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 (Horizon)

A Multicenter, Randomized Study to Evaluate the Safety and Efficacy of Lutikizumab for Induction and Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis

Ulcerative colitis (UC) is a type of inflammatory bowel disease that causes inflammation and bleeding from the lining of the rectum and colon (large intestine). The purpose of this study is to assess how safe and effective lutikizumab is in adult participants with moderate to severe UC and how lutikizumab compares to adalimumab in the treatment of UC. Adverse events and changes in disease activity will be assessed.

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Ulcerative Colitis
• Intervention / Treatment: Drug: Adalimumab; Drug: Lutikizumab; Drug: Lutikizumab

• Study Type: Interventional
• Enrollment (Actual): 156
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Bankstown, New South Wales, Australia, 2200
      • Bankstown-Lidcombe Hospital /ID# 259089
  • South Australia
    • Elizabeth Vale, South Australia, Australia, 5112
      • Lyell McEwin Hospital /ID# 260580
    • Woodville South, South Australia, Australia, 5011
      • The Queen Elizabeth Hospital /ID# 259482
  • Victoria
    • Fitzroy Melbourne, Victoria, Australia, 3065
      • St Vincent's Hospital Melbourne /ID# 259473
  • Western Australia
    • Murdoch, Western Australia, Australia, 6150
      • Fiona Stanley Hospital /ID# 259480
• Austria
  • Lower Austria
    • Sankt Pölten, Lower Austria, Austria, 3100
      • Universitaetsklinikum St. Poelten /ID# 258256
  • Vienna
    • Vienna, Vienna, Austria, 1090
      • Medizinische Universitaet Wien /ID# 258026
• Belgium
  • Ghent, Belgium, 9000
    • AZ Maria Middelares /ID# 258219
  • Liège, Belgium, 4000
    • CHU de Liege /ID# 258212
  • Brussels Capital
    • Anderlecht, Brussels Capital, Belgium, 1070
      • Universite Libre de Bruxelles - Hopital Erasme /ID# 258214
  • Oost-Vlaanderen
    • Ghent, Oost-Vlaanderen, Belgium, 9000
      • UZ Gent /ID# 258210
    • Sint-Niklaas, Oost-Vlaanderen, Belgium, 9100
      • Vitaz /Id# 258222
  • Vlaams-Brabant
    • Leuven, Vlaams-Brabant, Belgium, 3000
      • Universitair Ziekenhuis Leuven /ID# 258226
• Bulgaria
  • Plovdiv, Bulgaria, 4001
    • Umbal Kaspela /ID# 258336
  • Sofia, Bulgaria, 1202
    • 2nd Mhat /ID# 258337
  • Sofia, Bulgaria, 1431
    • UMHAT Sveti Ivan Rilski /ID# 261417
  • Varna, Bulgaria, 9009
    • UMHAT Multiprofile Hospital for Active Treatment Sveta Marina /ID# 258878
  • Sofia
    • Sofiya, Sofia, Bulgaria, 1527
      • Hospital Tsaritsa Yoanna /ID# 258338
    • Sofiya, Sofia, Bulgaria, 1632
      • Medical Center - Doverie /ID# 261936
    • Sofiya, Sofia, Bulgaria, 1784
      • ACIBADEM City Clinic Diagnostic-Consultative Center /ID# 258339
• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T5R 1W2
      • Gastroenterology and Internal Medicine Research Institution /ID# 258765
    • Edmonton, Alberta, Canada, T6K 4B2
      • Covenant Health /ID# 258799
  • Ontario
    • Vaughan, Ontario, Canada, L4L 4Y7
      • Toronto Digestive Disease Associates /ID# 260460
• Croatia
  • City of Zagreb
    • Zagreb, City of Zagreb, Croatia, 10000
      • Klinicki bolnicki centar Zagreb /ID# 258145
    • Zagreb, City of Zagreb, Croatia, 10000
      • Poliklinika Solmed /ID# 258147
  • County of Osijek-Baranja
    • Osijek, County of Osijek-Baranja, Croatia, 31000
      • POLIKLINIKA BORZAN d.o.o. /ID# 258146
  • Primorje-Gorski Kotar County
    • Rijeka, Primorje-Gorski Kotar County, Croatia, 51000
