Crohn's Disease, Ulcerative Colitis
Conditions
Brief summary
Ulcerative Colitis (UC) and Crohn's Disease (CD) are long-term conditions in the gut that can cause diarrhea, swelling (inflammation), bleeding from the anus, and belly pain. The main aim of this study is to check for how many participants with UC and CD signs and symptoms disappear after 3.5 months (14 weeks) of treatment with Vedolizumab (this is called remission). Participants will be treated with Vedolizumab for approximately 1 year (50 weeks). During the first 1.5 months (6 weeks), participants will receive Vedolizumab as an infusion in the vein (called intravenously). After this, participants will receive Vedolizumab as an injection under the skin (called subcutaneously) for the rest of the treatment. Participants for whom the treatment does not seem to work well after 3.5 months (14 weeks) will stop treatment with Vedolizumab and can change to another treatment and also there will be additional required visits at 6 months (26 weeks) and at 1 year (52 weeks). All participants will be checked again 4.5 months (18 weeks) after their last treatment with Vedolizumab. During the study, participants will visit their study clinic several times.
Interventions
DRUGVedolizumab IV
Vedolizumab IV infusion
DRUGVedolizumab SC
Vedolizumab SC injection
Sponsors
Takeda
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
To be eligible to participate in this study, participants must meet all the following criteria: 1. In the investigator's opinion, the participant can understand and comply with protocol requirements. 2. The participant signs and dates an electronic informed consent form (ICF) and any required privacy authorization prior to any study procedures. 3. The participant is 18 to 80 years of age at the time of signing the ICF. 4. The participant's immunization is up to date per vedolizumab US prescribing information (USPI). 5. Participants must meet the contraception recommendations. 6. The participant has a diagnosis of moderate to severely active UC or CD defined by the following: 1. CD: A Crohn's Disease Activity Index (CDAI) score of 220 to 450 and a SES-CD \>=6 (\>=4 if isolated ileal disease) at screening OR 2. UC: A complete Mayo score (MS) of 6 to 12 with endoscopy sub-score of 2 to 3 at screening. 7. UC or CD diagnosis established prior to screening by clinical and endoscopic evidence and corroborated by a histopathology report. 8. Demonstrated an inadequate response to, loss of response to, or intolerance of at least one of the following agents: corticosteroids, immunomodulators, and/or advanced therapy.
Exclusion criteria
Participants who meet any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of CD Participants With 2-item Patient-reported Outcome Measure (PRO-2) Remission at Week 14 | At Week 14 | PRO-2 remission is defined as 7-day average of very soft or liquid stool frequency (SF) less than and equal to (\<=) 2.8, 7-day average of abdominal pain (AP) score \<= 1.0, and neither worse than baseline. |
| Percentage of UC Participants With PRO-2 Remission at Week 14 | At Week 14 | PRO-2 remission is defined as Mayo rectal bleeding sub-score of 0 and stool frequency sub-score \<=1. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of CD and UC Participants With PRO-2 Remission at Weeks 6 and 52 | At Weeks 6 and 52 | PRO-2 remission for CD participants is defined as 7-day average of very soft or liquid SF \<= 2.8, 7-day average of AP score \<= 1.0, and neither worse than baseline. PRO-2 remission for UC participants is defined as Mayo rectal bleeding sub-score of 0 and stool frequency sub-score \<=1. |
| Percentage of CD and UC Participants With Clinical Response at Weeks 6, 14, and 52 | At Weeks 6, 14, and 52 | CD clinical response is defined as greater than and equal to (\>=) 100 points decrease from baseline in CDAI score. UC clinical response is defined as reduction in complete Mayo score of \>=3 points and \>=30 percent (%) from baseline with an accompanying decrease in rectal bleeding sub-score of \>=1 point or absolute rectal bleeding sub-score of \<=1 point or an absolute rectal bleeding sub-score of \<=1 point, or a reduction in partial Mayo score of \>=2 points and \>=25% from baseline, if complete Mayo score was not performed at visit. |
| Percentage of CD Participants With Endoscopic Response at Week 52 | At Week 52 | Endoscopic response is defined as a \>=50% reduction from baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD) score. SES-CD evaluates 4 endoscopic variables: the intestinal surface affected by ulcers, the intestinal surface affected by other inflammatory lesions, the presence of ulcers, and the presence of narrowing. |
| Percentage of CD Participants Achieving Endoscopic Remission at Week 52 | At Week 52 | Endoscopic remission as per SES-CD is defined as a SES-CD score of 0 to 4, with no individual sub-score greater than 1. SES-CD evaluates 4 endoscopic variables: the intestinal surface affected by ulcers, the intestinal surface affected by other inflammatory lesions, the presence of ulcers, and the presence of narrowing. |
| Percentage of UC Participants With Improvement of Endoscopic Appearance of the Mucosa at Week 52 | At Week 52 | Improvement of endoscopic appearance of the mucosa is defined as Modified Mayo endoscopic sub-score (MMES) of 0 or 1. |
| Percentage of UC Participants With Endoscopic Remission at Week 52 | At Week 52 | Endoscopic remission is defined as a centrally read complete Mayo endoscopy sub-score of 0. |
| Percentage of CD and UC Participants With Clinical Remission at Weeks 6, 14, and 52 | At Weeks 6, 14, and 52 | Clinical Remission for CD is defined as a CDAI \<150 point. Clinical remission for UC is defined as complete MS of \<=2 points and no participant sub-score greater than (\>) 1 point or defined as a partial Mayo score (stool frequency, rectal bleeding, physician's global assessment \[PGA\]) score of \<=2 and no individual sub-score \>1. |
| Percentage of CD and UC Participants With Clinical Remission at Week 52 | At Week 52 | Clinical remission for CD is defined as a CDAI \<150 point. Clinical remission for UC is defined as complete MS of \<=2 points and no participant sub-score \>1 point or defined as a partial Mayo score (stool frequency, rectal bleeding, PGA) score of \<=2 and no individual sub-score \>1. Percentage of CD and UC participants with clinical remission at Week 52, among those participants who achieved clinical remission at Week 6 and 14 will be reported. |
| Change From Baseline in C-reactive Protein (CRP) levels of CD and UC Participants at Weeks 6, 14, 26, and 52 | Baseline, Weeks 6, 14, 26, and 52 | Change from baseline in CRP levels of CD and UC participants at Weeks 6, 14, 26, and 52 will be reported. |
| Change From Baseline in Fecal Calprotectin Concentrations of CD and UC participants at Weeks 6, 14, and 52 | Baseline, Weeks 6, 14, and 52 | Change from baseline in fecal calprotectin concentrations of CD and UC participants at Weeks 6, 14, and 52 will be reported. |
| Percentage of CD and UC Participants With Serious Infections | Up to end of study (up to 72 weeks) | Percentage of CD and UC participants with serious infections will be reported. |
Countries
United States
Contacts
CONTACTTakeda Contact
STUDY_DIRECTORStudy Director
Takeda
Outcome results
None listed