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New GERD drug aims to heal esophagus damage when standard treatments fail

NCT ID NCT05055128

Disease control Sponsor: Cinclus Pharma Holding AB Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 01, 2026 · Last updated Jul 02, 2026 · Updated 1 time

Summary

This study tests an experimental drug called X842 in people with severe erosive esophagitis caused by GERD (chronic acid reflux). Participants have either severe esophagus damage (grades C or D) or milder damage that hasn't healed after 8 weeks of standard treatment. The trial compares X842 with the common medication lansoprazole to see which better heals the esophagus after 4 weeks, and tracks symptoms during a follow-up period. The goal is to find the right dose for future larger studies.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
X842
What this could lead to
If successful, X842 could offer a new treatment option for people with severe GERD-related esophagitis that hasn't healed with standard medications.
What could go wrong
This is an early phase 2 dose-finding study, so results may not confirm effectiveness. Side effects are still being evaluated, and the drug may not outperform existing treatments.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

248 people

The number who actually took part.

Started

Aug 2021

Finished

Sep 2022

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

esophagitis peptic esophagitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Erosive esophagitis

Contacts and locations

Locations

  • 2-nd MHAT

    Sofia, Sofia, 1202, Bulgaria

  • A. Aladashvili clinic LLC

    Tbilisi, K'alak'i T'bilisi, 0102, Georgia

  • Bekes Megyei Kozponti Korhaz, Dr.Rethy Pal Tagkorhaz

    Békéscsaba, Bekes County, 5600, Hungary

  • Centrum Medyczne Melita Medical

    Wroclaw, Lower Silesian Voivodeship, 50-449, Poland

  • ClinExpert Kft.

    Budapest, Pest County, 1032, Hungary

  • DCC XIV Sofia

    Sofia, Sofia-Grad, 1404, Bulgaria

  • DCC XIV Sofia

    Sofia, Sofia-Grad, 1408, Bulgaria

  • DCC-1 Sliven

    Plovdiv, Plovdiv, 4002, Bulgaria

  • Diagnostive Consultative Center-1 Sliven

    Sliven, Sliven, 8800, Bulgaria

  • ETG Skierniewice

    Skierniewice, 96-100, Poland

  • ETG Zamosc

    Zamość, 22-400, Poland

  • Emergency Cardiology Center named by acad. G. Chapidze

    Tbilisi, K'alak'i T'bilisi, Georgia

  • EuroMediCare Szpital Specjalistyczny z Przychodnia

    Wroclaw, 50-449, Poland

  • EuroMediCare Szpital Specjalistyczny z Przychodnia

    Wroclaw, 54-144, Poland

  • Genesis Clinical Research - Tampa

    Tampa, Florida, 33614, United States

  • KNP "Odeska oblasna klinichna likarnia" Odeskoi oblasnoi rady"

    Odesa, Odesa Oblast, 65025, Ukraine

  • KU "6-A miska klinichna likarnia"

    Zaporizhzhia, Zaporizhzhia Oblast, 69035, Ukraine

  • LTD Israeli-Georgian Medical Research Clinic "Helsicore"

    Tbilisi, K'alak'i T'bilisi, 0112, Georgia

  • LTD TSMU and Ingorokva High Medical Technology University Clinic

    Tbilisi, K'alak'i T'bilisi, 0141, Georgia

  • LTD"Brothers"

    Batumi, Adjara, 6010, Georgia

  • MHAT "Kaspela"

    Plovdiv, Plovdiv, 4002, Bulgaria

  • MHAT "Sveti Ivan Rilski" - Sofia

    Sofia, Sofia, 1431, Bulgaria

  • Medical Center "Biomed 99" Ltd

    Vidin, 3700, Bulgaria

  • Medical Center Excelsior

    Sofia, Sofia, 1407, Bulgaria

  • Medical Center Excelsior

    Sofia, Sofia-Grad, 1233, Bulgaria

  • Medical Center Hera - Gastroenterology office

    Sliven, Sliven, 8800, Bulgaria

  • Medical Center Hera - Gastroenterology office

    Sofia, Sofia, 1510, Bulgaria

  • Medical Center Medconsult Pleven

    Pleven, Pleven, 5800, Bulgaria

  • Medical Center New Rehabilitation Center EOOD

    Stara Zagora, Stara Zagora, 6003, Bulgaria

  • Medical Center Prolet EOOD

    Rousse, Ruse, 7000, Bulgaria

  • Medical Centre Asklepii

    Dupnitsa, Dupnitsa, 2600, Bulgaria

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

    Vinnytsia, Vinnytsia Oblast, 21009, Ukraine

  • Mhat "Hristo Botev"

    Vratsa, Vratsa, 3000, Bulgaria

  • NZOZ "Centrum Medyczne KERMED"

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

  • Oblasna komunalna ustanova "Chernivetska oblasna klinichna likarnia"

    Chernivtsi, Chernivtsi Oblast, 58001, Ukraine

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

    Oświęcim, 32-600, Poland

  • Pannonia Maganorvosi Centrum Kft

    Budapest, Budapest, H-1136, Hungary

  • ResTrial GastroEndo s.r.o.

    Prague, 143 00, Czechia

  • Szegedi Tudomanyegyetem Általános Orvostudományi Kar

    Szeged, Csongrád megye, H-6725, Hungary

  • Szpital Zakonu Bonifratrow Sw. Jana Bozego w Lodzi

    Lodz, Lódzkie, 90-302, Poland

  • Twoja Przychodnia - Szczecinskie Centrum Medyczne

    Szczecin, 71-270, Poland

  • Zvezdara University Medical Center

    Belgrade, Belgrade, 11000, Serbia

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Other studies related to the condition(s) this trial covers.