AzTrials
AzTrials

Ulcerative ColitisPhase 2NCT06257875

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

A Phase 2 study testing Lutikizumab and Adalimumab in people with Ulcerative Colitis, run by AbbVie at 191 sites in 30 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Ulcerative Colitis
What is being tested?
Lutikizumab and Adalimumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
156 participants
Where
191 sitesin 30 countries
Study dates
23 Mar 2024to Sep 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

191 sites in 30 countries.

191 sites in 30 countries

United States48 sites

  • Univ New Mexico /ID# 258490

    Albuquerque, New Mexico, 87131

  • University of Colorado Hospital /ID# 258388

    Aurora, Colorado, 80045

  • Massachusetts General Hospital /Id# 259817

    Boston, Massachusetts, 02114

  • NY Scientific /ID# 260937

    Brooklyn, New York, 11235-3919

  • Atrium Health /ID# 258506

    Charlotte, North Carolina, 28204-2963

  • DJL Clinical Research, PLLC /ID# 259465

    Charlotte, North Carolina, 28211

  • Clin Res Inst of Michigan, LLC /ID# 258386

    Chesterfield, Michigan, 48047

  • Clin Res Inst of Michigan, LLC /ID# 259267

    Chesterfield, Michigan, 48047

  • Northwestern Medicine - Northwestern Memorial Hospital /ID# 259592

    Chicago, Illinois, 60611

  • University of Chicago Medical Center /ID# 258491

    Chicago, Illinois, 60637

  • Gastro SB /ID# 258331

    Chula Vista, California, 91910-5619

  • Research Associates of South Florida, LLC /ID# 259813

    Coral Gables, Florida, 33134-2442

  • Southern California Res. Ctr. /ID# 258391

    Coronado, California, 92118-1408

  • Atlanta Ctr. for Gastro /ID# 259275

    Decatur, Georgia, 30033

  • Plains Clinical Research Center, LLC /ID# 258502

    Fargo, North Dakota, 58104-5925

  • University of Florida College of Medicine /ID# 260402

    Gainesville, Florida, 32610

  • Digestive Health Associates of Texas (DHAT) Research Institute - Garland /ID# 258358

