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Search / Trial NCT06548542

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

Launched by ABBVIE · Aug 8, 2024

Trial Information

Current as of July 22, 2025

Recruiting

Keywords

Crohn's Disease Risankizumab Abbv 382 Lutikizumab

ClinConnect Summary

This clinical trial is exploring new targeted therapies to treat adults with moderate to severe Crohn's Disease, a long-lasting condition that causes inflammation in the digestive tract and can lead to symptoms like belly pain, diarrhea, and weight loss. The study will test three specific medications: risankizumab, ABBV-382, and lutikizumab. About 500 participants will be enrolled across 300 locations worldwide, and they will be randomly assigned to receive one of these treatments. Each participant will go through a 12-week initial treatment phase followed by another 12 weeks of ongoing care, with the possibility of continuing treatment afterward.

To be eligible for the trial, participants need to be at least 18 years old, weigh at least 40 kg, and have a confirmed diagnosis of Crohn's Disease for at least three months. They should also have had a poor response to previous treatments. Throughout the study, participants will attend regular visits to a hospital or clinic for medical assessments, blood tests, and check for any side effects. It's important to note that being part of this trial may involve more visits and treatments compared to standard care. This study aims to find effective new options for managing Crohn's Disease and improving patients' quality of life.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 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 TaTs including biologics
  • Exclusion Criteria:
  • 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.

About Abbvie

AbbVie is a global biopharmaceutical company dedicated to developing innovative therapies that address complex health challenges. Founded in 2013 as a spin-off from Abbott Laboratories, AbbVie focuses on key therapeutic areas, including immunology, oncology, neuroscience, and virology. The company is committed to advancing scientific research and delivering groundbreaking treatments that enhance patient outcomes and quality of life. With a robust pipeline and a strong emphasis on collaboration, AbbVie strives to transform the future of medicine through its commitment to clinical excellence and patient-centered approaches.

