RecruitingPhase 3

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

Bulgaria, Czechia, Georgia500 participantsStarted 2025-09-11

Plain-language 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

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. The participant understands and voluntarily signs an Informed Consent Form (ICF) prior to initiation of any study-related assessments/procedures.
. Male or female participants aged 18 to 80 years, inclusive, at the time of signing the ICF.
. The participant is willing and able to comply with all aspects of the protocol (including endoscopies, PK sampling, tablet and capsule swallowing, electronic device \[e-device\] completion, etc.).
. The participant has endoscopically confirmed EE due to GERD of LA grades A to D during the Screening Period as assessed in Central Review by an Independent Review Committee (IRC).

Exclusion criteria

. Ongoing infection with HP or diagnosis and treatment of HP infection within 6 weeks of randomization OR any treatment with antibiotics or bismuth containing drugs within 6 weeks of randomization.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Healing of EE at Week 4 as assessed by endoscopy in participants with Baseline EE LA grades C/D.

Timeframe: From enrollment to the end of treatment at 4 weeks.

Trial details

NCT IDNCT07037875

SponsorCinclus Pharma Holding AB

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-08

Contact for this trial

Rikard Reneland, MD, PhD

+46 70 300 40 88 rikard.reneland@cincluspharma.com

View on ClinicalTrials.gov More GERD (Gastroesophageal Reflux Disease) trials