A Study in Patients With Erosive Esophagitis to Investigate Safety, Tolerability, and Healing Rates After 4 Weeks Treatment of X842 or Lansoprazole and Symptom Pattern During Subsequent 4 Weeks Treatment With Lansoprazole

NCT ID: NCT05055128

Last Updated: 2023-11-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 248 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-11
• Study Completion Date: 2022-09-01

Brief Summary

This study will be conducted in patients with erosive esophagitis due to gastro-esophageal reflux disease (GERD) Los Angeles (LA) grades C or D, and in patients with at least partial symptom response but still endoscopically unhealed (LA grades A or B) after 8 weeks history of standard treatment healing course with PPI, designed to support dose selection for Phase 3 and to investigate safety, tolerability, and healing rates after 4 weeks treatment of X842 or Lansoprazole, and symptom pattern during subsequent 4 weeks treatment with Lansoprazole.

Detailed Description

This is a randomized, double-blind, active comparator-controlled study with a parallel-group design including four arms with X842 and one arm with Lansoprazole.

Randomization to one of the treatments with X842 twice daily (BID) 25 mg, 50 mg, 75 mg, 100 mg, or Lansoprazole 30 mg once daily (QD) will be based on a 1:1:1:1:1 scheme.

The duration of each patient's participation in the study, including screening, blind treatment period, and open-label treatment period will be approximately 60 days. The patients will be randomized for 4 weeks of double-blind treatment and will be provided with investigational medicinal product for 35 days.

All patients will have an endoscopic evaluation after 4 weeks of treatment. Following the endoscopic evaluation, all patients will receive subsequent 4 weeks of open-label treatment with Lansoprazole. Repeated symptom evaluation to detect symptom patterns will be assessed during this period.

Conditions

Erosive Esophagitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

X842 25 mg BID

Patients will receive 2 tablets (X842 25mg + X842 dummy) and 1 capsule (Lansoprazole dummy) in the morning, and 2 tablets (X842 25 mg + X842 dummy) in the evening during 4-week double-blind treatment. Thereafter, patients will receive 1 capsule of Lansoprazole 30 mg QD for 4 weeks.

Group Type: EXPERIMENTAL

X842

Intervention Type: DRUG

Patients will receive X842 tablets.

X842 Dummy

Intervention Type: DRUG

Patients will receive matching placebo tablets for X842.

Lansoprazole

Intervention Type: DRUG

Patients will receive Lansoprazole capsule.

Lansoprazole Dummy

Intervention Type: DRUG

Patients will receive matching placebo capsules for Lansoprazole.

X842 50 mg BID

Patients will receive 2 tablets (X842 50 mg + X842 dummy) and 1 capsule (Lansoprazole dummy) in the morning, and 2 tablets (X842 50 mg + X842 dummy) in the evening during 4-week double-blind treatment. Thereafter, patients will receive 1 capsule of Lansoprazole 30 mg QD for 4 weeks.

Group Type: EXPERIMENTAL

X842

Intervention Type: DRUG

Patients will receive X842 tablets.

X842 Dummy

Intervention Type: DRUG

Patients will receive matching placebo tablets for X842.

Lansoprazole

Intervention Type: DRUG

Patients will receive Lansoprazole capsule.

Lansoprazole Dummy

Intervention Type: DRUG

Patients will receive matching placebo capsules for Lansoprazole.

X842 75 mg BID

Patients will receive 2 tablets (X842 50 mg + X842 25 mg) and 1 capsule (Lansoprazole dummy) in the morning, and 2 tablets (X842 50 mg + X842 25 mg) in the evening during 4-week double-blind treatment. Thereafter, patients will receive 1 capsule of Lansoprazole 30 mg QD for 4 weeks.

Group Type: EXPERIMENTAL

X842

Intervention Type: DRUG

Patients will receive X842 tablets.

Lansoprazole

Intervention Type: DRUG

Patients will receive Lansoprazole capsule.

Lansoprazole Dummy

Intervention Type: DRUG

Patients will receive matching placebo capsules for Lansoprazole.

X842 100 mg BID

Patients will receive 2 tablets (X842 50 mg×2) and 1 capsule (Lansoprazole dummy) in the morning, and 2 tablets (X842 50 mg×2) in the evening during 4-week double-blind treatment. Thereafter, patients will receive 1 capsule of Lansoprazole 30 mg QD for 4 weeks.

