Efficacy and Safety of Linaprazan Glurate versus Lansoprazole for Maintenance of Healing in Patients with Healed Erosive Esophagitis Due to Gastroesophageal Reflux Disease
- Trial ID
- 2025-522750-39-00
- Protocol
- CX842A2303
Trial statistics
Diseases & Conditions
Objectives
The primary objective is to confirm the non-inferiority of a high dose of linaprazan glurate compared to lansoprazole for the maintenance of healing in all grades of erosive esophagitis (EE) caused by gastroesophageal reflux disease (GERD) following 24 weeks of treatment. Secondary objectives include:
- Confirming the non-inferiority of a low dose of linaprazan glurate compared to lansoprazole in the maintenance of healing for all grades of EE after 24 weeks.
- Confirming the superiority of both high and low doses of linaprazan glurate compared to lansoprazole in maintaining healing for Los Angeles (LA) grades C/D after 24 weeks.
- Confirming the superiority of both high and low doses of linaprazan glurate compared to lansoprazole in maintaining healing for all grades of EE after 24 weeks.
- Evaluating participant-reported 24-hour heartburn-free days to confirm non-inferiority or superiority of linaprazan glurate doses compared to lansoprazole after 24 weeks.
- Assessing healing rates for both linaprazan glurate doses compared to lansoprazole after 52 weeks of maintenance treatment.
- Evaluating the safety and tolerability of linaprazan glurate doses compared to lansoprazole throughout the maintenance period.
Participants
This study involves 8 participants diagnosed with erosive esophagitis resulting from gastroesophageal reflux disease. The study population consists of both male and female patients within the age ranges specified by codes 3 and 4. Eligible individuals must have achieved healed esophagitis, as confirmed by endoscopic examination during a preceding phase 3 healing trial or a run-in period. Participants are required to demonstrate the ability to comply with all protocol requirements, including the use of an e-device and the performance of scheduled endoscopies.
Plans and Procedures
This Phase 3, randomized, double-blind, double-dummy, active comparator-controlled multicenter clinical trial is designed to evaluate the efficacy and safety of linaprazan glurate compared to lansoprazole for the maintenance of healing in patients with healed erosive esophagitis due to gastroesophageal reflux disease. The study utilizes a non-inferiority design to compare a high dose of the test product against the comparator. Following a screening process to confirm healed esophageal tissue via endoscopy, participants are assigned to treatment groups. The primary objective is to assess the maintenance of healing after 24 weeks of treatment, with secondary endpoints evaluating healing at 52 weeks and the frequency of heartburn-free days. Study procedures involve clinical assessments and the use of an electronic diary to monitor symptoms. Participant involvement is centered around a 24-week maintenance period, though long-term efficacy is assessed through 52 weeks.
Treatment
Linaprazan glurate is the experimental treatment administered in tablet form via oral use.
Lansoprazole is utilized as an active comparator and is administered via oral use.
A placebo is employed in a double-dummy design to match both the linaprazan glurate and the lansoprazole doses.
Efficacy
The primary efficacy endpoint is the maintained healing of erosive esophagitis after 24 weeks, which is evaluated through central reading of endoscopy. Secondary endpoints include the assessment of maintained healing from erosive esophagitis at 24 weeks specifically in participants presenting with Los Angeles grades C or D at baseline. Additionally, the percentage of heartburn-free days from baseline to week 24 is measured using an electronic diary. Long-term efficacy is assessed by comparing the maintenance of healing at 52 weeks between the high-dose and low-dose regimens of linaprazan glurate and the active comparator.
Inclusion and Exclusion Criteria
Inclusion Criteria
- An individual who has participated in a preceding linaprazan glurate healing trial will be asked to participate in this trial if the following criteria apply: 1. The participant understands and voluntarily signs an Informed Consent Form (ICF) prior to initiation of any trial-related assessments/procedures.
- The participant has a healed EE as assessed by central review of endoscopic examination either from the last regular visit in a preceding phase 3 healing trial OR from the Run-in Period to the present maintenance trial.
- The participant is willing and able to comply with all aspects of the protocol (including endoscopies, tablet and capsule swallowing, electronic device [e-device] completion, etc.).
Exclusion Criteria
- An individual who has participated in a preceding linaprazan glurate phase 3 healing trial can be enrolled in this maintenance trial unless they meet any of the following exclusion criteria: 1. EE as graded from the endoscopy during the Run-in Period (only applicable for participants with previous endoscopy >14 days before the last regular visit in the preceding healing trial).
