In short
Clinical trials are investigating LINAPRAZAN GLURATE in people with erosive esophagitis caused by gastroesophageal reflux disease (GERD). These studies look at how well it works, how safe it is, and how it compares with lansoprazole in adults with active or healed disease.
Key points
- Clinical trials are studying LINAPRAZAN GLURATE in adults with erosive esophagitis due to GERD. One Phase 3 trial looks at healing active, more severe disease after 4 weeks, while another Phase 3 trial looks at keeping healed disease from coming back over 24 weeks. The studies compare LINAPRAZAN GLURATE with lansoprazole. One trial includes participants with LA grade C/D disease at baseline, and the other includes people with healed erosive esophagitis. The main tests use endoscopy, which is a camera exam of the esophagus.
Trial overview
Two Phase 3 studies are investigating LINAPRAZAN GLURATE in people with erosive esophagitis due to gastroesophageal reflux disease (GERD). Both are interventional trials, which means the researchers give study treatment and then measure the results.
The first study is authorised and includes about 500 participants. The second study is completed and included 104 participants.
Study 1: healing of active erosive esophagitis
This randomized, multicenter Phase 3 study is designed to confirm the clinical efficacy of LINAPRAZAN GLURATE compared with lansoprazole in participants with erosive esophagitis due to GERD. Randomized means participants are assigned by chance to different study groups, and multicenter means the study is run at more than one site.
The main goal is to confirm superiority of LINAPRAZAN GLURATE 50 mg twice daily compared with lansoprazole for healing erosive esophagitis after 4 weeks of double-blind treatment. Double-blind means neither the participants nor the study staff know which treatment a person receives during the treatment period.
The primary outcome is healing of erosive esophagitis at Week 4, measured by endoscopy in participants who had LA grade C/D disease at baseline. LA grades C/D describe more severe erosive esophagitis.
Study 2: maintenance of healed erosive esophagitis
This randomized, multicenter Phase 3 trial studies participants with healed erosive esophagitis due to GERD and compares LINAPRAZAN GLURATE with lansoprazole for maintenance treatment. The study also evaluates safety, meaning it looks at how well participants tolerate the treatment during the study period.
The main goal is to confirm non-inferiority of the high-dose LINAPRAZAN GLURATE group compared with lansoprazole for keeping erosive esophagitis healed after 24 weeks. Non-inferiority means the study checks whether LINAPRAZAN GLURATE is not meaningfully worse than the comparison treatment.
The primary outcome is maintained healing of erosive esophagitis after 24 weeks, assessed by central reading of endoscopy.
Who can participate
These studies are for people with erosive esophagitis due to GERD. The first trial focuses on participants with active disease, especially those with LA grade C/D at baseline, while the second trial includes participants whose erosive esophagitis has already healed.
- Active disease group: people with erosive esophagitis that still needs healing, including those with more severe LA grade C/D disease at the start of the study.
- Healed disease group: people whose erosive esophagitis has healed and who are being studied to see whether healing stays in place over time.
Endpoints and assessments
An endpoint is the main result the researchers measure to judge whether the treatment works. In these studies, the key endpoint is based on endoscopy findings, which allow doctors to look directly at the esophagus and see whether healing has happened or stayed in place.
- Week 4 healing: the first trial checks whether erosive esophagitis has healed after 4 weeks in people with baseline LA grade C/D disease.
- 24-week maintenance: the second trial checks whether healing is still present after 24 weeks of treatment.
What the results mean
Together, these trials are testing LINAPRAZAN GLURATE in two important settings: first, to help heal active erosive esophagitis, and second, to keep healed disease from returning. The studies compare it with lansoprazole, which helps researchers understand whether LINAPRAZAN GLURATE may offer similar or better results in these patient groups.