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A randomized, phase 3 multicenter clinical trial to confirm the clinical efficacy and evaluate the safety of linaprazan glurate compared to lansoprazole in participants with healed erosive esophagitis (EE) due to gastroesophageal reflux disease (GERD)
EU CTIS ID: 2025-522750-39-00
What this study is testing
To confirm non-inferiority of linaprazan glurate ‘high dose’ compared to lansoprazole in the maintenance of healing of all grades of EE due to GERD after 24 weeks of maintenance treatment
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
- 2. 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.
- 3. 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.).
You likely can't join if
- 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).
- 10. 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.
- 11. Women who are pregnant or breast feeding
- 12. 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.
- 13. Individuals who have previously participated (completed or withdrawn) in this trial.
- 14. 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.
See the full eligibility criteria
Who can join
- 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.
- 2. 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.
- 3. 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.).
What rules you out
- 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).
- 10. 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.
- 11. Women who are pregnant or breast feeding
- 12. 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.
- 13. Individuals who have previously participated (completed or withdrawn) in this trial.
- 14. 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.
- 15. 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.
- 2. 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.
- 3. Significant noncompliance with protocol-specified procedures or treatment in the preceding healing trial as judged by the Investigator.
- 4. Adverse event (AE) resulting in premature discontinuation of IP in the preceding healing trial.
- 5. 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
- 6. History of adult asthma that required intensive treatment in an emergency room
- 7. Any planned major surgery within 52 weeks of the Run-in Period.
- 8. 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.
- 9. Enrollment in another interventional clinical trial, except for ongoing participation in an EE healing trial with linaprazan glurate.
The study team makes the final eligibility decision.
Where it's taking place
- Serbia
- Georgia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Serbia; Georgia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.