Safety and Efficacy of Adalimumab Versus Ustekinumab for One Year
SEAVUE
A Phase 3b, Multicenter, Randomized, Blinded, Active-Controlled Study to Compare the Efficacy and Safety of Ustekinumab to That of Adalimumab in the Treatment of Biologic Naïve Subjects With Moderately-to-Severely Active Crohn's Disease
3 other identifiers
interventional
386
18 countries
182
Brief Summary
The purpose of this study is to compare the efficacy of treatment with ustekinumab or adalimumab in biologic naive participants with moderately-to-severely active Crohn's disease (CD) who have previously failed or were intolerant to conventional therapy (corticosteroids and/or immunomodulators, such as azathioprine, 6-mercaptopurine, or methotrexate), as measured by clinical remission at one year.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Mar 2018
Typical duration for phase_3
182 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 7, 2018
CompletedFirst Posted
Study publicly available on registry
March 13, 2018
CompletedStudy Start
First participant enrolled
March 29, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 15, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
May 21, 2021
CompletedResults Posted
Study results publicly available
January 11, 2022
CompletedApril 29, 2025
April 1, 2025
2.7 years
March 7, 2018
December 14, 2021
April 25, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Clinical Remission at Week 52
Percentage of participants with clinical remission at Week 52 were assessed. Clinical remission was defined as a Crohn's Disease Activity Index (CDAI) score of less than (\<) 150 points (in general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities). The CDAI score is used to quantify the symptoms of participants with Crohn's Disease. A decrease in CDAI over time indicates improvement in disease activity.
Week 52
Secondary Outcomes (17)
Percentage of Participants With Corticosteroid-free Remission at Week 52
Week 52
Percentage of Participants With Clinical Response at Week 52
Week 52
Percentage of Participants in Patient Reported Outcome (PRO)-2 Symptom Remission at Week 52
Week 52
Percentage of Participants With Clinical Remission at Week 16
Week 16
Percentage of Participants With Endoscopic Remission at Week 52
Week 52
- +12 more secondary outcomes
Study Arms (2)
Group 1 (Ustekinumab)
EXPERIMENTALParticipants will receive intravenous (IV) infusion of ustekinumab (approximately 6 milligram/kilogram \[mg/kg\]) and 4 subcutaneous (SC) injections of placebo for adalimumab at Week 0, followed by 2 SC injections of placebo at Week 2. From Week 4 to Week 56, participants will self-administer one SC injection of ustekinumab 90 milligram (mg) every 8 weeks (q8w) starting at Week 8 and placebo adalimumab at the other designated every 2 weeks (q2w) dosing intervals.
Group 2 (Adalimumab)
ACTIVE COMPARATORParticipants will receive IV infusion of placebo for ustekinumab and 4 SC injections of adalimumab (each 40 mg, total dose 160 mg) at Week 0, followed by 2 SC injections of adalimumab (each 40 mg, total dose 80 mg) at Week 2. From Week 4 to Week 56, participants will self-administer 1 SC injection of adalimumab 40 mg q2w.
Interventions
Participants will receive placebo as SC injection to blind adalimumab.
Participants will receive placebo as IV infusion to blind ustekinumab.
Participants will receive ustekinumab 6 mg/kg (weight based dosing) as IV infusion.
Participants will self-administer SC injection of ustekinumab 90 mg.
Participants will self-administer multiple SC injections of adalimumab (each 40 mg) and will receive total dose of 160 mg at Week 0, 80 mg at Week 2, and 40 mg q2w from Week 4 to 56.
