding, a Physician's Global Index (PGA) and Mayo endoscopic findings (MES). Each variable is scored on a 4-point scale (0-3 points) where 0=none and 3=severe disease and summed to give a total disease activity score (range, 0-12), with higher scores representing more severe disease activity.
Time frame
At Week 8Secondary outcomes
1
Percentage of Participants Achieving Clinical Remission at Week 52 Based on Complete Mayo Score
Clinical remission based on complete Mayo Score is where a participant achieves complete Mayo Score ≤2 points with no individual subscore \>1 at Week 52. The complete Mayo Clinic Score includes 4 variables: Stool frequency, rectal bleeding, a PGA and MES. Each variable is scored on a 4-point scale (0-3 points) where 0=none and 3=severe disease and summed to give a total disease activity score (range, 0-12), with higher scores representing more severe disease activity.
Time frame
At Week 522
Percentage of Participants Achieving Clinical Remission at Weeks 8, 14, and 26 Based on Partial Mayo Score
Clinical remission based on complete Mayo Score is where a participant achieves partial Mayo Score ≤2 points with no individual subscore \>1. Partial Mayo Score consists of 3 variables of the Mayo Clinic Score: stool frequency, rectal bleeding and PGA. Each variable is scored on a 4-point scale (0-3 points) where 0=none and 3=severe disease. These scores are summed to give a total score range of 0 to 9 where higher scores indicate maximum disease activity.
Time frame
At Weeks 8, 14 and 263
Percentage of Participants Achieving Clinical Response at Weeks 2, 6, 8, 14, 26 and 52 Based on Complete or Partial Mayo Score
Clinical response based on complete Mayo Score is where a participant achieves a reduction in complete Mayo score of ≥3 points and ≥30% from Baseline or a partial Mayo score of ≥2 points and ≥25% from baseline, if the complete Mayo score was not performed at the visit with an accompanying decrease in rectal bleeding subscore of ≥1 point or absolute rectal bleeding subscore of ≤1 point. The complete Mayo Clinic Score includes 4 variables: Stool frequency, rectal bleeding, a PGA and MES. Each variable is scored on a 4-point scale (0-3 points) where 0=none and 3=severe disease and summed to give a total disease activity score (range, 0-12), with higher scores representing more severe disease activity.
Time frame
At Weeks 2, 6, 8, 14, 26, and 524
Percentage of Participants Achieving Clinical Remission at Week 8 and Week 52 Based on Modified Mayo Score
Clinical remission based on modified Mayo Score is where a participant achieves component modified Mayo score of ≤2 with modified MES ≤1, rectal bleeding = 0, and stool frequency ≤1. Modified Mayo Score consists of 3 variables: stool frequency, rectal bleeding and MES. Each variable is scored on a 4-point scale (0-3 points) where 0=none and 3=severe disease. These scores are summed to give a total score range of 0 to 9 where higher scores indicate maximum disease activity.
Time frame
At Weeks 8 and 52 Source ClinicalTrials.gov