Adults 18 to 80, any sex, with Pouchitis. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentage of Participants With Chronic or Recurrent Pouchitis Achieving Clinically Relevant Remission at Week 14Primary· Week 14
Clinically relevant remission is defined as modified Pouchitis Disease Activity Index (mPDAI) score \<5 and a reduction of mPDAI score by ≥2 points from Baseline. The 12-point mPDAI score is calculated as a sum of from two 6-point subscales, where 0 = best and 12 = worst.: 1) Clinical Symptoms: Stool Frequency (0=usual to postoperative stool frequency to 2=three or more stools/day\>postoperative usual); Rectal bleeding (0=None or rare to 1=Present daily); Fecal urgency or abdominal cramps (0=None to 2=Usual), Fever \[temperature \>37.8 degrees C\] (0=Absent and 1=Present) for a clinical sympto
Group
Value
95% CI
Placebo IV
9.8
3.3 – 21.4
Vedolizumab IV 300 mg
31.4
19.1 – 45.9
Percentage of Participants With Chronic or Recurrent Pouchitis Achieving Clinically Relevant Remission at Week 34Secondary· Week 34
Clinically relevant remission is defined as mPDAI score \<5 and a reduction of mPDAI score by ≥2 points from Baseline. The 12-point mPDAI score is calculated as a sum of from two 6-point subscales, where 0 = best and 12 = worst.: 1) Clinical Symptoms: Stool Frequency (0=usual to postoperative stool frequency to 2=3 or more stools/day\>postoperative usual); Rectal bleeding (0=None or rare to 1=Present daily); Fecal urgency or abdominal cramps (0=None to 2=Usual), Fever \[temperature \>37.8 degrees C\] (0=Absent and 1=Present) for a clinical symptoms subscore of 0 (best) to 6 (worse); 2) Endosco
Group
Value
95% CI
Placebo IV
17.6
8.4 – 30.9
Vedolizumab IV 300 mg
35.3
22.4 – 49.9
Percentage of Participants Achieving Pouchitis Disease Activity Index (PDAI) Remission at Weeks 14 and 34Secondary· Weeks 14 and 34
PDAI remission is PDAI score \<7 and a reduction of PDAI score by ≥3 points from Baseline. The 18-point PDAI score is calculated as a sum of three 6-point scales with total possible subscore of 0 (best) to 6 (worse) and possible total score of 0 (best) to 18 (worse):1)Clinical Symptoms:Stool Frequency(0=usual to postoperative stool frequency to 2=3 or more stools/day\>postoperative usual);Rectal bleeding(0=None or rare,1=Present daily);Fecal urgency/abdominal cramps(0=None to 2=Usual),Fever\[temperature\>37.8 degrees C\](0=Absent,1=Present);2)Endoscopic Inflammation:Edema,Granularity,Friabilit
Week 14
Group
Value
95% CI
Placebo IV
9.8
3.3 – 21.4
Vedolizumab IV 300 mg
35.3
22.4 – 49.9
Week 34
Group
Value
95% CI
Placebo IV
17.6
8.4 – 30.9
Vedolizumab IV 300 mg
37.3
24.1 – 51.9
Time to PDAI RemissionSecondary· Baseline up to Week 34
Time to remission-time in days from start of treatment to PDAI Remission(PDAI score \<7 and decrease in PDAI score ≥3 points from Baseline).18-point PDAI score-calculated as sum of 3, 6-point scales with total possible subscore of 0(best) to 6(worse) and possible total score of 0(best)to18(worse):1)Clinical Symptoms:Stool Frequency(0=usual to postoperative stool frequency to 2=3 or more stools/day\>postoperative usual);Rectal bleeding(0=None or rare,1=Present daily);Fecal urgency/abdominal cramps(0=None to 2=Usual),Fever\[temperature\>37.8 degrees C\](0=Absent,1=Present);2)Endoscopic Inflammat
Group
Value
95% CI
Placebo IV
NA
NA – NA
Vedolizumab IV 300 mg
239.0
101.0 – NA
Percentage of Participants Achieving a Partial mPDAI Response at Weeks 14 and 34Secondary· Weeks 14 and 34
