A Study of Vedolizumab in Adults With Ulcerative Colitis or Crohn's Disease in the Community Setting
Purpose
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.
Conditions
- Ulcerative Colitis
- Crohn's Disease
Eligibility
- Eligible Ages
- Between 18 Years and 80 Years
- Eligible Sex
- All
- Accepts 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. If participant is a woman of childbearing potential (WOCBP): 1. Agrees to use at least 1 form of highly effective contraception from signing the ICF until at least 18 weeks after the last dose of vedolizumab. 2. Agrees to avoid donating ova from signing the ICF throughout the duration of the study and for 18 weeks after the last dose of vedolizumab. 3. Has a negative urine pregnancy test within 3 days before first dose of vedolizumab. 4. Agrees to forego breastfeeding from first dose of vedolizumab through 18 weeks after the last dose of vedolizumab. 6. If participant is a fertile man: 1. Agrees to use contraception from signing the ICF until at least 18 weeks after the last dose of vedolizumab 2. Agrees to avoid donating sperm throughout the study and for 18 weeks after the last dose. 7. 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 subscore of 2 to 3 at screening 8. UC or CD diagnosis established prior to screening by clinical and endoscopic evidence and corroborated by a histopathology report. 9. 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 exclusion criteria will be excluded from participation in this study: 1. Received approved or investigational anti-integrin antibodies (i.e., vedolizumab, natalizumab, efalizumab, etrolizumab, abrilumab [AMG 181]) at any time prior to screening. 2. Failed (primary or secondary nonresponse) on more than 2 prior advanced treatments. 3. Use of corticosteroid enemas/suppositories within 2 weeks prior to screening (for UC and CD). 4. In the investigator's opinion the participant meets any contraindication, warnings and precautions, drug interactions, or special population considerations per the vedolizumab USPI, or has (medical history or known allergy, hypersensitivity, or intolerance to vedolizumab or its excipients) (Food and Drug administration [FDA] 2024). 5. Received any investigational biologic therapy <= 6 months prior to screening. 6. The participant has received an advanced treatment for an approved indication other than CD or UC. Advanced therapy include: TNF inhibitors (e.g. infliximab, adalimumab, certolizumab pegol), and IL 12/23 antagonist (e.g. ustekinumab, mirikizumab, risankizumab); and small molecules include JAK inhibitor (e.g. tofacitinib, upadacitinib) and sphingosine-1-phosphate (S1P) receptor modulator (e.g. etrasimod, ozanimod). 7. The participant has any evidence of an active infection during screening. 8. Ileostomy, colostomy, severe, or symptomatic stenosis of the intestine or short bowel syndrome. 9. A surgical procedure requiring general anesthesia within 3 months prior to screening or is planning to or is at risk of undergoing major surgery during the study period. 10. History of malignancy, except for the following: adequately treated nonmetastatic basal cell skin cancer; squamous cell skin cancer that has been adequately treated and that has not recurred for at least 1 year prior to screening; and history of cervical carcinoma in situ that has been adequately treated and that has not recurred for at least 3 years prior to screening. Participants with a remote history of malignancy (example, greater than (>) 10 years since completion of curative therapy without recurrence) will be considered based on the nature of the malignancy and the therapy received; this must be discussed with the sponsor on a case-by-case basis prior to enrollment. 11. History of or symptoms of progressive multifocal leukoencephalopathy (PML) in the investigator's opinion. 12. Has laboratory abnormalities during the screening period.
Study Design
- Phase
- Phase 4
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental UC Participants: Vedolizumab |
Participants with moderate to severely active UC will receive vedolizumab 300 milligrams (mg), intravenous (IV) infusion at Weeks 0 and 2. Following the first 2 vedolizumab IV doses, participant may be switched to vedolizumab 108 mg subcutaneous (SC) injection at Week 6, to be administered every 2 weeks until Week 50. Treating health care practitioner (HCP) may give an additional dose of vedolizumab IV at Week 6 with mandatory transition by Week 14. |
|
|
Experimental CD Participants: Vedolizumab |
Participants with moderate to severely active CD will receive vedolizumab 300 mg, IV infusion at Weeks 0 and 2. Following the first 2 vedolizumab IV doses, participant may be switched to vedolizumab 108 mg SC injection at Week 6, to be administered every 2 weeks until Week 50. Treating HCP may give an additional dose of vedolizumab IV at Week 6 with mandatory transition by Week 14. |
|
Recruiting Locations
Birmingham, Alabama 35243
Mobile, Alabama 36608
Gilbert, Arizona 85297
Sun City, Arizona 85351
Escondido, California 92025
Murrieta, California 92563
Colorado Springs, Colorado 80907
Colorado Springs, Colorado 80923
Littleton, Colorado 80120
Brooksville, Florida 34613
Kissimmee, Florida 34741
Miami, Florida 33176
Orange City, Florida 32763
Orlando, Florida 32803
Orlando, Florida 32806
Pensacola, Florida 32504
Pinellas Park, Florida 33781
Atlanta, Georgia 30327
Atlanta, Georgia 30342
Downers Grove, Illinois 60515
Glenview, Illinois 60026
Lake Barrington, Illinois 60010
Oak Lawn, Illinois 60453
Rockford, Illinois 61107
Springfield, Illinois 62703
Hutchinson, Kansas 67502
Crestview Hills, Kentucky 41017
Baton Rouge, Louisiana 70809
Lafayette, Louisiana 70503
Portland, Maine 04101
Chevy Chase, Maryland 20815
Glen Burnie, Maryland 21061
Framingham, Massachusetts 01702
New Bedford, Massachusetts 02740
Wyoming, Michigan 49519
Southaven, Mississippi 38671
Bridgeton, Missouri 63044
Columbia, Missouri 65201
Kansas City, Missouri 64111
Weldon Spring, Missouri 63304
Carmel, New York 10512
Cedarhurst, New York 11516
Fresh Meadows, New York 11040
New York, New York 10075
Seaford, New York 11783
Utica, New York 13502
Charlotte, North Carolina 28207
Statesville, North Carolina 28625
Wilmington, North Carolina 28403
Cincinnati, Ohio 45219
Dayton, Ohio 45414
Liberty Township, Ohio 45044
Mentor, Ohio 44060
Springboro, Ohio 45066
Westlake, Ohio 44145
Portland, Oregon 97220
Providence, Rhode Island 02904
Summerville, South Carolina 29486
Sioux Falls, South Dakota 57105
Kingsport, Tennessee 37663
El Paso, Texas 79936
Houston, Texas 77005
Houston, Texas 77079
Houston, Texas 77090
Kingwood, Texas 77339
Lubbock, Texas 79424
Waco, Texas 76712
Roanoke, Virginia 24014
More Details
- Status
- Recruiting
- Sponsor
- Takeda