A Study to Assess Adverse Events and Change in Disease Activity From Intravenous (IV) and Subcutaneous (SC) Lutikizumab in Adult Participants With Active Ulcerative Colitis
NCT ID: NCT06257875
Last Updated: 2025-10-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
156 participants
INTERVENTIONAL
2024-03-23
2027-09-30
Brief Summary
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Lutikizumab is an investigational product being developed for the treatment of moderate to severe UC. Participants are placed in groups called treatment arms. Each group receives a different treatment. In the Induction Period, participants will be randomized into 1 of 3 arms receiving lutikizumab Dose 1, lutikizumab Dose 2, or adalimumab. In the Maintenance Period, participants who responded to lutikizumab will be randomized into 1 of 2 arms of lutikizumab maintenance and participants who responded to adalimumab will continue to receive adalimumab. All participants who did not achieve clinical response per modified Mayo Score at the end of the Induction period will receive lutikizumab. Around 200 adult participants with UC will be enrolled at approximately 200 sites worldwide.
During the 12 week Induction Period, participants will be randomized to receive intravenous (IV) and subcutaneous (SC) lutikizumab or SC adalimumab. At the 12 week mark, participants who are on lutikizumab who have responded to treatment will be re-randomized to receive SC lutikizumab at different intervals until Week 52. Participants who are on adalimumab who are responding to treatment will continue to receive adalimumab. Participants who do not respond to treatment will receive SC lutikizumab. Participants who complete the Week 52 visit and in whom therapeutic benefit to study drug is confirmed by the investigator may roll over into an optional, 52-week long-term extension (LTE).
There may be higher treatment burden for participants in this trial compared to their standard of care. 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, checking for side effects and completing questionnaires.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Induction Group 1
Participants will receive Dose 1 of IV lutikizumab at Baseline followed by SC lutikizumab throughout induction.
Lutikizumab
Subcutaneous (SC) Injection
Lutikizumab
Intravenous (IV) Infusion
Induction Group 2
Participants will receive Dose 2 of IV lutikizumab at Baseline followed by SC lutikizumab throughout induction.
Lutikizumab
Subcutaneous (SC) Injection
Lutikizumab
Intravenous (IV) Infusion
Induction Group 3
Participants will receive adalimumab per label throughout induction.
Adalimumab
SC Injection
Maintenance Group 1
Participants who responded to lutikizumab induction group 1 or 2 will be re-randomized. Participants in this group will receive SC lutikizumab throughout the maintenance period.
Lutikizumab
Subcutaneous (SC) Injection
Maintenance Group 2
Participants who responded to lutikizumab induction group 1 or 2 will be re-randomized. Participants in this group will receive SC lutikizumab throughout the maintenance period.
Lutikizumab
Subcutaneous (SC) Injection
Maintenance Adalimumab
Participants who respond to adalimumab induction group 3 will continue to receive adalimumab per label in the maintenance period.
Adalimumab
SC Injection
Maintenance Non-Responders
Participants who do not respond to study drug at the end of induction period will receive SC lutikizumab in the maintenance period.
Lutikizumab
Subcutaneous (SC) Injection
Optional Long-Term Extension (LTE)
Participants who complete the maintenance period, are willing/able to inject study drug at home, and in whom therapeutic benefit to study drug is confirmed by the investigator, may participate in the optional 52-week LTE.
Lutikizumab
Subcutaneous (SC) Injection
Adalimumab
SC Injection
Interventions
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Lutikizumab
Subcutaneous (SC) Injection
Lutikizumab
Intravenous (IV) Infusion
Adalimumab
SC Injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Active UC with a Modified Mayo Score (mMS) of 5 to 9 points and Mayo Endoscopic Subscore (ESS) of 2 to 3 (confirmed by central review).
* Demonstrated inadequate response to, loss of response to, or intolerance to at least one of the following: oral aminosalicylates, corticosteroids, immunomodulators, and/or advanced therapies.
Exclusion Criteria
* Extent of inflammatory disease limited to the rectum as assessed by screening endoscopy.
* Prior inadequate response, intolerance or loss of response to adalimumab (including biosimilars). Note: Participant may be enrolled if he/she discontinued adalimumab for reasons other than those listed above (e.g., loss of insurance) or he/she has been exposed to other advanced therapies, including anti-TNFs other than adalimumab.