      • Specialty Hospital Medico /ID# 258169
  • Split-Dalmatia County
    • Split, Split-Dalmatia County, Croatia, 21000
      • Klinicki Bolnicki Centar (KBC) Split /ID# 258153
• Estonia
  • Pärnu, Estonia, 80010
    • Parnu Hospital /ID# 261783
  • Tartu, Estonia, 50406
    • Tartu University Hospital /ID# 261782
  • Harju
    • Tallinn, Harju, Estonia, 10617
      • West Tallinn Central Hospital /ID# 262035
    • Tallinn, Harju, Estonia, 13619
      • Medicum /ID# 268320
• France
  • Alpes-Maritimes
    • Nice, Alpes-Maritimes, France, 06202
      • Chu de Nice-Hopital L'Archet Ii /Id# 258041
  • Haute-Garonne
    • Toulouse, Haute-Garonne, France, 31400
      • CHU Toulouse - Hopital Rangueil /ID# 258044
  • Paris
    • Créteil, Paris, France, 94010
      • Hopitaux Universitaires Henri Mondor - Hopital Henri Mondor /ID# 258555
  • Pays de la Loire Region
    • Nantes, Pays de la Loire Region, France, 44000
      • Centre Hospitalier Universitaire de Nantes, Hotel Dieu -HME /ID# 258042
    • St-Priest-en-Jarez, Pays de la Loire Region, France, 42270
      • Centre Hospitalier Universitaire de Saint Etienne - Hopital Nord /ID# 258040
• Germany
  • Hamburg, Germany, 20246
    • Universitaetsklinikum Hamburg-Eppendorf /ID# 258617
  • Baden-Wurttemberg
    • Ulm, Baden-Wurttemberg, Germany, 89081
      • Universitaetsklinikum Ulm /ID# 258616
  • Bavaria
    • Munich, Bavaria, Germany, 81675
      • Klinikum rechts der Isar /ID# 260228
  • Rhineland-Palatinate
    • Ludwigshafen am Rhein, Rhineland-Palatinate, Germany, 67067
      • St. Marien- und St. Annastiftskrankenhaus /ID# 264691
  • Saxony
    • Leipzig, Saxony, Germany, 04103
      • Eugastro /ID# 260229
  • Schleswig-Holstein
    • Kiel, Schleswig-Holstein, Germany, 24105
      • Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 258614
• Greece
  • Athens, Greece, 10676
    • General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 257829
  • Thessaloniki, Greece, 54642
    • General Hospital of Thessaloniki Hippokrateio /ID# 260810
  • Attica
    • Athens, Attica, Greece, 11527
      • General Hospital of Chest Diseases of Athens SOTIRIA /ID# 257831
  • Crete
    • Heraklion, Crete, Greece, 71500
      • University General Hospital of Heraklion PA.G.N.I /ID# 257832
• Hungary
  • Budapest, Hungary, 1033
    • Clinexpert Kft /ID# 258449
  • Budapest, Hungary, 1036
    • Synexus Hungary Clinical Research Centre - Budapest /ID# 258915
  • Budapest, Hungary, 1085
    • Semmelweis Egyetem /ID# 258527
  • Szeged, Hungary, 6720
    • Szegedi Tudományegyetem /ID# 258095
  • Tolna County
    • Szekszárd, Tolna County, Hungary, 7100
      • Clinfan /ID# 258094
• Ireland
  • Dublin, Ireland, D09 XR63
    • Beaumont Hospital /ID# 261561
  • Dublin
    • Elm Park, Dublin, Ireland, D04 T6F4
      • St Vincents University Hospital /ID# 261560
• Israel
  • Petah Tikva, Israel, 4941492
    • Rabin Medical Center /ID# 258531
  • Central District
    • Ẕerifin, Central District, Israel, 70300
      • Yitzhak Shamir Medical Center /ID# 258533
  • Jerusalem
    • Jerusalem, Jerusalem, Israel, 91031
      • Shaare Zedek Medical Center /ID# 258529
  • Southern District
    • Beersheba, Southern District, Israel, 8410101
      • Soroka University Medical Center /ID# 258530
  • Tel Aviv
    • Ramat Gan, Tel Aviv, Israel, 5265601
      • The Chaim Sheba Medical Center /ID# 258532
    • Tel Aviv, Tel Aviv, Israel, 6423906
      • Tel Aviv Sourasky Medical Center /ID# 258528
• Italy
  • Cagliari
    • Monserrato, Cagliari, Italy, 09042
