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
Trial Overview
The trial is testing the effectiveness of Vonoprazan 20 mg daily against a placebo for reducing eosinophil levels in the esophagus after 12 weeks, with an extended evaluation up to 24 weeks.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Participants will be administered vonoprazan at a dose of 20 mg for 12 weeks. Participants will continue to receive the same dose for an additional 12 weeks.
Participants will be administered placebo for 12 weeks. Participants will then receive vonoprazan 20 mg for an additional 12 weeks.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Phathom Pharmaceuticals, Inc.
Lead Sponsor
Citations
A 96-week evaluation in patients with PPI-refractory disease
At 8 weeks, vonoprazan (20 mg) has shown healing rates that are 3.0-8.5% higher than those of lansoprazole (30 mg), and up to 1.1-fold greater ...
Vonoprazan shows efficacy similar to that of proton pump ...
Conclusions: Vonoprazan showed similar efficacy to PPIs in EoE. Keywords: Eosinophilic esophagitis; Esophagus; Gastric acid; Potassium- ...
Sustained Acid Suppression by Potassium-Competitive ...
We have begun an investigation of the effects of vonoprazan on patients with EoE who were found to be resistant to initial PPI (esomeprazole) therapy over 3 ...
Effectiveness of Potassium-Competitive Acid Blockers and ...
PPIs have been effective in more than half of the patients with EoE, with a clinical response rate of 65.0% (95% confidence interval, 57.2% to ...
Proton Pump Inhibitors for Inducing and Maintaining ...
Proton pump inhibitor (PPI) therapy results in clinical and histological remission in approximately 50% of eosinophilic esophagitis (EoE) ...
6.
investors.phathompharma.com
investors.phathompharma.com/news-releases/news-release-details/phathom-pharmaceuticals-announces-first-patient-dosed-phase-2News Release
Phathom Pharmaceuticals Announces First Patient Dosed in Phase 2 Study of VOQUEZNA® (vonoprazan) in Eosinophilic Esophagitis (EoE) ... safety ...
Study Details | NCT04124926 | Efficacy and Safety of ...
A Phase 3, Randomized, Double-Blind, Two Phase, Multicenter Study to Evaluate the Efficacy and Safety of Vonoprazan 20 mg Compared to Lansoprazole 30 mg for ...
Vonoprazan as a Long-term Maintenance Treatment for ...
In this phase IV randomized trial, vonoprazan had a similar safety profile to lansoprazole after 5 years and maintained healing longer. No malignant gastric ...
9.
journals.lww.com
journals.lww.com/ajg/fulltext/2023/10001/s593_first_interim_analysis_of_safety_and.949.aspxS593 First Interim Analysis of Safety and Effectiveness in...
A multicenter, single-arm, prospective, observational study, which aims to provide safety and effectiveness data on vonoprazan in a real-world setting.
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