18 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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Gastro SB /ID# 258331
Chula Vista, California, United States
Southern California Res. Ctr. /ID# 258391
Coronado, California, United States
Newport Huntington Medical Group /ID# 258371
Huntington Beach, California, United States
Om Research LLC /ID# 261383
Lancaster, California, United States
UC Irvine Health /ID# 259824
Orange, California, United States
University of Colorado Hospital /ID# 258388
Aurora, Colorado, United States
Research Associates of South Florida, LLC /ID# 259813
Coral Gables, Florida, United States
University of Florida College of Medicine /ID# 260402
Gainesville, Florida, United States
Auzmer Research /ID# 260940
Lakeland, Florida, United States
Atlantic Medical Research /ID# 258507
Margate, Florida, United States
Homestead Associates in Research /ID# 260392
Miami, Florida, United States
University of Miami /ID# 258396
Miami, Florida, United States
JD Medical Group, LLC /ID# 261235
Miami, Florida, United States
Gastroenterology Group Naples /ID# 258346
Naples, Florida, United States
AdventHealth Medical Group Blood & Marrow Transplant at Orlando /ID# 260945
Orlando, Florida, United States
GCP Clinical Research, LLC /ID# 260401
Tampa, Florida, United States
Atlanta Ctr. for Gastro /ID# 259275
Decatur, Georgia, United States
Gastroenterology Associates of Central Georgia, LLC /ID# 258359
Macon, Georgia, United States
Gastroenterology Consultants, P.C /ID# 258352
Roswell, Georgia, United States
Northwestern Medicine - Northwestern Memorial Hospital /ID# 259592
Chicago, Illinois, United States
University of Chicago Medical Center /ID# 258491
Chicago, Illinois, United States
IU Health University Hospital /ID# 260398
Indianapolis, Indiana, United States
Univ Kansas Med Ctr /ID# 258489
Kansas City, Kansas, United States
Louisiana Research Center, LLC /ID# 258330
Shreveport, Louisiana, United States
Massachusetts General Hospital /Id# 259817
Boston, Massachusetts, United States
Clin Res Inst of Michigan, LLC /ID# 258386
Chesterfield, Michigan, United States
Clin Res Inst of Michigan, LLC /ID# 259267
Chesterfield, Michigan, United States
Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinic /ID# 258493
Wyoming, Michigan, United States
Mayo Clinic - Rochester /ID# 258402
Rochester, Minnesota, United States
Univ New Mexico /ID# 258490
Albuquerque, New Mexico, United States
NY Scientific /ID# 260937
Brooklyn, New York, United States
NYU Langone Long Island Clinical Research Associates /ID# 258504
Lake Success, New York, United States
Weill Cornell Medicine/NYP /ID# 258953
New York, New York, United States
Columbia University Medical Center /ID# 258496
New York, New York, United States
Atrium Health /ID# 258506
Charlotte, North Carolina, United States
DJL Clinical Research, PLLC /ID# 259465
Charlotte, North Carolina, United States
Atrium Health Wake Forest Baptist Medical Center /ID# 260387
Winston-Salem, North Carolina, United States
Plains Clinical Research Center, LLC /ID# 258502
Fargo, North Dakota, United States
Digestive Disease Specialists /ID# 258499
Oklahoma City, Oklahoma, United States
Digestive Health Associates of Texas (DHAT) Research Institute - Garland /ID# 258358
Garland, Texas, United States
Baylor College of Medicine /ID# 258394
Houston, Texas, United States
BioStar Clinical Research Group - Houston - Katy Freeway /ID# 261164
Houston, Texas, United States
Clinical Associates in Research Therapeutics of America, LLC /ID# 258403
San Antonio, Texas, United States
Southern Star Research Institute, LLC /ID# 258347
San Antonio, Texas, United States
Tyler Research Institute, LLC /ID# 258383
Tyler, Texas, United States