      • Azienda Ospedaliero Universitaria di Cagliari - P.O. Duilio Casula /ID# 258455
  • Roma
    • Rome, Roma, Italy, 00149
      • Azienda Ospedaliera San Camillo Forlanini /ID# 258453
    • Rome, Roma, Italy, 00168
      • Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 258452
  • Verona
    • Negrar, Verona, Italy, 37024
      • IRCCS Ospedale Sacro Cuore Don Calabria /ID# 258456
• Japan
  • Aichi-ken
    • Gamagori-shi, Aichi-ken, Japan, 443-8501
      • Gamagori City Hospital /ID# 260682
    • Nagakute, Aichi-ken, Japan, 480-1195
      • Aichi Medical University Hospital /ID# 258867
  • Chiba
    • Kashiwa-shi, Chiba, Japan, 277-0871
      • Tsujinaka Hospital - Kashiwanoha /ID# 258548
    • Urayasu-shi, Chiba, Japan, 279-0021
      • Juntendo University Urayasu Hospital /ID# 259582
  • Fukuoka
    • Kitakyushu-shi, Fukuoka, Japan, 802-0077
      • Kitakyushu Municipal Medical Center /ID# 259600
  • Fukushima
    • Fukushima, Fukushima, Japan, 960-1295
      • Fukushima Medical University Hospital /ID# 259591
  • Gifu
    • Gifu, Gifu, Japan, 501-1194
      • Gifu University Hospital /ID# 259572
    • Ogaki-shi, Gifu, Japan, 503-8502
      • Ogaki Municipal Hospital /ID# 259905
  • Hiroshima
    • Fukuyama-shi, Hiroshima, Japan, 720-8520
      • National Hospital Organization Fukuyama Medical Center /ID# 258861
  • Hyōgo
    • Kobe, Hyōgo, Japan, 650-0015
      • Aoyama Clinic /ID# 259587
    • Nishinomiya-shi, Hyōgo, Japan, 663-8501
      • Hyogo Medical University Hospital /ID# 258827
  • Kagoshima-ken
    • Kagoshima, Kagoshima-ken, Japan, 892-0846
      • Sameshima Hospital /ID# 259589
    • Kagoshima, Kagoshima-ken, Japan, 8920804
      • Kagoshima IBD Gastroenterology Clinic /ID# 259603
  • Osaka
    • Fujidera-shi, Osaka, Japan, 583-0027
      • Sai Gastroenterology and Proctology Clinic /ID# 260832
    • Osaka, Osaka, Japan, 530-0011
      • Kinshukai Infusion Clinic /ID# 259588
  • Saga-ken
    • Saga, Saga-ken, Japan, 849-8501
      • Saga University Hospital /ID# 259625
  • Saitama
    • Saitama-shi, Saitama, Japan, 336-0963
      • Tokitokai Tokito clinic /ID# 259036
  • Shizuoka
    • Hamamatsu, Shizuoka, Japan, 431-3192
      • Hamamatsu University Hospital /ID# 259580
    • Sunto-gun, Shizuoka, Japan, 411-8611
      • NHO Shizuoka Medical Center /ID# 259033
  • Tokyo
    • Bunkyo-ku, Tokyo, Japan, 113-8519
      • Institute of Science Tokyo Hospital /ID# 259003
    • Hachioji-shi, Tokyo, Japan, 192-0032
      • Tokai University Hachioji Hospital /ID# 258897
    • Mitaka-shi, Tokyo, Japan, 181-8611
      • Kyorin University Hospital /ID# 259843
    • Shinjuku-ku, Tokyo, Japan, 162-8655
      • Center hospital of the National Center for Global Health and Medicine /ID# 259598
  • Toyama
    • Toyama, Toyama, Japan, 930-8550
      • Toyama Prefectural Central Hospital /ID# 259499
• Latvia
  • Daugavpils, Latvia, LV-5401
    • SIA Polana-D /ID# 262932
  • Liepāja, Latvia, LV-3414
    • Liepaja Regional Hospital /ID# 261484
  • Riga, Latvia, LV-1002
    • Pauls Stradins Clinical University Hospital /ID# 261483
• Lithuania
  • Kaunas, Lithuania, 50161
    • Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 261486
  • Panevezys, Lithuania, 35144
    • Panevezys Republican Hospital /ID# 261780
  • Vilnius, Lithuania, 08661
    • Vilnius University Hospital Santaros Klinikos /ID# 261487
• New Zealand
  • Otago
    • Otago, Otago, New Zealand, 9016
      • Dunedin Hospital /ID# 258584
  • Waikato Region
    • Hamilton, Waikato Region, New Zealand, 3240
      • Waikato Hospital /ID# 258607
