Ulcerative ColitisPhase 4PANORAMANCT06581328
A Study of Vedolizumab in Adults With Ulcerative Colitis (UC) or Crohn's Disease (CD) in the Community Setting
A Phase 4 study testing Vedolizumab IV and Vedolizumab SC in people with Ulcerative Colitis and Crohn's Disease, run by Takeda at 101 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ulcerative Colitis, Crohn's Disease
- What is being tested?
- Vedolizumab IV and Vedolizumab SC
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 101 sitesUnited States
- Study dates
- 27 Mar 2025to 1 Jun 2028
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To be eligible to participate in this study, participants must meet all the following criteria:
- In the investigator's opinion, the participant can understand and comply with protocol requirements.
- The participant signs and dates an electronic informed consent form (ICF) and any required privacy authorization prior to any study procedures.
- The participant is 18 to 80 years of age at the time of signing the ICF.
- The participant's immunization is up to date per vedolizumab US prescribing information (USPI).
- Participants must meet the contraception recommendations.
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- The participant has a diagnosis of moderate to severely active UC or CD defined by the following:
- 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
- UC: A complete Mayo score (MS) of 6 to 12 with endoscopy sub-score of 2 to 3 at screening.
- UC or CD diagnosis established prior to screening by clinical and endoscopic evidence and corroborated by a histopathology report.
- 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.
Who cannot join
- Participants who meet any of the following exclusion criteria will be excluded from participation in this study:
- Received approved or investigational anti-integrin antibodies (i.e., vedolizumab, natalizumab, efalizumab, etrolizumab, abrilumab [AMG 181]) at any time prior to screening.
- Failed (primary or secondary nonresponse) on more than 2 prior advanced treatments.
- Use of corticosteroid enemas/suppositories within 2 weeks prior to screening (for UC and CD).
- 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 a medical history or known allergy, hypersensitivity, or intolerance to vedolizumab or its excipients.
- Received any investigational biologic therapy <= 6 months prior to screening.
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- The participant has received an advanced treatment for an approved indication other than CD or UC within 60 days prior to screening.
- Advanced therapies include tumor necrosis factor (TNF) inhibitors, 12/23 antagonists, janus kinase (JAK) inhibitors, and sphingosine-1-phosphate (S1P) receptor modulators.
- The participant has any evidence of an active infection during screening.
- Ileostomy, colostomy, severe or symptomatic stenosis of the intestine, or short bowel syndrome.
- A surgical procedure requiring general anesthesia within 30 days prior to screening or planned or possible major surgery during the study period.
- History of malignancy, except for adequately treated nonmetastatic basal cell skin cancer; adequately treated squamous cell skin cancer that has not recurred for at least 1 year before screening; and adequately treated cervical carcinoma in situ that has not recurred for at least 3 years before screening. Participants with a remote history of malignancy (e.g., >10 years since completion of curative therapy without recurrence) will be considered based on the nature of the malignancy and therapy received; this must be discussed with the sponsor on a case-by-case basis before enrollment.
- Participants with any unstable or uncontrolled cardiovascular conditions, moderate to severe heart failure (New York Heart Association Class III or IV), pulmonary, hepatic, renal, gastrointestinal, genitourinary, hematological, coagulation, immunological, endocrine/metabolic, neurological, or other medical disorders that, in the investigator's opinion, would confound the study results or compromise participant safety.
- Participants with active cerebral or meningeal disease, signs or symptoms or a history of progressive multifocal leukoencephalopathy (PML), or any other major neurological disorder, including stroke, multiple sclerosis, brain tumor, or neurodegenerative disease.
- Participant is not on a stable dose of corticosteroid.
- Has any of the following laboratory abnormalities during the screening period: (a) hemoglobin <8 grams per deciliter (g/dL); (b) white blood cell (WBC) count <3.0 × 10^9 per liter (L); (c) lymphocyte count <0.5 × 10^9/L; (d) platelet count <100 × 10^9/L or >1200 × 10^9/L; (e) alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3.0 × the upper limit of normal (ULN); or (f) alkaline phosphatase (ALP) >1.5 × ULN. Historical laboratory data may be used for screening if available in the participant's electronic health record (EHR) within 6 weeks before screening.