Group Type: EXPERIMENTAL

X842

Intervention Type: DRUG

Patients will receive X842 tablets.

Lansoprazole

Intervention Type: DRUG

Patients will receive Lansoprazole capsule.

Lansoprazole Dummy

Intervention Type: DRUG

Patients will receive matching placebo capsules for Lansoprazole.

Lansoprazole

Patients will receive 2 tablets (X842 dummy×2) and 1 capsule (Lansoprazole 30 mg) in the morning, and 2 tablets (X842 dummy×2) in the evening during 4-week double-blind treatment. Thereafter, patients will receive 1 capsule of Lansoprazole 30 mg QD for 4 weeks.

Group Type: ACTIVE_COMPARATOR

X842 Dummy

Intervention Type: DRUG

Patients will receive matching placebo tablets for X842.

Lansoprazole

Intervention Type: DRUG

Patients will receive Lansoprazole capsule.

Interventions

X842

Patients will receive X842 tablets.

Intervention Type: DRUG

X842 Dummy

Patients will receive matching placebo tablets for X842.

Intervention Type: DRUG

Lansoprazole

Patients will receive Lansoprazole capsule.

Intervention Type: DRUG

Lansoprazole Dummy

Patients will receive matching placebo capsules for Lansoprazole.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Body mass index (BMI) ≥ 18 and ≤ 40 kg/m^2 at screening.

2. Gastro-esophageal reflux disease with endoscopically confirmed esophagitis:

• LA grade C or D ≤7 days before randomization (with or without historical PPI treatment) or
• LA grade A or B ≤7 days before randomization and history of treatment with the standard healing course of PPI for minimum of 8 weeks prior to screening and ≤7 days of non-treatment during this period and at least partial symptom response during the minimum of 8 weeks of PPI treatment.

3. Willing and able to comply with all aspects of the protocol (including capsule swallowing, diary completion, etc.).

4. Capable of signing informed consent form.

Exclusion Criteria

1. History or presence of any clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disease or disorder.

2. Patients with so-called "alarm features" in symptomatology, like odynophagia, severe dysphagia, bleeding, weight loss, anemia, and blood in stool pointing to a possible malignant disease of the gastrointestinal (GI) tract.

3. Present clinically significant psychiatric diagnosis.

4. History of malignancy of any organ system.

5. Presence of esophageal ulcer, stricture, Barrett´s esophagus or suspected esophagitis secondary to infection, inflammatory disease, ingestion of erosive chemicals or history of any surgical or medical condition which might significantly alter the Gastro-oesophageal reflux disease (GERD) status or the absorption, distribution, metabolism or excretion of drugs.

6. Known severe atrophic gastritis.

7. Any planned major surgery within the duration of the study.

8. History of a positive result for human immunodeficiency virus (HIV), Hepatitis B surface antigen (HBsAg), antibody to Hepatitis B core antigen (anti-HBcAg), or antibody to Hepatitis C virus (anti-HCV) or presence of these findings on screening.

9. History of long QTc syndrome (e.g. QTc ≥450 ms for males and ≥470 ms for females).

10. Cardiac arrhythmias or any clinically significant abnormalities in the resting 12-lead ECG at the time of screening, as judged by the Investigator.

11. History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity.

12. Current or history of alcohol, drug abuse and/or use of anabolic steroids within 2 years prior to screening.

13. Women who are pregnant or breastfeeding.

14. Patients who have previously participated (completed or withdrawn) in this study CX842A2201.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Parexel

INDUSTRY

Sponsor Role: collaborator

Cinclus Pharma AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Genesis Clinical Research - Tampa

Tampa, Florida, United States

Medical Center Excelsior

Sofia, Sofia-Grad, Bulgaria

DCC XIV Sofia

Sofia, Sofia-Grad, Bulgaria

DCC XIV Sofia

Sofia, Sofia-Grad, Bulgaria

Medical Centre Asklepii

Dupnitsa, , Bulgaria

Medical Center Medconsult Pleven

Pleven, , Bulgaria

DCC-1 Sliven

Plovdiv, , Bulgaria

MHAT "Kaspela"

