Study of Targeted Therapies for the Treatment of Adult Participants With Moderate to Severe Crohn's Disease

NCT06548542 | Recruiting Phase 2 FDA Drug

• 3 other identifiers: M24-8852024-513009-302024-513009-30-00
• Study Type: interventional
• Target: 540
• Locations: 31 countries
• Sites: 244

Brief 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. 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 540 participants will be enrolled in the study at approximately 300 sites worldwide. 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

Keywords

Crohn's Disease; Risankizumab; Trosunilimab; Lutikizumab; ABBV-8736

Outcome Measures

Primary Outcomes (1)

• 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.

  Week 12

Secondary Outcomes (3)

• Percentage of Participants who Achieve Endoscopic Response

  Week 12

• Percentage of Participants With Clinical Remission Per Stool Frequency/Abdominal Pain Score (SF/APS)

  Week 12

• Percentage of Participants With Clinical Remission Per Crohn's Disease Activity Index (CDAI)

  Week 12

Study Arms (7)

Monotherapy: Risankizumab

EXPERIMENTAL

Participants will receive Risankizumab Dose A as IV infusion and Risankizumab Dose B as SC injection.

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.

Drug: Risankizumab; Drug: Trosunilimab

Monotherapy: Trosunilimab

EXPERIMENTAL

Participants will receive trosunilimab Dose A as IV infusion and trosunilimab Dose B as SC injection.

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.

Drug: Risankizumab; Drug: Lutikizumab

Monotherapy: Lutikizumab

EXPERIMENTAL

Participants will receive Lutikizumab Dose A, Dose B and Dose C as SC injection.

Drug: Lutikizumab

Monotherapy: ABBV-8736 - OUS Only

EXPERIMENTAL

Participants will receive ABBV-8736 as IV infusion.

Drug: ABBV-8736

Long-Term Extension: Risankizumab Monotherapy

EXPERIMENTAL

Participants will receive Risankizumab Dose A as IV infusion and/or Risankizumab Dose B as SC injection for up to 72 weeks.

Drug: Risankizumab

Interventions

Risankizumab DRUG

Subcutaneous Injection

Combination Therapy: Risankizumab and Lutikizumab; Combination Therapy: Risankizumab and Trosunilimab; Long-Term Extension: Risankizumab Monotherapy; Monotherapy: Risankizumab

Trosunilimab DRUG

Intravenous Infusion

Combination Therapy: Risankizumab and Trosunilimab; Monotherapy: Trosunilimab

ABBV-8736 DRUG

Intravenous Infusion

Monotherapy: ABBV-8736 - OUS Only

Lutikizumab DRUG

Subcutaneous Injection

Combination Therapy: Risankizumab and Lutikizumab; Monotherapy: Lutikizumab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Participant who demonstrated intolerance to p19 inhibitors, including risankizumab.
• Participant who received any investigational TaT (or TaT that becomes approved during the conduct of the study) within 30 days or 5 half-lives prior to Baseline, whichever is longer. Note: If there is documentation of an undetectable (or below the lower limit of quantification/quantitation) drug level measured by a commercially available assay for any of the approved biologics above, there is no minimum washout prior to Baseline.
• 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (254)

Digestive Health Specialists /ID# 266216

Dothan, Alabama, 36301, United States

RECRUITING

East View Medical Research /ID# 270377

Mobile, Alabama, 36606, United States

RECRUITING

Southern California Res. Ctr /ID# 265549

Coronado, California, 92118, United States

RECRUITING

UC San Diego Health System /ID# 265565

La Jolla, California, 92037, United States

RECRUITING

uc davis medical center - patient support services building /ID# 265554

Sacramento, California, 95817, United States

RECRUITING

Clinical Applications Laboratories - San Diego - 3rd Avenue /ID# 267391

San Diego, California, 92103, United States

RECRUITING

Peak Gastroenterology Associates - Colorado Springs - North Cascade Avenue /ID# 265557

