2024-518714-31-00
Not yet recruiting
Phase 3
A randomized, phase 3, double-blind, double-dummy, active comparator-controlled multicenter study to evaluate the efficacy and safety of 2 doses of linaprazan glurate compared to lansoprazole in 4 or 8 weeks healing in participants with erosive esophagitis (EE) due to gastroesophageal reflux disease (GERD) of Los Angeles (LA) grades A to D
Cinclus Pharma Holding AB (publ)56 sites in 6 countries382 target enrollmentStarted: August 22, 2025Last updated:
Overview
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Cinclus Pharma Holding AB (publ)
- Enrollment
- 382
- Locations
- 56
- Primary Endpoint
- Healing of EE at Week 4 as assessed by endoscopy in participants with Baseline EE LA grades C/D.
Overview
Brief Summary
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.
Eligibility Criteria
- Ages
- 18 years to 65+ years (65+ Years, 18-64 Years)
- Accepts Healthy Volunteers
- No
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.
- •Body mass index (BMI) ≤ 18 and ≥ 40 kg/m2 at Screening.
- •Requiring concomitant therapy with any of the prohibited medications as defined in the protocol.
- •Any planned major surgery within 16 weeks of Screening.
- •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 study, or may interfere with study 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).
- •Known human immunodeficiency virus (HIV) infection/acquired immune deficiency syndrome (AIDS) or test positive for HIV antibodies at Screening.
- •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.
- •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.
- •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.
- •History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity to any component of the relevant study treatments, including excipients, as judged by the Investigator.
Outcomes
Primary Outcomes
Healing of EE at Week 4 as assessed by endoscopy in participants with Baseline EE LA grades C/D.
Healing of EE at Week 4 as assessed by endoscopy in participants with Baseline EE LA grades C/D.
Secondary Outcomes
- 1. Cumulative healing of EE at Week 8 as assessed by endoscopy at 4 and 8 weeks.
- 2. Healing of EE at Week 4 as assessed by endoscopy.
- 3. Percentage of 24-hour heartburn-free days from Baseline to Week 8 based on the electronic Diary.
- 4. Percentage of 24-hour heartburn-free days from Baseline to Week 4 based on the electronic Diary.
- 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.
- 6. Healing of EE at Week 4 as assessed by endoscopy in participants with Baseline EE LA grades C/D.
- 7. Change in weekly mean 24-hour heartburn severity from Baseline to Week 1, Week 4, and Week 8 based on electronic Diary.
- 8. Safety analysis based on frequency and severity of adverse events (AEs) and any other safety signals detected.
Investigators
Rikard Reneland
Scientific
Cinclus Pharma Holding AB (publ)
Study Sites (56)
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