A Study of Long-acting Antibodies Alone and in Combinations for Moderate to Severe Ulcerative Colitis
This study is looking at potential new treatments for adults living with moderate to severe ulcerative colitis, a type of inflammatory bowel disease. Researchers want to find out how effective and safe these new long-acting medicines are. The study will test different new treatments, sometimes on their own and sometimes in combinations, against a placebo (a dummy treatment with no active medicine). The medicine is given first as a drip into a vein, and then as injections under the skin. This research is in Phase 2, meaning it's an important step for figuring out if these new medicines could help people with ulcerative colitis in the future.
At a glance
What is this study about?
This study is investigating new long-acting medicines for adults who have ulcerative colitis that is moderate to severe. Ulcerative colitis is a long-lasting condition where the large intestine (colon) becomes inflamed, leading to symptoms like tummy pain and urgent toilet trips. The main aim of this study is to see if these new medicines can help improve symptoms and make people feel better, and also to check that they are safe to use. Researchers are particularly interested in how these new treatments work over time.
The study will look at several different approaches. Some people will receive one of the new medicines on its own, while others will receive a combination of two new medicines. Some will even receive a placebo, which looks like the study medicine but doesn't contain any active drug. This helps researchers compare the real effects of the new medicines. Initially, the medicine will be given through a drip into a vein, and then continued with injections under the skin.
This is a 'Phase 2' study, which means it's an important step in developing new treatments. It's designed to gather more information on how well the treatments work and if they are safe, before potentially moving on to larger studies. The medicines being tested are still investigational, meaning they haven't been approved for general use yet.
Key takeaways
- This study is for adults with moderate to severe ulcerative colitis.
- It tests new long-acting medicines, alone and in combinations, against a dummy treatment.
- The goal is to check how safe and effective these potential new medicines are.
- Participation involves initial IV drips followed by subcutaneous injections and regular check-ups.
- You might gain access to new treatments and contribute to future care for others.
Who may be eligible?
To join this study, you would need to be an adult who has been diagnosed with ulcerative colitis for at least three months. Your diagnosis must be confirmed by specific tests, like an endoscopy (a camera test) and biopsies (tissue samples). Your ulcerative colitis needs to be active, affecting a certain length of your bowel, and doctors would describe your condition as moderately to severely active based on specific scores and symptoms like bleeding.
There are also reasons why you might not be able to join. For example, if you have Crohn's disease or another type of inflammatory bowel disease that isn't ulcerative colitis. You also couldn't take part if you have a very severe form of colitis that might need emergency surgery or if you've already tried and failed many types of advanced treatments (four or more). Researchers want to make sure the study includes people who are a good fit for testing these specific new medicines safely.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older?
- Have you been diagnosed with ulcerative colitis for at least 3 months?
- Is your ulcerative colitis currently active and considered moderate to severe by your doctor?
- Do you *not* have Crohn's disease or a very severe form of colitis needing immediate surgery?
- Have you *not* tried four or more advanced treatments for ulcerative colitis that didn't work?
What does participation involve?
If you decide to take part, the study will have two main phases. In the first phase (Part A), which is open to everyone eligible at the start, you would receive one of the new medicines on its own. This part helps researchers check how safe the medicine is and get an early idea of how well it works. After Part A is underway, a second phase (Part B) will begin. In Part B, you would be randomly assigned to receive either one of the new medicines alone, a combination of new medicines, or a placebo (a dummy treatment).
Throughout the study, you would attend regular appointments for assessments. This would include check-ups, blood tests, and potentially further endoscopies to monitor your condition and how you're responding to the treatment. The new medicines are given as an initial drip into a vein, followed by regular injections under the skin (that you or a healthcare professional might learn to do). The total duration of your participation would depend on which treatment you receive and how your individual journey through the study unfolds.
Potential risks and benefits
Locations (223)
- Site 024Verified postcodeCanoga Park, United States· Recruiting
- Site 023Verified postcodeLa Jolla, United States· Recruiting
- Site 012Verified postcodeLancaster, United States· Recruiting
- Site 033Verified postcodeColorado Springs, United States· Recruiting
- Site 007Verified postcodeKissimmee, United States· Recruiting
- 029Verified postcodeMiami, United States· Recruiting
- Site 006Verified postcodeKansas City, United States· Recruiting
- Site 030Verified postcodeLouisville, United States· Recruiting
- Site 035Verified postcodeMarrero, United States· Recruiting
- Site 011Verified postcodeGlen Burnie, United States· Recruiting
- Site 003Verified postcodeBoston, United States· Recruiting
- Site 028Verified postcodeRochester, United States· Recruiting
Common questions
What is ulcerative colitis?
Ulcerative colitis is a long-term condition where the lining of your large intestine (colon and rectum) becomes inflamed, causing symptoms like tummy pain, diarrhoea, and bleeding.
What does 'long-acting antibodies' mean?
These are a type of medicine designed to stay in your body for a longer time, potentially requiring less frequent doses than some other treatments.
What is a placebo?
A placebo is a 'dummy' treatment that looks just like the real medicine but contains no active ingredients. It helps researchers understand the true effects of the study drug.
What is a 'Phase 2' study?
Phase 2 studies are an early stage of clinical research. They aim to find out if a new treatment is safe and effective in a small group of people before larger studies are done.
How will the medicine be given?
Initially, you'll receive the medicine through a drip into a vein (intravenous), and then it will switch to injections under the skin (subcutaneous).
How to find out more
SKYLINE-UC Trial Center
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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