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

NCT05055128 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: CX842A22012020-003319-91
• Study Type: interventional
• Target: 248
• Locations: 8 countries
• Sites: 42

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.

Conditions

Erosive Esophagitis

Keywords

Lansoprazole; Los Angeles Grade; Double-blind; Active comparator-controlled; Proton-pump inhibitor; Dose selection

Outcome Measures

Primary Outcomes (1)

• Number of Patients With Esophageal Mucosa Healing

  The healing of erosive esophagitis due to gastro-esophageal reflux disease (GERD) was assessed. It supported the dose selection X842,through the assessment of healing of erosive esophagitis due to GERD based on endoscopic assessment after 4 weeks of treatment. The dose that would lead to having 85% of the patients have esophageal mucosa healing after 4 weeks of treatment. Following the endoscopic evaluation, all patients received subsequent 4 weeks of open-label treatment with lansoprazole. Repeated symptom evaluation was assessed during this period to detect the symptom pattern. Endoscopy evaluation at 4 weeks was based on the level and duration of acid control achieved with X842. Symptom evaluation was assessed using the validated patient-reported outcome (PRO) QOLRAD (Heartburn version) and patient diaries (RESQ-eDiary).

  Week 4

Secondary Outcomes (5)

• Number of Patients With Adverse Events (AEs)

  From Screening (Day -7 to Day 0) until Week 8

• Percentage of Heartburn-Free 24-hour Days

  Weeks 1 and 8

• Percentage at Most-mild Heartburn 24-hour Days

  Weeks 1 and 8

• Investigator Assessment of Symptoms by Frequency and Severity

  Weeks 1 and 8

• Change From Baseline in Quality of Life in Reflux and Dyspepsia (QOLRAD) Score

  Baseline, Weeks 1, and 8

Study Arms (5)

X842 25 mg BID

EXPERIMENTAL

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.

Drug: X842; Drug: X842 Dummy; Drug: Lansoprazole; Drug: Lansoprazole Dummy

X842 50 mg BID

EXPERIMENTAL

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.

Drug: X842; Drug: X842 Dummy; Drug: Lansoprazole; Drug: Lansoprazole Dummy

X842 75 mg BID

EXPERIMENTAL

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.

Drug: X842; Drug: Lansoprazole; Drug: Lansoprazole Dummy

X842 100 mg BID

EXPERIMENTAL

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.

Drug: X842; Drug: Lansoprazole; Drug: Lansoprazole Dummy

Lansoprazole

ACTIVE COMPARATOR

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.

Drug: X842 Dummy; Drug: Lansoprazole

Interventions

X842 DRUG

Patients will receive X842 tablets.

X842 100 mg BID; X842 25 mg BID; X842 50 mg BID; X842 75 mg BID

X842 Dummy DRUG

Patients will receive matching placebo tablets for X842.

Lansoprazole; X842 25 mg BID; X842 50 mg BID

Lansoprazole DRUG

Patients will receive Lansoprazole capsule.

Lansoprazole; X842 100 mg BID; X842 25 mg BID; X842 50 mg BID; X842 75 mg BID

Lansoprazole Dummy DRUG

Patients will receive matching placebo capsules for Lansoprazole.

X842 100 mg BID; X842 25 mg BID; X842 50 mg BID; X842 75 mg BID

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Body mass index (BMI) ≥ 18 and ≤ 40 kg/m\^2 at screening.
• 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.
• Willing and able to comply with all aspects of the protocol (including capsule swallowing, diary completion, etc.).
• Capable of signing informed consent form.

You may not qualify if:

• History or presence of any clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disease or disorder.
• 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.
• Present clinically significant psychiatric diagnosis.
• History of malignancy of any organ system.
• 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.
• Known severe atrophic gastritis.
• Any planned major surgery within the duration of the study.
• 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.
• History of long QTc syndrome (e.g. QTc ≥450 ms for males and ≥470 ms for females).
• Cardiac arrhythmias or any clinically significant abnormalities in the resting 12-lead ECG at the time of screening, as judged by the Investigator.
• History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity.
• Current or history of alcohol, drug abuse and/or use of anabolic steroids within 2 years prior to screening.
• Women who are pregnant or breastfeeding.
• Patients who have previously participated (completed or withdrawn) in this study CX842A2201.