Colorado Springs, Colorado, 80907, United States

RECRUITING

Danbury Hospital, Western Connecticut Health Network /ID# 265556

Danbury, Connecticut, 06810, United States

RECRUITING

Yale University School of Medicine /ID# 266786

New Haven, Connecticut, 06510, United States

RECRUITING

Novum Research /ID# 278128

Clermont, Florida, 34711, United States

RECRUITING

University of Florida College of Medicine /ID# 266930

Gainesville, Florida, 32610, United States

RECRUITING

Nature Coast Clinical Research - Inverness /ID# 265874

Inverness, Florida, 34452-4717, United States

RECRUITING

Atlantic Medical Research /ID# 266207

Margate, Florida, 33063, United States

RECRUITING

A Plus Research /ID# 265878

Miami, Florida, 33144, United States

RECRUITING

Sanchez Clinical Research /ID# 265887

Miami, Florida, 33157, United States

RECRUITING

Advanced Research Institute, Inc /ID# 265548

New Port Richey, Florida, 34653, United States

RECRUITING

Hillcrest Medical Research, LLC /ID# 267237

Orange City, Florida, 32763, United States

RECRUITING

Endoscopic Research, Inc. /ID# 267211

Orlando, Florida, 32803, United States

RECRUITING

Gcp Clinical Research /ID# 278126

Tampa, Florida, 33609, United States

RECRUITING

AdventHealth Medical Group - Tampa - Bruce B Downs Boulevard /ID# 265538

Tampa, Florida, 33613, United States

RECRUITING

Florida Medical Clinic - Zephyrhills /ID# 267392

Zephyrhills, Florida, 33542, United States

RECRUITING

Gastroenterology Associates of Central Georgia /ID# 265547

Macon, Georgia, 31201, United States

RECRUITING

Treasure Valley Medical Research /ID# 267114

Boise, Idaho, 83706, United States

RECRUITING

University of Chicago Medical Center /ID# 267400

Chicago, Illinois, 60637, United States

RECRUITING

OSF St. Francis Medical Center /ID# 266973

Peoria, Illinois, 61637-0001, United States

RECRUITING

Springfield Clinic Main Campus /ID# 267434

Springfield, Illinois, 62703-2403, United States

RECRUITING

Indiana University Health University Hospital /ID# 278129

Indianapolis, Indiana, 46202, United States

RECRUITING

University of Kentucky Chandler Medical Center. /ID# 265564

Lexington, Kentucky, 40536, United States

RECRUITING

Metropolitan Gastroenterology Group - Chevy Chase /ID# 265877

Chevy Chase, Maryland, 20815, United States

RECRUITING

Lucida Clinical Trials /ID# 266548

New Bedford, Massachusetts, 02740, United States

RECRUITING

Henry Ford Medical Center - Columbus /ID# 266503

Novi, Michigan, 48377, United States

RECRUITING

Mayo Clinic-Rochester /ID# 265550

Rochester, Minnesota, 55905, United States

RECRUITING

GI Associates Research, LLC /ID# 267433

Columbia, Missouri, 65201, United States

RECRUITING

BVL Clinical Research /ID# 265870

Liberty, Missouri, 64068, United States

RECRUITING

Washington University School of Medicine - St. Louis /ID# 266938

St Louis, Missouri, 63130, United States

RECRUITING

Vector Clinical Trials /ID# 265561

Las Vegas, Nevada, 89128, United States

RECRUITING

NYU Langone Long Island Clinical Research Association /ID# 265566

Great Neck, New York, 11021, United States

RECRUITING

Icahn School of Medicine at Mount Sinai /ID# 266857

New York, New York, 10029, United States

COMPLETED

Northwell Health-Lenox Hill Hospital /ID# 265527

New York, New York, 10075, United States

RECRUITING

Care Access - Yonkers /ID# 266781

Yonkers, New York, 10701, United States

RECRUITING

Digestive Health Partners - Biltmore Office /ID# 265539

Asheville, North Carolina, 28801, United States

RECRUITING

Velocity Clinical Research - Durham /ID# 267712

Durham, North Carolina, 27701, United States

RECRUITING

University of Cincinnati /ID# 265589

Cincinnati, Ohio, 45267-2827, United States

RECRUITING

The Ohio State University /ID# 265577

Columbus, Ohio, 43210, United States

RECRUITING

Digestive Disease Specialists - Oklahoma /ID# 265901

Oklahoma City, Oklahoma, 73112, United States

RECRUITING

Penn State Health Milton South Hershey Medical Center /ID# 267126

Hershey, Pennsylvania, 17033, United States

RECRUITING

University of Pennsylvania /ID# 265904

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Gastroenterology Associates of Orangeburg /ID# 267548

Orangeburg, South Carolina, 29118, United States

RECRUITING

GI associates of Northeast Tennessee /ID# 265567

Johnson City, Tennessee, 37604, United States

RECRUITING

Gi Alliance - Cedar Park /ID# 268153

Cedar Park, Texas, 78613, United States

RECRUITING

Proactive Clinical Research /ID# 267305

El Paso, Texas, 79902, United States

COMPLETED

Digestive Health Associates of Texas (DHAT) Research Institute - Garland /ID# 266935

