Crohn's DiseasePhase 2Target CDNCT06548542
Study of Targeted Therapies for the Treatment of Adult Participants With Moderate to Severe Crohn's Disease
A Phase 2 study testing Risankizumab, Lutikizumab and Trosunilimab in people with Crohn's Disease, run by AbbVie at 255 sites in 33 countries.
Trial summary
Crohn's disease (CD) is a long-lasting disease that causes severe inflammation (redness, swelling), in the digestive tract, most frequently affecting the bowels. It can cause many different symptoms including belly pain, diarrhea, tiredness, and weight loss. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- Risankizumab, Lutikizumab and Trosunilimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 590 participants
- Where
- 255 sitesin 33 countries
- Study dates
- 4 Sep 2024to Jan 2030
- Phase
- Phase 2
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants' body weight must be >= 40 kg at Baseline.
- Confirmed diagnosis of CD for at least 3 months prior to Baseline. Documentation of biopsy results consistent with the diagnosis of CD as assessed by the Investigator must be available.
- CDAI >= 220 at Baseline.
- Endoscopic evidence of mucosal inflammation as documented by an SES-CD of >= 6 for ileocolonic or colonic disease or SES-CD of >= 4 for isolated ileal disease. All eligible scores exclude the presence of narrowing component and are determined by a reader.
- Participants must demonstrate intolerance or inadequate response to conventional therapies (OUS) and/or TaTs. TaTs include biologics and/or targeted small molecules.
Who cannot join
- Participant with history of intolerance to p19 inhibitors, including risankizumab.
- Participant who have any of the following: Current diagnosis of UC or indeterminate colitis. Currently known complications of CD such as: Current ostomy or ileoanal pouch; Current short gut or short bowel syndrome; Surgical bowel resection within the past 3 months prior to Baseline.
Trial locations and contacts
255 sites in 33 countries. Contact the study team or a site near you to ask about taking part.
255 sites in 33 countries
United States64 sites, 54 recruiting
- Recruiting
Digestive Health Partners - Biltmore Office /ID# 265539
Asheville, North Carolina, 28801
- Recruiting
Treasure Valley Medical Research /ID# 267114
Boise, Idaho, 83706
- Recruiting
Gi Alliance - Cedar Park /ID# 268153
Cedar Park, Texas, 78613
- Recruiting
Metropolitan Gastroenterology Group - Chevy Chase /ID# 265877
Chevy Chase, Maryland, 20815
- Recruiting
University of Chicago Medical Center /ID# 267400
Chicago, Illinois, 60637
- Recruiting
University of Cincinnati /ID# 265589
Cincinnati, Ohio, 45267-2827
- Recruiting
Novum Research /ID# 278128
Clermont, Florida, 34711
- Recruiting
Peak Gastroenterology Associates - Colorado Springs - North Cascade Avenue /ID# 265557
Colorado Springs, Colorado, 80907
- Recruiting
GI Associates Research, LLC /ID# 267433
Columbia, Missouri, 65201
- Recruiting
The Ohio State University /ID# 265577
Columbus, Ohio, 43210
- Recruiting
Southern California Res. Ctr /ID# 265549
Coronado, California, 92118
- Recruiting
Danbury Hospital, Western Connecticut Health Network /ID# 265556
Danbury, Connecticut, 06810
- Recruiting
Digestive Health Specialists /ID# 266216
Dothan, Alabama, 36301
- Completed
Proactive Clinical Research /ID# 267305
El Paso, Texas, 79902
- Recruiting
University of Florida College of Medicine /ID# 266930
Gainesville, Florida, 32610
- Completed
Digestive Health Associates of Texas (DHAT) Research Institute - Garland /ID# 266935
Garland, Texas, 75044
- Completed
Penn State Health Milton South Hershey Medical Center /ID# 267126
Hershey, Pennsylvania, 17033
- Recruiting
Houston Methodist Hospital /ID# 265533
