Vonoprazan for Eosinophilic Esophagitis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores the effectiveness of vonoprazan for individuals with eosinophilic esophagitis, a condition where certain white blood cells inflame the esophagus, making swallowing difficult. Participants will receive either vonoprazan or a placebo (a pill with no active medication) for 12 weeks, followed by an additional 12 weeks of vonoprazan for all. The trial aims to determine if vonoprazan can reduce the number of these white blood cells in the esophagus. It may suit those with frequent swallowing difficulties who have maintained a stable diet for at least six weeks. As a Phase 2 trial, it measures how well vonoprazan works in an initial, smaller group of people.
Will I have to stop taking my current medications?
The trial requires that you stop taking certain medications like PPIs, PCABs, and corticosteroids before joining. If you're on these, you'll need to stop them for a specific period before the trial starts.
Is there any evidence suggesting that vonoprazan is likely to be safe for humans?
Research has shown that vonoprazan is usually well-tolerated. Studies indicate its safety is comparable to lansoprazole, a common treatment for stomach acid issues, even with long-term use. For instance, one study found vonoprazan safe over five years without causing serious stomach problems.
Another study tested vonoprazan in everyday settings and found it safe and effective. While side effects are possible, research so far suggests vonoprazan is safe for long-term use in conditions like acid reflux.
This trial is in phase 2, meaning researchers are still assessing its safety and effectiveness for treating eosinophilic esophagitis. However, current data suggests vonoprazan is generally safe to use.12345Why do researchers think this study treatment might be promising for eosinophilic esophagitis?
Vonoprazan is unique because it works differently from most treatments for eosinophilic esophagitis, which often involve proton pump inhibitors (PPIs) like omeprazole. Unlike PPIs, vonoprazan is a potassium-competitive acid blocker (P-CAB) that blocks acid production in the stomach more quickly and effectively. This unique mechanism could offer faster relief for patients with eosinophilic esophagitis. Researchers are excited because this could provide a more efficient treatment option with potentially fewer side effects, addressing the need for alternatives to traditional therapies.
What evidence suggests that vonoprazan might be an effective treatment for eosinophilic esophagitis?
Research has shown that vonoprazan, a medicine that blocks stomach acid, might help treat eosinophilic esophagitis (EoE). Studies have found that it works similarly to proton pump inhibitors (PPIs), which help many people with EoE by reducing stomach acid. Even for patients who did not improve with regular PPI treatments, vonoprazan showed promising results. In some cases, it worked better than other acid blockers. This trial will evaluate vonoprazan as a treatment option for people with EoE, with participants initially receiving either vonoprazan or a placebo, followed by vonoprazan.26789
Who Is on the Research Team?
Medical Director
Principal Investigator
Phathom Pharmaceuticals
Are You a Good Fit for This Trial?
Adults with Eosinophilic Esophagitis (EoE) who've had dysphagia episodes, can follow study procedures, and have a certain level of eosinophils in their esophagus. They must be able to swallow pills and maintain a stable diet. Women must use contraception if they're of childbearing potential.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive vonoprazan 20 mg or placebo for 12 weeks
Extended Treatment
Participants continue to receive vonoprazan 20 mg for an additional 12 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Vonoprazan
Find a Clinic Near You
Who Is Running the Clinical Trial?
Phathom Pharmaceuticals, Inc.
Lead Sponsor