Sponsors & Collaborators

• Cinclus Pharma AG: lead
• Parexel: collaborator

Study Sites (42)

Genesis Clinical Research - Tampa

Tampa, Florida, 33614, United States

Location

Medical Center Excelsior

Sofia, Sofia-Grad, 1233, Bulgaria

Location

DCC XIV Sofia

Sofia, Sofia-Grad, 1404, Bulgaria

Location

DCC XIV Sofia

Sofia, Sofia-Grad, 1408, Bulgaria

Location

Medical Centre Asklepii

Dupnitsa, 2600, Bulgaria

Location

Medical Center Medconsult Pleven

Pleven, 5800, Bulgaria

Location

DCC-1 Sliven

Plovdiv, 4002, Bulgaria

Location

MHAT "Kaspela"

Plovdiv, 4002, Bulgaria

Location

Medical Center Prolet EOOD

Rousse, 7000, Bulgaria

Location

Diagnostive Consultative Center-1 Sliven

Sliven, 8800, Bulgaria

Location

Medical Center Hera - Gastroenterology office

Sliven, 8800, Bulgaria

Location

2-nd MHAT

Sofia, 1202, Bulgaria

Location

Medical Center Excelsior

Sofia, 1407, Bulgaria

Location

MHAT "Sveti Ivan Rilski" - Sofia

Sofia, 1431, Bulgaria

Location

Medical Center Hera - Gastroenterology office

Sofia, 1510, Bulgaria

Location

Medical Center New Rehabilitation Center EOOD

Stara Zagora, 6003, Bulgaria

Location

Medical Center "Biomed 99" Ltd

Vidin, 3700, Bulgaria

Location

Mhat "Hristo Botev"

Vratsa, 3000, Bulgaria

Location

ResTrial GastroEndo s.r.o.

Prague, 143 00, Czechia

Location

LTD"Brothers"

Batumi, Adjara, 6010, Georgia

Location

A. Aladashvili clinic LLC

Tbilisi, 0102, Georgia

Location

LTD Israeli-Georgian Medical Research Clinic "Helsicore"

Tbilisi, 0112, Georgia

Location

LTD TSMU and Ingorokva High Medical Technology University Clinic

Tbilisi, 0141, Georgia

Location

Emergency Cardiology Center named by acad. G. Chapidze

Tbilisi, Georgia

Location

Bekes Megyei Kozponti Korhaz, Dr.Rethy Pal Tagkorhaz

Békéscsaba, Bekes County, 5600, Hungary

Location

Szegedi Tudomanyegyetem Általános Orvostudományi Kar

Szeged, Csongrád megye, H-6725, Hungary

Location

ClinExpert Kft.

Budapest, Pest County, 1032, Hungary

Location

Pannonia Maganorvosi Centrum Kft

Budapest, H-1136, Hungary

Location

NZOZ "Centrum Medyczne KERMED"

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-681, Poland

Location

Centrum Medyczne Melita Medical

Wroclaw, Lower Silesian Voivodeship, 50-449, Poland

Location

Szpital Zakonu Bonifratrow Sw. Jana Bozego w Lodzi

Lodz, Lódzkie, 90-302, Poland

Location

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

Oświęcim, 32-600, Poland

Location

ETG Skierniewice

Skierniewice, 96-100, Poland

Location

Twoja Przychodnia - Szczecinskie Centrum Medyczne

Szczecin, 71-270, Poland

Location

EuroMediCare Szpital Specjalistyczny z Przychodnia

Wroclaw, 50-449, Poland

Location

EuroMediCare Szpital Specjalistyczny z Przychodnia

Wroclaw, 54-144, Poland

Location

ETG Zamosc

Zamość, 22-400, Poland

Location

Zvezdara University Medical Center

Belgrade, 11000, Serbia

Location

Oblasna komunalna ustanova "Chernivetska oblasna klinichna likarnia"

Chernivtsi, Chernivtsi Oblast, 58001, Ukraine

Location

KNP "Odeska oblasna klinichna likarnia" Odeskoi oblasnoi rady"

Odesa, Odesa Oblast, 65025, Ukraine

Location

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

Vinnytsia, Vinnytsia Oblast, 21009, Ukraine

Location

KU "6-A miska klinichna likarnia"

Zaporizhzhia, Zaporizhzhia Oblast, 69035, Ukraine

Location

Related Publications (2)

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

  PMID: 40470733 DERIVED

• 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.

  PMID: 40183130 DERIVED

MeSH Terms

Interventions

Lansoprazole

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

Results Point of Contact

• Title: Kajsa Larsson, MD, PhD
• Organization: Cinclus Pharma Holding AB

kajsa.larsson@cincluspharma.com

+46 70 675 01 28

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2021
• First Posted: September 24, 2021
• Study Start: August 11, 2021
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: November 1, 2023
• Results First Posted: November 1, 2023

Record last verified: 2023-10

Locations

CZ (1); PL (9); BU (17); HU (4); UA (4); US (1); GE (5); SE (1)