    Garland, Texas, 75044

  • Baylor College of Medicine /ID# 258394

    Houston, Texas, 77030

  • BioStar Clinical Research Group - Houston - Katy Freeway /ID# 261164

    Houston, Texas, 77084

  • University Physicians and Surgeons Inc. /ID# 260399

    Huntington, West Virginia, 25701

  • Newport Huntington Medical Group /ID# 258371

    Huntington Beach, California, 92648-5994

  • IU Health University Hospital /ID# 260398

    Indianapolis, Indiana, 46202-5149

  • Univ Kansas Med Ctr /ID# 258489

    Kansas City, Kansas, 66160

  • NYU Langone Long Island Clinical Research Associates /ID# 258504

    Lake Success, New York, 11042

  • Auzmer Research /ID# 260940

    Lakeland, Florida, 33813-4924

  • Om Research LLC /ID# 261383

    Lancaster, California, 93534

  • Gastroenterology Associates of Central Georgia, LLC /ID# 258359

    Macon, Georgia, 31201

  • Atlantic Medical Research /ID# 258507

    Margate, Florida, 33063-5737

  • Homestead Associates in Research /ID# 260392

    Miami, Florida, 33032

  • University of Miami /ID# 258396

    Miami, Florida, 33136

  • JD Medical Group, LLC /ID# 261235

    Miami, Florida, 33176-2302

  • Wisconsin Center for Advanced Research /ID# 258949

    Milwaukee, Wisconsin, 53215

  • Gastroenterology Group Naples /ID# 258346

    Naples, Florida, 34102

  • Weill Cornell Medicine/NYP /ID# 258953

    New York, New York, 10021-4872

  • Columbia University Medical Center /ID# 258496

    New York, New York, 10032-3729

  • Digestive Disease Specialists /ID# 258499

    Oklahoma City, Oklahoma, 73112

  • UC Irvine Health /ID# 259824

    Orange, California, 92868-3201

  • AdventHealth Medical Group Blood & Marrow Transplant at Orlando /ID# 260945

    Orlando, Florida, 32804-5505

  • Mayo Clinic - Rochester /ID# 258402

    Rochester, Minnesota, 55905-0001

  • Gastroenterology Consultants, P.C /ID# 258352

    Roswell, Georgia, 30076-4913

  • Clinical Associates in Research Therapeutics of America, LLC /ID# 258403

    San Antonio, Texas, 78212

  • Southern Star Research Institute, LLC /ID# 258347

    San Antonio, Texas, 78229-5390

  • Louisiana Research Center, LLC /ID# 258330

    Shreveport, Louisiana, 71105-6800

  • GCP Clinical Research, LLC /ID# 260401

    Tampa, Florida, 33609

  • Tyler Research Institute, LLC /ID# 258383

    Tyler, Texas, 75701

  • Texas Digestive Disease Consultants - Webster /ID# 258718

    Webster, Texas, 77598

  • Atrium Health Wake Forest Baptist Medical Center /ID# 260387

    Winston-Salem, North Carolina, 27157

  • Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinic /ID# 258493

    Wyoming, Michigan, 49519

Other trials in United States

Japan24 sites

  • Institute of Science Tokyo Hospital /ID# 259003

    Bunkyo-ku, Tokyo, 113-8519

  • Sai Gastroenterology and Proctology Clinic /ID# 260832

    Fujidera-shi, Osaka, 583-0027

  • Fukushima Medical University Hospital /ID# 259591

    Fukushima, Fukushima, 960-1295

  • National Hospital Organization Fukuyama Medical Center /ID# 258861

    Fukuyama-shi, Hiroshima, 720-8520

  • Gamagori City Hospital /ID# 260682

    Gamagori-shi, Aichi-ken, 443-8501

  • Gifu University Hospital /ID# 259572

    Gifu, Gifu, 501-1194

  • Tokai University Hachioji Hospital /ID# 258897

    Hachioji-shi, Tokyo, 192-0032

  • Hamamatsu University Hospital /ID# 259580

    Hamamatsu, Shizuoka, 431-3192

  • Sameshima Hospital /ID# 259589

    Kagoshima, Kagoshima-ken, 892-0846

  • Kagoshima IBD Gastroenterology Clinic /ID# 259603

    Kagoshima, Kagoshima-ken, 8920804

  • Tsujinaka Hospital - Kashiwanoha /ID# 258548

    Kashiwa-shi, Chiba, 277-0871

  • Kitakyushu Municipal Medical Center /ID# 259600

    Kitakyushu-shi, Fukuoka, 802-0077

  • Aoyama Clinic /ID# 259587

    Kobe, Hyōgo, 650-0015

  • Kyorin University Hospital /ID# 259843

    Mitaka-shi, Tokyo, 181-8611

  • Aichi Medical University Hospital /ID# 258867

    Nagakute, Aichi-ken, 480-1195

  • Hyogo Medical University Hospital /ID# 258827

    Nishinomiya-shi, Hyōgo, 663-8501

  • Ogaki Municipal Hospital /ID# 259905

    Ogaki-shi, Gifu, 503-8502

  • Kinshukai Infusion Clinic /ID# 259588

    Osaka, Osaka, 530-0011

  • Saga University Hospital /ID# 259625

    Saga, Saga-ken, 849-8501

  • Tokitokai Tokito clinic /ID# 259036

    Saitama-shi, Saitama, 336-0963

  • Center hospital of the National Center for Global Health and Medicine /ID# 259598