Garland, Texas, 75044, United States

COMPLETED

Houston Methodist Hospital /ID# 265533

Houston, Texas, 77030, United States

RECRUITING

Caprock Gastro Research - Lubbock - 80th Street /ID# 265541

Lubbock, Texas, 79424, United States

RECRUITING

GI Alliance: Mansfield /ID# 266947

Mansfield, Texas, 76063, United States

RECRUITING

Clinical Associates in Research Therapeutics of America, LLC /ID# 265899

San Antonio, Texas, 78212, United States

COMPLETED

Sun Research Institute /ID# 266723

San Antonio, Texas, 78215, United States

RECRUITING

Southern Star Research Institute /ID# 278124

San Antonio, Texas, 78229, United States

RECRUITING

Texas Digestive Disease Consultants - Southlake /ID# 265576

Southlake, Texas, 76092, United States

COMPLETED

Tyler Research Institute, LLC /ID# 265545

Tyler, Texas, 75701, United States

RECRUITING

Care Access - Ogden /ID# 266428

Ogden, Utah, 84403, United States

RECRUITING

Care Access - Salt Lake City /ID# 266785

Salt Lake City, Utah, 84124, United States

COMPLETED

Virginia Mason Hospital & Medical Center /ID# 265574

Seattle, Washington, 98101, United States

RECRUITING

Washington Gastroenterology - Tacoma /ID# 267302

Tacoma, Washington, 98405, United States

RECRUITING

Medizinische Universitaet Graz /ID# 275453

Graz, Styria, 8010, Austria

RECRUITING

Medizinische Universitaet Innsbruck /ID# 265930

Innsbruck, Tyrol, 6020, Austria

RECRUITING

Ordensklinikum Linz GmbH Barmherzige Schwestern /ID# 265929

Linz, Upper Austria, 4010, Austria

RECRUITING

Klinikum Wels-Grieskirchen GmbH /ID# 266035

Wels, Upper Austria, 4600, Austria

COMPLETED

Landeskrankenhaus Salzburg-Universitaetsklinikum der PMU (LKH) /ID# 265928

Salzburg, 5020, Austria

RECRUITING

Medizinische Universitaet Wien /ID# 265926

Vienna, 1090, Austria

RECRUITING

Imelda Ziekenhuis /ID# 265995

Bonheiden, Antwerpen, 2820, Belgium

RECRUITING

Universite Libre de Bruxelles - Hopital Erasme /ID# 265993

Anderlecht, Brussels Capital, 1070, Belgium

RECRUITING

CHU Saint-Pierre /ID# 266431

Brussels, Brussels Capital, 1000, Belgium

RECRUITING

Cliniques Universitaires UCL Saint-Luc /ID# 265521

Brussels, Brussels Capital, 1200, Belgium

RECRUITING

Groupe Sante CHC - Clinique du MontLegia /ID# 265522

Liège, Liege, 4000, Belgium

RECRUITING

Universite Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant /ID# 265517

Yvoir, Namur, 5530, Belgium

RECRUITING

Universitair Ziekenhuis Leuven /ID# 265519

Leuven, Vlaams-Brabant, 3000, Belgium

RECRUITING

AZ Groeninge /ID# 265544

Kortrijk, West-Vlaanderen, 8500, Belgium

RECRUITING

AZ Oostende /ID# 275534

Ostend, West-Vlaanderen, 8400, Belgium

RECRUITING

CHU de Liege /ID# 265542

Liège, 4000, Belgium

RECRUITING

Hospital Tsaritsa Yoanna /ID# 266235

Sofiya, Sofia, 1527, Bulgaria

RECRUITING

Medical Center - Doverie /ID# 267050

Sofiya, Sofia, 1632, Bulgaria

RECRUITING

ACIBADEM City Clinic Diagnostic-Consultative Center /ID# 266239

Sofiya, Sofia, 1784, Bulgaria

RECRUITING

Umbal Kaspela /ID# 266234

Plovdiv, 4001, Bulgaria

RECRUITING

MHAT Knyaginya Klementina /ID# 266238

Sofia, 1233, Bulgaria

RECRUITING

Acibadem City Clinic Tokuda University Hospital EAD /ID# 267437

Sofia, 1407, Bulgaria

RECRUITING

Military Medical Academy Multiprofile Hospital /ID# 267051

Sofia, 1606, Bulgaria

COMPLETED

UMHAT Multiprofile Hospital for Active Treatment Sveta Marina /ID# 266237

Varna, 9009, Bulgaria

COMPLETED

University of Calgary /ID# 265524

Calgary, Alberta, T2N 4Z6, Canada

RECRUITING