Eligibility Criteria
You may qualify if:
- Has Crohn's Disease (CD) or fistulizing CD of at least 3 months' duration, with colitis, ileitis, or ileocolitis, confirmed at some time in the past by radiography, histology, and/or endoscopy
- Has moderately-to-severely active CD with a baseline Crohn's disease activity index (CDAI) score of greater than or equal to (\>=) 220 and less than or equal to (\<=) 450
- Has one or more ulceration on screening ileocolonoscopy (which by definition, would result in an Simple Endoscopic Score for Crohn's Disease \[SES-CD\] of at least 3)
- Has failed or was intolerant to conventional therapy (corticosteroids, azathioprine \[AZA\], 6-mercaptopurine \[6-MP\] and/or methotrexate \[MTX\]) at adequate doses or is corticosteroid dependent
- Has not previously received an approved biologic for Crohn's Disease (i.e., infliximab, adalimumab, certolizumab pegol, ustekinumab, natalizumab, vedolizumab or approved biosimilars of these agents)
- Participants on oral corticosteroids (e.g., prednisone, budesonide) at a prednisone-equivalent dose of \<=40 or milligram/day (mg/day) or \<=9 mg/day of budesonide are budesonide \<=9 mg/day are permitted if doses are stable for 3 weeks prior to baseline
- Participants on AZA, 6-MP, or MTX at screening (or recently prior), must discontinue these medications at least 3 weeks prior to baseline
You may not qualify if:
- Has complications of CD that are likely to require surgery or would confound the ability to assess the effect of ustekinumab or adalimumab treatment using the CDAI, such as: active stoma; short-gut syndrome and severe or symptomatic strictures or stenosis
- Has had any kind of bowel resection within 6 months prior to baseline or other intra-abdominal surgery or a hospital admission for bowel obstruction within 3 months prior to baseline
- Has a stool culture or other examination positive for an enteric pathogen, including Clostridium difficile toxin, in the last 4 months unless a repeat examination is negative and there are no signs of ongoing infection with that pathogen
- Has received a Bacillus Calmette-Guerin (BCG) vaccination within 12 months or any other live bacterial or live viral vaccination within 2 weeks of baseline
- Has a history of, or ongoing, chronic or recurrent infectious disease, including but not limited to, chronic renal infection, chronic chest infection, recurrent urinary tract infection (eg, recurrent pyelonephritis or chronic nonremitting cystitis), or infected skin wounds or ulcers
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (182)
Alabama Medical Group
Mobile, Alabama, 36608, United States
Precision Research Institute
San Diego, California, 92114, United States
Peak Gastroenterology Associates
Colorado Springs, Colorado, 80907, United States
Gastro Associates of Fairfield County PC
Bridgeport, Connecticut, 06606, United States
Western Connecticut Health Network/Danbury Hospital
Danbury, Connecticut, 06810, United States
Medstar Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
Gastro Florida
Clearwater, Florida, 33756, United States
Florida Research Network, LLC
Gainesville, Florida, 32605, United States
Florida Center For Gastroenterology
Largo, Florida, 33777, United States
Center for Advanced Gastroenterology
Maitland, Florida, 32751, United States
Gastroenterology Group Of Naples
Naples, Florida, 34102, United States
Advanced Medical Research Center
Port Orange, Florida, 32127, United States
Apex Clinical Research
Tampa, Florida, 33612, United States
Cleveland Clinic Florida
Weston, Florida, 33331, United States
Atlanta Gastroenterology Specialists, PC
Suwanee, Georgia, 30024, United States
Grand Teton Research Group, PLLC
Idaho Falls, Idaho, 83404, United States
Health Science Research Center
Pratt, Kansas, 67124, United States
Tri-State Gastroenterology Assoc
Crestview Hills, Kentucky, 41017, United States
Gastroenterology Associates Of Hazard
Hazard, Kentucky, 41701, United States
University of Louisville
Louisville, Kentucky, 40202, United States
Texas Digestive Disease Consultants
Baton Rouge, Louisiana, 70809, United States
CroNOLA, LLC
Houma, Louisiana, 70360, United States
Louisiana Research Center, LLC
Shreveport, Louisiana, 71105, United States
Chevy Chase Clinical Research
Chevy Chase, Maryland, 20815, United States
Clinical Research Institute of Michigan, LLC
Chesterfield, Michigan, 48047, United States
Huron Gastroenterology Associates Center for Digestive Care
Ypsilanti, Michigan, 48197, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Saint Louis University Hospital
St Louis, Missouri, 63104, United States
Mercy Clinic East Community
St Louis, Missouri, 63141, United States
Saratoga Schenectady Gastroenterology Associates
Burnt Hills, New York, 12027, United States
NYU Langone Long Island Clinical Research Associates
Great Neck, New York, 11021, United States
Weill Cornell Medical College
New York, New York, 10021, United States
Mount Sinai School of Medicine
New York, New York, 10029, United States
Columbia University Medical Center
New York, New York, 10032, United States
Premier Medical Group Of The Hudson Valley, Pc
Poughkeepsie, New York, 12601, United States
University of Rochester Medical Center
Rochester, New York, 14642, United States
Digestive Health Partners
Asheville, North Carolina, 28801, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599, United States
Duke University Hospital Medical Center
Raleigh, North Carolina, 27609, United States
Wilmington Gastroenterology Associates
Wilmington, North Carolina, 28403, United States
Fargo Gastroenterology Clinic, PC
Fargo, North Dakota, 58103, United States
Northshore Gastroenterology Research, LLC
Beachwood, Ohio, 44122, United States
TriHealth Digestive Institute
Cincinnati, Ohio, 45242, United States
University Hospitals Case Medical Center
Cleveland, Ohio, 44106, United States
Ohio State University Hospital
Columbus, Ohio, 43210, United States
Dayton Gastroenterology, Inc
Dayton, Ohio, 45440, United States
Great Lakes Gastroenterology Research, LLC
Mentor, Ohio, 44060, United States
Digestive Disease Specialists Inc
Oklahoma City, Oklahoma, 73112, United States
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
Allegheny-Singer Research Institute
Pittsburgh, Pennsylvania, 15212-4756, United States
Gastroenterology Associates P.A.
