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Clinical Trial 17129


Study Summary:

The SHIELD 1 Study for Crohn’s Disease

If you’re living with Crohn’s disease, you’re well aware of how disruptive the symptoms can be to daily life. Diarrhea, abdominal pain, malnutrition, or anemia can be severe enough at times to affect quality of life or work productivity. Because there is no cure for Crohn’s disease or a single therapy that works for everyone, more effective treatment options are needed.

About the SHIELD 1 Study

The purpose of this study is to evaluate the safety of an oral investigational drug (study drug) and see how well it works in people with moderate to severe active Crohn’s disease. This study will look at how people react to the study drug and how the body uses it at different doses.

About the Study Drug

Participants in the SHIELD 1 study will be randomly assigned to receive one of two doses of the study drug or a placebo. A placebo is a capsule that looks like the study drug but does not contain any active medication. Participants have a 2 in 3 chance of receiving a dose of the study drug and a 1 in 3 chance of receiving the placebo. Participating in the SHIELD 1 study may or may not help your Crohn’s disease. However, by taking part in this study you will be making an important contribution to Crohn’s disease research that may benefit people with this condition in the future.

Who can participate in the study?

You (or someone you know) may be eligible for the SHIELD 1 study if you:

  • Are 18 years of age or older
  • Have been diagnosed with Crohn’s disease for at least 4 months
  • Have not responded to, are intolerant of, or stopped using corticosteroids or immunosuppressants
  • Do not have coeliac disease or ulcerative colitis

There are other eligibility criteria that your doctor will review with you.

What will happen during the study?

The study may last up to 22 weeks. During that time, eligible participants will need to:

  • Attend 8 study visits
  • Take the study drug every morning and evening for 12 weeks
  • Visit their doctor every 2 weeks for scheduled study visits
  • Use a telephone system starting 8 days before every other study visit to answer questions about their Crohn’s disease symptoms
  • Answer questions about their health and any medications they are taking
  • Complete questionnaires about their quality of life and employment

Participants who complete 12 weeks of the study may be invited to take part in one of two other studies examining long-term treatment with the study drug. Participants who do not take part in one of these studies will need to come to the study clinic for a final follow-up visit.

Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.