You’ve been asked to take part in this clinical research study because you suffer from Crohn’s disease.
These pages are designed to support the informed consent process, explaining the study so that you’re able to decide if you want to participate.
Please ask questions at any time. It’s important that you understand what it means to be in this research study before volunteering.
What is a clinical research study?
•• A clinical research study evaluates an investigational drug or device tosee if it’s safe and effective before it’s made available to the public.
•• All approved medications, even over-the-counter cold and painmedications, have been tested in clinical research studies.
•• All clinical research studies involving investigational drugs or devices are monitored by ethics review boards to protect the safety of all participants.
•• Government regulatory agencies review the results of research studies to decide if the investigational drugs or devices are safe and effective andshould be made available
About the investigational drug
•• The investigational drug, LY3074828 is an antibody made in a laboratory that’s intended to neutralize a chemical in the body that causes inflammation, thereby reducing the symptoms of Crohn’s disease.
•• The investigational drug and the placebo will be given to you by injection under the skin and intravenously (using an IV).
•• The study drug will be given to you only during this study and not after the study is over.
What’s the purpose of this study?
•• This study will assess how well LY3074828, the investigational study drug, can reduce the symptoms of Crohn’s disease.–– “Investigational” means that the study drug is currently being tested and isn’t approved for use by the public.
•• In this study, LY3074828 will be compared with a placebo. A placebo looks like the study drug but doesn’t contain any drug. Researchers use a placebo to see if the study drug works better than not taking anything.
The research study phases
You’ll join the study for up to approximately 2 and a half years, and have about 35 study appointments during that time.
What are my chances of getting the investigational drug?
You will have a 66% (2 in 3) chance of receiving the study drug and a 33% chance of receiving placebo. If you receive the study drug, you’ll receive 1 of 3 doses: 1000 mg, 600 mg, or 200 mg. Neither you nor thestudy doctor will know which dose you’re receiving.
What are some of the medical tests and assessmentsin with this study?
Some of the tests and assessments may include, but are not limited to:
•• Physical exam •• Vital signs •• Blood samples •• Height ••Weight •• Colonoscopy
•• Chest X-ray •• ECG •• Pregnancy tests •• Urine samples •• Stool samples
What will I have to do at home?
•• You’ll be asked to log in daily to your electronic handheld study diary.
In your diary, you’ll answer questions about your signs and symptoms.
The study staff will explain how to use the diary.
What are the possible side effects of the investigational drug?
In the first completed studies of LY3074828, the most common effects reported were:
•• Headache
•• Upper respiratory infection
•• Urinary tract infection (UTI)
A complete list of known risks can be found in the informed consent form.
What are the possible benefits of participating?
•• It’s possible that your condition or health may improve because of your
taking part in this study.
•• However, there’s no guarantee that you’ll benefit in any way.
•• Information from this study may help other people in the future.
How will my privacy be protected?
•• All information gathered remains confidential and will be coded with a number to keep your name private
•• No personal information such as your name or contact information will be listed in any reports
•• The coded information will only be seen by:
–– The study team at this clinic
–– The company sponsoring this clinical research study, their licensing partner, and business partners
–– The government regulatory agencies and institutional review board or ethics committee
It’s your choice
••While the investigational drug is being tested as a possible treatment for
migraine headaches, you may or may not receive any medical benefit by
participating.
•• You don’t have to join this study to treat your migraine headaches.
The study doctor will review your options with you.
•• If you decide to participate in this research study, you can change
your mind later — at any time, for any reason — and leave the
research study.
What are the next steps?
•• Read the informed consent document.
••Make sure all of your questions are answered by the study staff.
•• If you choose to participate:
–– Sign and date the informed consent document.
–– Complete or schedule your first study appointment.
We thank you for considering taking part in this clinical research study.
