A Phase 3 study of Vonoprazan in patients with H. pylori Infection
Research type
Research Study
Full title
A Phase 3 Randomized Multicenter Study to Evaluate the Efficacy and Safety of Open-Label Dual Therapy with Oral Vonoprazan 20 mg or Double-Blind Triple Therapy with Oral Vonoprazan 20 mg Compared to Double-Blind Triple Therapy with Oral Lansoprazole 30 mg Daily in Patients with Helicobacter Pylori Infection
IRAS ID
272741
Contact name
Christina Kyriakidou
Contact email
Sponsor organisation
Phathom Pharmaceuticals, Inc.
Eudract number
2019-002668-28
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 10 months, 21 days
Research summary
Research Summary
The study’s sponsor is Phathom Pharmaceuticals, Inc and this is a Phase 3 study which involves the examination of Helicobacter Pylori (HP) Infection by comparing the effectiveness and safety of the experimental drug Vonoprazan dual and triple therapy against Lansoprazole triple therapy, administered for 14 days.
HP is a bacterium which, when present in the stomach or small intestine, can cause inflammation, ulcers, and certain stomach cancers. A frequently used treatment for HP which treats the bacterial infection and allows healing, is to use a “Triple Therapy” consisting of a Proton Pump Inhibitor (PPI) such as lansoprazole with antibiotics like Clarithromycin and Amoxicillin.
Vonoprazan belongs to a class of acid-inhibitory agents called “Potassium-competitive acid blockers” and its effects have been shown to work better than Lansoprazole. Vonoprazan is being developed in combination with antibiotics to treat HP infections. The primary objective of the trial is to investigate how well Vonoprazan gets rid of HP Infection in comparison to the standard and current treatments.
Vonoprazan has been tested in humans previously and the results showed Vonoprazan is effective in treating HP with safety and tolerability similar to lansoprazole. Additionally, Vonoprazan is already being marketed in Asian and Latin American countries. Since 2015, an estimated 24 million patients in Japan have been treated with Vonoprazan.
Approximately 975 participants are expected to participate in this study with the duration of the study lasting approximately 11 to 15 weeks. Study Assessments will include blood/urine samples, breath tests, endoscopies, ECGs and gastric biopsies. Depending on the treatment group, participants may be aware of what drug they are taking as the study is examining open label dual therapy (two drugs) against two treatment groups of double-blinded triple therapies (three drugs).
Summary of Results
The efficacy of the vonoprazan dual (vonoprazan and amoxicillin) and triple (vonoprazan, clarithromycin and amoxicillin) therapies in the treatment of Helicobacter pylori infection was demonstrated by comparison to lansoprazole triple (lansoprazole, clarithromycin and amoxicillin) therapy.
Both vonoprazan-based regimens successfully met their primary efficacy endpoints, noninferiority of the Helicobacter pylori eradication rate versus lansoprazole triple therapy. More importantly, vonoprazan triple therapy and vonoprazan dual therapy met all secondary endpoints, demonstrating superior eradication rates versus lansoprazole triple therapy in all subjects and subjects with clarithromycin-resistant strains of Helicobacter pylori.
Dual therapy with vonoprazan/amoxicillin and triple therapy with vonoprazan/amoxicillin/clarithromycin were effective, safe, and well tolerated in the treatment of subjects with H pylori infection.REC name
East of Scotland Research Ethics Service REC 2
REC reference
20/ES/0016
Date of REC Opinion
17 Mar 2020
REC opinion
Further Information Favourable Opinion