Study on Long-Term Safety and Effectiveness of Upadacitinib for Patients with Ulcerative Colitis

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What is this study about?

This clinical trial is focused on studying the long-term safety and effectiveness of a medication called Upadacitinib in people with Ulcerative Colitis. Ulcerative Colitis is a chronic condition that causes inflammation and sores in the lining of the large intestine. The medication being tested, Upadacitinib, is a type of drug known as a Janus kinase (Jak) 1 inhibitor, which works by blocking certain enzymes in the body that are involved in the inflammatory process.

The purpose of this study is to evaluate how safe and effective Upadacitinib is over a long period. Participants in the study will take Upadacitinib in the form of a modified-release tablet, which means the medication is designed to be released slowly in the body. The study will also include a placebo group, which means some participants will receive a tablet that does not contain the active medication. This helps researchers compare the effects of the medication against no treatment.

Throughout the study, participants will be monitored regularly to assess any side effects and to see how well the medication is working in managing their Ulcerative Colitis symptoms. The study is designed to last for several years, allowing researchers to gather comprehensive data on the long-term use of Upadacitinib. Participants will have regular check-ups and assessments to ensure their safety and to track the progress of their condition.

1 joining the study

Upon joining the study, you will be required to provide written informed consent. This means you agree to participate and understand the study requirements.

2 initial assessment

An initial assessment will be conducted to ensure you meet the study’s inclusion criteria. This may involve reviewing your medical history and conducting necessary tests, such as a colonoscopy or sigmoidoscopy, to confirm eligibility.

3 medication administration

You will begin taking the study medication, upadacitinib, in the form of a modified-release tablet. The dosage is 30 mg taken orally once daily. This will continue for the duration of the study unless otherwise directed by the study team.

4 regular monitoring

Throughout the study, you will undergo regular monitoring to assess your health and the medication’s effects. This includes physical examinations, vital signs checks, and laboratory tests. These assessments help ensure your safety and the study’s integrity.

5 dose optimization substudy

If you are eligible, you may enter a dose optimization substudy. This involves adjusting the medication dosage based on your response and maintaining stable clinical remission. Regular assessments will continue to monitor your condition.

6 end of study

At the end of the study, a final assessment will be conducted. This includes a review of your health status and any changes observed during the study. The study team will discuss the next steps and any follow-up care if needed.

Who Can Join the Study?

  • The study is for people with Ulcerative Colitis, a condition that causes inflammation and sores in the colon.
  • You must have participated in a previous study (Study M14-234) and either not responded to treatment, lost response, or completed the study.
  • If you missed certain medical tests due to the COVID-19 pandemic, you might still be eligible if you showed improvement based on a specific score called the Partial Adapted Mayo Score.
  • You must be in stable condition, meaning you have had no symptoms like frequent bowel movements or bleeding for at least 6 months.
  • A recent medical test called an endoscopy should show mild or no inflammation in your colon.
  • You should not have started any new medication or increased your current medication for Ulcerative Colitis in the past 6 months.
  • Your fecal calprotectin level, a marker of inflammation in the intestines, should be 250 mg/kg or lower.
  • If you are a woman who can have children, you must have a negative pregnancy test at the start of the study and follow specific birth control guidelines.
  • You should be in generally good health as determined by the study doctor based on previous evaluations.
  • You must be able to understand and agree to the study requirements and provide written consent.
  • You should currently be taking a medication called upadacitinib at a dose of 30 mg daily for at least 6 months.
  • You should not have used any corticosteroid treatment for Ulcerative Colitis for at least 90 days before joining the study.
  • The study is open to both men and women.

Who Cannot Join the Study?

  • Patients who do not have a diagnosis of Ulcerative Colitis.
  • Patients who are not within the specified age range for the study.
  • Patients who belong to a group that is not included in the study.
  • Patients who are part of a vulnerable population that is not selected for the study.