Gastroenterology and Internal Medicine Research Institute /ID# 265610

Edmonton, Alberta, T5R 1W2, Canada

COMPLETED

University of Alberta Hospital /ID# 265614

Edmonton, Alberta, T6G 2B7, Canada

RECRUITING

Medicor Research /ID# 267405

Greater Sudbury, Ontario, P3C 1X3, Canada

RECRUITING

London Health Sciences Centre - University Hospital /ID# 267298

London, Ontario, N6A 5A5, Canada

RECRUITING

Toronto Digestive Disease Associates /ID# 267358

Vaughan, Ontario, L4L 4Y7, Canada

RECRUITING

Clinique IMD /ID# 272057

Montreal, Quebec, H3H 1E8, Canada

RECRUITING

Diex Recherche Quebec Inc. /ID# 265611

Québec, G1V 4T3, Canada

RECRUITING

Klinicki Bolnicki Centar Zagreb /ID# 265502

Grad Zagreb, City of Zagreb, 10000, Croatia

RECRUITING

Poliklinika Solmed /ID# 265509

Zagreb, City of Zagreb, 10000, Croatia

RECRUITING

Poliklinika Borzan d.o.o. /ID# 265503

Osijek, County of Osijek-Baranja, 31000, Croatia

RECRUITING

Specialty Hospital Medico /ID# 265504

Rijeka, Primorje-Gorski Kotar County, 51000, Croatia

RECRUITING

Klinicki Bolnicki Centar (KBC) Split /ID# 265511

Split, Split-Dalmatia County, 21000, Croatia

RECRUITING

Hepato-Gastroenterologie HK /ID# 265387

Hradec Králové, Hradec Kralove, 500 12, Czechia

RECRUITING

Iscare Klinické Centrum /ID# 265407

Prague, Praha 9, 190 00, Czechia

COMPLETED

SurGal Clinic /ID# 265388

Brno, South Moravian, 602 00, Czechia

RECRUITING

Aarhus Universitetshospital - Skejby /ID# 269064

Aarhus, Central Jutland, 8200, Denmark

RECRUITING

Odense University Hospital /ID# 267778

Odense, Region Syddanmark, 5000, Denmark

RECRUITING

Medicum /ID# 268304

Tallinn, Harju, 13619, Estonia

RECRUITING

East Tallinn Central Hospital /ID# 267658

Tallinn, 10138, Estonia

RECRUITING

Tartu University Hospital /ID# 267656

Tartu, 50406, Estonia

RECRUITING

Tampere University Hospital /ID# 267721

Tampere, Pirkanmaa, 33520, Finland

RECRUITING

Turku University Hospital /ID# 267723

Turku, Southwest Finland, 20520, Finland

RECRUITING

Chu de Nice-Hopital Larchet Ii /Id# 267478

Nice, Alpes-Maritimes, 06202, France

RECRUITING

CHU de Toulouse - Hôpital Rangueil /ID# 267479

Toulouse, Haute-Garonne, 31059, France

RECRUITING

CHU de Montpellier - Hopital Saint Eloi /ID# 265718

Montpellier, Herault, 34295, France

RECRUITING

Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou /ID# 266848

Rennes, Ille-et-Vilaine, 35033, France

RECRUITING

Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois /ID# 265703

Vandœuvre-lès-Nancy, Meurthe-et-Moselle, 54511, France

RECRUITING

Centre Hospitalier Universitaire de Bordeaux /ID# 265721

Pessac, Nouvelle-Aquitaine, 33604, France

COMPLETED

Centre Hospitalier Universitaire de Saint Etienne - Hopital Nord /ID# 265340

St-Priest-en-Jarez, Pays de la Loire Region, 42270, France

RECRUITING

Hospices Civils de Lyon - Centre Hospitalier Lyon-Sud /ID# 266851

Pierre-Bénite, Rhone, 69310, France

RECRUITING

Clinique Jules Verne /ID# 267480

Nantes, 44314, France

RECRUITING

Hopital Saint Antoine /ID# 265725

Paris, 75012, France

RECRUITING

Universitaetsklinikum Freiburg /ID# 265755

Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

RECRUITING

Universitaetsmedizin Mannheim /ID# 266961

Mannheim, Baden-Wurttemberg, 68167, Germany

RECRUITING

Universitaetsklinikum Ulm /ID# 266962

Ulm, Baden-Wurttemberg, 89081, Germany

RECRUITING

Universitaetsklinikum Erlangen /ID# 265927

Erlangen, Bavaria, 91054, Germany

RECRUITING

Klinikum der Universitaet Muenchen Grosshadern /ID# 269165

Munich, Bavaria, 81337, Germany

RECRUITING

