Study on the Effectiveness and Safety of Risankizumab for Patients 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 Risankizumab in people with Ulcerative Colitis. Ulcerative Colitis is a chronic condition that causes inflammation and sores in the lining of the large intestine. The study aims to evaluate how effective and safe Risankizumab is as a maintenance treatment for individuals with moderate to severe Ulcerative Colitis who have previously responded to an initial treatment with Risankizumab.

Participants in the study will receive either Risankizumab or a placebo. The study is divided into several parts. In the first part, the focus is on comparing Risankizumab with a placebo to see how well it works in maintaining the health of participants over a period of time. In the second part, the study will look at two different ways of adjusting the dose of Risankizumab to see which method is more effective. The third part of the study will continue to monitor the long-term safety of Risankizumab in participants who have completed the earlier parts of the study or who were unable to complete the final examination due to external factors like the COVID-19 pandemic or geopolitical issues.

The study will last for a total of 52 weeks, during which participants will be monitored for any changes in their condition. The goal is to see if Risankizumab can help maintain remission, which means the symptoms of Ulcerative Colitis are reduced or disappear. The study will also look at other factors like improvements in the lining of the intestine and overall quality of life. Participants will be closely observed to ensure their safety throughout the study.

1 joining the study

Participation begins after completing Study M16-067, including the final endoscopy. If the final endoscopy was not possible due to specific circumstances, enrollment in Sub-study 3 is allowed if a clinical response was achieved.

2 sub-study 1

This phase evaluates the effectiveness and safety of risankizumab compared to a placebo for maintaining treatment in individuals with moderate to severe ulcerative colitis.

Participants receive risankizumab or a placebo intravenously as a solution for infusion.

3 sub-study 2

This phase assesses two different dosing strategies for risankizumab as maintenance therapy. The strategies include therapeutic drug monitoring and clinical assessment for dose escalation.

Participants receive risankizumab intravenously as a solution for infusion.

4 sub-study 3

This phase focuses on the long-term safety of risankizumab for those who completed Sub-study 1 or 2, or those who responded to the initial treatment but could not complete the final endoscopy due to specific circumstances.

Participants receive risankizumab subcutaneously as a solution for injection in a pre-filled syringe.

5 continued treatment extension (CTE)

This phase provides ongoing treatment with risankizumab for those who completed Sub-study 3, ensuring continuous care until the treatment is commercially available or accessible locally.

Participants continue to receive risankizumab subcutaneously as a solution for injection in a pre-filled syringe.

Who Can Join the Study?

  • You must have completed a previous study called Study M16-067. This includes having a final examination of the colon, known as an endoscopy, unless it was missed due to the COVID-19 pandemic or conflicts in certain regions.
  • You must have shown improvement in your condition at the last visit of Study M16-067.
  • Both men and women can participate.
  • Participants should not be from vulnerable populations, which means groups that might need special protection or care.

Who Cannot Join the Study?

  • Patients who have not responded to the initial treatment with the study medication.
  • Patients with other significant health conditions that could interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who are unable to follow the study procedures or attend the required visits.
  • Patients who have participated in another clinical trial recently.
  • Patients with a history of severe allergic reactions to the study medication.
  • Patients with active infections that require treatment.
  • Patients with a history of certain types of cancer.
  • Patients who are using medications that could interfere with the study treatment.
  • Patients with a history of substance abuse or alcohol dependency.

