Clinical research studies are conducted to determine if potential new drugs are safe and if they work. Clinical research studies are performed according to government regulations that help protect the safety and rights of study participants.
A clinical investigator is a medical researcher in charge of conducting a clinical study and ensuring the well-being of study volunteers. The investigators conducting the DIVERSITY and SELECTION clinical studies are all qualified licensed physicians and medical specialists.
An investigational drug or research study drug is a drug that has not yet been approved by the local country regulatory agency for prescription by doctors.
Yes, participation in any clinical research study is completely voluntary. If you decide to stop participating at any time, your exit will not affect the medical care you would otherwise receive.
Informed consent is the process of learning the key facts and details about a clinical research study. This information will be provided to you before you decide to participate and as new information becomes available during your continued participation throughout the study. Once you have read the informed consent form and understand the details, including the risks and benefits, you can decide whether or not to sign the document. The informed consent process also includes opportunities for you to ask questions about the study. No study-related procedures will take place without a signed informed consent form.
Information about your personal health will be kept private and confidential in an encrypted database in France by the company hosting this website, Neonstone Ltd. With your permission, the information you provide via the prescreening form on this website about your medical history and health condition will be transferred to the study doctor’s office. A representative from the study doctor’s office will contact you to further determine your interest and eligibility. Your personal information will not be disclosed to anyone outside of this clinical research study group without your consent unless disclosure is required by law or regulations of the FDA, EMA, or similar local country regulatory agencies.
After answering the questions in the prescreening form, you will also have the option to sign up for future updates to be notified about other Crohn's disease and ulcerative colitis clinical studies. Respondents who do not qualify in the online prescreening form, or who are unable to locate a convenient site, will also be able to opt-in for updates which may affect their ability to participate. If you opt to receive these updates, you may receive emails from us in the future, but will have the option to decline further communications at any time.
These clinical studies are being conducted to find out whether the investigational drug is effective in treating the signs and symptoms of Crohn's disease and ulcerative colitis.
Your answers to the questions in the prescreening form will determine if you meet certain key criteria that are required to participate in the DIVERSITY or SELECTION studies. If you meet these criteria, you can provide your contact information to the participating doctor’s office of your choice via our website.
Their staff will then answer any questions you may have and will discuss the next steps to further determine whether you meet all of the criteria for participation. Not all people who complete the prescreening form will be able to participate in one of the studies.
If you meet the criteria in the prescreening form, the staff at the doctor’s office will ask you to review and sign an informed consent form that explains more about the study. Then the staff at the doctor’s office will ask more questions and run some medical tests to see if you meet all eligibility criteria to participate in the clinical research study.
If you qualify for DIVERSITY or SELECTION, you will come to the study doctor’s office for periodic visits for study exams to evaluate your general health and to discuss your Crohn’s disease or ulcerative colitis.
Feel free to discuss your study-related medical care with the study doctor or staff at any time during the course of the research study. It is important to take all study drugs as prescribed. You will answer questions regarding how you feel during your participation and whether the study drugs have been taken at the appropriate times. Participants are encouraged to discuss study participation with their general practitioner.
The studies each consist of 14-21 visits. The visits are 1-8 weeks apart, over a period of approximately 58 weeks (about one year).
Approximately 1,320 people worldwide will be enrolled in the DIVERSITY study, and approximately 1,300 people will be enrolled in the SELECTION study. These studies are looking for people who have moderate to severe active Crohn's disease or ulcerative colitis.
If you participate, study-related doctors’ visits, monitoring of your condition, and the study drug will be provided to you at no cost. Other drugs you may be taking for your Crohn’s disease or ulcerative colitis will not be paid for by the study. The study staff at the participating site will be able to answer any questions you may have. Participants are encouraged to discuss study participation with their general practitioner.
The choice to participate in this study is entirely yours. Your primary care doctor does not have to give his or her permission or a referral for you to participate in this study. However, you should tell your primary care physician about your participation and keep him or her informed about the study. You should also keep the study doctor informed if your primary care physician changes your Crohn's disease or ulcerative colitis treatment or if there are other changes to your health during the study.
A long-term extension study is a clinical study that allows participants to continue on the study drug after they have finished their participation in the original study. After completion of either the DIVERSITY or SELECTION studies, participants may have the opportunity to enroll in a long-term extension study of the investigational drug in Crohn’s disease or UC.
This investigational drug is a JAK1 inhibitor. JAK1 is a protein inside certain cells, including immune cells, which stimulates their activity. When immune cells are overactive, they can cause inflammation and trigger symptoms such as abdominal pain, diarrhea and bloody stools. These clinical research studies will help determine if the investigational drug reduces the signs and symptoms of Crohn’s disease and ulcerative colitis.
A placebo does not contain any active ingredients and looks the same as the study drug. The use of a placebo is important in clinical research studies because it allows researchers to determine how well the active study drug may be working.
Some people who participate in these studies will receive the active investigational drug and some will receive a placebo. Neither you nor the study doctor will be able to choose or know which study group you are in. However, the study doctor can find out if there is an emergency or if it is necessary to know for your health.
You could experience side effects associated with the study drug. The study staff will discuss the known risks in detail with you before you decide to participate.
After a clinical study is complete, all of the information is collected and analysed to help determine the study drug’s safety and efficacy. Please consult with your study doctor or regular healthcare provider to determine your treatment options after you have completed the study.
The DIVERSITY and SELECTION studies are being conducted by trained, qualified, and licensed medical doctors worldwide.
Gilead Sciences, Inc. and Galapagos NV are developing the investigational study drug and sponsoring these clinical research studies. GILEAD is a trademark of Gilead Sciences, Inc. All other trademarks referenced in this document are the property of their respective owners.