Texas Digestive Disease Consultants - Webster /ID# 258718
Webster, Texas, United States
University Physicians and Surgeons Inc. /ID# 260399
Huntington, West Virginia, United States
Wisconsin Center for Advanced Research /ID# 258949
Milwaukee, Wisconsin, United States
Bankstown-Lidcombe Hospital /ID# 259089
Bankstown, New South Wales, Australia
Lyell McEwin Hospital /ID# 260580
Elizabeth Vale, South Australia, Australia
The Queen Elizabeth Hospital /ID# 259482
Woodville South, South Australia, Australia
St Vincent's Hospital Melbourne /ID# 259473
Fitzroy Melbourne, Victoria, Australia
Fiona Stanley Hospital /ID# 259480
Murdoch, Western Australia, Australia
Universitaetsklinikum St. Poelten /ID# 258256
Sankt Pölten, Lower Austria, Austria
Medizinische Universitaet Wien /ID# 258026
Vienna, Vienna, Austria
Universite Libre de Bruxelles - Hopital Erasme /ID# 258214
Anderlecht, Brussels Capital, Belgium
UZ Gent /ID# 258210
Ghent, Oost-Vlaanderen, Belgium
Vitaz /Id# 258222
Sint-Niklaas, Oost-Vlaanderen, Belgium
Universitair Ziekenhuis Leuven /ID# 258226
Leuven, Vlaams-Brabant, Belgium
AZ Maria Middelares /ID# 258219
Ghent, , Belgium
CHU de Liege /ID# 258212
Liège, , Belgium
Hospital Tsaritsa Yoanna /ID# 258338
Sofiya, Sofia, Bulgaria
Medical Center - Doverie /ID# 261936
Sofiya, Sofia, Bulgaria
ACIBADEM City Clinic Diagnostic-Consultative Center /ID# 258339
Sofiya, Sofia, Bulgaria
Umbal Kaspela /ID# 258336
Plovdiv, , Bulgaria
2nd Mhat /ID# 258337
Sofia, , Bulgaria
UMHAT Sveti Ivan Rilski /ID# 261417
Sofia, , Bulgaria
UMHAT Multiprofile Hospital for Active Treatment Sveta Marina /ID# 258878
Varna, , Bulgaria
Gastroenterology and Internal Medicine Research Institution /ID# 258765
Edmonton, Alberta, Canada
Covenant Health /ID# 258799
Edmonton, Alberta, Canada
Toronto Digestive Disease Associates /ID# 260460
Vaughan, Ontario, Canada
Klinicki bolnicki centar Zagreb /ID# 258145
Zagreb, City of Zagreb, Croatia
Poliklinika Solmed /ID# 258147
Zagreb, City of Zagreb, Croatia
POLIKLINIKA BORZAN d.o.o. /ID# 258146
Osijek, County of Osijek-Baranja, Croatia
Specialty Hospital Medico /ID# 258169
Rijeka, Primorje-Gorski Kotar County, Croatia
Klinicki Bolnicki Centar (KBC) Split /ID# 258153
Split, Split-Dalmatia County, Croatia
West Tallinn Central Hospital /ID# 262035
Tallinn, Harju, Estonia
Medicum /ID# 268320
Tallinn, Harju, Estonia
Parnu Hospital /ID# 261783
Pärnu, , Estonia
Tartu University Hospital /ID# 261782
Tartu, , Estonia
Chu de Nice-Hopital L'Archet Ii /Id# 258041
Nice, Alpes-Maritimes, France
CHU Toulouse - Hopital Rangueil /ID# 258044
Toulouse, Haute-Garonne, France
Hopitaux Universitaires Henri Mondor - Hopital Henri Mondor /ID# 258555
Créteil, Paris, France
Centre Hospitalier Universitaire de Nantes, Hotel Dieu -HME /ID# 258042
Nantes, Pays de la Loire Region, France
Centre Hospitalier Universitaire de Saint Etienne - Hopital Nord /ID# 258040
St-Priest-en-Jarez, Pays de la Loire Region, France
Universitaetsklinikum Ulm /ID# 258616
Ulm, Baden-Wurttemberg, Germany
Klinikum rechts der Isar /ID# 260228
Munich, Bavaria, Germany
St. Marien- und St. Annastiftskrankenhaus /ID# 264691
Ludwigshafen am Rhein, Rhineland-Palatinate, Germany
Eugastro /ID# 260229
Leipzig, Saxony, Germany
Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 258614
Kiel, Schleswig-Holstein, Germany
Universitaetsklinikum Hamburg-Eppendorf /ID# 258617
Hamburg, , Germany
General Hospital of Chest Diseases of Athens SOTIRIA /ID# 257831
Athens, Attica, Greece
University General Hospital of Heraklion PA.G.N.I /ID# 257832
Heraklion, Crete, Greece
General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 257829
Athens, , Greece
General Hospital of Thessaloniki Hippokrateio /ID# 260810