Universitaetsklinikum Regensburg /ID# 275556

Regensburg, Bavaria, 93042, Germany

RECRUITING

Markus Krankenhaus /ID# 265938

Frankfurt am Main, Hesse, 60431, Germany

RECRUITING

Universitaetsklinikum Frankfurt /ID# 266827

Frankfurt am Main, Hesse, 60590, Germany

RECRUITING

Klinikum Lueneburg /ID# 266886

Lüneburg, Lower Saxony, 21339, Germany

RECRUITING

Universitaetsmedizin Essen /ID# 275535

Essen, North Rhine-Westphalia, 45147, Germany

RECRUITING

St. Marien- und St. Annastiftskrankenhaus /ID# 265912

Ludwigshafen am Rhein, Rhineland-Palatinate, 67067, Germany

RECRUITING

Universitaetsklinikum des Saarlandes /ID# 265753

Homburg, Saarland, 66424, Germany

RECRUITING

Universitaetsklinikum Carl Gustav Carus Dresden /ID# 265931

Dresden, Saxony, 01307, Germany

RECRUITING

Eugastro /ID# 266826

Leipzig, Saxony, 04103, Germany

RECRUITING

Studiengesellschaft BSF Unternehmergesellschaft /ID# 265751

Halle, Saxony-Anhalt, 06108, Germany

RECRUITING

Universitaetsklinikum Schleswig-Holstein - Campus Kiel /ID# 265738

Kiel, Schleswig-Holstein, 24105, Germany

RECRUITING

Universitaetsklinikum Schleswig-Holstein Campus Luebeck /ID# 267254

Lübeck, Schleswig-Holstein, 23538, Germany

COMPLETED

Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 265752

Berlin, 10117, Germany

RECRUITING

DRK Kliniken Berlin - Westend /ID# 265925

Berlin, 14050, Germany

RECRUITING

Krankenhaus Waldfriede /ID# 266676

Berlin, 14163, Germany

RECRUITING

Debreceni Egyetem-Klinikai Kozpont /ID# 267389

Debrecen, Hajdú-Bihar, 4032, Hungary

RECRUITING

Clinfan /ID# 267385

Szekszárd, Tolna County, 7100, Hungary

RECRUITING

Synexus Hungary Clinical Research Centre - Budapest /ID# 267384

Budapest, 1036, Hungary

COMPLETED

Semmelweis Egyetem /ID# 267064

Budapest, 1085, Hungary

RECRUITING

Semmelweis Egyetem /ID# 267068

Budapest, 1085, Hungary

RECRUITING

Szegedi Tudomanyegyetem /ID# 267386

Szeged, 6720, Hungary

RECRUITING

Letterkenny General Hospital /ID# 276677

Letterkenny, Donegal, F92 AE81, Ireland

RECRUITING

Portiuncula University Hospital /ID# 267771

Ballinasloe, Galway, H53 T971, Ireland

RECRUITING

Our Lady of Lourdes Hospital - Drogheda /ID# 267768

Drogheda, Louth, A92 VW28, Ireland

RECRUITING

Midland Regional Hospital Mullingar /ID# 267769

Mullingar, Westmeath, N91 NA43, Ireland

RECRUITING

St. Vincent's University Hospital /ID# 267766

Dublin, D04 T6F4, Ireland

RECRUITING

Beaumont Hospital /ID# 267770

Dublin, D09 XR63, Ireland

RECRUITING

Connolly Hospital /ID# 268021

Dublin, D15 X40D, Ireland

RECRUITING

Edith Wolfson Medical Center /ID# 267640

Holon, Central District, 5822012, Israel

RECRUITING

Soroka Medical Center /ID# 267235

Beersheba, Southern District, 8410101, Israel

RECRUITING

Tel Aviv Sourasky Medical Center /ID# 267307

Tel Aviv, Tel Aviv, 6423906, Israel

COMPLETED

Rambam Health Care Campus- Haifa /ID# 267641

Haifa, 3525408, Israel

RECRUITING

Azienda Ospedaliero Universitaria di Cagliari - P.O. Duilio Casula /ID# 267287

Monserrato, Cagliari, 09042, Italy

RECRUITING

Fondazione di Religione e di Culto Casa Sollievo della Sofferenza /ID# 267143

San Giovanni Rotondo, Foggia, 71013, Italy

RECRUITING

IRCCS Istituto Clinico Humanitas /ID# 265946

Rozzano, Lombardy, 20089, Italy

RECRUITING

IRCCS Ospedale San Raffaele /ID# 265951

Milan, Milano, 20132, Italy

RECRUITING

Azienda Ospedaliera Universitaria Policlinico Tor Vergata /ID# 265935

Rome, Roma, 00133, Italy

RECRUITING

Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Universita Cattolica /ID# 265940