Houston, Texas, 77030
- Recruiting
Indiana University Health University Hospital /ID# 278129
Indianapolis, Indiana, 46202
- Recruiting
Nature Coast Clinical Research - Inverness /ID# 265874
Inverness, Florida, 34452-4717
- Recruiting
GI associates of Northeast Tennessee /ID# 265567
Johnson City, Tennessee, 37604
- Recruiting
UC San Diego Health System /ID# 265565
La Jolla, California, 92037
- Recruiting
Nyu Langone Long Island Clinical Research Associates - Lake Success /ID# 265566
Lake Success, New York, 11042
- Recruiting
Vector Clinical Trials /ID# 265561
Las Vegas, Nevada, 89128
- Recruiting
University of Kentucky Chandler Medical Center /ID# 265564
Lexington, Kentucky, 40536
- Recruiting
Bvl Research /ID# 265870
Liberty, Missouri, 64068
- Recruiting
Caprock Gastro Research - Lubbock /ID# 265541
Lubbock, Texas, 79424
- Recruiting
Gastroenterology Associates of Central Georgia /ID# 265547
Macon, Georgia, 31201
Site Coordinator, 478-742-2600
- Completed
GI Alliance - Mansfield /ID# 266947
Mansfield, Texas, 76063
- Recruiting
Atlantic Medical Research /ID# 266207
Margate, Florida, 33063
- Recruiting
A Plus Research /ID# 265878
Miami, Florida, 33144
- Recruiting
Sanchez Clinical Research /ID# 265887
Miami, Florida, 33157
- Recruiting
East View Medical Research /ID# 270377
Mobile, Alabama, 36606
- Recruiting
Lucida Clinical Trials /ID# 266548
New Bedford, Massachusetts, 02740
- Recruiting
Yale University School of Medicine /ID# 266786
New Haven, Connecticut, 06510
- Recruiting
Advanced Research Institute, Inc /ID# 265548
New Port Richey, Florida, 34653
- Completed
Icahn School of Medicine at Mount Sinai /ID# 266857
New York, New York, 10029
- Recruiting
Northwell Health-Lenox Hill Hospital /ID# 265527
New York, New York, 10075
- Recruiting
Henry Ford Medical Center - Columbus /ID# 266503
Novi, Michigan, 48377
- Recruiting
Care Access - Ogden /ID# 266428
Ogden, Utah, 84403
- Recruiting
Digestive Disease Specialists - Oklahoma /ID# 265901
Oklahoma City, Oklahoma, 73112
- Recruiting
Hillcrest Medical Research, LLC /ID# 267237
Orange City, Florida, 32763
- Recruiting
Gastroenterology Associates of Orangeburg /ID# 267548
Orangeburg, South Carolina, 29118
- Recruiting
Endoscopic Research, Inc. /ID# 267211
Orlando, Florida, 32803
- Recruiting
OSF St. Francis Medical Center /ID# 266973
Peoria, Illinois, 61637-0001
- Recruiting
University of Pennsylvania - Perelman Center for Advanced Medicine /ID# 265904
Philadelphia, Pennsylvania, 19104
- Recruiting
Mayo Clinic-Rochester /ID# 265550
Rochester, Minnesota, 55905
- Completed
Velocity Clinical Research - Rockville /ID# 267712
Rockville, Maryland, 20854
- Recruiting
uc davis medical center - patient support services building /ID# 265554
Sacramento, California, 95817
- Completed
Care Access - Salt Lake City /ID# 266785
Salt Lake City, Utah, 84124
- Completed
Clinical Associates in Research Therapeutics of America, LLC /ID# 265899
San Antonio, Texas, 78212
- Recruiting
Sun Research Institute /ID# 266723
San Antonio, Texas, 78215
- Recruiting
Southern Star Research Institute /ID# 278124
San Antonio, Texas, 78229
- Completed
Clinical Applications Laboratories - San Diego - 3rd Avenue /ID# 267391
San Diego, California, 92103
- Recruiting
Virginia Mason Hospital and Medical Center /ID# 265574
Seattle, Washington, 98101
- Completed
Texas Digestive Disease Consultants - Southlake /ID# 265576
Southlake, Texas, 76092
- Recruiting
Springfield Clinic Main Campus /ID# 267434
Springfield, Illinois, 62703-2403
- Recruiting
Washington University /ID# 266938
St Louis, Missouri, 63110
- Recruiting
Washington Gastroenterology - Tacoma /ID# 267302
Tacoma, Washington, 98405
- Recruiting
Gcp Clinical Research /ID# 278126
Tampa, Florida, 33609
- Recruiting