Thessaloniki, , Greece
Clinfan /ID# 258094
Szekszárd, Tolna County, Hungary
Clinexpert Kft /ID# 258449
Budapest, , Hungary
Synexus Hungary Clinical Research Centre - Budapest /ID# 258915
Budapest, , Hungary
Semmelweis Egyetem /ID# 258527
Budapest, , Hungary
Szegedi Tudományegyetem /ID# 258095
Szeged, , Hungary
St Vincents University Hospital /ID# 261560
Elm Park, Dublin, Ireland
Beaumont Hospital /ID# 261561
Dublin, , Ireland
Yitzhak Shamir Medical Center /ID# 258533
Ẕerifin, Central District, Israel
Shaare Zedek Medical Center /ID# 258529
Jerusalem, Jerusalem, Israel
Soroka University Medical Center /ID# 258530
Beersheba, Southern District, Israel
The Chaim Sheba Medical Center /ID# 258532
Ramat Gan, Tel Aviv, Israel
Tel Aviv Sourasky Medical Center /ID# 258528
Tel Aviv, Tel Aviv, Israel
Rabin Medical Center /ID# 258531
Petah Tikva, , Israel
Azienda Ospedaliero Universitaria di Cagliari - P.O. Duilio Casula /ID# 258455
Monserrato, Cagliari, Italy
Azienda Ospedaliera San Camillo Forlanini /ID# 258453
Rome, Roma, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 258452
Rome, Roma, Italy
IRCCS Ospedale Sacro Cuore Don Calabria /ID# 258456
Negrar, Verona, Italy
Gamagori City Hospital /ID# 260682
Gamagori-shi, Aichi-ken, Japan
Aichi Medical University Hospital /ID# 258867
Nagakute, Aichi-ken, Japan
Tsujinaka Hospital - Kashiwanoha /ID# 258548
Kashiwa-shi, Chiba, Japan
Juntendo University Urayasu Hospital /ID# 259582
Urayasu-shi, Chiba, Japan
Kitakyushu Municipal Medical Center /ID# 259600
Kitakyushu-shi, Fukuoka, Japan
Fukushima Medical University Hospital /ID# 259591
Fukushima, Fukushima, Japan
Gifu University Hospital /ID# 259572
Gifu, Gifu, Japan
Ogaki Municipal Hospital /ID# 259905
Ogaki-shi, Gifu, Japan
National Hospital Organization Fukuyama Medical Center /ID# 258861
Fukuyama-shi, Hiroshima, Japan
Aoyama Clinic /ID# 259587
Kobe, Hyōgo, Japan
Hyogo Medical University Hospital /ID# 258827
Nishinomiya-shi, Hyōgo, Japan
Sameshima Hospital /ID# 259589
Kagoshima, Kagoshima-ken, Japan
Kagoshima IBD Gastroenterology Clinic /ID# 259603
Kagoshima, Kagoshima-ken, Japan
Sai Gastroenterology and Proctology Clinic /ID# 260832
Fujidera-shi, Osaka, Japan
Kinshukai Infusion Clinic /ID# 259588
Osaka, Osaka, Japan
Saga University Hospital /ID# 259625
Saga, Saga-ken, Japan
Tokitokai Tokito clinic /ID# 259036
Saitama-shi, Saitama, Japan
Hamamatsu University Hospital /ID# 259580
Hamamatsu, Shizuoka, Japan
NHO Shizuoka Medical Center /ID# 259033
Sunto-gun, Shizuoka, Japan
Institute of Science Tokyo Hospital /ID# 259003
Bunkyo-ku, Tokyo, Japan
Tokai University Hachioji Hospital /ID# 258897
Hachioji-shi, Tokyo, Japan
Kyorin University Hospital /ID# 259843
Mitaka-shi, Tokyo, Japan
Center hospital of the National Center for Global Health and Medicine /ID# 259598
Shinjuku-ku, Tokyo, Japan
Toyama Prefectural Central Hospital /ID# 259499
Toyama, Toyama, Japan
SIA Polana-D /ID# 262932
Daugavpils, , Latvia
Liepaja Regional Hospital /ID# 261484
Liepāja, , Latvia
Pauls Stradins Clinical University Hospital /ID# 261483
Riga, , Latvia
Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 261486
Kaunas, , Lithuania
Panevezys Republican Hospital /ID# 261780
Panevezys, , Lithuania
Vilnius University Hospital Santaros Klinikos /ID# 261487
Vilnius, , Lithuania
Dunedin Hospital /ID# 258584
Otago, Otago, New Zealand
Waikato Hospital /ID# 258607
Hamilton, Waikato Region, New Zealand
Hutt Hospital /ID# 258608
Lower Hutt, Wellington Region, New Zealand
Akershus Universitetssykehus /ID# 261586
Nordbyhagen, Akershus, Norway
Universitetssykehuset I Nord-Norge /ID# 261649
Tromsø, Troms, Norway
Gastromed Sp. z o.o /ID# 258310
Torun, Kuyavian-Pomeranian Voivodeship, Poland
