A Study Comparing the Effect and Safety of Linaprazan Glurate to Lansoprazole in Participants With Erosive Esophagitis (EE) Due to Gastroesophageal Reflux Disease (GERD)

• Status: NOT_YET_RECRUITING
• Trial end date: 2026-09-01

Summary

The goal of this clinical trial is to find out how well linaprazan glurate can heal erosive esophagitis (EE) caused by gastroesophageal reflux disease (GERD), compared to lansoprazole, a commonly used medication. Researchers will also evaluate whether linaprazan glurate:

• Reduces heartburn symptoms more effectively than lansoprazole
• Is safe and well tolerated, based on physical exams, blood tests, and vital signs (heart rate, blood pressure, temperature, and breathing rate)
• Causes any side effects during treatment
• Has different effects depending on how much of the drug is in the blood
• Works differently depending on participants' genes

Participants must be between 18 to 80 years old and have EE due to GERD confirmed by an endoscopy. Participants cannot join if they have an active Helicobacter pylori (HP) infection or were treated for HP in the past 6 weeks or have taken antibiotics or bismuth-containing drugs in the past 6 weeks.

The study is a randomized, double-blind, active comparator-controlled trial lasting up to 4 months. Randomized means that participants are assigned by chance (like flipping a coin) to one of the treatment groups and double-blind means neither the participants nor the study team will know which treatment is given. Participants will be placed into one of three groups (about 167 people in each group):

• Linaprazan glurate 50 mg twice a day
• Linaprazan glurate 50 mg once a day
• Lansoprazole 30 mg once a day

Everyone will take 2 tablets and 1 capsule by mouth daily for 8 weeks. Some tablets or capsules will be placebos (look like medicine but contain no active drug). Participants will:

• Undergo an endoscopy in the beginning and after 4 weeks of treatment
• If healing is not observed, another endoscopy may be done at 8 weeks
• During the procedure, doctors will use a thin, flexible tube with a camera to look at the esophagus and take small tissue samples (biopsies)
• Have blood and urine tests at clinic visits to check overall health
• Receive electrocardiograms (ECGs) to monitor heart function
• Complete daily questionnaires on an electronic device about symptoms and experiences

• Phase: PHASE3

Details

• Lead Sponsor: Cinclus Pharma Holding AB
• Treatments: BID protein, human; Lansoprazole