BridgeMD
A randomized, phase 3 multicenter study to confirm the clinical efficacy of linaprazan glurate compared to lansoprazole in participants with erosive esophagitis (EE) due to gastroesophageal reflux disease (GERD)
EU CTIS ID: 2024-518714-31-00
What this study is testing
To confirm superiority of linaprazan glurate 50 mg BID compared to lansoprazole in the healing of EE due to GERD of LA grades C/D after 4 weeks of double-blind 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
- 1. The participant understands and voluntarily signs an Informed Consent Form (ICF) prior to initiation of any trial-related assessments/procedures.
- 2. Male or female participants aged 18 to 80 years, inclusive, at the time of signing the ICF.
- 3. 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.).
- 4. 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).
You likely can't join if
- 1. 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.
- 10. Body mass index (BMI) ≤ 18 and ≥ 40 kg/m2 at Screening.
- 11. Requiring concomitant therapy with any of the prohibited medications as defined in the protocol.
- 12. Any planned major surgery within 16 weeks of Screening.
- 13. Any clinically significant laboratory parameter outside reference value that, 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. Any of these Screening laboratory test results are exclusionary, but re-test is allowed: a. Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 1.5 × the 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). c. Estimated glomerular filtration rate (eGFR) < 45 mL/min/1.73 m2 (as calculated by the central laboratory using the Modification of Diet in Renal Disease [MDRD] equation).
- 14. Known human immunodeficiency virus (HIV) infection/acquired immune deficiency syndrome (AIDS) or test positive for HIV antibodies at Screening.
See the full eligibility criteria
Who can join
- 1. The participant understands and voluntarily signs an Informed Consent Form (ICF) prior to initiation of any trial-related assessments/procedures.
- 2. Male or female participants aged 18 to 80 years, inclusive, at the time of signing the ICF.
- 3. 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.).
- 4. 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).
What rules you out
- 1. 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.
- 10. Body mass index (BMI) ≤ 18 and ≥ 40 kg/m2 at Screening.
- 11. Requiring concomitant therapy with any of the prohibited medications as defined in the protocol.
- 12. Any planned major surgery within 16 weeks of Screening.
- 13. Any clinically significant laboratory parameter outside reference value that, 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. Any of these Screening laboratory test results are exclusionary, but re-test is allowed: a. Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 1.5 × the 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). c. Estimated glomerular filtration rate (eGFR) < 45 mL/min/1.73 m2 (as calculated by the central laboratory using the Modification of Diet in Renal Disease [MDRD] equation).
- 14. Known human immunodeficiency virus (HIV) infection/acquired immune deficiency syndrome (AIDS) or test positive for HIV antibodies at Screening.
- 15. Known chronic/active viral hepatitis or test positive at Screening for hepatitis B virus (HBV: hepatitis B surface antigen [HBsAg] and/or hepatitis B core antigen [anti-HBc], with detectable HBV DNA) or hepatitis C virus (HCV: positive hepatitis C antibody [anti-HCV], with detectable HCV ribonucleic acid [RNA]). Participants with positive screening HBV or HCV serology, but with undetectable/negative HBV DNA or HCV RNA viral load are permitted to participate.
- 16. History of long QTc syndrome (e.g., QTc ≥ 450 ms for males and ≥ 470 ms for females) or discovery of long QTc syndrome at Screening, as calculated by the Fridericia formula (QTc = QT / RR1/3) as reviewed and interpreted by a central reader.
- 17. Cardiac arrhythmias or any clinically significant abnormalities in the resting 12-lead ECG at the time of Screening, as reviewed and interpreted on site by the Investigator and by a central reader.
- 18. History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity to any component of the relevant IP, including excipients, as judged by the Investigator.
- 19. Treatment with any investigational drug within 3 months prior to the first dose of the IP in this trial or is currently enrolled in another interventional clinical trial. Enrollment in the trial CX842A2303, which aims to study the maintenance of healing, is allowed while still participating in follow-up of the current trial.Enrollment in the trial CX842A2303, which aims to study the maintenance of healing, is allowed while still participating in follow-up of the current trial. Enrollment in the trial CX842A2303, which aims to study the maintenance of healing, is allowed while still participating in follow-up of the current trial.
- 2. 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 Screening. b. History of ventricular arrhythmia or implanted cardioverter defibrillator. c. Symptomatic congestive heart failure (New York Heart Association class 3-4). d. Family history of/diagnosis of hereditary arrhythmia syndrome. e. History of adult asthma that required intensive treatment in an emergency room.
- 20. Positive screen for drugs of abuse at Screening (amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, and opiates). Eligibility in trial participation will be assessed by the Investigator.
- 21. 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 Screening. Stable androgen substitution treatment for male hypogonadism is allowed.
- 22. Women who are pregnant or breast feeding.
- 23. 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.
- 24. Individuals who have previously participated (completed or withdrawn) in this trial. Note: rescreening is permitted under circumstances specified in the protocol, but never for participants who have undergone randomization.
- 25. 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 informed consent until 7 days after the last dose of IP.
- 26. A male participant with a partner of childbearing potential who is unwilling to routinely use highly effective contraception and is unwilling to remain abstinent from the signing of informed consent until at least 7 days after the last dose of IP.
- 3. History of malignancy of any organ system (other than completely treated localized basal cell carcinoma or non-metastatic squamous cell carcinoma of the skin or in situ cervical carcinoma), within the past 5 years.
- 4. 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*; a history of radiation therapy, radiofrequency ablation, endoscopic mucosal resection, or cryotherapy to the esophagus; or any history of caustic or physiochemical trauma. *Note: Participants with diagnosis of Schatzki's ring (mucosal tissue ring around lower esophageal sphincter) are eligible to participate, unless history of dilatation within 3 months of Screening.
- 5. History of any surgical or medical condition which might significantly alter the GERD status or the absorption, distribution, metabolism, or excretion of drugs. The Investigator is to be guided by evidence of any of the following: history of major GI surgery such as gastrectomy, any bariatric surgery, gastroenterostomy, bowel resection, or transjugular intrahepatic portosystemic shunt. Nissen fundoplication is not exclusionary as long as the participant is eligible according to other criteria.
- 6. Known severe atrophic gastritis as assessed from medical history or upper endoscopy during Screening.
- 7. Zollinger-Ellison syndrome or other gastric acid hypersecretory conditions.
- 8. History of treatment course with lansoprazole within 2 months prior to Screening.
- 9. Current peptic ulcer.
The study team makes the final eligibility decision.
Where it's taking place
- Georgia
- Serbia
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 Georgia; Serbia. 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.