Greenville, South Carolina, 29615, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37212, United States
Aztec Clinical Research, Inc.
Channelview, Texas, 77530, United States
DHAT Research Institute
Garland, Texas, 75044, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
University of Texas at Houston Medical School
Houston, Texas, 77030, United States
Gastroenterology Research of America, LLC
San Antonio, Texas, 78229, United States
Texas Digestive Disease Consultants
Southlake, Texas, 76092, United States
Tyler Research Institute, LLC
Tyler, Texas, 75701, United States
Gastroenterology Associates of Tidewater
Chesapeake, Virginia, 23320, United States
Verity Research, Inc
Fairfax, Virginia, 22031, United States
Gastroenterology Associates of Central Virginia
Lynchburg, Virginia, 24502, United States
Digestive And Liver Disease Specialists
Norfolk, Virginia, 23502, United States
McGuire VAMC
Richmond, Virginia, 23229, United States
Virginia Gastroenterology Institute
Suffolk, Virginia, 23434, United States
Washington Gastroenterology, PLLC
Bellevue, Washington, 98004, United States
Washington Gastroenterology, PLLC
Tacoma, Washington, 98405, United States
Monash Health, Monash Medical Centre
Clayton, 3168, Australia
Alfred Hospital
Melbourne, 3004, Australia
Mater Hospital Brisbane Inflammatory Bowel Diseases
South Brisbane, 4101, Australia
St John of God Subiaco Hospital
Subiaco, 6008, Australia
The Queen Elizabeth Hospital
Woodville South, 5011, Australia
UZ Gent
Ghent, 9000, Belgium
UZ Leuven
Leuven, 3000, Belgium
CHwapi
Tournai, 7500, Belgium
Hospital Das Clinicas Da Ufmg
Belo Horizonte - MG, 30130-100, Brazil
Inst Goiano Gastroenterologia e Endoscopia Digest Ltda - Clinica de Gastro
Goiânia, 74535-170, Brazil
Endogastro Clínica de Gastroenterologia e Endoscopia Digestiva Lida
Juiz de Fora, 36033-318, Brazil
Hospital das Clinicas de Porto Alegre
Porto Alegre, 90035-903, Brazil
Hospital Das Clinicas Da Faculdade De Medicina De RPUSP HCRP
Ribeirão Preto, 14098-900, Brazil
Universidade Federal do Rio de Janeiro - Faculdade de Medicina
Rio de Janeiro, 21941-590, Brazil
Hospital Copa D'Or
Rio de Janeiro, CEP: 22031-010, Brazil
Fundacao do ABC Centro Universitario FMABC
Santo André, 09060 870, Brazil
UMHAT 'Dr. Georgi Stranski', EAD
Pleven, 5800, Bulgaria
MHAT Rousse
Rousse, 7002, Bulgaria
2-nd MHAT
Sofia, 1202, Bulgaria
Diagnostic Consulting Center Mladost - M Varna
Varna, 9020, Bulgaria
University of Calgary
Calgary, Alberta, T2N4Z6, Canada
McMaster University
Hamilton, Ontario, L8S 4K1, Canada
London Health Sciences Centre
London, Ontario, N6A 5A5, Canada
CISSS de la Monteregie Centre
Greenfield Park, Quebec, J4V 2H1, Canada
CMIIM, Centre médical L'Enjeu
Mount Royal, Quebec, H7P 3E5, Canada
Fakultní nemocnice u sv. Anny v Brn
Brno, 656 91, Czechia
Nemocnice Horovice, a.s.
