Frequently asked questions (FAQs)
An investigational medicine is a medicine that has not been approved for use by the public.
Clinical studies (also known as clinical trials) are carefully controlled scientific investigations that help us answer important questions like:
Does an investigational medicine work?
Does it cause any unwanted effects?
Does it work better than existing options?
Thousands of people all around the world take part in clinical studies every year. The results of these studies must be approved by health authorities before a medicine or therapy can be used by the general public.
What are the different phases of clinical studies?
An investigational medicine must pass through several stages of clinical studies before it can be submitted for approval for general use by the public. Each stage helps us answer different questions. Only once an investigational medicine has been shown to be safe in one phase may it progress to the next.
Phase 1
The effect of an investigational medicine is assessed in a small group of people. This phase is important for ensuring that an investigational medicine is safe and helps us learn which doses may have a therapeutic effect.
Phase 2
These studies are conducted in a slightly larger group of people. The investigational medicine may be compared with a placebo to help us learn if it’s safe and effective, and to find out if there are any potential unwanted effects. It also helps determine the most appropriate dose for Phase 3.
Phase 3
These are larger and longer studies to help us understand more about the safety and effectiveness of an investigational medicine. Data from these studies help us determine if an investigational medicine can be approved for use by the public.
All studies in this program are in Phase 3.
Approved
Medicine approved for use by the public.
We’re conducting four clinical studies for people living with IBD: 2 for Crohn’s disease and 2 for ulcerative colitis. It’s called a program of clinical studies because we’re assessing the same investigational medicine across all 4 studies. If you decide to join, you’ll only take part in 1 study in this program. Which study you join will depend on whether you’re diagnosed with Crohn’s disease or ulcerative colitis. Please note, not all study sites are running all 4 studies. We therefore recommend you contact us to find out which studies are available near you.
We collaborated with IBD organizations, people living with IBD, and expert gastroenterologists to help shape important aspects of these studies. For example, how we assess eligibility, how we evaluate if the investigational medicine is working, and how we can support diversity. This process helped us ensure that the studies were designed to support the specific needs of people living with IBD.
Medicines and diseases can affect people differently depending on their age, gender, ethnicity, and race. That’s why it’s so important to have people from different backgrounds in clinical studies – so that we can learn more about how potential treatments might work for everyone. Our program of clinical studies is being conducted in approximately 40 countries and is available in over 50 languages, underscoring our commitment to incorporating diversity into our studies.
All study-related medicines and assessments will be provided at no cost to you. We may also be able to reimburse you for any associated costs, such as childcare and transport.
During the optional open-label extension, it may be possible for a trained nurse to conduct the study visits at your home or at another convenient location. The study team will be able to provide you with further information on this.
If you choose to take part in a clinical study in this program, your health may or may not improve. You may experience unwanted effects from your assigned study medicine or the study procedures. However, the study team will monitor you closely with frequent health assessments. You’ll also contribute to important research that could help other people living with IBD in the future.
No, participation is voluntary. It’s completely up to you whether you take part. We recommend discussing the information on this website with your family and friends to decide if joining a clinical study in this program is right for you.
You may withdraw your consent at any time without giving a reason. If you decide to leave the study, you will not lose access to any of your regular care. You’ll just need to let the study team know that you’re thinking about leaving so that they can advise you on how to stop taking part safely.
Your personal data and medical samples will be labeled with a participant identification number. This number is unique to you and not related to or derived from information that identifies you (such as your name or any other personally identifying information). Please speak to the study team if you would like more information on how your data will be protected.
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Please contact us to learn more or find out if you could take part.