Trial locations and contacts
101 sites in 1 country. Contact the study team or a site near you to ask about taking part.
101 sites in 1 country
United States101 sites, 78 recruiting
- Withdrawn
Presbyterian Health care services
Albuquerque, New Mexico, 87107
- Recruiting
Digestive Healthcare of Georgia
Atlanta, Georgia, 30327
Site Contact, 404-355-3200, mgalambos@yahoo.com
Michael Galambos
- Recruiting
AGA GA Research LLC
Atlanta, Georgia, 30342
Site Contact, 404-257-9000, brett.mendel@atlantagastro.com
Justin Mendel
- Recruiting
Baton Rouge General Medical Center - Bluebonnet Campus
Baton Rouge, Louisiana, 70809
Site Contact, 225-763-4828, cchapman@tddctx.com
Jonathon Chapman
- Recruiting
GI Alliance
Bellevue, Washington, 98405
Site Contact, 425-454-4768, nprocaccini@washgi.com
Nicholas Procaccini
- Recruiting
Gastro Health
Birmingham, Alabama, 35243
Site Contact, 205-838-3823, rshaffer@gastrohealth.com
Robert Shaffer
- Recruiting
SSM Health Medical Group
Bridgeton, Missouri, 63044
Site Contact, 314-291-8824, yezaz.ghouri@ssmhealth.com
Yezaz Ghouri
- Recruiting
Access Research Institute
Brooksville, Florida, 34613
Site Contact, 352-691-1140, s.muddassir@ariinstitute.com
Salman Muddassir
- Recruiting
Westchester Putnam Gastroenterology PC
Carmel, New York, 10512
Site Contact, 845-278-5223, rperinbasekar@putnamgi.com
Rajiv Perinbasekar
- Recruiting
Five Towns Gastroenterology
Cedarhurst, New York, 11516
Site Contact, 516-374-5570, marctfenster@gmail.com
Marc Fenster
- Recruiting
AZ Gastro Care
Chandler, Arizona, 85225
Site Contact, 480-393-0575, squreshi@azgastrocare.com
Shahbaz Ali Qureshi
- Recruiting
Charlotte Gastroenterology and Hepatology, P.L.L.C
Charlotte, North Carolina, 28207
Site Contact, 704-375-9485, gardiner.roddey@charlottegastro.com
John Gardiner Roddey
- Recruiting
Capital Digestive Care
Chevy Chase, Maryland, 20815
Site Contact, 301-841-6869, erica.cohen@capitaldigestivecare.com
Erica Cohen
- Recruiting
Gastro Health Research - Cincinnati
Cincinnati, Ohio, 45219
Site Contact, 513-682-2892, matkinson@gastrohealth.com
Matthew Atkinson
- Recruiting
Gastro Florida
Clearwater, Florida, 33762
Site Contact, 727-336-7682, lmweiss@gastrofl.com
Michael Weiss
- Recruiting
Peak Gastroenterology Associates
Colorado Springs, Colorado, 80907
Site Contact, 719-310-6719, bpatel@peakgastro.com
Bhaktasharan Patel
- Recruiting
GI Associates Research, LLC
Columbia, Missouri, 65201
Site Contact, 573-740-0800, michael.williams@objective.health
Michael Williams
- Recruiting
Tri-State Gastroenterology Associates
Crestview Hills, Kentucky, 41017
Site Contact, 859-341-3575 ext. 2240, mjones-research@tsddc.com
Michael Jones
- Recruiting
DSI Research Northridge LLC
Dayton, Ohio, 45414
Site Contact, 937-469-8047, rajeev.kurapati@objective.health
Rajeev Kurapati
- Withdrawn
Atlanta Center for Gastroenterology, P.C.