Rome, Roma, 00168, Italy

RECRUITING

A.O. Ordine Mauriziano di Torino /ID# 267144

Turin, Torino, 10128, Italy

RECRUITING

IRCCS Ospedale Sacro Cuore Don Calabria /ID# 265942

Negrar, Verona, 37024, Italy

RECRUITING

Azienda Ospedaliero-Universitaria Renato Dulbecco /ID# 267722

Catanzaro, 88100, Italy

RECRUITING

Azienda Ospedaliera Universitaria Gaetano Martino /ID# 267145

Messina, 98125, Italy

RECRUITING

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico /ID# 265949

Milan, 20122, Italy

RECRUITING

Liepaja Regional Hospital /ID# 267703

Liepāja, LV-3414, Latvia

RECRUITING

Pauls Stradins Clinical University Hospital /ID# 267705

Riga, LV-1002, Latvia

RECRUITING

Digestive Diseases Center GASTRO /ID# 267707

Riga, LV-1079, Latvia

RECRUITING

Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 267695

Kaunas, 50161, Lithuania

RECRUITING

Panevezys Republican Hospital /ID# 267709

Panevezys, 35144, Lithuania

RECRUITING

Vilnius University Hospital Santaros Klinikos /ID# 267711

Vilnius, 08661, Lithuania

RECRUITING

Elisabeth TweeSteden Ziekenhuis /ID# 265729

Tilburg, North Brabant, 5022 GC, Netherlands

RECRUITING

Amsterdam UMC, locatie AMC /ID# 268321

Amsterdam, North Holland, 1105 AZ, Netherlands

RECRUITING

Universitair Medisch Centrum Groningen /ID# 265736

Groningen, 9713 GR, Netherlands

RECRUITING

Universitair Medisch Centrum Utrecht /ID# 265731

Utrecht, 3584 CX, Netherlands

RECRUITING

Akershus University Hospital /ID# 267642

Lørenskog, Akershus, 1478, Norway

RECRUITING

Helse More- og Romsdal HF, Alesund sjukehus /ID# 267632

Ålesund, Møre og Romsdal, 6017, Norway

RECRUITING

Oslo Universitetssykehus Ulleval /ID# 267630

Oslo, 0450, Norway

RECRUITING

NZOZ Centrum Medyczne KERmed /ID# 266766

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-231, Poland

RECRUITING

Gastromed Sp. z o.o /ID# 266765

Torun, Kuyavian-Pomeranian Voivodeship, 87-100, Poland

RECRUITING

Malopolskie Centrum Kliniczne /ID# 265943

Krakow, Lesser Poland Voivodeship, 30-149, Poland

RECRUITING

Medical Network Sp.z.o.o. WIP Warsaw IBD Point Profesor Kierkus /ID# 266764

Warsaw, Masovian Voivodeship, 00-728, Poland

RECRUITING

Bodyclinic Sp. z o.o. sp.k. /ID# 265945

Warsaw, Masovian Voivodeship, 03-712, Poland

RECRUITING

Endoskopia Sp. z.o.o. /ID# 265934

Sopot, Pomeranian Voivodeship, 81-756, Poland

RECRUITING

H-T Centrum Medyczne Endoterapia /ID# 265937

Tychy, Silesian Voivodeship, 43-100, Poland

RECRUITING

Polimedica PTG Kielce /ID# 267066

Kielce, Świętokrzyskie Voivodeship, 25-338, Poland

COMPLETED

Unidade Local de Saude do Alto Ave, EPE /ID# 265892

Guimarães, Braga District, 4835-044, Portugal

RECRUITING

2CA-Braga, Hospital de Braga /ID# 265894

Braga, 4710-243, Portugal

RECRUITING

Unidade Local de Saude de Coimbra, EPE /ID# 267240

Coimbra, 3000-075, Portugal

RECRUITING

Unidade Local de Saude de Lisboa Ocidental, EPE /ID# 267242

Lisbon, 1449-005, Portugal

RECRUITING

Unidade Local de Saude de Santa Maria, EPE /ID# 266113

Lisbon, 1649-035, Portugal

RECRUITING

Unidade Local de Saude do Alto Minho, EPE - Hospital de Santa Luzia /ID# 265885

Viana do Castelo, 4900-408, Portugal

RECRUITING