AdventHealth Medical Group - Tampa - Bruce B Downs Boulevard /ID# 265538
Tampa, Florida, 33613
- Recruiting
Tyler Research Institute /ID# 265545
Tyler, Texas, 75701
- Recruiting
Care Access - Yonkers /ID# 266781
Yonkers, New York, 10701
- Recruiting
Florida Medical Clinic - Zephyrhills /ID# 267392
Zephyrhills, Florida, 33542
Germany21 sites, 20 recruiting
- Recruiting
Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 265752
Berlin, 10117
- Recruiting
DRK Kliniken Berlin - Westend /ID# 265925
Berlin, 14050
- Recruiting
Krankenhaus Waldfriede /ID# 266676
Berlin, 14163
- Recruiting
Universitaetsklinikum Carl Gustav Carus Dresden /ID# 265931
Dresden, Saxony, 01307
- Recruiting
Universitaetsklinikum Erlangen /ID# 265927
Erlangen, Bavaria, 91054
- Recruiting
Universitaetsmedizin Essen /ID# 275535
Essen, North Rhine-Westphalia, 45147
- Recruiting
Markus Krankenhaus /ID# 265938
Frankfurt am Main, Hesse, 60431
- Recruiting
Universitaetsklinikum Frankfurt /ID# 266827
Frankfurt am Main, Hesse, 60590
- Recruiting
Universitaetsklinikum Freiburg /ID# 265755
Freiburg im Breisgau, Baden-Wurttemberg, 79106
- Recruiting
Klinikum Fulda /ID# 275228
Fulda, Hesse, 36043
- Recruiting
Studiengesellschaft Mitteldeutschland GmbH /ID# 265751
Halle, Saxony-Anhalt, 06108
- Recruiting
Universitaetsklinikum des Saarlandes /ID# 265753
Homburg, Saarland, 66424
- Recruiting
Universitaetsklinikum Schleswig-Holstein - Campus Kiel /ID# 265738
Kiel, Schleswig-Holstein, 24105
- Recruiting
Eugastro /ID# 266826
Leipzig, Saxony, 04103
- Completed
Universitaetsklinikum Schleswig-Holstein Campus Luebeck /ID# 267254
Lübeck, Schleswig-Holstein, 23538
- Recruiting
St. Marien- und St. Annastiftskrankenhaus /ID# 265912
Ludwigshafen am Rhein, Rhineland-Palatinate, 67067
- Recruiting
Klinikum Lueneburg /ID# 266886
Lüneburg, Lower Saxony, 21339
- Recruiting
Universitaetsmedizin Mannheim /ID# 266961
Mannheim, Baden-Wurttemberg, 68167
- Recruiting
Klinikum der Universitaet Muenchen Grosshadern /ID# 269165
Munich, Bavaria, 81337
- Recruiting
Universitaetsklinikum Regensburg /ID# 275556
Regensburg, Bavaria, 93042
- Recruiting
Universitaetsklinikum Ulm /ID# 266962
Ulm, Baden-Wurttemberg, 89081
United Kingdom12 sites, 11 recruiting
- Recruiting
Velocity Clinical Research - Bristol /ID# 275736
Bristol, BS8 2RA
- Recruiting
University Hospital of Wales /ID# 275702
Cardiff, CF14 4XW
- Completed
University Hospital Coventry & Warwickshire NHS Trust /ID# 267128
Coventry, Warwickshire, CV2 2DX
- Recruiting
Western General Hospital /ID# 266333
Edinburgh, Edinburgh, City of, EH4 2XU
- Recruiting
Gartnavel General Hospital /ID# 266407
Glasgow, Glasgow City, G12 0YN
- Recruiting
Barts Health NHS Trust /ID# 266410
London, Greater London, E1 2ES
- Recruiting
Royal Free Hospital /ID# 268065
London, Greater London, NW3 2QG
- Recruiting
Guy's and St Thomas' NHS Foundation Trust /ID# 266336
London, Greater London, SE1 9RT
- Recruiting
St George University Hospitals NHS Foundation Trust /ID# 266335
London, Greater London, SW17 0QT
- Recruiting
Royal Victoria Infirmary /ID# 268064
Newcastle upon Tyne, NE1 4LP
- Recruiting
The John Radcliffe Hospital /ID# 266334
Oxford, Oxfordshire, OX3 9DU
- Recruiting
The Royal Wolverhampton NHS Trust /ID# 268158
Wolverhampton, West Midlands, WV10 0QP
Italy11 sites, 10 recruiting
- Recruiting
Azienda Ospedaliero-Universitaria Renato Dulbecco /ID# 267722
Catanzaro, 88100
- Completed
Azienda Ospedaliera Universitaria Gaetano Martino /ID# 267145
Messina, 98125
- Recruiting
IRCCS Ospedale San Raffaele /ID# 265951
Milan, Milano, 20132
- Recruiting
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 265949
Milan, 20122
- Recruiting
Azienda Ospedaliero Universitaria di Cagliari - P.O. Duilio Casula /ID# 267287