- Solitary esophageal ulcer in the proximal two-thirds of the esophagus, untreated Barrett’s esophagus or any other condition affecting the esophagus, including eosinophilic esophagitis; esophageal varices; viral or fungal infection; esophageal stricture.
- Significant noncompliance with protocol-specified procedures or treatment in the preceding healing trial as judged by the Investigator.
- Adverse event (AE) resulting in premature discontinuation of IP in the preceding healing trial.
- History or presence of any clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal (GI), endocrine, hematological, neurological disease or disorder, or psychiatric diagnosis which, in the opinion of the Investigator, may either put the participant at risk because of participation in the trial, or influence the trial results or the participant’s ability to participate in the trial. The following examples are conditions that would exclude the participant from participating: a. History of myocardial infarction/ acute coronary syndrome within 3 months prior to the M0 visit b. History of ventricular arrhythmia or implanted cardioverter defibrillator c. Symptomatic congestive heart failure (New York Heart Association [NYHA] class 3-4) d. Family history of/ diagnosis of hereditary arrhythmia syndrome
- History of adult asthma that required intensive treatment in an emergency room
- Any planned major surgery within 52 weeks of the Run-in Period.
- Any clinically significant laboratory parameter outside reference value that has occurred since Screening or Baseline values in the preceding healing trial and which, in the opinion of the Investigator, may suggest a new or insufficiently understood disease, may present an unreasonable risk to the participant as a result of his/her participation in the trial, or may interfere with trial assessments. The below laboratory test results during the Run-in Period* (HX/M0 visit) are exclusionary: a. Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 1.5 × upper limit of normal (ULN) for the central laboratory conducting the test. b. Serum total bilirubin (TBL) >1.5 × ULN for the central laboratory conducting the test. (individuals with Gilbert’s syndrome can be included). *Note: One retest is allowed during the Run-in Period.
- Enrollment in another interventional clinical trial, except for ongoing participation in an EE healing trial with linaprazan glurate.
- Current or history of alcohol, drug abuse, and/or use of androgens/anabolic steroids (testosterone and testosterone esters [enanthate, undecanoate, cypionate], methyltestosterone, oxandrolone, stanozolol, fluoxymesterone, danazol, tetrahydrogestrinone, 7α-methyl-19-nortestosterone) within 2 years prior to Run-in Period. Stable androgen substitution treatment for male hypogonadism is allowed.
- Women who are pregnant or breast feeding
- Individual is an employee of the Investigator, trial site, Sponsor, or Contract Research Organization (CRO) with direct involvement in the proposed trial or other trials under the direction of that Investigator, trial site, Sponsor, or CRO, as well as family members of the employee of the Investigator, trial site, Sponsor, or CRO.
- Individuals who have previously participated (completed or withdrawn) in this trial.
- A female participant of childbearing potential who is or may be sexually active with a non-sterilized male partner and who is unwilling to routinely use highly effective contraception from the signing of the ICF until 7 days after the last dose of IP.
- A male participant with a partner of childbearing potential who is unwilling to routinely use highly effective contraception and is unwilling to agree to not father a child from the signing of the ICF until at least 7 days after the last dose of IP.
Trial Status by Country
| Country | Status | Start of Recruitment | Planned Patients |
|---|---|---|---|
 Bulgaria | Not Recruiting | 28 Apr 2026 | 18 |
 Czechia | Not Recruiting | 28 Apr 2026 | 7 |
 Germany | Not Recruiting | 28 Apr 2026 | 5 |
 Hungary | Not Recruiting | 28 Apr 2026 | 9 |
 Poland | Not Recruiting | 28 Apr 2026 | 51 |
 Romania | Not Recruiting | 28 Apr 2026 | 6 |
Sites & Investigators
Investigational Products
Details about the medicinal products being studied in this clinical trial.
| Product Name | Role in Trial | Formulation | Administration | Max Daily Dose | Treatment Duration | EU MP Number |
|---|---|---|---|---|---|---|
LANSOPRAZOLE | Comparator | — | ORAL USE | 0 | 14 | SUB08403MIG |
LANSOPRAZOLE | Comparator | — | ORAL USE | 0 | 52 | SUB08403MIG |
Placebo to match lansoprazole high dose | Placebo | N/A | — | — | — | N/A |
Linaprazan glurate | Test | TABLET | ORAL USE | 0 | 54 | PRD11652791 |
Placebo to match Lansoprazole low dose | Placebo | N/A | — | — | — | N/A |
Placebo to match Linaprazan Glurate | Placebo | N/A | — | — | — | N/A |