LINAPRAZAN GLURATE for Erosive esophagitis due to gastroesophageal reflux disease (GERD)

Inclusion criteria

• {"criterion_text":"- 1. The participant understands and voluntarily signs an Informed Consent Form (ICF) prior to initiation of any trial-related assessments/procedures."}
• {"criterion_text":"- 2. Male or female participants aged 18 to 80 years, inclusive, at the time of signing the ICF."}
• {"criterion_text":"- 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.)."}
• {"criterion_text":"- 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)."}

Exclusion criteria

• {"criterion_text":"- 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."}
• {"criterion_text":"- 10. Body mass index (BMI) ≤ 18 and ≥ 40 kg/m2 at Screening."}
• {"criterion_text":"- 11. Requiring concomitant therapy with any of the prohibited medications as defined in the protocol."}
• {"criterion_text":"- 12. Any planned major surgery within 16 weeks of Screening."}
• {"criterion_text":"- 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)."}
• {"criterion_text":"- 14. Known human immunodeficiency virus (HIV) infection/acquired immune deficiency syndrome (AIDS) or test positive for HIV antibodies at Screening."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- 18. History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity to any component of the relevant IP, including excipients, as judged by the Investigator."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- 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.\tHistory of myocardial infarction/acute coronary syndrome within 3 months prior to Screening. b.\tHistory of ventricular arrhythmia or implanted cardioverter defibrillator. c.\tSymptomatic congestive heart failure (New York Heart Association class 3-4). d.\tFamily history of/diagnosis of hereditary arrhythmia syndrome. e.\tHistory of adult asthma that required intensive treatment in an emergency room."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- 22. Women who are pregnant or breast feeding."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- 6. Known severe atrophic gastritis as assessed from medical history or upper endoscopy during Screening."}
• {"criterion_text":"- 7. Zollinger-Ellison syndrome or other gastric acid hypersecretory conditions."}
• {"criterion_text":"- 8. History of treatment course with lansoprazole within 2 months prior to Screening."}
• {"criterion_text":"- 9. Current peptic ulcer."}

Primary endpoints

• {"endpoint_text":"- Healing of EE at Week 4 as assessed by endoscopy in participants with Baseline EE LA grades C/D.","definition_or_measurement_approach":"Assessed by endoscopy in participants with Baseline EE LA grades C/D."}

Secondary endpoints

• {"endpoint_text":"- 1. Cumulative healing of EE at Week 8 as assessed by endoscopy at 4 and 8 weeks.","definition_or_measurement_approach":"Assessed by endoscopy at Week 4 and Week 8 (cumulative healing at Week 8)."}
• {"endpoint_text":"- 2. Healing of EE at Week 4 as assessed by endoscopy.","definition_or_measurement_approach":"Assessed by endoscopy at Week 4."}
• {"endpoint_text":"- 3. Percentage of 24-hour heartburn-free days from Baseline to Week 8 based on the electronic Diary.","definition_or_measurement_approach":"Measured using the electronic Diary to calculate percentage of 24-hour heartburn-free days from Baseline to Week 8."}
• {"endpoint_text":"- 4. Percentage of 24-hour heartburn-free days from Baseline to Week 4 based on the electronic Diary.","definition_or_measurement_approach":"Measured using the electronic Diary to calculate percentage of 24-hour heartburn-free days from Baseline to Week 4."}
• {"endpoint_text":"- 5. Cumulative healing of EE at Week 8 as assessed by endoscopy at 4 and 8 weeks in participants with Baseline EE LA grades C/D.","definition_or_measurement_approach":"Assessed by endoscopy at Week 4 and Week 8 (cumulative healing at Week 8) in participants with Baseline LA grades C/D."}
• {"endpoint_text":"- 6. Healing of EE at Week 4 as assessed by endoscopy in participants with Baseline EE LA grades C/D.","definition_or_measurement_approach":"Assessed by endoscopy at Week 4 in participants with Baseline LA grades C/D."}
• {"endpoint_text":"- 7. Change in weekly mean 24-hour heartburn severity from Baseline to Week 1, Week 4, and Week 8 based on electronic Diary.","definition_or_measurement_approach":"Measured via electronic Diary to compute change in weekly mean 24-hour heartburn severity at Weeks 1, 4, and 8 vs Baseline."}
• {"endpoint_text":"- 8. Safety analysis based on frequency and severity of adverse events (AEs) and any other safety signals detected.","definition_or_measurement_approach":"Safety assessed by recording frequency and severity of adverse events and other detected safety signals."}

Methods

• Patient Leaflet (patient-facing recruitment material available as K2_Recruitment material Patient Leaflet)
• Physician Referral Letter (referral by physicians; K2_Recruitment material Physician Referral Letter)
• Patient Poster (patient-facing poster in some member states)
• Advocacy Fact Sheet (advocacy-facing recruitment material)

Bulgaria

Earliest CTIS Part Ii Submission Date

24-07-2025

Latest Decision Or Authorization Date

20-03-2026

Processing Time Days

239

Number Of Sites

17

Number Of Participants

100

Germany

Earliest CTIS Part Ii Submission Date

11-08-2025

Latest Decision Or Authorization Date

10-03-2026

Processing Time Days

211

Number Of Sites

5

Number Of Participants

5

Romania

Earliest CTIS Part Ii Submission Date

19-05-2025

Latest Decision Or Authorization Date

23-03-2026

Processing Time Days

308

Number Of Sites

3

Number Of Participants

20

Czechia

Earliest CTIS Part Ii Submission Date

19-05-2025

Latest Decision Or Authorization Date

17-03-2026

Processing Time Days

302

Number Of Sites

7

Number Of Participants

24

Hungary

Earliest CTIS Part Ii Submission Date

02-07-2025

Latest Decision Or Authorization Date

27-03-2026

Processing Time Days

268

Number Of Sites

11

Number Of Participants

62

Poland

Earliest CTIS Part Ii Submission Date

13-08-2025

Latest Decision Or Authorization Date

27-03-2026

Processing Time Days

226

Number Of Sites

31

Number Of Participants

186

Primary sponsor

Full Name

Cinclus Pharma Holding AB (publ)

Organisation Type

Pharmaceutical company

Country Of Registered Address

Sweden

Contract research organisations

Name

Psi Cro AG

Responsibilities

Feasibility, Medical Monitoring, Translations, Trial Supply Management, Vendor Management

Name

Evidera Limited

Responsibilities

E-data capture

Name

Lablytica Life Science AB

Responsibilities

sponsor duties code: 4

Third parties

• {"country":"Sweden","full_name":"Lablytica Life Science AB","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Pharmaceutical company"}
• {"country":"Switzerland","full_name":"Psi Cro AG","duties_or_roles":"Feasibility, Medical Monitoring, Translations, Trial Supply Management, Vendor Management (sponsor duties codes: 1,12,15,2,5,6)","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"Evidera Limited","duties_or_roles":"E-data capture","organisation_type":"Pharmaceutical company"}