Monserrato, Cagliari, 09042
- Recruiting
IRCCS Ospedale Sacro Cuore Don Calabria /ID# 265942
Negrar, Verona, 37024
- Recruiting
Azienda Ospedaliera Universitaria Policlinico Tor Vergata /ID# 265935
Rome, Roma, 00133
- Recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Universita Cattolica /ID# 265940
Rome, Roma, 00168
- Recruiting
IRCCS Istituto Clinico Humanitas /ID# 265946
Rozzano, Lombardy, 20089
- Recruiting
Fondazione di Religione e di Culto Casa Sollievo della Sofferenza /ID# 267143
San Giovanni Rotondo, Foggia, 71013
- Recruiting
A.O. Ordine Mauriziano di Torino /ID# 267144
Turin, Torino, 10128
Belgium10 sites, 10 recruiting
- Recruiting
Universite Libre de Bruxelles - Hopital Erasme /ID# 265993
Anderlecht, Brussels Capital, 1070
- Recruiting
Imelda Ziekenhuis /ID# 265995
Bonheiden, Antwerpen, 2820
- Recruiting
CHU Saint-Pierre /ID# 266431
Brussels, Brussels Capital, 1000
Site Coordinator, +32 2 535 46 03
- Recruiting
Cliniques Universitaires UCL Saint-Luc /ID# 265521
Brussels, Brussels Capital, 1200
- Recruiting
AZ Groeninge /ID# 265544
Kortrijk, West-Vlaanderen, 8500
- Recruiting
Universitair Ziekenhuis Leuven /ID# 265519
Leuven, Vlaams-Brabant, 3000
- Recruiting
Groupe Sante CHC - Clinique du MontLegia /ID# 265522
Liège, Liege, 4000
- Recruiting
CHU de Liege /ID# 265542
Liège, 4000
- Recruiting
AZ Oostende /ID# 275534
Ostend, West-Vlaanderen, 8400
- Recruiting
Universite Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant /ID# 265517
Yvoir, Namur, 5530
France10 sites, 9 recruiting
- Recruiting
CHU de Montpellier - Hopital Saint Eloi /ID# 265718
Montpellier, Herault, 34295
- Recruiting
Clinique Jules Verne /ID# 267480
Nantes, 44314
- Recruiting
Chu de Nice-Hopital Larchet Ii /Id# 267478
Nice, Alpes-Maritimes, 06202
- Recruiting
Hopital Saint Antoine /ID# 265725
Paris, 75012
- Completed
Centre Hospitalier Universitaire de Bordeaux /ID# 265721
Pessac, New Aquitaine, 33604
- Recruiting
Hospices Civils de Lyon - Centre Hospitalier Lyon-Sud /ID# 266851
Pierre-Bénite, Rhone, 69310
- Recruiting
Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou /ID# 266848
Rennes, Ille-et-Vilaine, 35033
- Recruiting
Centre Hospitalier Universitaire de Saint Etienne - Hopital Nord /ID# 265340
St-Priest-en-Jarez, Pays de la Loire Region, 42270
- Recruiting
CHU de Toulouse - Hopital Rangueil /ID# 267479
Toulouse, Occitanie, 31059
- Recruiting
Centre Hospitalier Regional Universitaire de Nancy - Hopitaux de Brabois /ID# 265703
Vandœuvre-lès-Nancy, Meurthe-et-Moselle, 54511
Bulgaria8 sites, 6 recruiting
- Recruiting
Umbal Kaspela /ID# 266234
Plovdiv, 4001
- Recruiting
MHAT Knyaginya Klementina /ID# 266238
Sofia, 1233
- Recruiting
Acibadem City Clinic Tokuda University Hospital EAD /ID# 267437
Sofia, 1407
- Completed
Military Medical Academy Multiprofile Hospital /ID# 267051
Sofia, 1606
- Recruiting
Hospital Tsaritsa Yoanna /ID# 266235
Sofiya, Sofia, 1527
- Recruiting
Medical Center - Doverie /ID# 267050
Sofiya, Sofia, 1632
- Recruiting
ACIBADEM City Clinic Diagnostic-Consultative Center /ID# 266239
Sofiya, Sofia, 1784
- Completed
UMHAT Multiprofile Hospital for Active Treatment Sveta Marina /ID# 266237
Varna, 9009
Canada8 sites, 7 recruiting
- Recruiting
University of Calgary /ID# 265524
Calgary, Alberta, T2N 4Z6
- Completed
Gastroenterology and Internal Medicine Research Institute /ID# 265610
Edmonton, Alberta, T5R 1W2
- Recruiting
University of Alberta Hospital /ID# 265614
Edmonton, Alberta, T6G 2B7
- Recruiting
Medicor Research /ID# 267405
Greater Sudbury, Ontario, P3C 1X3
- Recruiting
London Health Sciences Centre - University Hospital /ID# 267298
London, Ontario, N6A 5A5
- Recruiting
Clinique IMD /ID# 272057
Montreal, Quebec, H3H 1E8
- Recruiting
Diex Recherche Quebec Inc. /ID# 265611