Plovdiv, , Bulgaria

Medical Center Prolet EOOD

Rousse, , Bulgaria

Diagnostive Consultative Center-1 Sliven

Sliven, , Bulgaria

Medical Center Hera - Gastroenterology office

Sliven, , Bulgaria

2-nd MHAT

Sofia, , Bulgaria

Medical Center Excelsior

Sofia, , Bulgaria

MHAT "Sveti Ivan Rilski" - Sofia

Sofia, , Bulgaria

Medical Center Hera - Gastroenterology office

Sofia, , Bulgaria

Medical Center New Rehabilitation Center EOOD

Stara Zagora, , Bulgaria

Medical Center "Biomed 99" Ltd

Vidin, , Bulgaria

Mhat "Hristo Botev"

Vratsa, , Bulgaria

ResTrial GastroEndo s.r.o.

Prague, , Czechia

LTD"Brothers"

Batumi, Adjara, Georgia

A. Aladashvili clinic LLC

Tbilisi, , Georgia

LTD Israeli-Georgian Medical Research Clinic "Helsicore"

Tbilisi, , Georgia

LTD TSMU and Ingorokva High Medical Technology University Clinic

Tbilisi, , Georgia

Emergency Cardiology Center named by acad. G. Chapidze

Tbilisi, , Georgia

Bekes Megyei Kozponti Korhaz, Dr.Rethy Pal Tagkorhaz

Békéscsaba, Bekes County, Hungary

Szegedi Tudomanyegyetem Általános Orvostudományi Kar

Szeged, Csongrád megye, Hungary

ClinExpert Kft.

Budapest, Pest County, Hungary

Pannonia Maganorvosi Centrum Kft

Budapest, , Hungary

NZOZ "Centrum Medyczne KERMED"

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland

Centrum Medyczne Melita Medical

Wroclaw, Lower Silesian Voivodeship, Poland

Szpital Zakonu Bonifratrow Sw. Jana Bozego w Lodzi

Lodz, Lódzkie, Poland

Oswiecimskie Centrum Badan Klinicznych Medicome Sp. z o.o.

Oświęcim, , Poland

ETG Skierniewice

Skierniewice, , Poland

Twoja Przychodnia - Szczecinskie Centrum Medyczne

Szczecin, , Poland

EuroMediCare Szpital Specjalistyczny z Przychodnia

Wroclaw, , Poland

EuroMediCare Szpital Specjalistyczny z Przychodnia

Wroclaw, , Poland

ETG Zamosc

Zamość, , Poland

Zvezdara University Medical Center

Belgrade, , Serbia

Oblasna komunalna ustanova "Chernivetska oblasna klinichna likarnia"

Chernivtsi, Chernivtsi Oblast, Ukraine

KNP "Odeska oblasna klinichna likarnia" Odeskoi oblasnoi rady"

Odesa, Odesa Oblast, Ukraine

Medychnyi Tsentr TOV "KHELS KLINIK" - viddil Gasrtroenterology, Hepatology and Endocrinology

Vinnytsia, Vinnytsia Oblast, Ukraine

KU "6-A miska klinichna likarnia"

Zaporizhzhia, Zaporizhzhia Oblast, Ukraine

Countries

United States; Bulgaria; Czechia; Georgia; Hungary; Poland; Serbia; Ukraine

References

Paper Alert. Eur J Gastroenterol Hepatol. 2025 Jul 1;37(7):887-890. doi: 10.1097/MEG.0000000000003011. Epub 2025 May 28.

Reference Type: DERIVED

PMID: 40470733 (View on PubMed)

Sharma P, Vaezi M, Unge P, Andersson K, Larsson K, Popadiyn I, Rosenholm M, Rosztoczy A, Yektaei E, Armstrong D. Clinical Trial: Dose-Finding Study of Linaprazan Glurate, A Novel Potassium-Competitive Acid Blocker, Versus Lansoprazole for the Treatment of Erosive Oesophagitis. Aliment Pharmacol Ther. 2025 May;61(10):1590-1602. doi: 10.1111/apt.70109. Epub 2025 Apr 4.

Reference Type: DERIVED

PMID: 40183130 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2020-003319-91

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CX842A2201

Identifier Type: -

Identifier Source: org_study_id