A Study Comparing the Effect and Safety of Linaprazan Glurate to Lansoprazole in Participants With Erosive Esophagitis (EE) Due to Gastroesophageal Reflux Disease (GERD)

NCT07037875 | Not Yet Recruiting Phase 3 DMC

• 3 other identifiers: CX842A23012024-518714-31-00UTN U1111-1315-2237
• Study Type: interventional
• Target: 500
• Locations: 7 countries
• Sites: 75

Brief Summary

The goal of this clinical trial is to find out how well linaprazan glurate can heal erosive esophagitis (EE) caused by gastroesophageal reflux disease (GERD), compared to lansoprazole, a commonly used medication. Researchers will also evaluate whether linaprazan glurate:

• Reduces heartburn symptoms more effectively than lansoprazole
• Is safe and well tolerated, based on physical exams, blood tests, and vital signs (heart rate, blood pressure, temperature, and breathing rate)
• Causes any side effects during treatment
• Has different effects depending on how much of the drug is in the blood
• Works differently depending on participants' genes Participants must be between 18 to 80 years old and have EE due to GERD confirmed by an endoscopy. Participants cannot join if they have an active Helicobacter pylori (HP) infection or were treated for HP in the past 6 weeks or have taken antibiotics or bismuth-containing drugs in the past 6 weeks. The study is a randomized, double-blind, active comparator-controlled trial lasting up to 4 months. Randomized means that participants are assigned by chance (like flipping a coin) to one of the treatment groups and double-blind means neither the participants nor the study team will know which treatment is given. Participants will be placed into one of three groups (about 167 people in each group):
• Linaprazan glurate 50 mg twice a day
• Linaprazan glurate 50 mg once a day
• Lansoprazole 30 mg once a day Everyone will take 2 tablets and 1 capsule by mouth daily for 8 weeks. Some tablets or capsules will be placebos (look like medicine but contain no active drug). Participants will:
• Undergo an endoscopy in the beginning and after 4 weeks of treatment
• If healing is not observed, another endoscopy may be done at 8 weeks
• During the procedure, doctors will use a thin, flexible tube with a camera to look at the esophagus and take small tissue samples (biopsies)
• Have blood and urine tests at clinic visits to check overall health
• Receive electrocardiograms (ECGs) to monitor heart function
• Complete daily questionnaires on an electronic device about symptoms and experiences

Conditions

GERD (Gastroesophageal Reflux Disease)

Outcome Measures

Primary Outcomes (1)

• Healing of EE at Week 4 as assessed by endoscopy in participants with Baseline EE LA grades C/D.

  From enrollment to the end of treatment at 4 weeks.

Study Arms (3)

Group 1: Linaprazan glurate 50 mg BID

EXPERIMENTAL

Drug: Linaprazan glurate 50 mg Twice Daily (BID)

Group 2: Linaprazan glurate 50 mg QD

EXPERIMENTAL

Drug: Linaprazan Glurate 50 mg Once Daily (QD)

Group 3: Lansoprazole 30 mg QD

ACTIVE COMPARATOR

Drug: Lansoprazole 30 mg Once Daily (QD)

Interventions

Linaprazan glurate 50 mg Twice Daily (BID) DRUG

Participants in this group will receive a total daily dose of 100 mg of linaprazan glurate, administered as 50 mg in the morning and 50 mg in the evening. In the morning, they take one 50 mg linaprazan glurate tablet along with a placebo capsule that matches the appearance of the lansoprazole capsule. In the evening, they take another 50 mg linaprazan glurate tablet, without any additional placebo.

Group 1: Linaprazan glurate 50 mg BID

Linaprazan Glurate 50 mg Once Daily (QD) DRUG

Participants in this group will receive a total daily dose of 50 mg of linaprazan glurate, taken once daily in the morning. In the morning, they take one 50 mg linaprazan glurate tablet along with a placebo capsule that mimics the lansoprazole capsule. In the evening, they take a placebo tablet that mimics the appearance of the linaprazan glurate tablet.

Group 2: Linaprazan glurate 50 mg QD

Lansoprazole 30 mg Once Daily (QD) DRUG

Participants in this group will receive a total daily dose of 30 mg of lansoprazole, taken once daily in the morning. In the morning, they take one 30 mg lansoprazole capsule along with a placebo tablet that mimics the linaprazan glurate tablet. In the evening, they take another placebo tablet resembling linaprazan glurate.

