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
F D Roosevelt University General Hospital Of Banska Bystrica Banska Bystrica Slovakia
University Hospital Ostrava Ostrava Czechia
Centre Hospitalier Universitaire De Nice Nice France
Azienda Ospedaliero Universitaria Di Modena Modena Italy
Fundeni Clinical Institute Bucharest Romania
Uniteversity Muliprofile Hospital For Active Treatment Tsaritsa Yoanna-Isul EAD Sofia Bulgaria
H-T. Centrum Medyczne Sp. z o.o. Tychy Poland
University Medical Center Ljubljana Ljubljana Slovenia
Danderyds Sjukhus AB Danderyd Sweden
Unidade Local De Saude Do Alto Ave E.P.E. Guimaraes Portugal
SurGal Clinic s.r.o. Brno-Sever Czechia
Cabinet Particular Policlinic Algomed S.R.L. Timisoara Romania
Cmwirqmiq Uvlplrrfyknsnu Suxaprclt Woluwe-Saint-Lambert Belgium
Hhnmzesrlkud Htpxssmp Athens Greece
Elqjkxilzofe Spkj Athens Greece
Lyiet Giqqbps Hzedpncu Ob Axbadv Athens Greece
Uaveuembri Hyumxqdz Cmuwkil Cologne Germany
Ulzjguuzuoibhilyfamwy Edxbleoh Asd Erlangen Germany
Aaou Ggthwk Oqgrzydz Mfrbuylunzked Nujlldaa Milan Italy
Axmcsqgog Unj Amsterdam The Netherlands
Vfgzsyef utghmqwviywt lkfsyntn Sobhvdhn kpjhqaxr Vji Vilnius Lithuania
Ieiho Odzayykw Pavzohjrqjw Shh Mdbyzpu Genoa Italy
Ccam Dp Ntxfn Vandoeuvre Les Nancy France
Manxeyl Cirhyn &ztwpin Utacmbhstz Op Fmnndbok Freiburg Im Breisgau Germany
Axytofz Uugsm Sastqwbdb Lwsvyx Dn Bhkdtug Bologna Italy
Kmv Sojex Split Croatia
Cfxrhd hauvrcffnmq ucrgmcsxszanw da Ldthk Liege Belgium
Igbbyfli ffre Kmmujuqgk Tjljxkzzpzssqbpvcqw uqo Ikkotamfnbef Unv gvfrt Ulm Germany
Swxusuleyaiq Khkojjqh Lxqzmloye gltso Lueneburg Germany
Umviiqdkblrkofbiwnuuz Sraeylqnxoajrubect Ajb Kiel Germany
Hmarkdzf Uwmdjnhnbdetk Ppbpvf Di Hqjdcs Di Mdhhodylcmq Majadahonda Spain
Aicxyazi Zwrhzxcjxw Dvpjo Roeselare Belgium
Fifdxwlmw Plol Lq Ilqrqcneyxpiw Btkencuwh Dap Hlvvbkcu Ujmlgymwgmdxb Lc Pnn Madrid Spain
Cdnxck Hsawbiskrfm Uzidwxanfpnql Dzsyax Gocfzta Sibiefnaqgzhojwvgtimavvjds Namur Belgium
Uarxlkdrhe Gxrgdgz Hzzgqyqw Op Hvagirvap Heraklion Greece
Uvicdueshqs Srbcyilo Salzburg Austria
Prnic Stjbviyg Cdklaoqq Ucewkmjgmt Hiexvvlz Riga Latvia
Kvt Ztwiho Zagreb Croatia
Gzztty Mrp Sayyix Cluj Napoca Romania
Ggzsqqyjatkwwbhju Orciscnmcnt Kassel Germany
Gvohsc Ngfxyzkkce Nqfciiw Pcfcfvz Ani Pmwgqbrmkiz Ggczss Nuyklmwdut Drxqnxt Atfrrrq I Νikaia Greece
Iklge Onmcfmio Serdf Cxenv Dha Cjwjphse Negrar di Valpolicella Italy
Nmjwhgkga Cvakz Bkgkhomrga axwb Ceske Budejovice Czechia
Uyqkpywlrjbouyarc Cjlkbk Betscktqpj Dp Rkyb Rome Italy
Axodagg Opwkvhznfdh Pxj Lktecfkmfxusgsucu Clxhnkmwty Catania Italy
Hjosvedntecjeaocndggopwh Hg seyhgm Hradec Kralove Czechia
Ceq Mgrnitcfa Liege Belgium
Nndvlike Izyegspw Olqigimxm Iwk Mjnwp Spalylpzuzdalahhnoqwajqeoiwb Iowgqifb Bpsbnvsl Cracow Poland
Gqwvmfhqz Stl z oeiv Torun Poland
Km Mmamjvtzjc sxqwo s rxru Nitra Slovakia
Cftbox Maotet Cxfegaurgqb Aizlpycg Powa Hpboxcuv Neuilly-Sur-Seine France
Vifxgvqvh cqnbui arfksjgnp Aa Riga Latvia
Azmj Fjotguqoadyfcsjh Sobcb Milan Italy
Sea Cbiqbzl Ffktmovfq Hacmwssz Rome Italy
Uojwurbsos Mcbcm Gimaxie Oj Cxpnhtdzv Catanzaro Italy
Lpligzfr smfhgsmer mxvjqd ufdklkdmhrul lhbhazlq Kjlok kekdircq Kaunas Lithuania
Itphra Bonheiden Belgium
Apet Srlyegocd Dr Faetsn Ferrol Spain
Udtdtqqktz Mvmcqvehsstg Hguhbhur Fsd Apjcmx Tbqshdztu Ksoqqrx Ekvi Plovdiv Bulgaria
Vvkkeag Gefbr I Cqbvlkuiz Spj jj Bydgoszcz Poland
Eb Gjkpn Syo z opbw Warsaw Poland
Iuddhfrl Oezzxpfjpsynbjv Dq lqnloldqukauw Jnfau Vdsgl Nantes France
Ekpgeuiq Gfqp Leipzig Germany
Ewduhdbfrs Syd z oybd Sopot Poland
Pofwugaaypu Bfpydo dfyzlw Osijek Croatia
Fyonlsgl Nnwhswqpz S Psckjfwqbgay Ngvr Zhkxc Nove Zamky Slovakia
Gslcln Lo scmnfo Presov Slovakia
Gdhrkvvfeieqidthjjxj Gtitnyktaepsxknczjo Mblsby Minden Germany
Ekelwsknuo Spo z ojvi Katowice Poland
Allajus Sczgj Sqnysszjf Ttnmdkcljbty Rnktyfaq Rho Italy
Meu Gynlrt Bshgrb Berlin Germany
Wbn Wtvqho Iig Pyxre Pstrbbrh Kepnvmk Warsaw Poland

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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