Crohn's disease is a type of inflammatory bowel disease (IBD) that can affect any part of the small or large intestines. Crohn's disease causes inflammation of the intestines, which can lead to symptoms of diarrhea, fever, fatigue, abdominal pain, blood in the faeces, reduced appetite, and weight loss. The inflammation often spreads into deeper layers of the bowel tract, causing the symptoms to develop gradually over time. As a result of this, the symptoms of Crohn's disease can range from mild to severe, according to the disease picture.
Sometimes patients experience remission for a period, meaning patients do not experience any signs or symptoms of the disease for a while but eventually, they return. Crohn’s disease can have a severe effect on patients' daily lives, affect their ability to perform regular activities, and in some cases lead to life-threatening complications.
No known cure for Crohn’s disease exists, however therapies exist that can reduce the signs and symptoms of the disease. The currently approved and available treatment options consist of:
Use of medication to reduce inflammation of the intestine, giving the infected segment time to heal, which in return can relieve symptoms.
Removal of the infected segment of the intestine by surgery to return the patient to a better state of quality of life.
Diet and nutritional therapy, as certain foods can worsen the condition.
The aim of the study is to assess the safety and effectiveness of the study medication in patients with moderate to severe Crohn’s disease. By participating in this study, you will have the opportunity to test the study medication being investigated for Crohn’s disease.
If you are qualified and are enrolled in a study, you may receive a placebo instead of the study medication. A placebo is a substance provided instead of the study medication and contains no active ingredients. The use of a placebo is standard practice in research studies investigating the effect of study medications and used as a measure of comparison. Your chance of receiving a placebo will be explained by study staff in advance of your participation.
Please note that participating in a research study and receiving a placebo greatly contributes to the research and necessary to assess the safety and efficacy of a study medication. You have the right to withdraw from participation at any moment in time, without giving any explanations. In that case, the study team will follow you up as appropriate.
Who can participate?
Candidates who fulfill the following criteria may be eligible for the study:
Male and female between 18-75 years
Have a diagnosis of Crohn’s disease of at least 3 months’ duration.
Is diagnosed with moderate to severe Crohn’s disease
Other criteria are also required before you may pre-qualify for participation in the study. To find out, please click on the link below and answer the digital questionnaire.
- British Columbia
- Quebec City
- New York
- North Carolina
There will be no additional costs to you if you choose to participate in this research study. The investigational medication and any tests required by the study are provided by the study team, and you may receive reimbursement for travel expenses incurred by taking part in the research study until your participation is complete.
The research study assesses the safety and effectiveness of investigational medications in treatment of moderate to severe Crohn’s disease. If you are interested and qualify to participate, staff at a study site will provide you with a detailed overview of the steps required to participate before you agree to take part in the study. The staff will also take the time to review and discuss any questions you may have to ensure you are comfortable with participation.
The duration of study participation is approximately 112 weeks, in four following periods:
The screening period is conducted to confirm your eligibility for the research study based on clinical or laboratory assessments. For the screening session, you will have to visit a study site up to a month before you may receive the study medication. At the screening visit, staff will ask you some questions about your health and perform some tests (e.g., blood test, pregnancy test, measure body weight and height, ECG, etc.), including an endoscopy. More detailed information about these tests and endoscopy will be provided to you once you are at the clinic.
During the screening period, you will also have to record data daily in an electronic diary throughout your participation. The study staff will explain how to use the electronic diary.
To participate in the study, some drugs used to treat Crohn's disease or other diseases will have to be terminated before receiving the study medication. This is called a washout period. The period can vary according to the type of drug you are currently using. The study staff will provide you with information about the washout period's length.
Study treatment and Open Label Extension period
If you are eligible to participate in a study after the screening period, you will enter a study treatment period. Here you will receive either a study medication or a placebo. The maximum length of exposure to the study medication is up to 104 weeks, however the study treatment period can vary accordingly to how you respond to the study medication. During the study treatment period, you will take the study medication by oral capsules twice a day, once in the morning and once in the evening. You will have to visit the study site during the study treatment period for various examinations and to assess your safety while you are participating in the study. In this period, you will also have to enter daily data using the electronic study diary.
After termination of the study treatment, you will enter a 4-week post-study treatment follow-up period. During this period, you will be in contact with the study team who will monitor your health. Besides, your health will be closely monitored by study staff throughout your participation in the research study. You can withdraw your participation at any time without providing any reason.
In the figure below, you can see the maximum duration of the different periods of the research study.