The aim of this study is to find out whether a study medication could be a potential new treatment option for adults who have moderate to severe ulcerative colitis.
Approximately 40 people across Europe and the USA are expected to take part.
The study is divided into four sections:
- Screening – you will undergo some tests to see if the study is right for you.
- Part A: Induction treatment – you will receive the study medication for 12 weeks.
- Part B: Maintenance treatment – if you continue in the study, you will receive the study medication for a further 92 weeks.
- Follow-up – you will have your health monitored for 14 weeks after finishing the study medication.
All participants in the study will receive the study medication.
You may then be able to join Part B of the study. All participants continuing in Part B (Maintenance treatment) will receive the study medication.
The study medication will be administered once every 4 weeks.
- In Part A, an intravenous (IV) infusion administers the study medication in liquid form from a bag, slowly into a vein in your arm.
- In Part B, a subcutaneous (SC) injection delivers the study medication via a small needle under the skin.
Study treatment could last up to 2 years. Overall, the study could last up to 30 months (2 and a half years).
You will be asked to attend around 30 visits to the study center throughout the study to have some medical tests and assessments.
No medication is completely without side effects. One of the aims of this study is to find out about any side effects the study medication may cause. The study team will be monitoring your health and well-being closely and will stop study treatment if there are any concerns.
During visits to the study center, you will undergo tests and assessments. The purpose of these tests is to check on your health and understand how your body is responding to the experimental study medication.