Decatur, Georgia, 30033
- Recruiting
Yapp, Rockford M.D. (Private Practice)
Downers Grove, Illinois, 60515
Site Contact, 859-999-4506, rgjsy34@aol.com
Rockford Yapp
- Recruiting
The Clinical Trials Network CTNX LLC
El Paso, Texas, 79936
Site Contact, 915-702-0165, iegbuna.research@gastrocareep.com
Ikenna Egbuna
- Recruiting
IMIDeology
Elmhurst, New York, 11373
Site Contact, 929-374-4054, kevintin@yahoo.com
Kevin Tin
- Recruiting
Gastroenterology and Liver Institute
Escondido, California, 92025
Site Contact, 808-469-0575, drgara@giandliver.org
Naveen Gara
- Recruiting
Gastro Health Research - Framingham
Framingham, Massachusetts, 01702
Site Contact, 508-620-9200, sfine@gastrohealth.com
Steven Fine
- Recruiting
Intercity Gastroenterology
Fresh Meadows, New York, 11040
Site Contact, 929-405-0165, g.shahzad@synapsetrial.com
Ghulamullah Shahzad
- Recruiting
Amel Med LLC
Georgetown, Texas, 78628
Site Contact, 512-593-6022, masi.khaja@gmail.com
Masi Khaja
- Recruiting
Spectrum Research Institute LLC
Gilbert, Arizona, 85297
Site Contact, 480-801-9260, donnad@sevalleygi.com
Donna DeSantis
- Recruiting
Woodholme Gastroenterology
Glen Burnie, Maryland, 21061
Site Contact, 410-783-8441, konwueme@fomatmedical.com
Kenolisa Onwueme
- Recruiting
GI Alliance - Glenview
Glenview, Illinois, 60026
Site Contact, 847-677-1170, nmerel@illinoisgastro.com
Nina Merel
- Recruiting
Carolina Digestive Diseases
Greenville, North Carolina, 27834
Site Contact, 252-758-8181, pgoldstein@cddgastro.com
Phillip Goldstein
- Withdrawn
Doral Medical Research, LLC
Hialeah, Florida, 33016
- Recruiting
Kelsey Research Foundation
Houston, Texas, 77005
Site Contact, 713-442-1700, sheela.chandra@kelsey-seybold.com
Sheela Chandra
- Recruiting
MedCare Pharma LLC
Houston, Texas, 77079
Site Contact, 713-777-2776, alan.glombicki@medcarepharama.care
Alan Glombicki
- Withdrawn
Integrity Advanced Therapeutics
Houston, Texas, 77090
- Recruiting
Spring Clinical Research
Houston, Texas, 77090
Site Contact, 832-885-7723, sushma@springclinicalresearch.com
Sushma Gorrela
- Recruiting
Hutchinson Clinic
Hutchinson, Kansas, 67502
Site Contact, 620-669-2500, greenm@hutchclinic.com
Michael Green
- Recruiting
Mid America Gastro Intestinal Consultants
Kansas City, Missouri, 64111
Site Contact, 888-635-0552, hillarybownik@cctdoctors.com
Hillary Bownik
- Recruiting
Gastro Health & Nutrition
Katy, Texas, 77494
Site Contact, 346-509-4141, dverma@yourgastrohealth.com
Dharmendra Verma
- Recruiting
Tri-Cities Gastroenterology
Kingsport, Tennessee, 37663
Site Contact, 423-279-1404, gifry6@yahoo.com
Stephen Fry
- Recruiting
One of a Kind Clinical Research Center LLC
Kingwood, Texas, 77339
Site Contact, 713-704-6800, sguha@hrgastro.com
Sushovan Guha
- Recruiting
Digestive and Liver Center of Florida, P.A.