Memorial Healthcare International S.R.L. /Id# 267328

Bucharest, București, 013823, Romania

RECRUITING

Spitalul Clinic Colentina /ID# 267208

Bucharest, București, 020125, Romania

RECRUITING

Clinica Gastro Med SRL /ID# 267204

Cluj-Napoca, Cluj, 400380, Romania

RECRUITING

OncoHelp Association /ID# 267203

Timișoara, Timiș County, 300239, Romania

RECRUITING

Clinical Hospital Center Zvezdara /ID# 265605

Belgrade, Beograd, 11000, Serbia

RECRUITING

Military Medical Academy /ID# 267452

Belgrade, Beograd, 11000, Serbia

RECRUITING

University Clinical Hospital Center "Dr. Dragisa Misovic - Dedinje" /ID# 265607

Belgrade, Beograd, 11000, Serbia

RECRUITING

Clinical Hospital Center - Bežanijska Kosa /ID# 265604

Belgrade, Beograd, 11080, Serbia

RECRUITING

Leskovac General Hospital /ID# 265606

Leskovac, Jablanicki Okrug, 16000, Serbia

RECRUITING

General Hospital Djordje Joanovic /ID# 266040

Zrenjanin, Vojvodina, 23000, Serbia

RECRUITING

University Clinical Center Vojvodina /ID# 265603

Novi Sad, 21000, Serbia

RECRUITING

Mount Elizabeth Hospital /ID# 268354

Singapore, Central Singapore, 228510, Singapore

RECRUITING

Gleneagles Hospital /ID# 268385

Singapore, Central Singapore, 258500, Singapore

RECRUITING

National University Hospital /ID# 268128

Singapore, 119074, Singapore

RECRUITING

Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica /ID# 266064

Banská Bystrica, Banská Bystrica Region, 975 17, Slovakia

RECRUITING

KM Management, spol. s.r.o. /ID# 266070

Nitra, Nitra Region, 949 01, Slovakia

RECRUITING

Gastro I., s.r.o. /ID# 267159

Prešov, Presov, 080 01, Slovakia

RECRUITING

ENDOMED s.r.o /ID# 266068

Košice, 040 01, Slovakia

RECRUITING

General Hospital Celje /ID# 267699

Celje, 3000, Slovenia

RECRUITING

University Medical Centre Ljubljana /ID# 267697

Ljubljana, 1000, Slovenia

RECRUITING

Inje University Haeundae Paik Hospital /ID# 266380

Busan, Busan Gwang Yeogsi, 48108, South Korea

RECRUITING

Dong-A University Medical Center /ID# 266709

Busan, Busan Gwang Yeogsi, 49201, South Korea

RECRUITING

The Catholic University of Korea, Daejeon St. Mary's Hospital /ID# 265488

Daejeon, Daejeon Gwang Yeogsi, 34943, South Korea

RECRUITING

Chungang University Hospital /ID# 266427

Dongjak-gu, Seoul Teugbyeolsi, 06973, South Korea

RECRUITING

Samsung Medical Center /ID# 265489

Seoul, Seoul Teugbyeolsi, 06351, South Korea

RECRUITING

Kyungpook National University Chilgok Hospital /ID# 265487

Daegu, 41404, South Korea

RECRUITING

Complejo Hospitalario Universitario de Santiago (CHUS) /ID# 266902

Santiago de Compostela, A Coruna, 15706, Spain

RECRUITING

Hospital Universitario Virgen Macarena /ID# 266648

Seville, Sevilla, 41009, Spain

RECRUITING

Hospital Universitario Virgen del Rocio /ID# 266727

Seville, Sevilla, 41013, Spain

RECRUITING

Hospital Clinic de Barcelona /ID# 265415

Barcelona, 08036, Spain

COMPLETED

Hospital Universitario 12 de Octubre /ID# 265444

Madrid, 28041, Spain

RECRUITING

Hospital Universitario La Paz /ID# 265412

Madrid, 28046, Spain

RECRUITING

Hospital Alvaro Cunqueiro /ID# 266647

Pontevedra, 36312, Spain

RECRUITING

Hospital Universitari i Politècnic La Fe /ID# 265478