Hořovice, 268 31, Czechia
Hepato-gastroenterologie HK, s.r.o.
Hradec Králové, 500 12, Czechia
Fakultni nemocnice Kralovske Vinohrady
Prague, 100 34, Czechia
ISCARE a.s.
Prague, 190 00, Czechia
CHU Amiens
Amiens, 80054, France
CHRU Montpellier - Hopital Saint-Eloi
Montpellier, 34295, France
Hotel Dieu
Nantes, 44035, France
Hopital Saint Louis
Paris, 75010, France
CHU Saint Etienne
Saint-Priest-en-Jarez, 42270, France
Clinique Ambroise Pare
Toulouse, 31082, France
Universitatsklinikum Freiburg
Freiburg im Breisgau, 79106, Germany
Asklepios Westklinikum
Hamburg, 22559, Germany
Uniklinikum Heidelberg
Heidelberg, 69120, Germany
MVZ Portal10
Münster, 48151, Germany
Réthy Pál Kórház - Rendelőintézet
Békéscsaba, H-5600, Hungary
Magyar Honvedseg Egeszsegugyi Kozpont
Budapest, 1134, Hungary
Semmelweis Egyetem
Budapest, H-1088, Hungary
Debreceni Egyetem Klinikai Kozpont
Debrecen, H-4032, Hungary
Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz
Miskolc, 3526, Hungary
Markusovszky Egyetemi Oktatokorhaz
Szombathely, H-9700, Hungary
Policlinico Sant'Orsola Malpighi
Bologna, 40138, Italy
AOU Policlinico G.Martino
Messina, 98125, Italy
ASST Fatebenefratelli Sacco
Milan, 20157, Italy
Azienda Ospedaliera di Padova
Padua, 35128, Italy
Ospedale Villa Sofia-Cervello
Palermo, 90146, Italy
Azienda Ospedaliera G.Salvini Ospedale di Rho
Rho, Italy
Azienda Ospedaliera Universitaria 'Policlinico Tor Vergata'
Roma, 00133, Italy
Azienda Complesso Ospedaliero San Filippo Neri
Roma, 00135, Italy
Fondazione Policlinico Gemelli Università Cattolica
Roma, 168, Italy
Istituto Clinico Humanitas
Rozzano, 20089, Italy
AO Ordine Mauriziano
Torino, 10128, Italy
VUMC Amsterdam
Amsterdam, 1081 HV, Netherlands
Rijnstate Ziekenhuis
Arnhem, 6815 AD, Netherlands
UMCG
Groningen, 9713 GZ, Netherlands
Leiden University Medical Center
Leiden, 2333 ZA, Netherlands
Radboudumc
Nijmegen, 6525 GA, Netherlands
Sint Franciscus Gasthuis
Rotterdam, 3045 PM, Netherlands
Ikazia Ziekenhuis
Rotterdam, 3083 AN, Netherlands
Gastromed Kralisz Romatowski Stachurska Sp. j.
Bialystok, 15-322, Poland
Synexus Polska Sp z o o
Gdansk, 80 382, Poland
Centrum Medyczne Plejady
Krakow, 30 363, Poland
Centrum Medyczne Pratia Poznan
Krakow, 30510, Poland
Uniwersytecki Szpital Kliniczny nr 1 im. N. Barlickiego
Lodz, 90-153, Poland
Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie Oddzial Gastroenterologii
Lublin, 20 954, Poland
Centrum Medyczne Medyk
Rzeszów, 35-326, Poland
Endoskopia Sp z o o z siedziba w Sopocie
Sopot, 81 756, Poland
Centralny Szpital Kliniczny MSWiA w Warszawie
Warsaw, 02-507, Poland
Niepubliczny Zaklad Opieki Zdrowotnej Vivamed Jadwiga Miecz
Warsaw, 03 580, Poland
Gabinety Lekarskie Bodyclinic
Warsaw, 03-712, Poland
Melita Medical Sp. z o.o.