Kissimmee, Florida, 34741
Site Contact, 407-384-7388, batiquzzaman@crosceola.com
Basher Atiquzzaman
- Recruiting
Combined Gastro LLC
Lafayette, Louisiana, 70503
Site Contact, 337-235-9779, jacque@gastroclinic.com
Jacque Noel
- Recruiting
Gastroenterology and Internal Medicine Specialists, SC
Lake Barrington, Illinois, 60010
Site Contact, 708-560-7299, drbhuva@avicennaclinical.com
Manish Bhuva
- Withdrawn
NYU Langone Long Island Clinical Research Associates
Lake Success, New York, 11042
- Recruiting
Gastro Health Research - Liberty Township
Liberty Township, Ohio, 45044
Site Contact, 513-872-4549, smartin@gastrohealth.com
Stephen Martin
- Withdrawn
UAMS Health Gastroenterology Clinic
Little Rock, Arkansas, 72205
- Recruiting
Rocky Mountain Endocopy Centers LLC
Littleton, Colorado, 80120
Site Contact, 303-722-8987, rmg@fomatmedical.com
Erik Springer
- Recruiting
West Texas Research Institute
Lubbock, Texas, 79424
Site Contact, 806-696-4440, sameerislam@gastrosiresearch.com
Sameer Islam
- Recruiting
Great Lakes Gastroenterology Research, LLC
Mentor, Ohio, 44060
Site Contact, 440-205-1225, kfriedenberg@thectnx.com
Keith Friedenberg
- Recruiting
GI Alliance
Metairie, Louisiana, 70006
Site Contact, 504-456-8020, catinis@metrogi.com
George Catinis
- Recruiting
Gastro Health Research - Miami
Miami, Florida, 33176
Site Contact, 786-539-3215, jlopez@gastrohealth.com
Joanna Lopez
- Recruiting
East View Medical Research
Mobile, Alabama, 36608
Site Contact, 251-277-9090, jdsiegelmd@gmail.com
Jonathan Siegel
- Withdrawn
Inland Empire Gastroenterology
Murrieta, California, 92562
- Recruiting
United Clinical Research Institute
Murrieta, California, 92563
Site Contact, 951-566-5229 ext. 120, drhongpi@unitedmd.com
John Hong
- Withdrawn
Suburban Gastroenterology
Naperville, Illinois, 60540
- Recruiting
Lucida Clinical Trials LLC
New Bedford, Massachusetts, 02740
Site Contact, 508-720-2015, jreich@lucidaclinical.com
Jason Reich
- Withdrawn
Lenox Hill Hospital
New York, New York, 10075
- Recruiting
New York Gastroenterology Associates
New York, New York, 10075
Site Contact, 917-855-1993, ana.tuyama@nygahealth.com
Ana Tuyama
- Withdrawn
Manhattan Clinical Research, LLC
New York, New York, 10279
- Withdrawn
Digestive Health Institute
Newport Beach, California, 92663
- Recruiting
GI Partners of Illinois - Southwest Gastroenterology
Oak Lawn, Illinois, 60453
Site Contact, 708-253-5810, drberkelhammer@avicennaclinical.com
Charles Berkelhammer
- Withdrawn
Advanced Research Institute
Ogden, Utah, 84405
- Withdrawn
Knowledge Research Center
Orange, California, 92868
- Recruiting
Endoscopic Research, Inc.
Orlando, Florida, 32803
Site Contact, 407-896-1726, ilaganeri@cdhfl.com
Marlon Ilagan
- Recruiting
Orlando Health-Orlando Regional Medical Center
Orlando, Florida, 32806
Site Contact, 321-842-7900, udayakumar.navaneethan@orlandohealth.com
Udayakumar Navaneethan
- Withdrawn
Digestive and Liver Center of Florida
Orlando, Florida, 32825
- Recruiting
Gastro Health Research - Pensacola
Pensacola, Florida, 32504
Site Contact, 850-436-4536, fnewman@gastrohealth.com
Frederic Newman
- Withdrawn
Pinehurst Medical Clinic Inc
Pinehurst, North Carolina, 28374
- Recruiting
West Central Gastroenterology d/b/a Gastro Florida
Pinellas Park, Florida, 33781
Site Contact, 727-347-0005 ext. 1040, tglamour@gastrofl.com
Tejinder Glamour
- Withdrawn
MNGI Digestive Health, P.A.
