Rosnilimab for Ulcerative Colitis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called Rosnilimab, an experimental drug for people with moderate to severe ulcerative colitis (UC), a condition that causes inflammation and sores in the colon. The goal is to determine the safety and effectiveness of Rosnilimab compared to a placebo, which contains no active medicine. Participants will receive either a high dose, low dose, or placebo to compare results. Ideal candidates are those who have struggled with other UC treatments and continue to experience symptoms. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
Do I need to stop my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that Rosnilimab is likely to be safe for humans?
Research has shown that Rosnilimab is generally safe and well-tolerated. In earlier studies, participants taking Rosnilimab did not develop cancer or die from the treatment. Reports suggest that Rosnilimab is safer compared to other common treatments for similar conditions, such as biologics or JAK inhibitors. Overall, the treatment has demonstrated promising safety evidence, making it a potential option for those considering joining clinical trials for ulcerative colitis.12345
Why do researchers think this study treatment might be promising for ulcerative colitis?
Unlike the standard treatments for ulcerative colitis, which often include anti-inflammatory drugs like mesalamine or immunosuppressants such as azathioprine, Rosnilimab offers a novel approach. Researchers are excited about Rosnilimab because it targets specific immune pathways that are not addressed by existing therapies. This could potentially lead to more effective relief of symptoms and better disease management. Furthermore, Rosnilimab is administered via subcutaneous injection, which may provide a more convenient and less invasive option compared to some current treatments that require intravenous administration.
What evidence suggests that Rosnilimab might be an effective treatment for ulcerative colitis?
Research has shown that Rosnilimab, a new treatment under study in this trial, may help with ulcerative colitis (UC). Studies have found that certain immune cells, called PD-1+ T cells, are more common in the inflamed areas of people with UC, and Rosnilimab targets these cells. Early results suggest that Rosnilimab works similarly to JAK inhibitors, which are known to reduce inflammation in UC. In other diseases like rheumatoid arthritis, Rosnilimab demonstrated increasing benefits over six months, suggesting it might work well over time. While more research is needed specifically for UC, these early findings are promising. Participants in this trial will receive either a high dose or low dose of Rosnilimab, or a placebo, to evaluate its effectiveness and safety.12345
Who Is on the Research Team?
Zurab Machaidze, MD
Principal Investigator
AnaptysBio, Inc.
Are You a Good Fit for This Trial?
This trial is for adults over 18 with moderate to severe active ulcerative colitis, confirmed by a recent colonoscopy. Participants should have been diagnosed before Day 1 of the study and show specific scores on medical scales that measure UC severity.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Rosnilimab or placebo for 12 weeks to evaluate efficacy and safety
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Rosnilimab
Find a Clinic Near You
Who Is Running the Clinical Trial?
AnaptysBio, Inc.
Lead Sponsor