Long-term study of upadacitinib tablets for adults with Crohn’s disease

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What is this study about?

This study focuses on people with Crohn’s Disease, which is a long-term inflammatory condition affecting the digestive system. The study will evaluate a medication called upadacitinib (also known as ABT-494), which is taken as a modified-release tablet by mouth. The purpose is to observe how well this medication works and how safe it is when used for an extended period in people who have already completed a previous study of the same treatment.

The medication will be given as a daily dose of either 15 mg or 30 mg for up to 96 months (8 years). During the study, researchers will monitor how well the treatment controls the symptoms of Crohn’s Disease, including improvements in digestive system inflammation, reduction in abdominal pain, and changes in bowel movements. They will also track how many participants are able to stop using steroid medications.

Throughout the study, participants will have regular check-ups to monitor their health and assess how well the treatment is working. The study will look at various aspects of the disease, including quality of life, ability to work, and any hospital visits related to Crohn’s Disease. Researchers will also keep track of any side effects that may occur during the long-term use of the medication.

1 Initial assessment

After completing the previous 52-week study (M13-740), your eligibility for this long-term extension study will be evaluated

The study medication (upadacitinib) will be provided in the form of modified-release tablets for oral use

2 Treatment period

You will continue taking upadacitinib tablets by mouth daily

The study will monitor your condition for up to 96 months (8 years)

Regular assessments will occur at months 12, 24, 36, 48, 60, 72, 84, and 96

Your dose may be adjusted to 30 mg daily if needed

3 Regular monitoring

Your Crohn’s disease symptoms will be regularly evaluated

Blood tests will be performed to check inflammation markers

Stool samples will be collected to measure specific proteins related to gut inflammation

Gut examinations (endoscopy) will be conducted at specific intervals

Quality of life questionnaires will need to be completed during visits

4 Safety assessments

Regular checks will monitor any side effects or changes in your health

Your use of other medications, particularly steroids, will be tracked

Any hospital visits or procedures related to Crohn’s disease will be recorded

Who Can Join the Study?

  • Must have completed the previous study (Study M13-740) through Week 52
  • Must be an adult (18 years or older)
  • Both men and women can participate
  • Female participants must meet one of these conditions:
    • Be postmenopausal (no longer having menstrual periods for at least 12 months naturally)
    • Be surgically sterile (having had surgery that prevents pregnancy)
    • Use an effective method of birth control during the study
  • Must be able and willing to participate in a long-term study testing the medication upadacitinib
  • Must be diagnosed with Crohn’s Disease

Who Cannot Join the Study?

  • Patients who did not complete the previous Study M13-740
  • Patients younger than 18 years old
  • Pregnant or breastfeeding women
  • Patients with active tuberculosis (an infectious bacterial disease affecting the lungs)
  • Patients with serious active infections requiring treatment
  • Patients with history of lymphoma (cancer of the lymphatic system) or other malignancies in the past 5 years
  • Patients with severe liver disease
  • Patients with severe kidney disease requiring dialysis
  • Patients currently taking other biological treatments for Crohn’s Disease
  • Patients with a known allergy or hypersensitivity to upadacitinib
  • Patients with uncontrolled high blood pressure
  • Patients with severe heart conditions
  • Patients participating in other clinical trials
  • Patients unable to provide informed consent
  • Patients with history of drug or alcohol abuse within the past 6 months

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
Santa Sp. z o.o. Lodz Poland
MVZ Portal 10 Munster Germany
Universitair Medisch Centrum Utrecht Utrecht The Netherlands
Centre Hospitalier Universitaire Amiens Picardie Amiens France
Gastro LM s.r.o. Presov Slovakia
Htgwhajf Hfewcthb Hvidovre Denmark
Czup De Njany Vandoeuvre Les Nancy France
Avgcwmlwe Uxf Amsterdam The Netherlands
Pzbbvfefi Iwnwefjr Mzsknbld Mqgzsmojrgok Sqmar Wosrknlnznrc I Acobczxttazzr Warsaw Poland

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Denmark Denmark
Not recruiting
24.10.2016
France France
Not recruiting
24.10.2016
Germany Germany
Not recruiting
24.10.2016
Poland Poland
Not recruiting
24.10.2016
Slovakia Slovakia
Not recruiting
24.10.2016
The Netherlands The Netherlands
Not recruiting
24.10.2016

Trial locations

Investigated drugs:

Upadacitinib (also known as ABT-494) is a medication that works by reducing inflammation in the body. It belongs to a class of drugs called JAK inhibitors. This medication helps control the immune system’s response and is used to treat Crohn’s disease, which is a chronic inflammatory condition affecting the digestive system. The medication is taken orally and helps reduce symptoms such as abdominal pain, diarrhea, and fatigue that are common in people with Crohn’s disease.

Crohn’s Disease – A chronic inflammatory bowel disease that can affect any part of the digestive tract, from mouth to anus, but most commonly involves the end of the small intestine and beginning of the colon. The inflammation caused by Crohn’s disease often spreads deep into the layers of affected bowel tissue, creating patches of inflamed tissue surrounded by healthy areas. The condition can cause abdominal pain, diarrhea, fatigue, weight loss, and malnutrition. Symptoms typically develop gradually and can range from mild to severe, with periods of active disease followed by periods of remission. The disease can cause changes in the bowel wall that lead to scarring and thickening over time.

Trial ID:
2024-510727-19-00
Protocol code:
M14-327
NCT ID:
NCT02782663
Trial Phase:
Therapeutic exploratory (Phase II)

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