Plymouth, Minnesota, 55446
- Recruiting
Portland Gastroenterology Center
Portland, Maine, 04101
Site Contact, 207-773-7964, noemi.baffy@portlandgastro.com
Noemi Baffy
- Recruiting
The Oregon Clinic, P.C.
Portland, Oregon, 97220
Site Contact, 503-935-8322, pkiyasu@orclinic.com
Phillip Kiyasu
- Recruiting
University Gastroenterology
Providence, Rhode Island, 02904
Site Contact, 401-227-8393, lisa.mueller@gialliance.com
Lisa Mueller
- Withdrawn
Advanced Research Institute
Reno, Nevada, 89511
- Recruiting
Gastroenterology Consultants of Southwest Virginia.
Roanoke, Virginia, 24014
Site Contact, 540-345-4900, nirishshah@gmail.com
Nirish Shah
- Withdrawn
Gastroenterology Group of Rochester
Rochester, New York, 14620
- Recruiting
Rockford Gastroenterology Associates, Ltd.
Rockford, Illinois, 61107
Site Contact, 815-397-7340, drpatel@rockfordgi.com
Sunil Patel
- Withdrawn
Medical Associates Research Group, Inc.
San Diego, California, 92123
- Recruiting
ProHealth (Seaford) (Optum)
Seaford, New York, 11783
Site Contact, 516-796-9000, cserer@prohealthcare.com
Corina Serer
- Recruiting
Sanford Center for Digestive Health
Sioux Falls, South Dakota, 57105
Site Contact, 605-328-8900, ahmed.kurdi@sanfordhealth.org
Ahmed Kurdi
- Recruiting
Delta Gastroenterology and Endoscopy Center
Southaven, Mississippi, 38671
Site Contact, 662-280-8222, uduncan@deltagastro.net
Ulric Duncan
- Recruiting
DSI Research LLC
Springboro, Ohio, 45066
Site Contact, 937-293-2169, anjali.morey@objective.health
Anjali Morey
- Recruiting
Springfield Clinic
Springfield, Illinois, 62703
Site Contact, 217-528-7541, dshuster@springfieldclinic.com
Dmitry Shuster
- Recruiting
Piedmont Healthcare
Statesville, North Carolina, 28625
Site Contact, 404-605-2632, brandon.marion@piedmonthealthcare.com
Brandon Marion
- Withdrawn
Centricity Research VIR - DBA IACT Health Virginia Gastroenterology Institute Research
Suffolk, Virginia, 23435
- Recruiting
Palmetto Primary Care Physician Division of Gastroenterology
Summerville, South Carolina, 29486
Site Contact, 843-376-0760, bvanleer1@gmail.com
Brett Van Leer-Greenberg
- Recruiting
GI Alliance- Sun City
Sun City, Arizona, 85351
Site Contact, 623-972-2116, ctrivedipi@arizonadigestivehealth.com
Chirag Trivedi
- Withdrawn
Syracuse VA Medical Center
Syracuse, New York, 13210
- Withdrawn
Texas Gastro Consultants
Tomball, Texas, 77375
- Recruiting
Digestive Disease Medicine
Utica, New York, 13502
Site Contact, 315-624-7000, harvey.allen@kinstonmd.com
Harvey Allen
- Recruiting
Digestive Research of Central Texas, LLC
Waco, Texas, 76712
Site Contact, 940-222-6675, hanumantha.ancha@objective.health
Hanumantha Ancha
- Recruiting
GI Alliance - Webster
Webster, Texas, 77598
Site Contact, 281-480-6264, sjafri@tddctx.com
Syed Jafri
- Recruiting
St Charles Clinical Research
Weldon Spring, Missouri, 63304
Site Contact, 314-567-3377, lw@gidoctor.net
Leonard Weinstock
- Recruiting
Crystal Run (Optum)
West Nyack, New York, 10994
Site Contact, 845-703-3964 ext. 13199, thaider@crystalrunhealthcare.com
Tehseen Haider
- Recruiting
Riverview Health
Westfield, Indiana, 46074
Site Contact, 317-948-3369, sashidharvarma@yahoo.com
Sashidhar Sagi
- Recruiting
NorthShore Gastroenterology Research, LLC
Westlake, Ohio, 44145
Site Contact, 440-250-7630, kharris@northshoregastro.org
Kimberly Harris
- Withdrawn
TMPG Clinical Research
Williamsburg, Virginia, 23188
- Recruiting
Wilmington Gastroenterology Associates
Wilmington, North Carolina, 28403
Site Contact, 910-362-1011, wking@trialmgt.com
William King
- Recruiting
Gastroenterology Associates of Western Michigan, P.L.C.