    Shinjuku-ku, Tokyo, 162-8655

  • NHO Shizuoka Medical Center /ID# 259033

    Sunto-gun, Shizuoka, 411-8611

  • Toyama Prefectural Central Hospital /ID# 259499

    Toyama, Toyama, 930-8550

  • Juntendo University Urayasu Hospital /ID# 259582

    Urayasu-shi, Chiba, 279-0021

Other trials in Japan

Bulgaria7 sites

  • Umbal Kaspela /ID# 258336

    Plovdiv, 4001

  • 2nd Mhat /ID# 258337

    Sofia, 1202

  • UMHAT Sveti Ivan Rilski /ID# 261417

    Sofia, 1431

  • Hospital Tsaritsa Yoanna /ID# 258338

    Sofiya, Sofia, 1527

  • Medical Center - Doverie /ID# 261936

    Sofiya, Sofia, 1632

  • ACIBADEM City Clinic Diagnostic-Consultative Center /ID# 258339

    Sofiya, Sofia, 1784

  • UMHAT Multiprofile Hospital for Active Treatment Sveta Marina /ID# 258878

    Varna, 9009

Other trials in Bulgaria

Poland7 sites

  • Centrum Medyczne Lukamed Sp. z o.o. /ID# 258457

    Chojnice, Pomeranian Voivodeship, 89-600

  • Centrum Opieki Zdrowotnej Orkan-Med Stec-Michalska Sp. j. /ID# 258842

    Ksawerów, Łódź Voivodeship, 95-054

  • Medrise Sp. z o.o. /ID# 258561

    Lublin, Lublin Voivodeship, 20-582

  • Twoja Przychodnia SCM /ID# 259280

    Szczecin, West Pomeranian Voivodeship, 71-434

  • Gastromed Sp. z o.o /ID# 258310

    Torun, Kuyavian-Pomeranian Voivodeship, 87-100

  • H-T Centrum Medyczne Endoterapia /ID# 258540

    Tychy, Silesian Voivodeship, 43-100

  • Centrum Medyczne Melita Medical /ID# 258379

    Wroclaw, Lower Silesian Voivodeship, 53-611

Other trials in Poland

Belgium6 sites

  • Universite Libre de Bruxelles - Hopital Erasme /ID# 258214

    Anderlecht, Brussels Capital, 1070

  • UZ Gent /ID# 258210

    Ghent, Oost-Vlaanderen, 9000

  • AZ Maria Middelares /ID# 258219

    Ghent, 9000

  • Universitair Ziekenhuis Leuven /ID# 258226

    Leuven, Vlaams-Brabant, 3000

  • CHU de Liege /ID# 258212

    Liège, 4000

  • Vitaz /Id# 258222

    Sint-Niklaas, Oost-Vlaanderen, 9100

Other trials in Belgium

Germany6 sites

  • Universitaetsklinikum Hamburg-Eppendorf /ID# 258617

    Hamburg, 20246

  • Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 258614

    Kiel, Schleswig-Holstein, 24105

  • Eugastro /ID# 260229

    Leipzig, Saxony, 04103

  • St. Marien- und St. Annastiftskrankenhaus /ID# 264691

    Ludwigshafen am Rhein, Rhineland-Palatinate, 67067

  • Klinikum rechts der Isar /ID# 260228

    Munich, Bavaria, 81675

  • Universitaetsklinikum Ulm /ID# 258616

    Ulm, Baden-Wurttemberg, 89081

Other trials in Germany

Israel6 sites

  • Soroka University Medical Center /ID# 258530

    Beersheba, Southern District, 8410101

  • Shaare Zedek Medical Center /ID# 258529

    Jerusalem, Jerusalem, 91031

  • Rabin Medical Center /ID# 258531

    Petah Tikva, 4941492

  • The Chaim Sheba Medical Center /ID# 258532

    Ramat Gan, Tel Aviv, 5265601

  • Tel Aviv Sourasky Medical Center /ID# 258528

    Tel Aviv, Tel Aviv, 6423906

  • Yitzhak Shamir Medical Center /ID# 258533

    Tsrifin, Central District, 70300

Other trials in Israel

Serbia6 sites

  • Clinical Hosp Center Zvezdara /ID# 257766

    Belgrade, Beograd, 11000

  • University Clinical Center Serbia /ID# 257764

    Belgrade, Beograd, 11000

  • Clinical Hospital Center Dr Dragisa Misovic - Dedinje /ID# 257768

    Belgrade, Beograd, 11040

  • Clin Hosp Ctr Bezanijska Kosa /ID# 257765