Québec, G1V 4T3
- Recruiting
Toronto Digestive Disease Associates /ID# 267358
Vaughan, Ontario, L4L 4Y7
Poland8 sites, 7 recruiting
- Recruiting
Centrum Medyczne KERmed /ID# 266766
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-231
- Completed
Polimedica PTG Kielce /ID# 267066
Kielce, Świętokrzyskie Voivodeship, 25-338
- Recruiting
Malopolskie Centrum Kliniczne /ID# 265943
Krakow, Lesser Poland Voivodeship, 30-149
- Recruiting
Endoskopia Sp. z.o.o. /ID# 265934
Sopot, Pomeranian Voivodeship, 81-756
- Recruiting
Gastromed Sp. z o.o /ID# 266765
Torun, Kuyavian-Pomeranian Voivodeship, 87-100
- Recruiting
H-T Centrum Medyczne Endoterapia /ID# 265937
Tychy, Silesian Voivodeship, 43-100
- Recruiting
Medical Network Sp. z o.o. /ID# 266764
Warsaw, Masovian Voivodeship, 00-728
- Recruiting
Bodyclinic Sp. z o.o. sp.k. /ID# 265945
Warsaw, Masovian Voivodeship, 03-712
Spain8 sites, 7 recruiting
- Completed
Hospital Clinic de Barcelona /ID# 265415
Barcelona, 08036
- Recruiting
Hospital Universitario 12 de Octubre /ID# 265444
Madrid, 28041
- Recruiting
Hospital Universitario La Paz /ID# 265412
Madrid, 28046
- Recruiting
Hospital Alvaro Cunqueiro /ID# 266647
Pontevedra, 36312
- Recruiting
Complejo Hospitalario Universitario de Santiago /ID# 266902
Santiago de Compostela, A Coruna, 15706
- Recruiting
Hospital Universitario Virgen Macarena /ID# 266648
Seville, Sevilla, 41009
- Recruiting
Hospital Universitario Virgen del Rocio /ID# 266727
Seville, Sevilla, 41013
- Recruiting
Hospital Universitari i Politecnic La Fe /ID# 265478
Valencia, 46026
Ireland7 sites, 7 recruiting
- Recruiting
Portiuncula University Hospital /ID# 267771
Ballinasloe, Galway, H53 T971
- Recruiting
Our Lady of Lourdes Hospital - Drogheda /ID# 267768
Drogheda, Louth, A92 VW28
- Recruiting
St. Vincent's University Hospital /ID# 267766
Dublin, D04 T6F4
- Recruiting
Beaumont Hospital /ID# 267770
Dublin, D09 XR63
- Recruiting
Connolly Hospital /ID# 268021
Dublin, D15 X40D
- Recruiting
Letterkenny General Hospital /ID# 276677
Letterkenny, Donegal, F92 AE81
- Recruiting
Midland Regional Hospital Mullingar /ID# 267769
Mullingar, Westmeath, N91 NA43
Serbia7 sites, 7 recruiting
- Recruiting
Clinical Hospital Center Dr. Dragisa Misovic - Dedinje /ID# 265607
Belgrade, Beograd, 11000
- Recruiting
Clinical Hospital Center Zvezdara /ID# 265605
Belgrade, Beograd, 11000
- Recruiting
Military Medical Academy /ID# 267452
Belgrade, Beograd, 11000
- Recruiting
Clinical Hospital Center Bezanijska Kosa /ID# 265604
Belgrade, Beograd, 11080
- Recruiting
Leskovac General Hospital /ID# 265606
Leskovac, Jablanicki Okrug, 16000
- Recruiting
University Clinical Center Vojvodina /ID# 265603
Novi Sad, 21000
- Recruiting
General Hospital Djordje Joanovic /ID# 266040
Zrenjanin, Vojvodina, 23000
Austria6 sites, 5 recruiting
- Recruiting
Medizinische Universitaet Graz /ID# 275453
Graz, Styria, 8010
- Recruiting
Medizinische Universitaet Innsbruck /ID# 265930
Innsbruck, Tyrol, 6020
- Recruiting
Ordensklinikum Linz GmbH Barmherzige Schwestern /ID# 265929
Linz, Upper Austria, 4010
- Recruiting
Landeskrankenhaus Salzburg-Universitaetsklinikum der PMU (LKH) /ID# 265928
Salzburg, 5020
- Recruiting
Medizinische Universitaet Wien /ID# 265926
Vienna, 1090
- Completed
Klinikum Wels-Grieskirchen Gmbh /ID# 266035
Wels, Upper Austria, 4600
Hungary6 sites, 5 recruiting
- Completed
Synexus Hungary Clinical Research Centre - Budapest /ID# 267384
Budapest, 1036
- Recruiting
Semmelweis Egyetem /ID# 267064
Budapest, 1085
- Recruiting
Semmelweis Egyetem /ID# 267068
Budapest, 1085
- Recruiting
Debreceni Egyetem /ID# 267389
Debrecen, 4032
- Recruiting
Szegedi Tudomanyegyetem /ID# 267386
Szeged, Csongrád megye, 6720
- Recruiting
Clinfan /ID# 267385