Wyoming, Michigan, 49519
Site Contact, 616-328-5344, acoates@gastro-assoc-wm.com
Allan Coates
- Recruiting
Huron Gastro
Ypsilanti, Michigan, 48197
Site Contact, 734-418-7736 ext. 18, soofin@hurongastro.com
Najm Soofi
About this study
Official title: A Phase 4 Study Evaluating Moderate to Severely Active Ulcerative Colitis or Crohn's Disease and the Use of Vedolizumab Subcutaneous Within a Community Setting
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
- Being tested
- Vedolizumab IV, Vedolizumab SC
- Medical subject headings
- Colitis, Ulcerative, Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vedolizumab IVDrug
Also called Entyvio
Vedolizumab IV infusion
Vedolizumab SCDrug
Also called Entyvio
Vedolizumab SC injection
| Study group | Role | What they receive |
|---|---|---|
| UC Participants: Vedolizumab | Experimental | 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. Receives: Drug: Vedolizumab IV; Drug: Vedolizumab SC |
| CD Participants: Vedolizumab | Experimental | 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. Receives: Drug: Vedolizumab IV; Drug: Vedolizumab SC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of CD Participants With 2-item Patient-reported Outcome Measure (PRO-2) Remission 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.
Measured: At Week 14
Percentage of UC Participants With PRO-2 Remission at Week 14
PRO-2 remission is defined as Mayo rectal bleeding sub-score of 0 and stool frequency sub-score <=1.
Measured: At Week 14
Secondary outcomes (11)
Percentage of CD and UC Participants With PRO-2 Remission 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.
Measured: At Weeks 6 and 52
Percentage of CD and UC Participants With Clinical Response 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.
Measured: At Weeks 6, 14, and 52
Percentage of CD Participants With Endoscopic Response 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.
Measured: At Week 52
Percentage of CD Participants Achieving Endoscopic Remission 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.
Measured: At Week 52
Percentage of UC Participants With Improvement of Endoscopic Appearance of the Mucosa at Week 52
Improvement of endoscopic appearance of the mucosa is defined as Modified Mayo endoscopic sub-score (MMES) of 0 or 1.
Measured: At Week 52
Percentage of UC Participants With Endoscopic Remission at Week 52
Endoscopic remission is defined as a centrally read complete Mayo endoscopy sub-score of 0.
Measured: At Week 52
Percentage of CD and UC Participants With Clinical Remission 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.
Measured: At Weeks 6, 14, and 52
Percentage of CD and UC Participants With Clinical Remission 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.
Measured: At Week 52
Change From Baseline in C-reactive Protein (CRP) levels of CD and UC Participants at 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.
Measured: Baseline, Weeks 6, 14, 26, and 52
Change From Baseline in Fecal Calprotectin Concentrations of CD and UC participants at 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.
Measured: Baseline, Weeks 6, 14, and 52
Percentage of CD and UC Participants With Serious Infections
Percentage of CD and UC participants with serious infections will be reported.
Measured: Up to end of study (up to 72 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2024
- Study start27 Mar 2025
- Primary completion1 May 2027 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06581328
- Sponsor's protocol ID
- Vedolizumab-4063
- Acronym
- PANORAMA
- Status last verified
- Oct 2026
- First submitted
- 30 Aug 2024
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.