Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A Phase 2, Multicenter, Open-Label Extension (OLE) Study to Observe the Long-Term Efficacy, Safety, and Tolerability of Repeated Administration of Upadacitinib (ABT-494) in Subjects with Crohn's Disease

This research is an ongoing study for people with Crohn's disease who have already taken part in a previous trial using the drug Upadacitinib. The main goal is to find out how well Upadacitinib works in the long run to reduce symptoms and keep people in remission (when symptoms disappear). Researchers will also carefully watch for any side effects and how well people tolerate the drug over several years. They'll regularly check if volunteers are feeling better, if their gut health is improving, and if they can stop taking steroids. This helps us understand the long-term benefits and safety of Upadacitinib for Crohn's disease.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

AbbVie Deutschland GmbH & Co. KG

Enrolment target

Start

24 Jun 2024

Crohn's Disease (CD)

What is this study about?

This study is designed for people who have Crohn's disease and have already been involved in an earlier study looking at a medication called Upadacitinib. Think of it as a follow-up – the original study found out if Upadacitinib could help people in the short term, and now this study wants to see what happens over a much longer period.

The main aim is to understand two key things: how effective Upadacitinib is at managing Crohn's symptoms and keeping the disease under control over many years, and how safe it is to take for a long time. Researchers will be looking at whether people's symptoms improve, if their Crohn's disease goes into remission (meaning symptoms have largely disappeared), and if they can reduce or stop other medications like steroids. They'll also monitor any side effects that might occur.

By following participants for an extended period, this study hopes to provide valuable information about the long-term benefits and potential risks of Upadacitinib. This will help doctors and patients make more informed decisions about treatment options for Crohn's disease in the future.

Key takeaways

This study is for adults with Crohn's disease.
It's a long-term follow-up for those who previously took Upadacitinib.
Researchers are checking the drug's long-term safety and effectiveness.
The goal is to see if symptoms stay under control and if side effects occur over time.
Participants will have regular medical check-ups and continue taking the medication.
It aims to provide important information for future Crohn's treatments.

Who may be eligible?

To be part of this study, you must have Crohn's disease.

You also need to have successfully completed a previous study (Study M13-740) that involved taking the same medication, Upadacitinib. This means the doctors leading the current study will already know about your health and how you responded to the drug in the past.

Only adults aged 18 years and older can take part, regardless of whether they are male or female.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Do I have Crohn's disease?
Am I 18 years old or older?
Did I previously take part in Study M13-740 which involved Upadacitinib?
Am I willing to have regular health checks and continue taking the study medication?

Answer every question to see your result.

What does participation involve?

If you join this study, you would continue to take the study medication, Upadacitinib. You'll have regular visits to the clinic, which will include examinations, blood tests, and sometimes other tests like ones to check your gut health. These ongoing checks are to monitor how well the medication is working for you and to look for any side effects. The study plans to follow participants for several years, potentially up to 8 years, to gather long-term information.

Potential risks and benefits

Potential benefits of taking part could include continued improvement in your Crohn's disease symptoms and overall well-being, as well as ongoing access to the study medication. However, like all medications, Upadacitinib can have side effects, and some might be serious. The research team will regularly check for these. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (6)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Slovakia
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Unverified
Netherlands
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Unverified
France
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Unverified
Germany
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Unverified
Poland
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Unverified
Denmark

Common questions

What is Upadacitinib?

Upadacitinib is a medication being studied for conditions like Crohn's disease to help reduce inflammation and symptoms.

What does 'remission' mean in Crohn's disease?

Remission means that the symptoms of your Crohn's disease have significantly reduced or disappeared, and your disease is under good control.

Why is this study important for people with Crohn's disease?

This study helps us understand if Upadacitinib continues to work well and safely over many years, offering more long-term treatment insights for Crohn's disease.

Will I know if the drug is working for me?

The study team will regularly check your symptoms, and conduct tests to see how your Crohn's disease is responding to the treatment.

Can I stop taking part in the study if I want to?

Yes, you are free to leave the study at any time, and this will not affect your usual medical care.