    Belgrade, Beograd, 11080

  • General Hospital Leskovac /ID# 257767

    Leskovac, Jablanicki Okrug, 16000

  • University Clinical Center Vojvodina /ID# 257763

    Novi Sad, 21000

Other trials in Serbia

South Korea6 sites

  • Inje University Haeundae Hospital /ID# 258822

    Busan, Busan Gwang Yeogsi, 48108

  • Dong-A University Medical Center /ID# 258423

    Busan, Busan Gwang Yeogsi, 49201

  • The Catholic University of Korea, Daejeon St. Mary's Hospital /ID# 258424

    Daejeon, Daejeon Gwang Yeogsi, 34943

  • Kangbuk Samsung Hospital /ID# 258416

    Seoul, Seoul Teugbyeolsi, 03181

  • Samsung Medical Center /ID# 258420

    Seoul, Seoul Teugbyeolsi, 06351

  • Yonsei University Health System Severance Hospital /ID# 258422

    Seoul, 03722

Other trials in South Korea

Australia5 sites

  • Bankstown-Lidcombe Hospital /ID# 259089

    Bankstown, New South Wales, 2200

  • Lyell McEwin Hospital /ID# 260580

    Elizabeth Vale, South Australia, 5112

  • St Vincent's Hospital Melbourne /ID# 259473

    Fitzroy Melbourne, Victoria, 3065

  • Fiona Stanley Hospital /ID# 259480

    Murdoch, Western Australia, 6150

  • The Queen Elizabeth Hospital /ID# 259482

    Woodville South, South Australia, 5011

Other trials in Australia

Croatia5 sites

  • POLIKLINIKA BORZAN d.o.o. /ID# 258146

    Osijek, County of Osijek-Baranja, 31000

  • Specialty Hospital Medico /ID# 258169

    Rijeka, Primorje-Gorski Kotar County, 51000

  • Klinicki Bolnicki Centar (KBC) Split /ID# 258153

    Split, Split-Dalmatia County, 21000

  • Klinicki bolnicki centar Zagreb /ID# 258145

    Zagreb, City of Zagreb, 10000

  • Poliklinika Solmed /ID# 258147

    Zagreb, City of Zagreb, 10000

Other trials in Croatia

France5 sites

  • Hopitaux Universitaires Henri Mondor - Hopital Henri Mondor /ID# 258555

    Créteil, Paris, 94010

  • Centre Hospitalier Universitaire de Nantes, Hotel Dieu -HME /ID# 258042

    Nantes, Pays de la Loire Region, 44000

  • Chu de Nice-Hopital L'Archet Ii /Id# 258041

    Nice, Alpes-Maritimes, 06202

  • Centre Hospitalier Universitaire de Saint Etienne - Hopital Nord /ID# 258040

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

  • CHU Toulouse - Hopital Rangueil /ID# 258044

    Toulouse, Haute-Garonne, 31400

Other trials in France

Hungary5 sites

  • Clinexpert Kft /ID# 258449

    Budapest, 1033

  • Synexus Hungary Clinical Research Centre - Budapest /ID# 258915

    Budapest, 1036

  • Semmelweis Egyetem /ID# 258527

    Budapest, 1085

  • Szegedi Tudományegyetem /ID# 258095

    Szeged, 6720

  • Clinfan /ID# 258094

    Szekszárd, Tolna County, 7100

Other trials in Hungary

United Kingdom5 sites

  • Addenbrookes Hospital /ID# 258744

    Cambridge, Cambridgeshire, CB2 2QQ

  • Gartnavel General Hospital /ID# 258741

    Glasgow, Glasgow City, G12 0YN

  • Dup_Guys and St Thomas NHS Foundation Trust - Guy's Hospital /ID# 258730

    London, Greater London, SE1 9RT

  • Barts Health NHS Trust /ID# 258600

    London, E1 2ES

  • Oxford University Hospitals NHS Foundation Trust /ID# 258745

    Oxford, Oxfordshire, OX3 9DU

Other trials in United Kingdom

Estonia4 sites

  • Parnu Hospital /ID# 261783

    Pärnu, 80010

  • West Tallinn Central Hospital /ID# 262035

    Tallinn, Harju, 10617

  • Medicum /ID# 268320

    Tallinn, Harju, 13619

