Disease background
Ulcerative colitis (UC) is a chronic condition that causes inflammation and sores in the lining of the colon (large intestine). UC is a type of inflammatory bowel disease (IBD). It is most commonly diagnosed in young adults but can develop at any age. The condition leads to symptoms like diarrhea, abdominal pain, fatigue, and sometimes weight loss and dehydration. While the exact cause of UC is not fully understood, it is believed to be linked to an overactive immune system attacking the colon. Genetics and environmental factors may also contribute.
UC is typically managed with medications such as anti-inflammatory drugs, immunosuppressants, and biologics to reduce inflammation and control symptoms. In severe cases, surgery to remove the colon may be necessary. Risk factors for UC include a family history of the disease, and there is also an increased risk of developing colon cancer over time if the condition is left untreated.
Therapeutic background
Managing ulcerative colitis can be challenging and does not only affect physical well-being but often the individual’s quality of life and mental health. This research study is therefore assessing the safety and tolerability of a new oral investigational drug for individuals with active ulcerative colitis.
If you are interested and fulfil the criteria for participation, you have the opportunity to participate in this research study.
Who can participate?
- Diagnosed with ulcerative colitis
- Currently having an active flare-up of symptoms
- 18 – 75 years of age
- Failed to achieve remission with current UC medication and recommended a change in therapy
- Have not had surgery to treat their UC
Locations
- London
- Manchester
Reimbursement
If you are eligible and enrolled in the study you will receive financial compensation for your time and expenses, such as travel. The study site staff will provide more information. The study procedure and tests required by the study are provided free of charge.
Study description
The research study will assess the safety and tolerability of an investigational oral medication for individuals with ulcerative colitis. If you are interested and qualify to participate, staff at the study site will provide you with a detailed overview of the steps required to participate before you agree to take part. The staff will also take the time to review and discuss any questions you may have to ensure you are comfortable with participation. You have the right to withdraw from the trial with or without a reason at any time. This will not impact your future possibilities to receive health care.
Screening and baseline visit
Before you can be enrolled in the research study, you will undergo a pre-screening assessment over the phone to assess your eligibility. Your suitability for participation in the study will be further assessed at the study site. At the study site, the study will be explained to you in detail, your questions will be answered, and you will be asked to sign the consent form. Your health status will be evaluated, and additional tests, such as blood tests, may be conducted.
The intervention
The study involves taking a single dose of an investigational oral medication for individuals with active ulcerative colitis. Before receiving the medication, you will enter a screening period to carefully assess your health and suitability for the study. If you qualify, you will be admitted to the study clinic one day before receiving the single dose of the investigational medication. Thereafter, you will be monitored for the next 24 hours before being discharged. In total, your stay at the study site is expected to last 48 hours.
Follow-up
You will have a follow-up visit 5-7 days after your inpatient stay at the study site.
Study timeline
The study drug will be given once only. However, your health status will need to be assessed prior to receiving the study drug and you will be followed-up thereafter.