Partial mPDAI response is defined as a reduction in mPDAI score by ≥2 points from Baseline. The 12-point mPDAI score is calculated as a sum of from two 6-point subscales, where 0 = best and 12 = worst:1) Clinical Symptoms: Stool Frequency (0=usual to postoperative stool frequency to 2=3 or more stools/day\>postoperative usual); Rectal bleeding (0=None or rare to 1=Present daily); Fecal urgency or abdominal cramps (0=None to 2=Usual), Fever \[temperature \>37.8 degrees C\] (0=Absent and 1=Present) for a clinical symptoms subscore of 0 (best) to 6 (worse); 2) Endoscopic Inflammation Findings: Ed
Week 14
Group
Value
95% CI
Placebo IV
33.3
20.8 – 47.9
Vedolizumab IV 300 mg
62.7
48.1 – 75.9
Week 34
Group
Value
95% CI
Placebo IV
29.4
17.5 – 43.8
Vedolizumab IV 300 mg
51.0
36.6 – 65.2
Change From Baseline in PDAI Endoscopic Inflammation Subscore at Weeks 14 and 34Secondary· Baseline up to Weeks 14 and 34
The PDAI Endoscopic Inflammation subscore is a sum of scores from findings for Edema, Granularity, Friability, Loss of vascular pattern, Mucous exudates, and Ulcerations, each scored on 0=not present to 1=present scale summed up to a subscore ranging from 0 (best) to 6 (worse) where higher scores = more severe disease. A negative change from Baseline indicates improvement. LOCF method was used for analyses.
Baseline
Group
Value
95% CI
Placebo IV
4.5
± 1.36
Vedolizumab IV 300 mg
4.6
± 1.15
Change from Baseline at Week 14
Group
Value
95% CI
Placebo IV
-0.2
± 1.36
Vedolizumab IV 300 mg
-1.1
± 1.59
Change from Baseline at Week 34
Group
Value
95% CI
Placebo IV
-0.6
± 1.86
Vedolizumab IV 300 mg
-1.2
± 1.87
Change From Baseline in PDAI Acute Histologic Inflammation Subscore at Weeks 14 and 34Secondary· Baseline up to Weeks 14 and 34
The PDAI Acute Histologic Inflammation subscore is a sum score from findings for Polymorphic nuclear leukocyte infiltration (0=None to 3=Severe plus crypt abscess), and Ulceration per low power field \[mean\] (0=0% to 3= \>50%) summed up to a subscore ranging from 0 (best) to 6 (worse) where higher scores = more severe disease. A negative change from Baseline indicates improvement. LOCF method was used for analyses.
Baseline
Group
Value
95% CI
Placebo IV
2.6
± 1.39
Vedolizumab IV 300 mg
2.5
± 1.42
Change from Baseline at Week 14
Group
Value
95% CI
Placebo IV
-0.1
± 1.33
Vedolizumab IV 300 mg
-0.4
± 1.98
Change from Baseline at Week 34
Group
Value
95% CI
Placebo IV
-0.2
± 1.52
Vedolizumab IV 300 mg
-0.2
± 2.03
Change From Baseline in Total PDAI Score at Weeks 14 and 34Secondary· Baseline up to Weeks 14 and 34
The 18-point PDAI score is calculated as a sum of three 6-point scales with total possible subscore of 0 (best) to 6 (worse) and possible total score of 0 (best) to 18 (worse):1)Clinical Symptoms:Stool Frequency(0=usual to postoperative stool frequency to 2=3 or more stools/day\>postoperative usual);Rectal bleeding(0=None or rare,1=Present daily);Fecal urgency/abdominal cramps(0=None to 2=Usual),Fever\[temperature\>37.8 degrees C\](0=Absent,1=Present);2)Endoscopic Inflammation:Edema,Granularity,Friability,Loss of vascular pattern,Mucous exudates,Ulcerations. Each item is scored on scale of 0=n
Baseline
Group
Value
95% CI
Placebo IV
10.5
± 2.48
Vedolizumab IV 300 mg
10.5
± 2.20
Change from Baseline at Week 14
Group
Value
95% CI
Placebo IV
-1.3
± 2.68
Vedolizumab IV 300 mg
-2.7
± 3.86
Change from Baseline at Week 34
Group
Value
95% CI
Placebo IV
-1.6
± 3.41
Vedolizumab IV 300 mg
-2.9
± 3.93
Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Weeks 14, 22, and 34Secondary· Baseline up to Weeks 14, 22, and 34