  • Wellington Region
    • Lower Hutt, Wellington Region, New Zealand, 5010
      • Hutt Hospital /ID# 258608
• Norway
  • Akershus
    • Nordbyhagen, Akershus, Norway, 1474
      • Akershus Universitetssykehus /ID# 261586
  • Troms
    • Tromsø, Troms, Norway, 9019
      • Universitetssykehuset I Nord-Norge /ID# 261649
• Poland
  • Kuyavian-Pomeranian Voivodeship
    • Torun, Kuyavian-Pomeranian Voivodeship, Poland, 87-100
      • Gastromed Sp. z o.o /ID# 258310
  • Lower Silesian Voivodeship
    • Wroclaw, Lower Silesian Voivodeship, Poland, 53-611
      • Centrum Medyczne Melita Medical /ID# 258379
  • Lublin Voivodeship
    • Lublin, Lublin Voivodeship, Poland, 20-582
      • Medrise Sp. z o.o. /ID# 258561
  • Pomeranian Voivodeship
    • Chojnice, Pomeranian Voivodeship, Poland, 89-600
      • Centrum Medyczne Lukamed Sp. z o.o. /ID# 258457
  • Silesian Voivodeship
    • Tychy, Silesian Voivodeship, Poland, 43-100
      • H-T Centrum Medyczne Endoterapia /ID# 258540
  • West Pomeranian Voivodeship
    • Szczecin, West Pomeranian Voivodeship, Poland, 71-434
      • Twoja Przychodnia SCM /ID# 259280
  • Łódź Voivodeship
    • Ksawerów, Łódź Voivodeship, Poland, 95-054
      • Centrum Opieki Zdrowotnej Orkan-Med Stec-Michalska Sp. j. /ID# 258842
• Puerto Rico
  • Bayamón, Puerto Rico, 00960
    • Clinical Research Investigator Group, LLC /ID# 260647
  • San Juan, Puerto Rico, 00918-3501
    • Caribbean Medical Research Center /ID# 268395
  • San Juan, Puerto Rico, 00935
    • School of Medicine University of Puerto Rico-Medical Science Campus /ID# 258508
• Serbia
  • Novi Sad, Serbia, 21000
    • University Clinical Center Vojvodina /ID# 257763
  • Beograd
    • Belgrade, Beograd, Serbia, 11000
      • Clinical Hosp Center Zvezdara /ID# 257766
    • Belgrade, Beograd, Serbia, 11000
      • University Clinical Center Serbia /ID# 257764
    • Belgrade, Beograd, Serbia, 11040
      • Clinical Hospital Center Dr Dragisa Misovic - Dedinje /ID# 257768
    • Belgrade, Beograd, Serbia, 11080
      • Clin Hosp Ctr Bezanijska Kosa /ID# 257765
  • Jablanicki Okrug
    • Leskovac, Jablanicki Okrug, Serbia, 16000
      • General Hospital Leskovac /ID# 257767
• Slovenia
  • Celje, Slovenia, 3000
    • General Hospital Celje /ID# 261482
  • Ljubljana, Slovenia, 1000
    • Univ Medical Ctr Ljubljana /ID# 261474
  • Murska Sobota, Slovenia, 9000
    • Splosna bolnisnica Murska Sobota /ID# 262486
• South Africa
  • Gauteng
    • Johannesburg, Gauteng, South Africa, 1619
      • Clinresco Centers /ID# 258431
    • Pretoria, Gauteng, South Africa, 1692
      • Johese Clinical Research Midstream /ID# 260195
  • Western Cape
    • CAPE TOWN Milnerton, Western Cape, South Africa, 7441
      • Spoke Research Inc /ID# 258432
    • Cape Town, Western Cape, South Africa, 7800
      • Private Practice Dr MN Rajabally /ID# 260671
• South Korea
  • Seoul, South Korea, 03722
    • Yonsei University Health System Severance Hospital /ID# 258422
  • Busan Gwang Yeogsi
    • Busan, Busan Gwang Yeogsi, South Korea, 48108
      • Inje University Haeundae Hospital /ID# 258822
    • Busan, Busan Gwang Yeogsi, South Korea, 49201
      • Dong-A University Medical Center /ID# 258423
  • Daejeon Gwang Yeogsi
    • Daejeon, Daejeon Gwang Yeogsi, South Korea, 34943
      • The Catholic University of Korea, Daejeon St. Mary's Hospital /ID# 258424
  • Seoul Teugbyeolsi
    • Seoul, Seoul Teugbyeolsi, South Korea, 03181
      • Kangbuk Samsung Hospital /ID# 258416
    • Seoul, Seoul Teugbyeolsi, South Korea, 06351
