A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis
This study is looking into a new medicine called Duvakitug for people living with moderate to severe Ulcerative Colitis, a long-term condition that affects the bowel. The main goal is to find out if Duvakitug is effective at keeping the condition stable over time and if it is safe to use. Some participants will receive Duvakitug, while others will receive a placebo (a dummy medicine with no active ingredients). This helps researchers see if the new medicine really works better than no treatment. The study involves people who have already shown a good response to Duvakitug in a previous study. It's designed to compare the new medicine against a placebo over 40 weeks, followed by an optional longer period where everyone gets Duvakitug, potentially lasting up to 280 weeks in total.
At a glance
What is this study about?
This research study is called a clinical trial, and its main purpose is to test a new medicine named Duvakitug. It's for people who have Ulcerative Colitis (UC), specifically those whose condition is considered moderate to severe. Ulcerative Colitis is a long-term illness where the lining of the large bowel becomes inflamed and develops tiny sores, causing symptoms like tummy pain, diarrhoea, and tiredness.
The study is focused on whether Duvakitug can help keep UC under control after people have already shown a good response to the treatment. It's also about making sure the medicine is safe to use over a longer period. To do this fairly, some people will receive Duvakitug, and others will get a 'placebo', which looks exactly like the medicine but contains no active ingredients. Neither you nor the study team will know which you are receiving, which helps make the results as accurate as possible.
This is a 'Phase 3' study, meaning it's one of the final stages of testing a new medicine before it might be considered for wider use. By taking part, you would be helping doctors and scientists understand if Duvakitug could be a useful new option for people with Ulcerative Colitis.
Key takeaways
- This study is testing a new medicine called Duvakitug for moderate to severe Ulcerative Colitis.
- It aims to see if Duvakitug can keep the condition stable and is safe over time.
- Some participants will get Duvakitug, others a dummy treatment (placebo) in the first phase.
- Participation could last from about 40 weeks up to over 5 years, with regular clinic visits.
- You must have already shown a good response to Duvakitug in a previous study to join.
- It's voluntary, and you can withdraw at any point without affecting your care.
Who may be eligible?
To be considered for this study, you would generally need to be an adult aged between 18 and 80 years old. In some cases, young people aged 16 or 17 might be able to take part if their physical development is similar to an adult's.
You would also need to have Ulcerative Colitis that is moderate to severe. Importantly, you must have previously participated in another study (called SUNSCAPE-1) and shown a good response to Duvakitug, and completed a bowel examination at the end of that study. If you decide to continue into the longer part of this study, you would need to have completed the initial 40-week period or participated in another specific study (TV48574-IMM-20038).
There are also reasons why you might not be able to join. For example, if you have any other health conditions or allergies to Duvakitug that the study doctor believes would make it unsafe for you to participate or make it hard for you to follow the study rules. These are just some of the main points, and the study team would go through all the details with you to see if you are a good fit.
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 between 18 and 80 years old? (16-17 might be possible if physically mature).
- Do you have moderate to severe Ulcerative Colitis?
- Have you taken part in a study called SUNSCAPE-1 and responded well to Duvakitug?
- Do you feel you could attend regular clinic visits for up to 5 years?
- Are you willing to potentially receive a placebo during the initial part of the study?
- Do you have any other serious health conditions or allergies to Duvakitug?
What does participation involve?
If you decide to take part, the study could last for different lengths of time. The first part, where Duvakitug is compared to a placebo, lasts for 40 weeks. If you do well in this part, you might have the option to continue in a longer part of the study for up to an additional 240 weeks, where everyone receives Duvakitug. This means the total time you could be in the study might be up to about 286 weeks (just over five years).
If you don't join the longer part of the study, your participation would end after the initial 40 weeks, followed by a final check-up about 45 days later. Throughout the study, you would have regular visits to the clinic for check-ups and to see how you're getting on. These visits could be as many as 21 during the initial 40-week period, and up to 11 more if you continue in the longer part. The study team would explain exactly what each visit involves, which might include blood tests, physical examinations, and answering questions about your health and how you're feeling.
Potential risks and benefits
Locations (171)
- Del Sol Research Management, LLC - Site Number: 8400012Verified postcodeTucson, United States· Recruiting
- Southern California GI & Liver Centers - Site Number: 8400062Verified postcodeCoronado, United States· Recruiting
- United Medical Doctors CA - Site Number: 8400044Verified postcodeMurrieta, United States· Recruiting
- Om Research, LLC - Victorville - Site Number: 8400022Verified postcodeVictorville, United States· Recruiting
- Peak Gastroenterology Associates - Colorado Springs - Site Number: 8400039Verified postcodeColorado Springs, United States· Recruiting
- Clinical Research of Osceola - Site Number: 8400013Verified postcodeKissimmee, United States· Recruiting
- Bioresearch Partner-Kendale Lakes - Site Number: 8400053Verified postcodeMiami, United States· Recruiting
- NMC Research LLC - Site Number: 8400033Verified postcodeTampa, United States· Recruiting
- Atlanta Gastroenterology Associates-Site Number: 8400109Verified postcodeAtlanta, United States· Recruiting
- Grand Teton Research Group, PLLC-Site Number: 8400127Verified postcodeIdaho Falls, United States· Recruiting
- GI Alliance - Gurnee-Site Number:Verified postcodeGurnee, United States· Recruiting
- Gastroenterology Health Partners, PLLC - New Albany - Site Number: 8400100Verified postcodeNew Albany, United States· Recruiting
Common questions
What is Ulcerative Colitis?
Ulcerative Colitis is a long-term condition where the large bowel (colon and rectum) becomes inflamed and develops small sores, leading to symptoms like tummy pain, bloody diarrhoea, and fatigue.
What is Duvakitug?
Duvakitug is the name of the new medicine being tested in this study. It's hoped to help manage Ulcerative Colitis, but it's still in the research stage.
What is a 'placebo'?
A placebo is a dummy treatment that looks exactly like the real medicine but contains no active ingredients. It's used to fairly compare the new medicine against no treatment at all.
How long will I be in the study?
The first part lasts 40 weeks. If you choose and are able to, you could continue for an optional longer period, making your total time in the study up to about 5 years.
Do I have to keep taking part?
No, you can decide to leave the study at any time, for any reason. Your decision will not affect your usual medical care.
How to find out more
Trial Transparency email recommended (Toll free for US & Canada)
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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