Szekszárd, Tolna County, 7100
Portugal6 sites, 6 recruiting
- Recruiting
2CA-Braga, Hospital de Braga /ID# 265894
Braga, 4710-243
- Recruiting
Unidade Local de Saude de Coimbra /ID# 267240
Coimbra, 3000-075
- Recruiting
Unidade Local de Saude do Alto Ave, EPE /ID# 265892
Guimarães, Braga District, 4835-044
- Recruiting
Centro Hospitalar De Lisboa Ocidental - Hospital De Egas Moniz /ID# 267242
Lisbon, Lisbon District, 1349-019
- Recruiting
Unidade Local de Saude de Santa Maria /ID# 266113
Lisbon, 1649-035
- Recruiting
Unidade Local de Saude do Alto Minho, EPE - Hospital de Santa Luzia /ID# 265885
Viana do Castelo, 4900-408
South Korea6 sites, 6 recruiting
- Recruiting
Inje University Haeundae Paik Hospital /ID# 266380
Busan, Busan Gwang Yeogsi, 48108
- Recruiting
Dong-A University Medical Center /ID# 266709
Busan, Busan Gwang Yeogsi, 49201
- Recruiting
Kyungpook National University Chilgok Hospital /ID# 265487
Daegu, 41404
- Recruiting
The Catholic University of Korea, Daejeon St. Mary's Hospital /ID# 265488
Daejeon, Daejeon Gwang Yeogsi, 34943
- Recruiting
Samsung Medical Center /ID# 265489
Seoul, Seoul Teugbyeolsi, 06351
- Recruiting
Chungang University Hospital /ID# 266427
Seoul, Seoul Teugbyeolsi, 06973
Croatia5 sites, 5 recruiting
- Recruiting
Klinicki Bolnicki Centar Zagreb /ID# 265502
Grad Zagreb, City of Zagreb, 10000
- Recruiting
Poliklinika Borzan d.o.o. /ID# 265503
Osijek, County of Osijek-Baranja, 31000
- Recruiting
Specialty Hospital Medico /ID# 265504
Rijeka, Primorje-Gorski Kotar County, 51000
- Recruiting
Klinicki Bolnicki Centar Split /ID# 265511
Split, Split-Dalmatia County, 21000
- Recruiting
Poliklinika Solmed /ID# 265509
Zagreb, City of Zagreb, 10000
Turkey (Türkiye)5 sites, 5 recruiting
- Recruiting
Hacettepe Universitesi Tip Fakultesi /ID# 266394
Ankara, 06230
- Recruiting
Kocaeli University Research and Application Hospital /ID# 267772
Dilovası, Kocaeli, 41455
- Recruiting
Bezmialem Vakif Universitesi /ID# 266399
Istanbul, 34093
- Recruiting
Istanbul University Istanbul Medical Faculty /ID# 266299
Istanbul, 34093
- Recruiting
Karadeniz Teknik Universitesi Tip Fakultesi /ID# 266303
Trabzon, 61080
Israel4 sites, 3 recruiting
- Recruiting
Soroka Medical Center /ID# 267235
Beersheba, Southern District, 8410101
- Recruiting
Rambam Health Care Campus- Haifa /ID# 267641
Haifa, 3109601
- Recruiting
Edith Wolfson Medical Center /ID# 267640
Holon, Central District, 5822012
- Completed
Tel Aviv Sourasky Medical Center /ID# 267307
Tel Aviv, Tel Aviv, 6423906
Netherlands4 sites, 4 recruiting
- Recruiting
Amsterdam University Medical Center /ID# 268321
Amsterdam, North Holland, 1105 AZ
- Recruiting
Universitair Medisch Centrum Groningen /ID# 265736
Groningen, 9713 GR
- Recruiting
Elisabeth TweeSteden Ziekenhuis /ID# 265729
Tilburg, North Brabant, 5022 GC
- Recruiting
Universitair Medisch Centrum Utrecht /ID# 265731
Utrecht, 3584 CX
Romania4 sites, 4 recruiting
- Recruiting
Memorial Healthcare International /ID# 267328
Bucharest, Bucharest, 013823
- Recruiting
Spitalul Clinic Colentina /ID# 267208
Bucharest, Bucharest, 020125
- Recruiting
Clinica Gastro Med /ID# 267204
Cluj-Napoca, Cluj, 400380
- Recruiting
OncoHelp Association /ID# 267203
Timișoara, Timiș County, 300239
Slovakia4 sites, 4 recruiting
- Recruiting
Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica /ID# 266064
Banská Bystrica, Banská Bystrica Region, 975 17
- Recruiting
Endomed /ID# 266068
Košice, Košice Region, 040 13
Site Coordinator, +421 905 271 215, fedurco@endomed.sk
- Recruiting
KM Management, spol. s.r.o. /ID# 266070
Nitra, Nitra Region, 949 01
Site Coordinator, +421 905 686 916, gregusova.studie@gmail.com
- Recruiting
Gastro I., s.r.o. /ID# 267159
Prešov, Presov, 080 01