      • Samsung Medical Center /ID# 258420
• Spain
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz /ID# 258172
  • Seville, Spain, 41009
    • Hospital Universitario Virgen Macarena /ID# 258175
  • A Coruna
    • Santiago de Compostela, A Coruna, Spain, 15706
      • Complejo Hospitalario Universitario de Santiago (CHUS) /ID# 259114
  • Navarre
    • Pamplona, Navarre, Spain, 31008
      • Hospital Universitario de Navarra /ID# 258173
• Switzerland
  • Bern, Switzerland, 3010
    • Inselspital, Universitaetsspital Bern /ID# 260106
  • Bern, Switzerland, 3012
    • Intesto /ID# 260114
• Taiwan
  • Hsinchu, Taiwan, 30059
    • National Taiwan University Hospital - Hsinchu branch /ID# 259422
  • Taichung, Taiwan, 40447
    • China Medical University Hospital /ID# 258478
  • Taoyuan, Taiwan, 333
    • Linkou Chang Gung Memorial Hospital /ID# 258724
  • Taipei
    • Taipei City, Taipei, Taiwan, 100
      • National Taiwan University Hospital /ID# 258476
• United Kingdom
  • London, United Kingdom, E1 2ES
    • Barts Health NHS Trust /ID# 258600
  • Cambridgeshire
    • Cambridge, Cambridgeshire, United Kingdom, CB2 2QQ
      • Addenbrookes Hospital /ID# 258744
  • Glasgow City
    • Glasgow, Glasgow City, United Kingdom, G12 0YN
      • Gartnavel General Hospital /ID# 258741
  • Greater London
    • London, Greater London, United Kingdom, SE1 9RT
      • Dup_Guys and St Thomas NHS Foundation Trust - Guy's Hospital /ID# 258730
  • Oxfordshire
    • Oxford, Oxfordshire, United Kingdom, OX3 9DU
      • Oxford University Hospitals NHS Foundation Trust /ID# 258745
• United States
  • California
    • Chula Vista, California, United States, 91910-5619
      • Gastro SB /ID# 258331
    • Coronado, California, United States, 92118-1408
      • Southern California Res. Ctr. /ID# 258391
    • Huntington Beach, California, United States, 92648-5994
      • Newport Huntington Medical Group /ID# 258371
    • Lancaster, California, United States, 93534
      • Om Research LLC /ID# 261383
    • Orange, California, United States, 92868-3201
      • UC Irvine Health /ID# 259824
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Hospital /ID# 258388
  • Florida
    • Coral Gables, Florida, United States, 33134-2442
      • Research Associates of South Florida, LLC /ID# 259813
    • Gainesville, Florida, United States, 32610
      • University of Florida College of Medicine /ID# 260402
    • Lakeland, Florida, United States, 33813-4924
      • Auzmer Research /ID# 260940
    • Margate, Florida, United States, 33063-5737
      • Atlantic Medical Research /ID# 258507
    • Miami, Florida, United States, 33032
      • Homestead Associates in Research /ID# 260392
    • Miami, Florida, United States, 33136
      • University of Miami /ID# 258396
    • Miami, Florida, United States, 33176-2302
      • JD Medical Group, LLC /ID# 261235
    • Naples, Florida, United States, 34102
      • Gastroenterology Group Naples /ID# 258346
    • Orlando, Florida, United States, 32804-5505
      • AdventHealth Medical Group Blood & Marrow Transplant at Orlando /ID# 260945
    • Tampa, Florida, United States, 33609
      • GCP Clinical Research, LLC /ID# 260401
  • Georgia
    • Decatur, Georgia, United States, 30033
      • Atlanta Ctr. for Gastro /ID# 259275
    • Macon, Georgia, United States, 31201
      • Gastroenterology Associates of Central Georgia, LLC /ID# 258359
    • Roswell, Georgia, United States, 30076-4913
      • Gastroenterology Consultants, P.C /ID# 258352
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern Medicine - Northwestern Memorial Hospital /ID# 259592
