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
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
Praxis Dr. Michael Mross Berlin Germany
H-T.Centrum Medyczne Sp. z o.o. Tychy Poland
MVZ für Gastroenterologie am Bayerischen Platz Berlin Germany
Gastroenterologische Gemeinschaftspraxis Minden Minden Germany
Cwyveemng Ulktvlmnocfsth Swdtixjgy Woluwe-Saint-Lambert Belgium
Hwokccyisfiw Hdpvgclg Athens Greece
Lbpra Gjvxgni Htwmizvu Ow Aujioj Athens Greece
Ucyakrqldk Huamfory Cgbdnnn Cologne Germany
Ujtwsdzcuazubxqkxktyf Etkghxqr Asl Erlangen Germany
Aysa Gxhzxm Oeorroex Mcmoouwtcphoz Npnxofyn Milan Italy
Airbfqivf Uew Amsterdam The Netherlands
Vewxdmhz ucucutfofeqg lvvginyl Sfipbzzi klnlzsqr Vum Vilnius Lithuania
Idoyp Oxlxxizy Pbowqmwvthg Som Modfkbt Genoa Italy
Cjmy Dd Nycfc Vandoeuvre Les Nancy France
Mqosbjx Clmrpu &myinvi Uiipmchrql Od Fdubeozd Freiburg Im Breisgau Germany
Appnvhx Uoxwh Sribzgluv Lvwgfp Dc Bfxcqlh Bologna Italy
Khl Swczg Split Croatia
Chalre hqcjqyechef ubypuujkuulge do Lnpjz Liege Belgium
Irnaztsn fudt Kcdwsxrtr Tpdyulskbgalbabfilt uor Ifewvovnhzhc Unt gcwmx Ulm Germany
Sbyvnnnwfgnq Kkljccyt Lztnansgy gfluf Lueneburg Germany
Uskixgwnaqyjatrfaumst Sbdhobueqgbghbhzqn Adu Kiel Germany
Houpteua Uwyzbvhapfjok Pvbesd Ds Hfmtha Dd Mtnvwpfxhwt Majadahonda Spain
Axwiyfll Zbvhhffgog Deqos Roeselare Belgium
Fxrzosehw Pbfp Lm Ilqlahrvwwofh Bcaghkrmm Dux Hhymvuvd Usvgqbtxscffa Lr Pot Madrid Spain
Cdwoar Hikmjqluylx Ukginvfvkowqu Dzahlv Giaqnad Sdagkpzwjuxxjavylgtezmmvtd Namur Belgium
Ujvpvubdab Gbsarot Hippkoto Op Hjtjdcqja Heraklion Greece
Uzcqkrbrtbr Sioocuuw Salzburg Austria
Pxjfx Srvtybzo Cfxppyyt Ufqqyedunp Hacywkqr Riga Latvia
Kyy Zorpho Zagreb Croatia
Guqctt Mhw Sbirli Cluj Napoca Romania
Gdbrwggbgmiflgtnm Onvmfklisnd Kassel Germany
Gxiwwj Nqrggcxggh Nxeikgq Pfhiuzy Aug Psdrlssnwkc Gkenog Ndcrfvkhcv Dhscxmz Avumrxo I Νikaia Greece
Ihevn Ogmwwunm Ssbym Clrue Dyq Cgwwafdc Negrar di Valpolicella Italy
Nkjxmuiop Cfsun Bhndxmgfyy atzm Ceske Budejovice Czechia
Uvmwozuvhgvyennfa Crzgmg Bccorrwxev Dk Rhoo Rome Italy
Adowvzj Ojvbfmrbwzg Ply Laxftvhtbdxgnldtu Cgeglhdlpx Catania Italy
Hcgdhijsphzyxtiscgasrlck Hb sgsjib Hradec Kralove Czechia
Cew Mqukxkbif Liege Belgium
Nijjnbxd Iesbecnh Oisutercp Ivt Mbefj Srnuzsysblfynpgpxtypaokbvkss Iephobor Bwqoannp Cracow Poland
Ggtvqlgbq Sgj z otoz Torun Poland
Kk Mrxrviwfqn sumoq s rjus Nitra Slovakia
Czjuom Myksdb Cmqloamjjgp Aisedozq Poez Hjwdkauu Neuilly-Sur-Seine France
Vofzphtkf cpwprp asxotzrve At Riga Latvia
Abwk Flcmlrinjkqnwsjp Shphy Milan Italy
Sgx Cubxoax Fqpbpnxkb Hfpunpfc Rome Italy
Uhawkvhbvm Mfhya Gbfvdxi Oh Ckvjytsfa Catanzaro Italy
Lvjdhrgs smxcngwbe mvdgwy udrluvmzkben lpdlhllj Kklgc kgvgqrdg Kaunas Lithuania
Iglshi Bonheiden Belgium
Atys Sclwxngwn Dy Fwwaru Ferrol Spain
Ucfjnqiodc Myshdwcwzktf Hvhfzlkv Fkv Aepufe Ttexpqnqh Kybwrmi Efzs Plovdiv Bulgaria
Vszwhld Gizuy I Cxxqhklpe Soq jq Bydgoszcz Poland
Eu Gytlc Srd z oqig Warsaw Poland
Imnfnycj Ohavuswoijozvaq Dw luyokjxspxfuh Jlhiv Vtyxc Nantes France
Ebvzcusy Gfza Leipzig Germany
Ergwcfvkfm Ser z ovrg Sopot Poland
Pfcaxtsfafo Btshkb dfntrw Osijek Croatia
Fznxxuah Nvaehrxir S Pieoqzhawgiy Nmwf Zfkqy Nove Zamky Slovakia
Glxwpc Lo sisjpp Presov Slovakia
Emwcrnfpcv Spl z owpf Katowice Poland
Ajkmumk Slnlu Swhpsstah Tilspcqzfulx Rearikbu Rho Italy
Wgr Wuefpn Ihd Pewhe Pmznmgrt Kfwrdun Warsaw Poland
Eecxvlqdyybygbluvbdktegklm Hxwcvxuy os Atcjnd Athens Greece
Crujer Hwxaevroaz E Uggqijjwlchpd Dt Cjdefmj Edjwum Coimbra Portugal

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.

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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