A Phase 3 study of Vonoprazan in patients with Erosive Esophagitis
Research type
Research Study
Full title
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 Healing in Patients with Erosive Esophagitis and to Evaluate the Efficacy and Safety of Vonoprazan (10 mg and 20 mg) Compared to Lansoprazole 15 mg for the Maintenance of Healing in Patients with Healed Erosive Esophagitis
IRAS ID
272094
Contact name
Christina Kyriakidou
Contact email
Sponsor organisation
Phathom Pharmaceuticals, Inc.
Eudract number
2019-002579-33
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 4 months, 16 days
Research summary
Summary of Research
The study’s Sponsor is Phathom Pharmaceuticals, Inc.
This study is examining Erosive Esophagitis (EE), a disease which causes heartburn, burning sensations in the throat and pain when swallowing. This is due to acid reflux, with the acid eroding/damaging the aforementioned bodily functions.
Standard treatment for EE is to use medication called Proton Pump Inhibitors (PPI). As Proton Pumps are responsible for acid secretion in the stomach, PPIs attempt to stop/block extra acid from being produced, which results in the erosive damage.
The study drug, Vonoprazan, belongs to a class of acid-inhibitory agents called “potassium-competitive acid blockers” and is being developed for healing of all grades of EE with relief of heartburn, plus maintenance of healing of all grades of EE and relief of heartburn.
Vonoprazan has been tested in humans previously and the results have been favourable, so it’s considered to be safe and tolerable. Additionally, Vonoprazan is already being marketed in Asian and Latin America countries. As of 2015, an estimated 24 million patients in Japan have been treated with Vonoprazan, which means it’s becoming an established product there.
This study will further examine the safety and effectiveness of the drug in Western countries, after favourable results and establishing of Vonoprazan in Asian and Latin American countries. The examination primarily concerns the healing and maintenance of healing of EE by Vonoprazan.
1000 participants are expected to take part globally. Depending on study criteria, participants will need to have 10-12 visits to the study site over 10 months.
Study procedures include blood samples, breath tests, endoscopies, ECGs, diary updates and questionnaires.
This double blind study will consist of two main phases, the first of which concerns how Vonoprazan healings EE and the second to see how long the healing is maintained.
Summary of Results
In the Healing Phase, vonoprazan 20 mg successfully met the primary efficacy endpoint, of similar erosive esophagitis (EE) healing rates by Week 8 versus lansoprazole 30 mg. In addition, vonoprazan 20 mg was better in EE healing rates at Week 2 in subjects with more severe EE (Los Angeles (LA) Classification Grade C or D) at baseline and similar for the percentage of 24-hour heartburn-free days versus lansoprazole 30 mg. Similar results were observed between vonoprazan 20 mg and lansoprazole 30 mg for the secondary efficacy endpoint of percentage of subjects with onset of sustained resolution of heartburn by Day 3. Clinically meaningful differences favoring vonoprazan were observed for the healing of all EE grades at Week 2 and at Week 8 in subjects with more severe EE.
In the Maintenance Phase, vonoprazan 10 mg and 20 mg successfully met the primary efficacy endpoint, of similar maintenance of EE healing at Week 24 versus lansoprazole 15 mg, while also meeting the secondary comparisons demonstrating better maintenance of EE healing at Week 24. Both vonoprazan doses also met secondary endpoints demonstrating better maintenance of EE healing at Week 24 in subjects with more severe EE at baseline and similar percentages of 24-hour heartburn-free days versus lansoprazole 15 mg.
Vonoprazan was safe and well tolerated in the treatment of subjects with EE.REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
19/YH/0424
Date of REC Opinion
26 Mar 2020
REC opinion
Further Information Favourable Opinion