Group 3: Lansoprazole 30 mg QD

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.
• 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 study, or influence the study results or the participant's ability to participate in the study. The following examples are conditions that would exclude the patient from participating:
• History of myocardial infarction/acute coronary syndrome within 3 months prior to Screening.
• History of ventricular arrhythmia or implanted cardioverter defibrillator.
• Symptomatic congestive heart failure (New York Heart Association class 3-4).
• Family history of/diagnosis of hereditary arrhythmia syndrome.
• History of adult asthma that required intensive treatment in an emergency room.
• 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.
• 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: Patients 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.
• Known severe atrophic gastritis as assessed from medical history or upper endoscopy during Screening.
• Zollinger-Ellison syndrome or other gastric acid hypersecretory conditions.
• History of treatment course with lansoprazole within 2 months prior to Screening.
• Current peptic ulcer.
• Body mass index (BMI) ≤ 18 and ≥ 40 kg/m² at Screening.

Sponsors & Collaborators

• Cinclus Pharma Holding AB: lead

Study Sites (75)

Medical Center "Orange"

Sofia, Sofia City Province, 1343, Bulgaria

Location

Multiprofile Hospital for Active Treatment - "Vita"

Sofia, Sofia City Province, 1407, Bulgaria

Location

Diagnostic and Consulting Center Alexandrovska

Sofia, Sofia City Province, 1431, Bulgaria

Location

Diagnostic Consultative Center - Focus-5

Sofia, Sofia City Province, 1463, Bulgaria

Location

Medical Center Hera

Sofia, Sofia City Province, 1510, Bulgaria

Location

University Multiprofile Hospital for Active Treatment "Tsaritsa Yoanna - ISUL"

Sofia, Sofia City Province, 1527, Bulgaria

Location

University Multiprofile Hospital for Active Treatment and Emergency Medicine "N.I. Pirogov

Sofia, Sofia City Province, 1606, Bulgaria

Location

20th Diagnostic Consultancy Center

Sofia, Sofia City Province, 1618, Bulgaria

Location

Multiprofile Hospital for Active Treatment "Sv. Ivan Rilski - 2003" OOD

Dupnitsa, 2600, Bulgaria

Location

Multiprofile Hospital For Active Treatment St. Ivan Rilski Gorna Oriahovitsa EOOD

Gorna Oryahovitsa, 5100, Bulgaria

Location

Medical Center Hera

Kyustendil, 2500, Bulgaria

Location

University Multiprofile Hospital for Active Treatment "Sveta Marina"

Pleven, 5800, Bulgaria

Location

Multiprofile Hospital for Active Treatment "Sveti Panteleymon"

Plovdiv, 4000, Bulgaria

Location

Diagnosis - Consulting Centre 1

Sliven, Bulgaria

Location

First Private Hospital Vratsa

Vratsa, 3000, Bulgaria

Location

SurGal Clinic s.r.o.

Brno, 602 00, Czechia

Location

Military Hospital Brno, Internal Department

Brno, 615 00, Czechia

Location

University Hospital Brno

Brno, 625 00, Czechia

Location

PreventaMed s.r.o.

Olomouc, 779 00, Czechia

Location

Gastromedic s.r.o.

Pardubice, 53003, Czechia

Location

Hospital Prachatice a.s.

Prachatice, 38301, Czechia

Location

Endohope Morava s.r.o.

Zábřeh, 78901, Czechia

Location

Khozrevanidze's Clinic

Batumi, 6000, Georgia

Location

JSC Georgian Clinics

Kutaisi, 4600, Georgia

Location

LTD Aversi Clinic

Marneuli, 3000, Georgia

Location

LTD Krol Medical Corporation

Tbilisi, 0101, Georgia

Location

The New Hospitals

Tbilisi, 0114, Georgia

Location

Israeli - Georgian Medical Research Clinic Healthycore LLC

Tbilisi, 0119, Georgia

Location

Janmrtelobis Sakhli LLC

Tbilisi, 0144, Georgia

Location

LLC Geo Hospitals

Tbilisi, 0144, Georgia

Location

LTD Aversi Clinic

Tbilisi, 0160, Georgia

Location

LEPL The First University Clinic of Tbilisi State Medical University

Tbilisi, 0178, Georgia

Location

Malkhaz Katsiashvili Multiprofile Emergency Medicine Center LLC

Tbilisi, 0180, Georgia

Location

Diakonie Hospital

Mannheim, Baden-Wurttemberg, 68163, Germany

Location

Medical Care Unit Dachau

Dachau, Bavaria, 85221, Germany

Location

Clinic for Internal Medicine Munich-Sued

Munich, Bavaria, 81379, Germany

Location

Bekes County Central Hospital Dr. Rethy Pal Member Hospital, 4th Department of Internal Medicine - Gastroenterology - Hepatology

Békéscsaba, H-5600, Hungary

Location

G1 Institute

Budapest, 1036, Hungary

Location

Clinexpert Ltd. Budapest

Budapest, H-1033, Hungary

Location

Obuda Healthcare Center Ltd.