Valencia, 46026, Spain

RECRUITING

University Hospital Zurich /ID# 275755

Zurich, Canton of Zurich, 8091, Switzerland

RECRUITING

Inselspital, Universitaetsspital Bern /ID# 265733

Bern, 3010, Switzerland

RECRUITING

Intesto /ID# 265728

Bern, 3012, Switzerland

COMPLETED

China Medical University Hospital /ID# 265924

Taichung, 40447, Taiwan

RECRUITING

National Taiwan University Hospital /ID# 265921

Taipei, 100, Taiwan

RECRUITING

Taipei Veterans General Hospital- Taipei City /ID# 276064

Taipei, 112, Taiwan

RECRUITING

Linkou Chang Gung Memorial Hospital /ID# 265922

Taoyuan, 333, Taiwan

RECRUITING

Kocaeli University Research and Application Hospital /ID# 267772

Dilovası, Kocaeli, 41455, Turkey (Türkiye)

RECRUITING

Hacettepe Universitesi Tip Fakultesi /ID# 266394

Ankara, 06230, Turkey (Türkiye)

RECRUITING

Bezmialem Vakif Üniversitesi /ID# 266399

Istanbul, 34093, Turkey (Türkiye)

RECRUITING

Istanbul University Istanbul Medical Faculty /ID# 266299

Istanbul, 34093, Turkey (Türkiye)

RECRUITING

Karadeniz Teknik Universitesi Tip Fakultesi /ID# 266303

Trabzon, 61080, Turkey (Türkiye)

RECRUITING

Western General Hospital - NHS Lothian /ID# 266333

Edinburgh, Edinburgh, City of, EH4 2XU, United Kingdom

RECRUITING

Gartnavel General Hospital /ID# 266407

Glasgow, Glasgow City, G12 0YN, United Kingdom

RECRUITING

Barts Health NHS Trust /ID# 266410

London, Greater London, E1 2ES, United Kingdom

RECRUITING

Royal Free Hospital /ID# 268065

London, Greater London, NW3 2QG, United Kingdom

RECRUITING

Guy's Hospital /ID# 266336

London, Greater London, SE1 9RT, United Kingdom

RECRUITING

St George University Hospitals NHS Foundation Trust /ID# 266335

London, Greater London, SW17 0QT, United Kingdom

RECRUITING

The John Radcliffe Hospital /ID# 266334

Oxford, Oxfordshire, OX3 9DU, United Kingdom

RECRUITING

The Royal Wolverhampton NHS Trust /ID# 268158

Guildford, Surrey, GU2 7XX, United Kingdom

RECRUITING

University Hospital Coventry & Warwickshire NHS Trust /ID# 267128

Coventry, Warwickshire, CV2 2DX, United Kingdom

RECRUITING

Velocity Clinical Research - Bristol /ID# 275736

Bristol, BS8 2RA, United Kingdom

RECRUITING

University Hospital of Wales /ID# 275702

Cardiff, CF14 4XW, United Kingdom

RECRUITING

Royal Victoria Infirmary /ID# 268064

Newcastle upon Tyne, NE1 4LP, United Kingdom

RECRUITING

Related Links

• Related Info

MeSH Terms

Conditions

Crohn Disease

Interventions

risankizumab; lutikizumab

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Central Study Contacts

ABBVIE CALL CENTER

CONTACT

844-663-3742; abbvieclinicaltrials@abbvie.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2024
• First Posted: August 12, 2024
• Study Start: September 4, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): August 1, 2028
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
• Access Criteria: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

Locations

SL (4); DK (2); SE (7); CA (8); NO (3); BE (10); RO (4); CR (5); IL (4); IE (7); CH (3); SG (3); FR (10); PT (6); GB (12); BU (8); TW (4); ES (3); NL (4); DE (20); IT (11); AU (6); HU (6); LI (3); US (64); KR (6); FI (2); PL (8); CZ (3); TU (5); LA (3)