    • Chicago, Illinois, United States, 60637
      • University of Chicago Medical Center /ID# 258491
  • Indiana
    • Indianapolis, Indiana, United States, 46202-5149
      • IU Health University Hospital /ID# 260398
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • Univ Kansas Med Ctr /ID# 258489
  • Louisiana
    • Shreveport, Louisiana, United States, 71105-6800
      • Louisiana Research Center, LLC /ID# 258330
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital /Id# 259817
  • Michigan
    • Chesterfield, Michigan, United States, 48047
      • Clin Res Inst of Michigan, LLC /ID# 258386
    • Chesterfield, Michigan, United States, 48047
      • Clin Res Inst of Michigan, LLC /ID# 259267
    • Wyoming, Michigan, United States, 49519
      • Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinic /ID# 258493
  • Minnesota
    • Rochester, Minnesota, United States, 55905-0001
      • Mayo Clinic - Rochester /ID# 258402
  • New Mexico
    • Albuquerque, New Mexico, United States, 87131
      • Univ New Mexico /ID# 258490
  • New York
    • Brooklyn, New York, United States, 11235-3919
      • NY Scientific /ID# 260937
    • Lake Success, New York, United States, 11042
      • NYU Langone Long Island Clinical Research Associates /ID# 258504
    • New York, New York, United States, 10021-4872
      • Weill Cornell Medicine/NYP /ID# 258953
    • New York, New York, United States, 10032-3729
      • Columbia University Medical Center /ID# 258496
  • North Carolina
    • Charlotte, North Carolina, United States, 28204-2963
      • Atrium Health /ID# 258506
    • Charlotte, North Carolina, United States, 28211
      • DJL Clinical Research, PLLC /ID# 259465
    • Winston-Salem, North Carolina, United States, 27157
      • Atrium Health Wake Forest Baptist Medical Center /ID# 260387
  • North Dakota
    • Fargo, North Dakota, United States, 58104-5925
      • Plains Clinical Research Center, LLC /ID# 258502
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
      • Digestive Disease Specialists /ID# 258499
  • Texas
    • Garland, Texas, United States, 75044
      • Digestive Health Associates of Texas (DHAT) Research Institute - Garland /ID# 258358
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine /ID# 258394
    • Houston, Texas, United States, 77084
      • BioStar Clinical Research Group - Houston - Katy Freeway /ID# 261164
    • San Antonio, Texas, United States, 78212
      • Clinical Associates in Research Therapeutics of America, LLC /ID# 258403
    • San Antonio, Texas, United States, 78229-5390
      • Southern Star Research Institute, LLC /ID# 258347
    • Tyler, Texas, United States, 75701
      • Tyler Research Institute, LLC /ID# 258383
    • Webster, Texas, United States, 77598
      • Texas Digestive Disease Consultants - Webster /ID# 258718
  • West Virginia
    • Huntington, West Virginia, United States, 25701
      • University Physicians and Surgeons Inc. /ID# 260399
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53215
      • Wisconsin Center for Advanced Research /ID# 258949

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Participant has had a diagnosis of Ulcerative Colitis (UC) for at least 90 days prior to Baseline. Appropriate documentation of biopsy results consistent with the diagnosis of UC in the assessment of the investigator, must be available.
• 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:

• Current diagnosis of Crohn's Disease (CD) or inflammatory bowel disease-unclassified.