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
Turku University Hospital Turku Finland
Centre Hospitalier Universitaire De Nice Nice France
Az Maria Middelares Gent Gent Belgium
Hopital Saint Eloi Montpellier France
Instytut Pomnik Centrum Zdrowia Dziecka Warsaw Poland
Klaipedos universiteto ligonine VšĮ Klaipeda Lithuania
Crwozw Hunpsfyuqks Dcvdyvljkszpt Vijstx La Roche sur Yon France
Uhmujfylvokjhrpsvtxrp Noghnsqsfz Hb Tromsø Norway
Eysfjldvdbxh Szck Athens Greece
Nhjol Eewpoqq Mhnywls Cstehi Fblclxwvjq Tallin Estonia
Bhsanvrr Heabzumh Dublin Ireland
Hqsxzqen Uadkbbmysmiqs dz A Cyznab A Coruna Galicia Spain
Uekffteqmelvtddsrmgbq Tyhtxwdye Aeo Tuebingen Germany
Fakenqvwyf Iiyeu Cr Gdppdn Oxiyspws Mddtyijo Prprcowvvia Milan Italy
Ueboomtluaml Mjbclxe Cgqtffl Uivibhg Utrecht The Netherlands
Azcuaysn Ublptovwki Hzgxkmdv Lorenskog Norway
Kgn Swsvr Split Croatia
St Vdswqldjhtjnadd Ufzzknglug Hbrmprwm Dublin Ireland
Ufmioimcnxewckfekldgi Soddigqpsbojkeemqr Ayi Kiel Germany
Ctmwmn Hzgpmaxakzh Lthh Shd Pierre Benite France
Ajjbbzkw Zcqxzcrpbg Dznzh Roeselare Belgium
Cuob Czpiis Ctlwgch Auidiepgq Busmu Aoqursxkmq Braga Portugal
Iintjtcggi Gnebuzf Hxkjqpzx Ok Tmhrnocnmldy Thessaloniki Greece
Pvjgj Sutlryug Ccmecnwy Ubzxoiseja Hpfmfpqu Riga Latvia
Umgenqzdbm Tyncdasf Hmrciqsp Mhbzxszqqhtz Szombathely Hungary
Aempmcm Omkaelqmpuz Olwjxyrx Rxljgry Volgg Skbpl Cjafcbsr Palermo Italy
Btfhn Vkxfnhiuo Kqxnlnzkn Kvbubm Bekescsaba Hungary
Ihobj Owafzkvk Srgwk Cydxc Dni Cpnqhsux Negrar di Valpolicella Italy
Avgw Cephaenb svvurx Prague Czechia
Tfxogvu Ukfrapcrxm Hkoelxkq Tampere Finland
Trgha Uyrrheouhc Hztelqcj Tartu Estonia
Sirglljcs Rhlepqk Ubkernboms Mfzevip Cchjxw Nijmegen The Netherlands
Ubuzxujxrp Hmahmmdp Ghyiwb Galway Ireland
Aosdedenm Uhx Amsterdam The Netherlands
Sjebfmhbtd Ulppouqsye Budapest Hungary
Hxqoyykdgarwwfmoydbhjmvj Hm skhqnw Hradec Kralove Czechia
Lozwgjryujojrb Kgwtvlloig Ay Pohja-Tallinna Linnaosa Estonia
Gxwvghamp Sql z opjt Torun Poland
Egdy Thncmqd Cscnayu Hrcwvdlx Tallin Estonia
Vgmloxnym cktxuw apkgpinwt Az Riga Latvia
Swpdxia Etppiihw Oaatna Kuucky Es Rcspnbdnixwycv Igjqwra Sopron Hungary
Abue Fluimfcthwywlzlj Sxocu Milan Italy
Ipmczh afdc Prague Czechia
Hodevejw De Swosy Mekhu Edsbmj Lisbon Portugal
Lgzumxbt soboreqcf mpzrjs uoxnmbhxxqyn ldcapmcl Kguko kymarmah Kaunas Lithuania
Ef Gcybk Sot z oeor Warsaw Poland
Uyrievi Lelur Dj Seqdr Df Awwq Mlvko Elqxdj Ponte De Lima Portugal
Ctgetpz Fuwnphz Hxuglakj Dsjnlwvg Ckocyzn Fldcnng Hpoddxhg Nqud Jyvaskyla Finland
Uohpuwn Lqwzl Dl Scflb Dv Eohyo O Dmyik E Vyfzb Estvwp Santa Maria Da Feira Portugal
Eimtyziudb Srm z ozml Sopot Poland
Fdxwmqgj Nybbbmack S Pjyffwzccvvd Nllt Zwilt Nove Zamky Slovakia
Gjvqwa Lm sgfyqq Presov Slovakia
Tdabmaqi Gnaxhtz Hofnsiip Oy Afqhlm I Slkblge Athens Greece
Axnpprwsj sedvbx Trebovice Czechia
Grhcmfeqavycfkzxe ar Bmgabxueatd Ptdrq Berlin Germany
Mxpejlqshifcg Vznwvnnxingahitkwt Phlxtw 1e Munster 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
12.05.2017
Belgium Belgium
Not recruiting
12.05.2017
Croatia Croatia
Not recruiting
12.05.2017
Czechia Czechia
Not recruiting
12.05.2017
Estonia Estonia
Not recruiting
12.05.2017
Finland Finland
Not recruiting
12.05.2017
France France
Not recruiting
12.05.2017
Germany Germany
Not recruiting
12.05.2017
Greece Greece
Not recruiting
12.05.2017
Hungary Hungary
Not recruiting
12.05.2017
Ireland Ireland
Not recruiting
12.05.2017
Italy Italy
Not recruiting
12.05.2017
Latvia Latvia
Not recruiting
12.05.2017
Lithuania Lithuania
Not recruiting
12.05.2017
Norway Norway
Not recruiting
12.05.2017
Poland Poland
Not recruiting
12.05.2017
Portugal Portugal
Not recruiting
12.05.2017
Slovakia Slovakia
Not recruiting
12.05.2017
Spain Spain
Not recruiting
12.05.2017
The Netherlands The Netherlands
Not recruiting
12.05.2017

Trial locations

Investigated Drugs:

Upadacitinib is a medication being studied for its effects on ulcerative colitis, a condition that causes inflammation and sores in the digestive tract. This medication works by blocking certain enzymes in the body that are involved in the inflammatory process. By doing so, it aims to reduce inflammation and help manage the symptoms of ulcerative colitis, potentially improving the quality of life for those affected by this condition. The study is focused on understanding how safe and effective this medication is when used over a long 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. The disease typically begins in the rectum and can extend to involve the entire colon. Symptoms often include abdominal pain, diarrhea, and rectal bleeding. The inflammation leads to frequent bowel movements and an urgent need to defecate. Over time, the disease can cause the colon to lose its ability to function properly.

Trial ID:
2023-505699-31-00
Protocol code:
M14-533
Trial Phase:
Therapeutic confirmatory (Phase III)

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