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
F D Roosevelt University General Hospital Of Banska Bystrica Banska Bystrica Slovakia
KBC Zagreb Zagreb Croatia
ASST Fatebenefratelli Sacco Milan Italy
Danderyds Sjukhus AB Danderyd Sweden
Azienda Ospedaliero Universitaria Di Modena Modena Italy
Centre hospitalier universitaire de Liege Liege Belgium
Staedtisches Klinikum Lueneburg gGmbH Lueneburg Germany
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
Hospital Universitario Puerta De Hierro De Majadahonda Majadahonda Spain
San Camillo Forlanini Hospital Rome Italy
Algemeen Ziekenhuis Delta Roeselare Belgium
Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikos Kaunas Lithuania
University General Hospital Of Heraklion Heraklion Greece
Area Sanitaria De Ferrol Ferrol Spain
University Multiprofile Hospital For Active Treatment Kaspela EOOD Plovdiv Bulgaria
Vitamed Galaj I Cichomski Sp. j. Bydgoszcz Poland
Eb Group Sp. z o.o. Warsaw Poland
Eugastro GmbH Leipzig Germany
Unidade Local De Saude Do Alto Ave E.P.E. Guimaraes Portugal
Endoskopia Sp. z o.o. Sopot Poland
SurGal Clinic s.r.o. Brno-Sever Czechia
Poliklinika Borzan d.o.o. Osijek Croatia
Fakultna Nemocnica S Poliklinikou Nove Zamky Nove Zamky Slovakia
Cabinet Particular Policlinic Algomed S.R.L. Timisoara Romania
Hippokration Hospital Athens Greece
Evangelismos S.A. Athens Greece
Universitaetsklinikum Erlangen AöR Erlangen Germany
ASST Grande Ospedale Metropolitano Niguarda Milan Italy
Universita’ Campus Bio-medico Di Roma Rome Italy
Vilniaus universiteto ligonine Santaros klinikos VšĮ Vilnius Lithuania
IRCCS Ospedale Policlinico San Martino Genoa Italy
Uniteversity Muliprofile Hospital For Active Treatment Tsaritsa Yoanna-Isul EAD Sofia Bulgaria
Hepato-Gastroenterologie HK s.r.o. Hradec Kralove Czechia
Medical Center – University Of Freiburg Freiburg Im Breisgau Germany
CHC MontLegia Liege Belgium
Centre Hospitalier Universitaire De Nice Nice France
H-T. Centrum Medyczne Sp. z o.o. Tychy Poland
Gastromed Sp. z o.o. Torun Poland
KM Management spol. s r.o. Nitra Slovakia
University Medical Center Ljubljana Ljubljana Slovenia
Centre Medico Chirurgical Ambroise Pare Hartmann Neuilly-Sur-Seine France
Veselibas centru apvieniba AS Riga Latvia
KBC Split Split Croatia
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH Ulm Germany
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur Namur Belgium
Gastro LM s.r.o. Presov Slovakia
University Hospital Ostrava Ostrava Czechia
IRCCS Ospedale Sacro Cuore Don Calabria Negrar di Valpolicella Italy
Nemocnice Ceske Budejovice a.s. Ceske Budejovice Czechia
Uniklinikum Salzburg Salzburg Austria
Economicus Sp. z o.o. Katowice Poland
Fundeni Clinical Institute Bucharest Romania
Cccldhahv Uduearxlhdjcyi Smykiswsn Woluwe-Saint-Lambert Belgium
Ifdnnx Bonheiden Belgium
Gualwd Msi Sqhhno Cluj Napoca Romania
Gcxnao Nkscpehyyl Njxsvmk Psqnjhs Aqx Ppmiidjkoyy Gximzs Nihrmmowqz Dzrmscm Agibzwd I Νikaia Greece
Legpi Gbrfsyh Hvqhqqni Ob Abtxtg Athens Greece
Gsaipwplkxjadmnuv Ogjownesjfr Kassel Germany
Uznzuzhhsx Hvyhfeov Cpcedin Cologne Germany
Aczozcrxe Ulj Amsterdam The Netherlands
Aulzajz Okddtylzbvo Pvj Lvertaceqauzhwcbc Ctuzojmucg Catania Italy
Cnfv Dx Nvfkb Vandoeuvre Les Nancy France
Nyazgvfw Ilmbvwfw Okjyrzigl Iar Mknvl Slkellcnazdgfkihytamzleznnrh Iekdowko Bhjpzlmk Cracow Poland
Adsinnh Uhdgf Slcmohfwm Lylwxo Dq Bjlpxob Bologna Italy
Ugkuvltvei Moyix Gtypgyu Ok Chhklkrrp Catanzaro Italy
Flpdarlcp Pwbq La Irfiodovlkcru Bcqwatzvq Dks Hkkvtofr Uhpevdzfovjso Ld Pfu Madrid Spain
Itcaphym Oauoppwhgpqcbmn Dx ldpbsiqmckhuj Jqfin Vzbwg Nantes France
Gqnvbzsuqlswypsgddsu Gankdoklfhqiuxldjzv Mxhkpq Minden Germany
Wkf Wuvgiy Iya Psofk Padkndsa Kmeljwc Warsaw Poland
Awxfnrp Sseqi Sxqbzuucf Tgzozpynxszh Roauxqem Rho Italy
Moy Gxllww Bterww Berlin Germany

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
28.08.2018
Belgium Belgium
Not recruiting
28.08.2018
Bulgaria Bulgaria
Not recruiting
28.08.2018
Croatia Croatia
Not recruiting
28.08.2018
Czechia Czechia
Not recruiting
28.08.2018
France France
Not recruiting
28.08.2018
Germany Germany
Not recruiting
28.08.2018
Greece Greece
Not recruiting
28.08.2018
Italy Italy
Not recruiting
28.08.2018
Latvia Latvia
Not recruiting
28.08.2018
Lithuania Lithuania
Not recruiting
28.08.2018
Poland Poland
Not recruiting
28.08.2018
Portugal Portugal
Not recruiting
28.08.2018
Romania Romania
Not recruiting
28.08.2018
Slovakia Slovakia
Not recruiting
28.08.2018
Slovenia Slovenia
Not recruiting
28.08.2018
Spain Spain
Not recruiting
28.08.2018
Sweden Sweden
Not recruiting
28.08.2018
The Netherlands The Netherlands
Not recruiting
28.08.2018

Trial locations

Investigated drugs:

Risankizumab is a medication being studied for its effectiveness and safety in treating ulcerative colitis, a condition that causes inflammation and sores in the digestive tract. The trial is examining how well this medication works as a long-term treatment for people who have already shown improvement with initial treatment. The study also looks at different ways of adjusting the dosage to maintain the benefits of the medication. Additionally, the trial aims to ensure that patients can continue receiving the medication safely over an extended period.

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, leading to symptoms such as abdominal pain, diarrhea, and rectal bleeding. The disease often progresses with periods of exacerbation and remission, where symptoms may worsen and then improve. Over time, the inflammation can cause the colon to become less effective at absorbing water and nutrients, leading to further complications. The exact cause of ulcerative colitis is not fully understood, but it is believed to involve an abnormal immune response in the gut. Environmental factors, genetics, and an imbalance in gut bacteria may also play a role in its development.

Trial ID:
2023-506994-36-00
Protocol code:
M16-066
NCT ID:
NCT03398135
Trial Phase:
Therapeutic confirmatory (Phase III)

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