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Induction Group 1; Participants will receive Dose 1 of IV lutikizumab at Baseline followed by SC lutikizumab throughout induction.	Drug: Lutikizumab; Subcutaneous (SC) Injection; Other Names: ABT-981; Drug: Lutikizumab; Intravenous (IV) Infusion; Other Names: ABT-981
Experimental: Induction Group 2; Participants will receive Dose 2 of IV lutikizumab at Baseline followed by SC lutikizumab throughout induction.	Drug: Lutikizumab; Subcutaneous (SC) Injection; Other Names: ABT-981; Drug: Lutikizumab; Intravenous (IV) Infusion; Other Names: ABT-981
Experimental: Induction Group 3; Participants will receive adalimumab per label throughout induction.	Drug: Adalimumab; SC Injection; Other Names: Humira
Experimental: 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.	Drug: Lutikizumab; Subcutaneous (SC) Injection; Other Names: ABT-981; Drug: Lutikizumab; Intravenous (IV) Infusion; Other Names: ABT-981
Experimental: 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.	Drug: Lutikizumab; Subcutaneous (SC) Injection; Other Names: ABT-981; Drug: Lutikizumab; Intravenous (IV) Infusion; Other Names: ABT-981
Experimental: Maintenance Adalimumab; Participants who respond to adalimumab induction group 3 will continue to receive adalimumab per label in the maintenance period.	Drug: Adalimumab; SC Injection; Other Names: Humira
Experimental: 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.	Drug: Lutikizumab; Subcutaneous (SC) Injection; Other Names: ABT-981; Drug: Lutikizumab; Intravenous (IV) Infusion; Other Names: ABT-981
Experimental: 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.	Drug: Adalimumab; SC Injection; Other Names: Humira; Drug: Lutikizumab; Subcutaneous (SC) Injection; Other Names: ABT-981; Drug: Lutikizumab; Intravenous (IV) Infusion; Other Names: ABT-981

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants who Achieve Endoscopic Improvement	Endoscopic Improvement is defined as Mayo Endoscopic Subscore (ESS) of 0 or 1. Endoscopies were assessed by a blinded central reader and scored according to the following scale: 0 = Normal appearance of mucosa; 1 = Mild disease (erythema, decreased vascular pattern); 2 = Moderate disease (marked erythema, lack of vascular pattern, any friability, erosions); 3 = Severe disease (spontaneous bleeding, ulceration).	Week 12
Number of Participants with Adverse Events (AEs)	An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.	Up to approximately Week 104

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants who Achieve Clinical Remission Per Modified Mayo Score (mMS)	Clinical remission on the mMS is defined as Endoscopy subscore = 0 or 1, AND Rectal bleeding subscore = 0, AND Stool frequency subscore <= 1, AND not greater than baseline. The mMS is a composite score of UC disease activity based on the following 3 subscores: SFS, scored from 0 (normal number of stools) to 3 (5 or more stools more than normal); RBS, scored from 0 (no blood seen) to 3 (blood alone passed); ESS, scored from 0 (normal appearance of mucosa) to 3 (severe disease [spontaneous bleeding, ulceration]). The overall mMS ranges from 0 to 9 with higher scores representing more severe disease. The number of responders is calculated based on the total number of participants and estimated response rate, rounding to a nearest whole integer.	Week 12
Percentage of Participants who Achieve Clinical Response Per mMS	Clinical response per mMS is defined as decrease from baseline >=2 points and >=30%, PLUS a decrease in RBS >= 1 or an absolute RBS <=1. The mMS is a composite score of UC disease activity based on the following 3 subscores: SFS, scored from 0 (normal number of stools) to 3 (5 or more stools more than normal); RBS, scored from 0 (no blood seen) to 3 (blood alone passed); ESS, scored from 0 (normal appearance of mucosa) to 3 (severe disease [spontaneous bleeding, ulceration]). The overall mMS ranges from 0 to 9 with higher scores representing more severe disease. The number of responders is calculated based on the total number of participants and estimated response rate, rounding to a nearest whole integer.	Week 12
Percentage of Participants who Achieve Endoscopic Remission	Endoscopic remission is defined as Mayo Endoscopic Subscore (ESS) of 0. Endoscopies were assessed by a blinded central reader and scored according to the following scale: 0 = Normal appearance of mucosa; 1 = Mild disease (erythema, decreased vascular pattern); 2 = Moderate disease (marked erythema, lack of vascular pattern, any friability, erosions); 3 = Severe disease (spontaneous bleeding, ulceration).	Week 12

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: ABBVIE INC., AbbVie

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): March 23, 2024
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: October 2, 2023
• First Submitted That Met QC Criteria: February 6, 2024
• First Posted (Actual): February 14, 2024

Study Record Updates

• Last Update Posted (Estimated): October 7, 2025
• Last Update Submitted That Met QC Criteria: October 2, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Ulcerative Colitis; Adalimumab; Lutikizumab
• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Colitis; Colitis, Ulcerative; Amino Acids, Peptides, and Proteins; Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Adalimumab; lutikizumab
• Other Study ID Numbers: M23-703; 2023-505678-14-00 (Other Identifier: EU CT)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
• IPD Sharing Access Criteria: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No