Wroclaw, 50 449, Poland
ETG Zamosc
Zamość, 22-400, Poland
Irkutsk State Medical Academy of Postgraduate Education
Irkutsk, 664079, Russia
GU Moscow Regional Research Clinical Institute n.a. M.F.Vla
Moscva, 129090, Russia
Rostov State Medical University
Rostov-on-Don, 344022, Russia
Elizavetinskaya hospital
Saint Petersburg, 195257, Russia
City Clinical Hospital #31
Saint Petersburg, 197110, Russia
GBUZ Respublican Clinical Hospital n.a. GG Kuvatova
Ufa, 450005, Russia
City Clinical Hospital # 21
Ufa, 450071, Russia
OOO MO New Hospital
Yekaterinburg, 620109, Russia
Clinical Hospital Center Zemun
Belgrade, 11080, Serbia
Clinical Hospital Center Zvezdara
Belgrade, 11080, Serbia
University Clinical Center Kragujevac
Kragujevac, 34000, Serbia
University Clinical Center NIS
Niš, 18000, Serbia
Clinical Center of Vojvodina
Vojvodina, 21000, Serbia
Clinical Hospital Center Bezanijska Kosa
Zemun, 11080, Serbia
Yeungnam University Hospital
Daegu, 42415, South Korea
The Catholic university of Korea, St. Vincent's Hospital
Gyeonggi-do, 16247, South Korea
Seoul National University Bundang Hospital
Seongnam-si, 13620, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
Severance Hospital Yonsei University Health System
Seoul, 120-752, South Korea
Hosp. Del Mar
Barcelona, 08003, Spain
Hosp. de La Santa Creu I Sant Pau
Barcelona, 08025, Spain
Hosp. Univ. Dr. Josep Trueta
Girona, 17007, Spain
Hosp. Univ. Central de Asturias
Oviedo, 33011, Spain
Corporacio Sanitari Parc Tauli
Sabadell, 08208, Spain
Hosp Clinico Univ de Salamanca
Salamanca, 37007, Spain
Hosp. Univ. Marques de Valdecilla
Santander, 39008, Spain
Hosp. Virgen Macarena
Seville, 41009, Spain
Hosp. Univ. Rio Hortega
Valladolid, 47012, Spain
Hosp. Univ. Miguel Servet
Zaragoza, 50009, Spain
Royal United Hospital
Bath, BA1 3NG, United Kingdom
Pennine Acute Hospitals-Fairfield General Hospital
Bury, BL9 7TD, United Kingdom
Kingston Hospital
Kingston upon Thames, KT2 7QB, United Kingdom
Guy's and St Thomas' Hospital
London, SE1 7EH, United Kingdom
St George's Hospital
London, SW17 0QT, United Kingdom
Southampton University Hospitals NHS Trust
Southampton, SO16 6YD, United Kingdom
Musgrove Park Hospital
Taunton, TA1 5DA, United Kingdom
Related Publications (3)
Venkat S, Zeeman M, Hart A, Bhagat S, Galbraith DA, Hoops T, Ufberg PJ, Izanec J, Freeman TC, Mcrae B, Shinzaki S, Jairath V, Panaccione R, Sands BE, Branigan P. Serum protein profiles differ with adalimumab and ustekinumab treatment in moderately to severely active Crohn's disease. J Crohns Colitis. 2025 Dec 5;19(11):jjaf197. doi: 10.1093/ecco-jcc/jjaf197.
PMID: 41258994DERIVEDHasskamp J, Meinhardt C, Timmer A. Anti-IL-12/23p40 antibodies for induction of remission in Crohn's disease. Cochrane Database Syst Rev. 2025 May 13;5(5):CD007572. doi: 10.1002/14651858.CD007572.pub4.
PMID: 40357993DERIVEDSands BE, Irving PM, Hoops T, Izanec JL, Gao LL, Gasink C, Greenspan A, Allez M, Danese S, Hanauer SB, Jairath V, Kuehbacher T, Lewis JD, Loftus EV Jr, Mihaly E, Panaccione R, Scherl E, Shchukina OB, Sandborn WJ; SEAVUE Study Group. Ustekinumab versus adalimumab for induction and maintenance therapy in biologic-naive patients with moderately to severely active Crohn's disease: a multicentre, randomised, double-blind, parallel-group, phase 3b trial. Lancet. 2022 Jun 11;399(10342):2200-2211. doi: 10.1016/S0140-6736(22)00688-2.
PMID: 35691323DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- DIRECTOR MEDICAL AFFAIRS MD
- Organization
- Janssen Scientific Affairs, LLC
Study Officials
- STUDY DIRECTOR
Janssen Scientific Affairs, LLC Clinical Trial
Janssen Scientific Affairs, LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 7, 2018
First Posted
March 13, 2018
Study Start
March 29, 2018
Primary Completion
December 15, 2020
Study Completion
May 21, 2021
Last Updated
April 29, 2025
Results First Posted
January 11, 2022
Record last verified: 2025-04