Taiwan4 sites, 4 recruiting
- Recruiting
China Medical University Hospital /ID# 265924
Taichung, 40447
- Recruiting
National Taiwan University Hospital /ID# 265921
Taipei, 100
- Recruiting
Taipei Veterans General Hospital /ID# 276064
Taipei, 112
- Recruiting
Linkou Chang Gung Memorial Hospital /ID# 265922
Taoyuan City, 333
Czechia3 sites, 2 recruiting
- Recruiting
SurGal Clinic /ID# 265388
Brno, South Moravian, 602 00
- Recruiting
Hepato-Gastroenterologie HK /ID# 265387
Hradec Králové, Hradec Kralove, 500 12
- Completed
Iscare Klinicke Centrum /ID# 265407
Prague, Praha 9, 190 00
Estonia3 sites, 2 recruiting
- Recruiting
North Estonia Medical Centre /ID# 268304
Tallinn, Harju, 13419
- Recruiting
East Tallinn Central Hospital /ID# 267658
Tallinn, 10138
- Completed
Tartu University Hospital /ID# 267656
Tartu, 50406
Latvia3 sites, 3 recruiting
- Recruiting
Liepaja Regional Hospital /ID# 267703
Liepāja, LV-3414
- Recruiting
Pauls Stradins Clinical University Hospital /ID# 267705
Riga, LV-1002
- Recruiting
Digestive Diseases Center GASTRO /ID# 267707
Riga, LV-1079
Lithuania3 sites, 3 recruiting
- Recruiting
Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 267695
Kaunas, 50161
- Recruiting
Panevezys Republican Hospital /ID# 267709
Panevezys, 35144
- Recruiting
Vilnius University Hospital Santaros Klinikos /ID# 267711
Vilnius, 08661
Norway3 sites, 3 recruiting
- Recruiting
Helse More- og Romsdal HF, Alesund sjukehus /ID# 267632
Ålesund, Møre og Romsdal, 6017
- Recruiting
Akershus University Hospital /ID# 267642
Lorenskog, Akershus, 1478
- Recruiting
Oslo Universitetssykehus Ulleval /ID# 267630
Oslo, 0450
Singapore3 sites, 3 recruiting
- Recruiting
Mount Elizabeth Hospital /ID# 268354
Singapore, Central Singapore, 228510
- Recruiting
Gleneagles Hospital /ID# 268385
Singapore, Central Singapore, 258500
- Recruiting
National University Hospital /ID# 268128
Singapore, 119074
Switzerland3 sites, 2 recruiting
- Recruiting
Inselspital, Universitaetsspital Bern /ID# 265733
Bern, 3010
Site Coordinator, +41 31 632 59 00
- Completed
Intesto /ID# 265728
Bern, 3012
- Recruiting
University Hospital Zurich /ID# 275755
Zurich, Canton of Zurich, 8091
Denmark2 sites, 2 recruiting
- Recruiting
Aarhus Universitetshospital - Skejby /ID# 269064
Aarhus, Central Jutland, 8200
- Recruiting
Odense University Hospital /ID# 267778
Odense, Region Syddanmark, 5000
Finland2 sites, 2 recruiting
- Recruiting
Tampere University Hospital /ID# 267721
Tampere, Pirkanmaa, 33520
- Recruiting
Turku University Hospital /ID# 267723
Turku, Southwest Finland, 20520
Slovenia2 sites, 2 recruiting
- Recruiting
General Hospital Celje /ID# 267699
Celje, 3000
- Recruiting
University Medical Centre Ljubljana /ID# 267697
Ljubljana, 1000
About this study
Official title: A Phase 2a Multicenter, Randomized, Platform Study of Targeted Therapies for the Treatment of Adult Subjects With Moderate to Severe Crohn's Disease
Crohn's disease (CD) is a long-lasting disease that causes severe inflammation (redness, swelling), in the digestive tract, most frequently affecting the bowels. It can cause many different symptoms including belly pain, diarrhea, tiredness, and weight loss. Treatments are available but do not work the same for all patients or may stop working over time. This study will evaluate the effectiveness and adverse events of targeted therapies (TaTs) for adult participants with moderate to severe CD.
The medicines assessed in this study are risankizumab, trosunilimab, lutikizumab, and ABBV-8736. When participants join the study, they will be randomized into available study treatment groups. Adult participants with CD will be enrolled. Around 590 participants will be enrolled in the study at approximately 300 sites worldwide.
