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
Bekes Varmegyei Koezponti Korhaz Bekescsaba Hungary
Universitair Medisch Centrum Utrecht Utrecht The Netherlands
Instytut Pomnik Centrum Zdrowia Dziecka Warsaw Poland
University Hospital Galway Galway Ireland
Hepato-Gastroenterologie HK s.r.o. Hradec Kralove Czechia
Laane-Tallinna Keskhaigla AS Pohja-Tallinna Linnaosa Estonia
Centre Hospitalier Universitaire De Nice Nice France
Gastromed Sp. z o.o. Torun Poland
Klaipedos universiteto ligonine VšĮ Klaipeda Lithuania
Soproni Erzsebet Oktato Korhaz Es Rehabilitacios Intezet Sopron Hungary
Eb Group Sp. z o.o. Warsaw Poland
Semmelweis University Budapest Hungary
Veselibas centru apvieniba AS Riga Latvia
Pauls Stradins Clinical University Hospital Riga Latvia
F D Roosevelt University General Hospital Of Banska Bystrica Banska Bystrica Slovakia
Centre Hospitalier Departemental Vendee La Roche sur Yon France
Universitetssykehuset Nord-Norge HF Tromsø Norway
Evangelismos S.A. Athens Greece
University Teaching Hospital Markusovszky Szombathely Hungary
Universitaetsklinikum Tuebingen AöR Tuebingen Germany
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico Milan Italy
Tampere University Hospital Tampere Finland
Tartu University Hospital Tartu Estonia
Turku University Hospital Turku Finland
East Tallinn Central Hospital Tallin Estonia
KBC Split Split Croatia
ASST Fatebenefratelli Sacco Milan Italy
Iscare a.s. Prague Czechia
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
Centre Hospitalier Lyon Sud Pierre Benite France
Hospital De Santa Maria E.P.E. Lisbon Portugal
Algemeen Ziekenhuis Delta Roeselare Belgium
Az Maria Middelares Gent Gent Belgium
Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikos Kaunas Lithuania
CCAB Centro Clinico Academico Braga Associacao Braga Portugal
Unidade Local De Saude Do Alto Minho E.P.E. Ponte De Lima Portugal
Ippokratio General Hospital Of Thessaloniki Thessaloniki Greece
Central Finland Hospital District Central Finland Hospital Nova Jyvaskyla Finland
Unidade Local De Saude De Entre O Douro E Vouga E.P.E. Santa Maria Da Feira Portugal
Endoskopia Sp. z o.o. Sopot Poland
Fakultna Nemocnica S Poliklinikou Nove Zamky Nove Zamky Slovakia
Gastro LM s.r.o. Presov Slovakia
Hopital Saint Eloi Montpellier France
North Estonia Medical Centre Foundation Tallin Estonia
Beaumont Hospital Dublin Ireland
IRCCS Ospedale Sacro Cuore Don Calabria Negrar di Valpolicella Italy
Thoracic General Hospital Of Athens I Sotiria Athens Greece
Gastroenterologie am Bayerischen Platz Berlin Germany
Axon Clinical s.r.o. Prague Czechia
Medizinisches Versorgungszentrum Portal 10 Munster Germany
Savbqqzug Rgawwda Upmbsrhhrj Mnwoguq Cnyhks Nijmegen The Netherlands
Axmxzvuv Uvbdxzhvsl Hdkfnbrl Lorenskog Norway
Asralushg Upo Amsterdam The Netherlands
Sq Vuqpkxrcyaaqszb Ucnibedhjf Hwgfohkw Dublin Ireland
Afrkuat Ormajblwmbc Ollmdavx Rcwkyfl Vhmke Sfjqz Csvckeej Palermo Italy
Hgtfylrc Ujvxovzktidcg dd A Ciwwix A Coruna Galicia Spain
Aihfqyjsg scuaen Trebovice Czechia

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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