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A Study to Assess Adverse Events and Change in Disease Activity of Risankizumab Subcutaneous Induction Treatment for Moderately to Severely Active Crohn's Disease.

We're studying how Risankizumab affects Crohn's Disease symptoms and side effects.

Recruiting
18 years and older
All
Phase 3

Crohn's disease (CD) is a condition that causes inflammation (redness and swelling) in the digestive tract, often affecting the bowels. Symptoms include tummy pain, diarrhea, tiredness, and losing weight. This study looks at how safe and effective a medicine called risankizumab, given as a shot under the skin (subcutaneous), is for treating adults with moderate to severe CD.

The study is divided into three parts: Period A, Period B, and Period C. In the beginning, participants will either get risankizumab or a placebo (a fake treatment). Depending on how they respond, they may get different doses of risankizumab or continue with a placebo in the following periods. In the last part, all eligible participants will receive risankizumab. There will be about 276 adult participants from around the world.

  • The study lasts about 93 weeks, with up to 24 weeks for initial treatment and 52 weeks for follow-up.
  • Participants must have moderate to severe CD diagnosed for at least 3 months.
  • People with other bowel diseases or certain conditions can't join.
Study details
    Crohn's Disease

NCT06063967

AbbVie

4 May 2025

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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