The IBDQ is an instrument used to assess quality of life in adult participants with inflammatory bowel disease (IBD). It includes 32 questions on 4 domains of Health-Related Quality-of-Life (HRQOL): Bowel Systems (10 items), Emotional Function (12 items), Social Function (5 items), and Systemic Function (5 items). Participants are asked to recall symptoms and quality of life from the last 2 weeks and rate each item on a 7-point Likert scale (1=worst to 7=best). A total IBDQ score is calculated by summing the scores from each domain; the total IBDQ score ranges from 32 to 224, with lower scores
Baseline
Group
Value
95% CI
Placebo IV
131.5
± 30.78
Vedolizumab IV 300 mg
137.9
± 33.53
Change from Baseline at Week 14
Group
Value
95% CI
Placebo IV
14.6
± 26.67
Vedolizumab IV 300 mg
18.3
± 29.20
Change from Baseline at Week 22
Group
Value
95% CI
Placebo IV
16.0
± 29.12
Vedolizumab IV 300 mg
21.3
± 31.28
Change from Baseline at Week 34
Group
Value
95% CI
Placebo IV
10.4
± 25.98
Vedolizumab IV 300 mg
24.4
± 34.21
Change From Baseline in Cleveland Global Quality of Life (CGQL) at Weeks 14, 22, and 34Secondary· Baseline up to Weeks 14, 22, and 34
The CGQL (Fazio score) is a quality-of-life indicator specifically for participants with ileal pouch-anal anastomosis. Participants rate 3 items (current quality of life, current quality of health, and current energy level), each on a scale of 0 to 10 (0=worst; 10=best). The scores are added, and the final CGQL utility score is obtained by dividing this result by 30. The total score ranges from 0 (worst) to 1 (best) where lower scores indicate less quality of life. A negative change from Baseline indicates worsening. LOCF method was used for analyses.
Baseline
Group
Value
95% CI
Placebo IV
0.522
± 0.1953
Vedolizumab IV 300 mg
0.556
± 0.1626
Change from Baseline at Week 14
Group
Value
95% CI
Placebo IV
0.051
± 0.1518
Vedolizumab IV 300 mg
0.088
± 0.1715
Change from Baseline at Week 22
Group
Value
95% CI
Placebo IV
0.073
± 0.1491
Vedolizumab IV 300 mg
0.093
± 0.1648
Change from Baseline at Week 34
Group
Value
95% CI
Placebo IV
0.056
± 0.1544
Vedolizumab IV 300 mg
0.083
± 0.1831
Adverse events — posted to ClinicalTrials.gov
Time frame: From first dose of study drug up to 18 weeks after last dose (Up to 50 weeks).
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Placebo IV
Serious: 4/51 (8%)
Deaths: 0/51
Vedolizumab IV 300 mg
Serious: 3/51 (6%)
Deaths: 0/51
Serious adverse events (5 terms)
Reaction
System
Placebo IV
Vedolizumab IV 300 mg
Pouchitis
Gastrointestinal disorders
—
—
Abdominal pain
Gastrointestinal disorders
—
—
Intestinal obstruction
Gastrointestinal disorders
—
—
Gastroenteritis
Infections and infestations
—
—
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
The purpose of this study is to compare the efficacy of vedolizumab intravenous (IV) and placebo in terms of the percentage of participants with chronic or recurrent pouchitis achieving clinically relevant remission.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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NCT07016165 — Ciprofloxacin vs Ceftazidime for Empirical Treatment of High-Risk Neutropenic Fever in Children With Hematologic Maligna
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· recruiting
NCT05846399 — CAT BITE Antibiotic Prophylaxis for the Hand/Forearm (CATBITE)
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· recruiting
NCT05844735 — A Randomized Placebo- and Active Comparator-controlled Study to Evaluate the Photosafety of SAR441566
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· completed
Other recruiting trials for Pouchitis
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Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Takeda
Last refreshed: 24 February 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02790138.