Budapest, H-1036, Hungary

Location

Synexus Hungary Ltd.

Budapest, H-1036, Hungary

Location

Central Hospital of Northern Pest - Military Hospital, Department of Gastroenterology

Budapest, H-1062, Hungary

Location

Main Railway Outpatient Clinic Debrecen, Department of Gastroenterology

Debrecen, H-4025, Hungary

Location

Heves County Markhot Ferenc Teaching Hospital and Clinic, Department of General and Vascular Surgery

Eger, H-3300, Hungary

Location

University of Szeged, Department of Internal Medicine- Western Site

Szeged, H-6720, Hungary

Location

Fejer County St. Gyorgy University Teaching Hospital, Department of Internal Medicine I

Székesfehérvár, H-8000, Hungary

Location

Javorszky Odon Hospital Vac, Department of Gastroenterology

Vác, H-2600, Hungary

Location

NZOZ Specialist Gastrology Centre GASTROMED

Bialystok, 15-322, Poland

Location

"MEDIS" Medical Center

Bydgoszcz, 85-229, Poland

Location

NZOZ KERmed Medical Centre

Bydgoszcz, 85-231, Poland

Location

CLINSANTE Clinical Research Centre Ewa Galczak-Nowak, Malgorzata Trzaska

Bydgoszcz, 85-794, Poland

Location

St. John Paul 2nd Municipal Hospital in Elblag, Department of Internal Diseases

Elblag, 82-300, Poland

Location

Synexus Polska Sp. z o.o. Branch in Gdansk

Gdansk, 80-382, Poland

Location

Synexus Polska Sp. z o.o. Branch in Katowice

Katowice, 40-040, Poland

Location

"Vita Longa" Non-Public Healthcare Facility, Limited Liability Company

Katowice, 40-748, Poland

Location

Independent Public Healthcare Facility University Hospital in Krakow, NSSU Endoscopy Department

Krakow, 30-688, Poland

Location

FutureMeds Krakow

Krakow, 31-501, Poland

Location

Independent Public Healthcare Facility, Norbert Barlicki University Teaching Hospital No. 1 of the Medical University in Lodz, Clinical Department of General Gastroenterology and Oncology

Lodz, 90-153, Poland

Location

Hospital of Brothers Hospitallers of Saint John of God In Lodz, Endoscopy Lab

Lodz, 93-357, Poland

Location

Oswiecim Clinical Trial Centre

Oświęcim, 32-600, Poland

Location

EMC Medical Institute Joint Stock Company, CERTUS Private Healthcare Facility Hospital No. 1, CERTUS Private Healthcare Facility Ambulatories

Poznan, 60-309, Poland

Location

Synexus Polska Sp. z o.o. Branch in Poznan

Poznan, 60-702, Poland

Location

New health-CK, Kieltucki and partners g.p.

Staszów, 28-200, Poland

Location

Gastromed Sp. z o.o. (LLC)

Torun, 87-100, Poland

Location

FutureMeds Warsaw Center

Warsaw, 00-215, Poland

Location

Therapia Nova

Warsaw, 01-595, Poland

Location

ETG Warszawa

Warsaw, 02-677, Poland

Location

Futuremeds Targowek

Warsaw, 03-291, Poland

Location

WIP Warsaw IBD Point Profesor Kierkus

Warsaw, 04-501, Poland

Location

Medical Centre Oporow

Wroclaw, 52-416, Poland

Location

FutureMeds Wroclaw

Wroclaw, 53-673, Poland

Location

ETG Zamosc

Zamość, 22-400, Poland

Location

Colentina Clinical Hospital, Department of Gastroenterology

Bucharest, 020125, Romania

Location

Cluj Napoca County Emergency Clinical Hospital, Internal Medicine III

Cluj-Napoca, 400006, Romania

Location

TVM MED SERV SRL, Medical Center for Gastroenterology, Hepatology and Digestive Endoscopy

Cluj-Napoca, 400061, Romania

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

BID protein, human; Lansoprazole

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Central Study Contacts

Rikard Reneland, MD, PhD

CONTACT

+46 70 300 40 88; rikard.reneland@cincluspharma.com

Kajsa Larsson, MD, PhD

CONTACT

+46 70 675 01 28; kajsa.larsson@cincluspharma.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2025
• First Posted: June 26, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: September 11, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

BU (15); HU (11); RO (3); CZ (7); GE (11); PL (25); DE (3)