Centrum Medyczne Melita Medical /ID# 258379
Wroclaw, Lower Silesian Voivodeship, Poland
Medrise Sp. z o.o. /ID# 258561
Lublin, Lublin Voivodeship, Poland
Centrum Medyczne Lukamed Sp. z o.o. /ID# 258457
Chojnice, Pomeranian Voivodeship, Poland
H-T Centrum Medyczne Endoterapia /ID# 258540
Tychy, Silesian Voivodeship, Poland
Twoja Przychodnia SCM /ID# 259280
Szczecin, West Pomeranian Voivodeship, Poland
Centrum Opieki Zdrowotnej Orkan-Med Stec-Michalska Sp. j. /ID# 258842
Ksawerów, Łódź Voivodeship, Poland
Clinical Research Investigator Group, LLC /ID# 260647
Bayamón, , Puerto Rico
Caribbean Medical Research Center /ID# 268395
San Juan, , Puerto Rico
School of Medicine University of Puerto Rico-Medical Science Campus /ID# 258508
San Juan, , Puerto Rico
Clinical Hosp Center Zvezdara /ID# 257766
Belgrade, Beograd, Serbia
University Clinical Center Serbia /ID# 257764
Belgrade, Beograd, Serbia
Clinical Hospital Center Dr Dragisa Misovic - Dedinje /ID# 257768
Belgrade, Beograd, Serbia
Clin Hosp Ctr Bezanijska Kosa /ID# 257765
Belgrade, Beograd, Serbia
General Hospital Leskovac /ID# 257767
Leskovac, Jablanicki Okrug, Serbia
University Clinical Center Vojvodina /ID# 257763
Novi Sad, , Serbia
General Hospital Celje /ID# 261482
Celje, , Slovenia
Univ Medical Ctr Ljubljana /ID# 261474
Ljubljana, , Slovenia
Splosna bolnisnica Murska Sobota /ID# 262486
Murska Sobota, , Slovenia
Clinresco Centers /ID# 258431
Johannesburg, Gauteng, South Africa
Johese Clinical Research Midstream /ID# 260195
Pretoria, Gauteng, South Africa
Private Practice Dr MN Rajabally /ID# 260671
Cape Town, Western Cape, South Africa
Spoke Research Inc /ID# 258432
CAPE TOWN Milnerton, Western Cape, South Africa
Inje University Haeundae Hospital /ID# 258822
Busan, Busan Gwang Yeogsi, South Korea
Dong-A University Medical Center /ID# 258423
Busan, Busan Gwang Yeogsi, South Korea
The Catholic University of Korea, Daejeon St. Mary's Hospital /ID# 258424
Daejeon, Daejeon Gwang Yeogsi, South Korea
Kangbuk Samsung Hospital /ID# 258416
Seoul, Seoul Teugbyeolsi, South Korea
Samsung Medical Center /ID# 258420
Seoul, Seoul Teugbyeolsi, South Korea
Yonsei University Health System Severance Hospital /ID# 258422
Seoul, , South Korea
Complejo Hospitalario Universitario de Santiago (CHUS) /ID# 259114
Santiago de Compostela, A Coruna, Spain
Hospital Universitario de Navarra /ID# 258173
Pamplona, Navarre, Spain
Hospital Universitario La Paz /ID# 258172
Madrid, , Spain
Hospital Universitario Virgen Macarena /ID# 258175
Seville, , Spain
Inselspital, Universitaetsspital Bern /ID# 260106
Bern, , Switzerland
Intesto /ID# 260114
Bern, , Switzerland
National Taiwan University Hospital /ID# 258476
Taipei City, Taipei, Taiwan
National Taiwan University Hospital - Hsinchu branch /ID# 259422
Hsinchu, , Taiwan
China Medical University Hospital /ID# 258478
Taichung, , Taiwan
Linkou Chang Gung Memorial Hospital /ID# 258724
Taoyuan, , Taiwan
Addenbrookes Hospital /ID# 258744
Cambridge, Cambridgeshire, United Kingdom
Gartnavel General Hospital /ID# 258741
Glasgow, Glasgow City, United Kingdom
Dup_Guys and St Thomas NHS Foundation Trust - Guy's Hospital /ID# 258730
London, Greater London, United Kingdom
Oxford University Hospitals NHS Foundation Trust /ID# 258745
Oxford, Oxfordshire, United Kingdom
Barts Health NHS Trust /ID# 258600
London, , United Kingdom
Countries
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Related Links
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Other Identifiers
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2023-505678-14-00
Identifier Type: OTHER
Identifier Source: secondary_id
M23-703
Identifier Type: -
Identifier Source: org_study_id
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