  • Tartu University Hospital /ID# 261782

    Tartu, 50406

Other trials in Estonia

Greece4 sites

  • General Hospital of Chest Diseases of Athens SOTIRIA /ID# 257831

    Athens, Attica, 11527

  • General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 257829

    Athens, 10676

  • University General Hospital of Heraklion PA.G.N.I /ID# 257832

    Heraklion, Crete, 71500

  • General Hospital of Thessaloniki Hippokrateio /ID# 260810

    Thessaloniki, 54642

Other trials in Greece

Italy4 sites

  • Azienda Ospedaliero Universitaria di Cagliari - P.O. Duilio Casula /ID# 258455

    Monserrato, Cagliari, 09042

  • IRCCS Ospedale Sacro Cuore Don Calabria /ID# 258456

    Negrar, Verona, 37024

  • Azienda Ospedaliera San Camillo Forlanini /ID# 258453

    Rome, Roma, 00149

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 258452

    Rome, Roma, 00168

Other trials in Italy

South Africa4 sites

  • Private Practice Dr MN Rajabally /ID# 260671

    Cape Town, Western Cape, 7800

  • Spoke Research Inc /ID# 258432

    CAPE TOWN Milnerton, Western Cape, 7441

  • Clinresco Centers /ID# 258431

    Johannesburg, Gauteng, 1619

  • Johese Clinical Research Midstream /ID# 260195

    Pretoria, Gauteng, 1692

Other trials in South Africa

Spain4 sites

  • Hospital Universitario La Paz /ID# 258172

    Madrid, 28046

  • Hospital Universitario de Navarra /ID# 258173

    Pamplona, Navarre, 31008

  • Complejo Hospitalario Universitario de Santiago (CHUS) /ID# 259114

    Santiago de Compostela, A Coruna, 15706

  • Hospital Universitario Virgen Macarena /ID# 258175

    Seville, 41009

Other trials in Spain

Taiwan4 sites

  • National Taiwan University Hospital - Hsinchu branch /ID# 259422

    Hsinchu, 30059

  • China Medical University Hospital /ID# 258478

    Taichung, 40447

  • National Taiwan University Hospital /ID# 258476

    Taipei City, Taipei, 100

  • Linkou Chang Gung Memorial Hospital /ID# 258724

    Taoyuan City, 333

Other trials in Taiwan

Canada3 sites

  • Gastroenterology and Internal Medicine Research Institution /ID# 258765

    Edmonton, Alberta, T5R 1W2

  • Covenant Health /ID# 258799

    Edmonton, Alberta, T6K 4B2

  • Toronto Digestive Disease Associates /ID# 260460

    Vaughan, Ontario, L4L 4Y7

Other trials in Canada

Latvia3 sites

  • SIA Polana-D /ID# 262932

    Daugavpils, LV-5401

  • Liepaja Regional Hospital /ID# 261484

    Liepāja, LV-3414

  • Pauls Stradins Clinical University Hospital /ID# 261483

    Riga, LV-1002

Other trials in Latvia

Lithuania3 sites

  • Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 261486

    Kaunas, 50161

  • Panevezys Republican Hospital /ID# 261780

    Panevezys, 35144

  • Vilnius University Hospital Santaros Klinikos /ID# 261487

    Vilnius, 08661

Other trials in Lithuania

New Zealand3 sites

  • Waikato Hospital /ID# 258607

    Hamilton, Waikato Region, 3240

  • Hutt Hospital /ID# 258608

    Lower Hutt, Wellington Region, 5010

  • Dunedin Hospital /ID# 258584

    Otago, Otago, 9016

Other trials in New Zealand

Puerto Rico3 sites

  • Clinical Research Investigator Group, LLC /ID# 260647

    Bayamón, 00960

  • Caribbean Medical Research Center /ID# 268395

    San Juan, 00918-3501

  • School of Medicine University of Puerto Rico-Medical Science Campus /ID# 258508