Read more
Risankizumab and trosunilimab are given as an injection under the skin or as an infusion into the vein. Lutikizumab is given as an injection under the skin. ABBV-8736 is given as an infusion into the vein.
There may be higher treatment burden for participants in this trial compared to their standard of care treatment without participating in this study. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, endoscopies, checking for side effects and completing questionnaires and a daily diary.
- Conditions
- Crohn's Disease
- Being tested
- Risankizumab, Lutikizumab, Trosunilimab, ABBV-8736
- Keywords
- Crohn's Disease, Risankizumab, Trosunilimab, Lutikizumab, ABBV-8736
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RisankizumabDrug
Subcutaneous Injection
LutikizumabDrug
Subcutaneous Injection
TrosunilimabDrug
Intravenous Infusion
RisankizumabDrug
Intravenous Infusion
TrosunilimabDrug
Subcutaneous Injection
ABBV-8736Drug
Intravenous Infusion
| Study group | Role | What they receive |
|---|---|---|
| Monotherapy: Risankizumab | Experimental | Participants will receive Risankizumab Dose A as IV infusion and Risankizumab Dose B as SC injection. Receives: Drug: Risankizumab |
| Combination Therapy: Risankizumab and Trosunilimab | Experimental | Participants will receive Risankizumab Dose A as IV infusion and Risankizumab Dose C as SC injection; and trosunilimab Dose A as IV infusion and trosunilimab Dose B as SC injection. Receives: Drug: Risankizumab; Drug: Trosunilimab |
| Monotherapy: Trosunilimab | Experimental | Participants will receive trosunilimab Dose A as IV infusion and trosunilimab Dose B as SC injection. Receives: Drug: Trosunilimab |
| Combination Therapy: Risankizumab and Lutikizumab | Experimental | Participants will receive Risankizumab Dose A as IV infusion and Risankizumab Dose C as SC injection; and Lutikizumab Dose A, Dose B and Dose C as SC injection. Receives: Drug: Risankizumab; Drug: Lutikizumab |
| Monotherapy: Lutikizumab | Experimental | Participants will receive Lutikizumab Dose A, Dose B and Dose C as SC injection. Receives: Drug: Lutikizumab |
| Monotherapy: ABBV-8736 - OUS Only | Experimental | Participants will receive ABBV-8736 Dose A as IV infusion. Receives: Drug: ABBV-8736 |
| Combination Therapy: ABBV-466 (Risankizumab/Trosunilimab) | Experimental | Participants will receive Risankizumab Dose A as IV infusion and Risankizumab Dose C as SC injection; and trosunilimab Dose C as IV infusion and trosunilimab Dose D as SC injection. Receives: Drug: Risankizumab; Drug: Trosunilimab |
| Long-Term Extension: Risankizumab Monotherapy | Experimental | Participants will receive Risankizumab Dose A as IV infusion and/or Risankizumab Dose B and Dose C as SC injection for up to 72 weeks. Receives: Drug: Risankizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants who Achieve Endoscopic Remission
The Simple Endoscopic Score for Crohn's Disease (SES-CD) assesses endoscopic disease severity by evidence of active intestinal mucosal inflammation. Endoscopic Remission is defined as SES-CD ≤ 4 and no sub score greater than 1 in any individual variable, as scored by a central reader.
Measured: Week 12
Number of Participants with Adverse Events (AEs)
An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
Measured: Up to approximately 96 weeks
Secondary outcomes (3)
Percentage of Participants who Achieve Endoscopic Response
The SES-CD assesses endoscopic disease severity by evidence of active intestinal mucosal inflammation. Endoscopic Response is defined as a decrease in SES-CD ≥ 50% from Baseline, as scored by central reader.
Measured: Week 12
Percentage of Participants With Clinical Remission Per Stool Frequency/Abdominal Pain Score (SF/APS)
SF/APS clinical remission is defined as the average daily SF ≤ 2.8 and not worse than Baseline AND average daily AP score ≤ 1 and not worse than Baseline.
Measured: Week 12
Percentage of Participants With Clinical Remission Per Crohn's Disease Activity Index (CDAI)
The CDAI consists of 8 components; 7 are based on participant diary entries, participant interviews, physical examinations, measurement of body weight and height and 1 is based on laboratory analysis. CDAI clinical remission of Crohn's disease is defined as CDAI < 150
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2024
- Study start4 Sep 2024
- Primary completionJan 2030 (estimated)
- Study completionJan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- More trials run by AbbVieThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 590 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06548542
- Sponsor's protocol ID
- M24-885
- Other IDs
- 2024-513009-30-00
- Acronym
- Target CD
- Status last verified
- Sep 2026
- First submitted
- 8 Aug 2024
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.