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
Pauls Stradins Clinical University Hospital Riga Latvia
Universitetssykehuset Nord-Norge HF Tromsø Norway
KBC Zagreb Zagreb Croatia
Noe LGA Gesundheit Region Mitte GmbH St. Poelten Austria
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum) Munich Germany
Centre hospitalier universitaire de Liege Liege Belgium
Universitair Ziekenhuis Gent Gent Belgium
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
San Camillo Forlanini Hospital Rome Italy
Az Maria Middelares Gent Gent Belgium
Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikos Kaunas Lithuania
University Hospital St Marina Varna Varna Bulgaria
Twoja Przychodnia Szczecinskie Centrum Medyczne Sp. z o.o. Szczecin Poland
Centrum Opieki Zdrowotnej Orkan-Med Stec – Michalska Sp. j. Ksawerow Poland
Vitaz Sint-Niklaas Belgium
University General Hospital Of Heraklion Heraklion Greece
University Multiprofile Hospital For Active Treatment Kaspela EOOD Plovdiv Bulgaria
Ippokratio General Hospital Of Thessaloniki Thessaloniki Greece
Eugastro GmbH Leipzig Germany
Poliklinika Borzan d.o.o. Osijek Croatia
Medicinski Centar Doverie AD Sofia Bulgaria
Splosna Bolnisnica Celje Celje Slovenia
Respublikine Panevezio ligonine VšĮ Panevezys Lithuania
Clinexpert Kft. Budapest Hungary
Sihtasutus Parnu Haigla Paernu Estonia
Melita Medical sp. z o.o. Wroclaw Poland
Vilniaus universiteto ligonine Santaros klinikos VšĮ Vilnius Lithuania
Tartu University Hospital Tartu Estonia
Universidade De Santiago De Compostela Santiago De Compostela Spain
Uniteversity Muliprofile Hospital For Active Treatment Tsaritsa Yoanna-Isul EAD Sofia Bulgaria
Laane-Tallinna Keskhaigla AS Pohja-Tallinna Linnaosa Estonia
Centre Hospitalier Universitaire De Nantes Nantes France
Liepajas Regionala Slimnica SIA Liepaja Latvia
Centre Hospitalier Universitaire De Nice Nice France
Specijalna Bolnica Medico Rijeka Croatia
H-T. Centrum Medyczne Sp. z o.o. Tychy Poland
University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD Sofia Bulgaria
St Vincent’s University Hospital Dublin Ireland
University Medical Center Ljubljana Ljubljana Slovenia
Poliklinika Solmed d.o.o. Zagreb Croatia
KBC Split Split Croatia
Medrise Sp. z o.o. Lublin Poland
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH Ulm Germany
Hopital Beaujon Clichy France
Azienda Ospedaliera Universitaria Di Cagliari Monserrato Italy
Beaumont Hospital Dublin Ireland
IRCCS Ospedale Sacro Cuore Don Calabria Negrar di Valpolicella Italy
Second Multiprofile Hospital For Active Treatment – Sofia EAD Sofia Bulgaria
Uniklinikum Salzburg Salzburg Austria
Aktsiaselts Medicum Tervishoiuteenused Tallin Estonia
Upibaktpxx Mxrvkzc Cajjvi Hrdolpkibnkrvnsuo Hamburg Germany
Sjpqzie Befbxtvdhi Mjilyo Snskhy Murska Sobota Slovenia
Swy Pbqzjiuf Daugavpils Latvia
Svs Mpmpzt Udx Ssf Ahonesqmhbmuafkjwkttp Ludwigshafen Am Rhein Germany
Lzmfy Gcjhcsj Halaycwb Oj Abteyb Athens Greece
Cpcouig Mntdjcxr Lwctdsa Jmqfsv Łrlq Chojnice Poland
Adkjjfwt Ughoruvyon Hkxomcux Lorenskog Norway
Stemkzwrj Rimbnfc Uvbgqifjqa Mcxufno Canvbr Nijmegen The Netherlands
Shu Exzdjiagq Hnwwekqq Twuihmz Tilburg The Netherlands
Fmjmbjxzn Ptso Li Isijkazxlhtem Bowttfmkh Duq Hopqquzb Ustmufzlcvwyi Lj Pwm Madrid Spain
Ivqxrumx dc Ccfqeszxxpba Hxekbwdqogd Uklheniadrpmf de Svptt Eecyrdz (rcrjwjk Saint Priest En Jarez France
Ehfvsaxkfodjuaxfasckxwegzp Hbiwloul oj Aoxcwg Athens Greece

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.

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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