    San Juan, 00935

Other trials in Puerto Rico

Slovenia3 sites

  • General Hospital Celje /ID# 261482

    Celje, 3000

  • Univ Medical Ctr Ljubljana /ID# 261474

    Ljubljana, 1000

  • Splosna bolnisnica Murska Sobota /ID# 262486

    Murska Sobota, 9000

Other trials in Slovenia

Austria2 sites

  • Universitaetsklinikum St. Poelten /ID# 258256

    Sankt Pölten, Lower Austria, 3100

  • Medizinische Universitaet Wien /ID# 258026

    Vienna, State of Vienna, 1090

Other trials in Austria

Ireland2 sites

  • Beaumont Hospital /ID# 261561

    Dublin, D09 XR63

  • St Vincents University Hospital /ID# 261560

    Elm Park, Dublin, D04 T6F4

Other trials in Ireland

Norway2 sites

  • Akershus Universitetssykehus /ID# 261586

    Nordbyhagen, Akershus, 1474

  • Universitetssykehuset I Nord-Norge /ID# 261649

    Tromsø, Troms, 9019

Other trials in Norway

Switzerland2 sites

  • Inselspital, Universitaetsspital Bern /ID# 260106

    Bern, 3010

  • Intesto /ID# 260114

    Bern, 3012

Other trials in Switzerland

About this study

Official title: 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.

Read more

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.

Being tested
Lutikizumab, Adalimumab
Keywords
Ulcerative Colitis, Lutikizumab, Adalimumab
Medical subject headings
Colitis, Ulcerative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LutikizumabDrug

    Also called ABT-981

    Subcutaneous (SC) Injection

  • LutikizumabDrug

    Also called ABT-981

    Intravenous (IV) Infusion

  • AdalimumabDrug

    Also called Humira

    SC Injection

Study groups in NCT06257875
Study groupRoleWhat they receive
Induction Group 1ExperimentalParticipants will receive Dose 1 of IV lutikizumab at Baseline followed by SC lutikizumab throughout induction.
Receives: Drug: Lutikizumab
Induction Group 2ExperimentalParticipants will receive Dose 2 of IV lutikizumab at Baseline followed by SC lutikizumab throughout induction.
Receives: Drug: Lutikizumab
Induction Group 3ExperimentalParticipants will receive adalimumab per label throughout induction.
Receives: Drug: Adalimumab
Maintenance Group 1ExperimentalParticipants 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.
Receives: Drug: Lutikizumab
Maintenance Group 2ExperimentalParticipants 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.
Receives: Drug: Lutikizumab
Maintenance AdalimumabExperimentalParticipants who respond to adalimumab induction group 3 will continue to receive adalimumab per label in the maintenance period.
Receives: Drug: Adalimumab
Maintenance Non-RespondersExperimentalParticipants who do not respond to study drug at the end of induction period will receive SC lutikizumab in the maintenance period.
Receives: Drug: Lutikizumab
Optional Long-Term Extension (LTE)ExperimentalParticipants 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.
Receives: Drug: Lutikizumab; Drug: Adalimumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: Week 12

  2. 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.

    Measured: Up to approximately Week 104

Secondary outcomes (3)

  1. 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.

    Measured: Week 12

  2. 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.

    Measured: Week 12

  3. 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).

    Measured: Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Feb 2024
  2. Study start23 Mar 2024
  3. Primary completionSep 2027 (estimated)
  4. Study completionSep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
156 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06257875
Sponsor's protocol ID
M23-703
Other IDs
2023-505678-14-00, 2023
Status last verified
Oct 2025
First submitted
2 Oct 2023
Last updated
7 Oct 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Lutikizumab and Adalimumab in people with Ulcerative Colitis, run by AbbVie at 191 sites in 30 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 7 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 191 sites in United States, Japan, Bulgaria, Poland, Belgium and 25 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants who Achieve Endoscopic Improvement (time frame: Week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06257875.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2025.

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