Duvakitug for Ulcerative Colitis
(SUNSCAPE-2 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called duvakitug to determine its effectiveness for people with ulcerative colitis, a condition causing inflammation and sores in the colon. The study compares three different doses of duvakitug with a placebo (a treatment with no active drug) to identify the most effective dose. It aims to assess the long-term safety and effectiveness of duvakitug. Individuals with moderate to severe ulcerative colitis who have responded well to previous treatments might be suitable candidates for this trial. As a Phase 3 trial, it represents the final step before FDA approval, offering participants a chance to contribute to the potential availability of a new treatment.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that duvakitug is generally safe. In earlier studies, patients handled the treatment well, experiencing only a few side effects. Most participants reported mild to moderate reactions, common with new treatments, such as minor skin irritation at the injection site.
In another study on similar conditions, duvakitug showed promise in reducing inflammation, crucial for treating ulcerative colitis. This treatment is in the final stages of testing, indicating that its safety has been carefully evaluated so far. However, as with any treatment, some risk remains. Researchers will closely monitor participants to ensure their safety during the trial.12345Why do researchers think this study treatment might be promising for Ulcerative Colitis?
Most treatments for ulcerative colitis, like mesalamine, corticosteroids, and biologics, focus on reducing inflammation in the colon. But Duvakitug works differently, targeting specific pathways involved in the immune response, which could mean more precise control of inflammation. Researchers are excited because Duvakitug is administered through a subcutaneous injection, which can be more convenient and less invasive compared to some other treatment methods like intravenous infusions. This combination of a new mechanism of action and a more patient-friendly delivery method makes Duvakitug a promising option for those with ulcerative colitis.
What evidence suggests that duvakitug might be an effective treatment for ulcerative colitis?
Research has shown that duvakitug may help treat ulcerative colitis. In one study, 36% of patients taking a 450 mg dose and 48% taking a 900 mg dose experienced significant symptom relief, compared to 20% who took a placebo (a pill with no active medicine). This indicates that many more people felt better with duvakitug than with no treatment. The treatment also led to improved results when doctors examined the intestines with a camera. This evidence suggests duvakitug could be very effective for people with moderate to severe ulcerative colitis.14678
Are You a Good Fit for This Trial?
This trial is for adults aged 18 to 80 with moderately to severely active Ulcerative Colitis. Eligible participants must have shown a clinical response in a previous study (SUNSCAPE-1) and completed an endoscopy. Those under 18 may join if they are fully physically developed.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Pivotal Maintenance Sub-Study
Participants receive the study medication or placebo for maintenance of ulcerative colitis
Follow-up
Participants are monitored for safety and effectiveness after treatment
Open-Label Extension (OLE) Sub-Study
Participants may opt into continuation of treatment long-term with open-label duvakitug
What Are the Treatments Tested in This Trial?
Interventions
- Duvakitug
Find a Clinic Near You
Who Is Running the Clinical Trial?
Sanofi
Lead Sponsor
Paul Hudson
Sanofi
Chief Executive Officer since 2019
Degree in Economics from Manchester Metropolitan University
Christopher Corsico
Sanofi
Chief Medical Officer
MD from Cornell University, MPH in Chronic Disease Epidemiology from Yale University
Teva Branded Pharmaceutical Products R&D LLC
Industry Sponsor