Locations

San Diego, California, United States

Inverness, Florida, United States

Orange City, Florida, United States

Orlando, Florida, United States

Macon, Georgia, United States

New Bedford, Massachusetts, United States

Las Vegas, Nevada, United States

Yonkers, New York, United States

Asheville, North Carolina, United States

Tyler, Texas, United States

Dothan, Alabama, United States

Colorado Springs, Colorado, United States

Miami, Florida, United States

Miami, Florida, United States

New Port Richey, Florida, United States

Zephyrhills, Florida, United States

Liberty, Missouri, United States

Columbus, Ohio, United States

Oklahoma City, Oklahoma, United States

Orangeburg, South Carolina, United States

Johnson City, Tennessee, United States

Ogden, Utah, United States

Salt Lake City, Utah, United States

Quebec, , Canada

Boise, Idaho, United States

Columbia, Missouri, United States

Mansfield, Texas, United States

Tacoma, Washington, United States

Southlake, Texas, United States

Springfield, Illinois, United States

Chevy Chase, Maryland, United States

Garland, Texas, United States

San Antonio, Texas, United States

New York, New York, United States

Cincinnati, Ohio, United States

Cedar Park, Texas, United States

Mobile, Alabama, United States

Peoria, Illinois, United States

Calgary, Alberta, Canada

Durham, North Carolina, United States

Wels, Oberoesterreich, Austria

Lisboa, , Portugal

Guimaraes, Braga, Portugal

Braga, , Portugal

Coimbra, , Portugal

Lisboa, , Portugal

Viana Do Castelo, , Portugal

Seville, Sevilla, Spain

Barcelona, , Spain

Madrid, , Spain

Kiel, Schleswig Holstein, Germany

Berlin, , Germany

Haifa, , Israel

Torun, Kujawsko Pomorskie, Poland

Lubbock, Texas, United States

San Antonio, Texas, United States

Sofiya, Sofia, Bulgaria

Sofiya, Sofia, Bulgaria

Sofiya, Sofia, Bulgaria

Plovdiv, , Bulgaria

Sofia, , Bulgaria

Sofia, , Bulgaria

Leipzig, Sachsen, Germany

Sopot, Pomorskie, Poland

Varna, , Bulgaria

Budapest, , Hungary

Riga, , Latvia

Madrid, , Spain

Hradec Králové, Hradec Kralove, Czechia

Krakow, Malopolskie, Poland

Kielce, Swietokrzyskie, Poland

Prague, Praha 9, Czechia

Halle (Saale), Sachsen Anhalt, Germany

Cluj Napoca, Cluj, Romania

Košice, , Slovakia

Santiago De Compostela, , Spain

Salzburg, , Austria

Wien, , Austria

Plovdiv, , Bulgaria

Vaughan, Ontario, Canada

Berlin, , Germany

Bydgoszcz, Kujawsko Pomorskie, Poland

Mannheim, Baden Wuerttemberg, Germany

Timișoara, Timis, Romania

Belgrade, Beograd, Serbia

Coronado, California, United States

Danbury, Connecticut, United States

Zagreb, Grad Zagreb, Croatia

Osijek, Osjecko Baranjska Zupanija, Croatia

Rijeka, , Croatia

Dresden, Sachsen, Germany

Warszawa, Mazowieckie, Poland

Cluj Napoca, Cluj, Romania

Belgrade, Beograd, Serbia

Tampa, Florida, United States

El Paso, Texas, United States

Leskovac, Jablanicki Okrug, Serbia

Santiago De Compostela, A Coruna, Spain

Holon, Hamerkaz, Israel

Tel Aviv, Tel Aviv, Israel

Turin, Torino, Italy

Warsaw, Mazowieckie, Poland

Bucharest, Bucuresti, Romania

Bucharest, , Romania

Novi Sad, , Serbia

Pontevedra, , Spain

Brno, Jihomoravsky Kraj, Czechia

Kaunas, , Lithuania

Ulm, Baden Wuerttemberg, Germany

Saint Louis, Missouri, United States

Tallinn, Harjumaa, Estonia

Tallinn, Harjumaa, Estonia

St Priest En Jarez, Loire, France

Montpellier, , France

Homburg, Saarland, Germany

Ballinasloe, Galway, Ireland

Rome, Roma, Italy

Riga, , Latvia

Belgrade, Beograd, Serbia

Seville, Sevilla, Spain

Glasgow, Scotland, United Kingdom

London, , United Kingdom

Pierre Benite, Rhone, France

Paris, , France

Zrenjanin, Vojvodina, Serbia

Leuven, Vlaams Brabant, Belgium

Be'er Sheva, Hadarom, Israel

Dublin, , Ireland

Erlangen, Bayern, Germany

Berlin, , Germany

Szeged, , Hungary

Ljubljana, , Slovenia

Toulouse Cedex 9, Haute Garonne, France

Szekszárd, Tolna, Hungary

Negrar, Verona, Italy

Tilburg, Noord Brabant, Netherlands

Bern, , Switzerland

Lueneburg, Niedersachsen, Germany

Tychy, Slaskie, Poland

Nantes, , France

Rennes, , France

Freiburg, Baden Wuerttemberg, Germany

Utrecht, , Netherlands

Banska Bystrica, Banskobystricky Kraj, Slovakia

Margate, Florida, United States

Vandoeuvre Les Nancy, Lorraine, France

Lübeck, Schleswig Holstein, Germany

Drogheda, Louth, Ireland

Liège, Liege, Belgium

Lexington, Kentucky, United States

Philadelphia, Pennsylvania, United States

Split, Splitsko Dalmatinska Zupanija, Croatia

Tartu, , Estonia

Ludwigshafen Am Rhein, Rheinland Pfalz, Germany

Mullingar, Westmeath, Ireland

Liepaja, , Latvia

Panevezys, , Lithuania

Celje, , Slovenia

Barcelona, , Spain

Milan, Milano, Italy

Seoul, Seoul Teugbyeolsi, Korea, Republic Of

Nitra, Nitriansky Kraj, Slovakia

Nice, Alpes Maritimes, France

Dublin, , Ireland

Daegu, , Korea, Republic Of

Vilnius, , Lithuania

Prešov, Presovsky Kraj, Slovakia

Nice, Alpes Maritimes, France

San Giovanni Rotondo, Foggia, Italy

Dongjak Gu, Gyeonggido, Korea, Republic Of

Messina, , Italy

Valencia, , Spain

Houston, Texas, United States

New York, New York, United States

Liege, , Belgium

Montpellier, Herault, France

Dongjak Gu, Seoul Teugbyeolsi, Korea, Republic Of

Busan, Busan Gwang Yeogsi, Korea, Republic Of

Yvoir, Namur, Belgium

Daejeon, Daejeon Gwang Yeogsi, Korea, Republic Of

Guildford, Surrey, United Kingdom

Edmonton, Alberta, Canada

Pessac Cedex, Gironde, France

Budapest, , Hungary

Rozzano, Lombardia, Italy

Busan, Busan Gwang Yeogsi, Korea, Republic Of

Newcastle Upon Tyne, , United Kingdom

Innsbruck, Tirol, Austria

London, Ontario, Canada

Dublin, , Ireland

Rome, Roma, Italy

Oxford, Oxfordshire, United Kingdom

Monserrato, Cagliari, Italy

Frankfurt Am Main, Hessen, Germany

Haifa, H Efa, Israel

Budapest, , Hungary

Woluwe Saint Lambert, Bruxelles Capitale, Belgium

Hershey, Pennsylvania, United States

Kortrijk, West Vlaanderen, Belgium

Sacramento, California, United States

New Haven, Connecticut, United States

Linz, , Austria

Bruxelles, Bruxelles Capitale, Belgium

Sofia, , Bulgaria

St Priest En Jarez, Loire, France

Catanzaro, , Italy

Great Neck, New York, United States

Alesund, More Og Romsdal, Norway

Glasgow, Glasgow City, United Kingdom

London, Greater London, United Kingdom

Brussels, Bruxelles Capitale, Belgium

Singapore, , Singapore

Bonheiden, Antwerpen, Belgium

Anderlecht, Bruxelles Capitale, Belgium

La Jolla, California, United States

Amsterdam, Noord Holland, Netherlands

Singapore, Central Singapore, Singapore

Singapore, Central Singapore, Singapore

Oslo, , Norway

Groningen, , Netherlands

Linz, Oberoesterreich, Austria

Bucharest, Bucuresti, Romania

Lørenskog, Akershus, Norway

Quebec, , Canada

Coventry, Warwickshire, United Kingdom

Frankfurt, Hessen, Germany

Edinburgh, , United Kingdom

Chicago, Illinois, United States

London, Greater London, United Kingdom

Graz, Steiermark, Austria

Prague, , Czechia

Edinburgh, , United Kingdom

Debrecen, Hajdu Bihar, Hungary

Budapest, , Hungary

Edinburgh, , United Kingdom

Novi, Michigan, United States

London, Greater London, United Kingdom

Rochester, Minnesota, United States

Patients applied

0 patients applied

Trial Officials

ABBVIE INC.

Study Director

AbbVie

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported