Study on the Safety and Effectiveness of Lutikizumab and Adalimumab for Adults with Moderate to Severe Ulcerative Colitis

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What is this study about?

This clinical trial is focused on studying the effects of a medication called lutikizumab in adults with ulcerative colitis, a condition that causes inflammation and sores in the colon and rectum. The study will compare the safety and effectiveness of lutikizumab to another medication known as adalimumab, which is already used to treat this condition. Participants in the study will receive either lutikizumab, adalimumab, or a placebo, which is a substance with no active medication.

The purpose of the study is to evaluate how well lutikizumab works in reducing the symptoms of ulcerative colitis and to monitor any side effects. The study will involve both intravenous (IV) and subcutaneous (SC) forms of lutikizumab, meaning the medication will be administered either through a vein or under the skin. Participants will be monitored over a period of time to assess changes in their disease activity and any adverse events they may experience.

Throughout the study, participants will undergo regular assessments to track their progress. The study aims to determine the percentage of participants who show improvement in their condition by week 12. This includes looking at endoscopic improvement, which involves examining the inside of the colon, as well as clinical remission and response, which refer to the reduction or disappearance of symptoms. The study is expected to last for up to 52 weeks, providing valuable information on the long-term effects of lutikizumab in treating ulcerative colitis.

1 joining the study

Upon joining the study, the participant is confirmed to have a diagnosis of ulcerative colitis for at least 90 days. This includes documentation of biopsy results consistent with the diagnosis.

The participant must have active ulcerative colitis with a Modified Mayo Score (mMS) of 5 to 9 points and a Mayo Endoscopic Subscore (ESS) of 2 to 3.

2 initial treatment phase

The participant receives adalimumab or lutikizumab as part of the treatment. Adalimumab is administered as a 40 mg solution for injection under the skin (subcutaneous) using a pre-filled syringe.

Lutikizumab is administered either as a subcutaneous injection or as an intravenous infusion, depending on the specific treatment plan.

3 treatment administration

The participant receives the medication according to the study’s schedule. The frequency and dosage are determined by the study protocol and may vary between participants.

The treatment aims to evaluate the safety and effectiveness of lutikizumab compared to adalimumab in managing ulcerative colitis.

4 monitoring and assessment

Throughout the study, the participant’s health and response to the treatment are closely monitored. This includes regular assessments of disease activity and any side effects experienced.

The primary goal is to determine the percentage of participants who achieve endoscopic improvement at week 12.

5 evaluation of results

At week 12, the participant’s progress is evaluated to determine if there has been clinical remission or response according to the Modified Mayo Score.

The study also assesses the percentage of participants who achieve endoscopic remission at this time.

Who Can Join the Study?

  • The participant must have been diagnosed with Ulcerative Colitis (UC) for at least 90 days before starting the study. There should be proper documentation, like biopsy results, that confirms this diagnosis.
  • The participant must have active UC, which means their condition is currently causing symptoms. This is measured using a Modified Mayo Score (mMS) of 5 to 9 points and a Mayo Endoscopic Subscore (ESS) of 2 to 3. These scores are confirmed by a central review.
  • The participant must have shown an inadequate response, lost response, or been intolerant to at least one of the following treatments: oral aminosalicylates, corticosteroids, immunomodulators, and/or advanced therapies. This means the treatments did not work well enough, stopped working, or caused side effects that could not be tolerated.
  • Both male and female participants are eligible to join the study.
  • The study does not include vulnerable populations, which means it is not designed for groups that might need special protection or care.

Who Cannot Join the Study?

  • Patients who have other serious health conditions that could interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who have had a recent surgery or are planning to have surgery during the study period.
  • Patients who are currently participating in another clinical trial.
  • Patients who have a history of severe allergic reactions to medications.
  • Patients who have an active infection that requires treatment.
  • Patients who have a history of drug or alcohol abuse.
  • Patients who have been diagnosed with cancer in the past five years.
  • Patients who have a history of heart disease or other serious heart conditions.
  • Patients who have a history of liver or kidney disease.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Centre Hospitalier Universitaire De Nantes Nantes France
Centre Hospitalier Universitaire De Nice Nice France
Hopital Beaujon Clichy France
Az Maria Middelares Gent Gent Belgium
Clinexpert Kft. Budapest Hungary
Uniteversity Muliprofile Hospital For Active Treatment Tsaritsa Yoanna-Isul EAD Sofia Bulgaria
H-T. Centrum Medyczne Sp. z o.o. Tychy Poland
University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD Sofia Bulgaria
University Medical Center Ljubljana Ljubljana Slovenia
Medrise Sp. z o.o. Lublin Poland
University Hospital St Marina Varna Varna Bulgaria
Unvykqluxkosyzqmqnuhn Ndnbvofirv He Tromsø Norway
Nrw Lee Gfvepztbst Rfcfcd Mxyus Gtrn St. Poelten Austria
Lozqc Gpwhxjt Hwocxygi Oe Alipif Athens Greece
Ejouuysngnjytfqbndoxaahwad Hjxjoyzy oh Acodxx Athens Greece
Bnkdaitr Hmayxrjl Dublin Ireland
Ahhjzcnq Uixxspmxbj Hldkutmp Lorenskog Norway
Vmwifqxk ucwzduoofjbh lrqjmshy Smiasvpf kjrtnful Vzz Vilnius Lithuania
Ukleqrlkcnne Dt Stndnlqm Dc Crhzmgwlgt Santiago De Compostela Spain
Sipdxbhybg Bzyezrb Mpejiy Rijeka Croatia
Psukblwdpow Scfxnp dksqqu Zagreb Croatia
Ksg Sklwd Split Croatia
Koxwrqcf ddu Ttpflngdsqu Ulhdyxcxfnyu Myfzzmpu (iiu Krwqwnvrx Munich Germany
Ugzlimkbys Msgltfg Cpxnbh Hsdlbcitljavnpgqx Hamburg Germany
Crupbk hxsimzjjmtu uprnreireikfr dh Lkwct Liege Belgium
Ibeaogpy fyvb Kvybaicrj Tcxqloffjhyinowltfo uhd Igupyvtijoph Upo gufsf Ulm Germany
Uagwhvzyvnap Zqwriweulz Gjxa Gent Belgium
Umxtdjyyrumueoomodybn Szpoiapnsjulzsosqp Axr Kiel Germany
Fctnxufeb Pfpz Ld Igbbjwusihfbc Bkdwdgdsp Dxg Hgpqtwfb Ubshzmvrslksn Lk Pax Madrid Spain
Vkgjd Sint-Niklaas Belgium
Uplxerassm Gkyjjen Hxkcpwre Oi Hoyfhivsh Heraklion Greece
Iujmahlxgh Gniymgf Hegntbpy Om Tpaxhymdvnmf Thessaloniki Greece
Uuaymyrtofl Stnoogyk Salzburg Austria
See Mtfdhk Unc Sbr Aqpamwppzyoestusqipib Ludwigshafen Am Rhein Germany
Pqujx Svsqbief Cdomwyht Uzvziirhim Hlgpafvh Riga Latvia
Stbdoaq Blcfbtnvji Mhrijf Slhirt Murska Sobota Slovenia
Kdk Zcofbo Zagreb Croatia
Srjzpiugzt Pyiyw Hmqebj Paernu Estonia
Calnpfc Moagubys Lpiaefs Jgqhkq Łtiv Chojnice Poland
Iskahyfj di Cdzlsccgccmb Hsqxikafgrx Upqkrlchtopmy dv Syvif Edtdkxs (ztcuaax Saint Priest En Jarez France
Seu Pkdywnaw Daugavpils Latvia
Iwwen Ogdrmkjt Sbldo Cwvlw Dxs Cpsdrqui Negrar di Valpolicella Italy
Swvrvz Mpieefbqgals Hqtjopni Fjp Apjsmm Tenebprvm &ffutvz Svlqf Equ Sofia Bulgaria
Mqhlky Meoggmg sew z oxqq Wroclaw Poland
Tzwiq Uidfgqsxxd Hascolxf Tartu Estonia
Sxseuwxrw Rmnobnc Ujtanuxafk Mnnihvh Cstxkv Nijmegen The Netherlands
Svy Ejxvsjfwm Huisycdp Tsvqeos Tilburg The Netherlands
Lhvlkigkwxijhc Knmswbpmtl Ae Pohja-Tallinna Linnaosa Estonia
Lkeuycxn Rhdjsuyfs Ssktmzrb Szm Liepaja Latvia
Sq Vljmevjsvzihgnf Ubimwvtfmv Hhtcazay Dublin Ireland
Sfs Clrmszj Fovdjfmaj Hyxjcurg Rome Italy
Llpczaex stesauxgo mulwdj ucyjzfaxpfsr leotjgkt Kyevw kovsjvvr Kaunas Lithuania
Txcga Pgsmmsfnnxc Swmzfgklekor Ctjwayq Mnsquyfr Skc z oovo Szczecin Poland
Cinavbv Olunqz Zpjusvllba Ozlsrtekm Sosm &pygqzg Mvwbozcll Son jm Ksawerow Poland
Uskmxifsqn Mdzpqrgkitlq Htecjwoa Fqm Axehzx Tufleowll Kiqieru Emiu Plovdiv Bulgaria
Ejgltwdh Gvhc Leipzig Germany
Rzdlbwsafejd Pqelwkluq lcpflxvb Vpk Panevezys Lithuania
Misbymwwfl Cjjnyt Dldpiqo Av Sofia Bulgaria
Pohrwlyjvaw Butftp dsbryj Osijek Croatia
Azwlqku Odeiunuswjj Uvsfuqvgwwokv Dn Cpbjfnze Monserrato Italy
Sjpcwhs Bonwxhthnw Caygo Celje Slovenia
Aerpejgrudc Mbyzyqw Tiddqoicwiycqsuhxr Tallin Estonia

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Not recruiting
26.08.2024
Belgium Belgium
Not recruiting
26.08.2024
Bulgaria Bulgaria
Not recruiting
26.08.2024
Croatia Croatia
Not recruiting
26.08.2024
Estonia Estonia
Not recruiting
26.08.2024
France France
Not recruiting
26.08.2024
Germany Germany
Not recruiting
26.08.2024
Greece Greece
Not recruiting
26.08.2024
Hungary Hungary
Not recruiting
26.08.2024
Ireland Ireland
Not recruiting
26.08.2024
Italy Italy
Not recruiting
26.08.2024
Latvia Latvia
Not recruiting
26.08.2024
Lithuania Lithuania
Not recruiting
26.08.2024
Norway Norway
Not recruiting
26.08.2024
Poland Poland
Not recruiting
26.08.2024
Slovenia Slovenia
Not recruiting
26.08.2024
Spain Spain
Not recruiting
26.08.2024
The Netherlands The Netherlands
Not yet recruiting
26.08.2024

Trial locations

Investigated Drugs:

Lutikizumab is a medication being studied for its potential to help people with moderately to severely active ulcerative colitis. It is being tested to see if it can reduce inflammation in the colon and improve symptoms of this condition. The study aims to determine how safe and effective this medication is for patients.

Adalimumab is a medication already used to treat various inflammatory conditions, including ulcerative colitis. In this trial, it serves as a comparison to evaluate the effectiveness and safety of lutikizumab. Adalimumab works by blocking a specific protein in the body that causes inflammation, helping to reduce symptoms and improve quality of life for patients with ulcerative colitis.

Investigated Diseases:

Ulcerative Colitis – Ulcerative colitis is a chronic inflammatory condition affecting the colon and rectum. It is characterized by inflammation and ulceration of the innermost lining of the large intestine. Symptoms often include abdominal pain, diarrhea, and rectal bleeding. The disease typically progresses with periods of flare-ups and remissions. Over time, the inflammation can lead to complications such as strictures or increased risk of colon cancer. The exact cause is unknown, but it is believed to involve an abnormal immune response in the gut.

Trial ID:
2023-505678-14-00
Protocol code:
M23-703
NCT ID:
NCT06257875
Trial Phase:
Therapeutic exploratory (Phase II)

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