Phase 2
N=248
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
Erosive Esophagitis
Bottom Line
View on ClinicalTrials.gov: NCT05055128 ↗Enrolled (actual)
248
Serious AEs
0.8%
Results posted
Nov 2023
Primary outcome: Primary: Number of Patients With Esophageal Mucosa Healing — 28; 28; 32; 18 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- X842 (Drug); X842 Dummy (Drug); Lansoprazole (Drug); Lansoprazole Dummy (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Cinclus Pharma AG
- Primary completion
- Sep 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With Esophageal Mucosa Healing |
28; 28; 32; 18; 20 | — |
| SECONDARY Number of Patients With Adverse Events (AEs) |
15; 10; 12; 11; 10; 14 | — |
| SECONDARY Percentage of Heartburn-Free 24-hour Days |
27.0; 25.1; 29.2; 26.1; 19.1; 82.4 | — |
| SECONDARY Percentage at Most-mild Heartburn 24-hour Days |
75.3; 67.9; 79.4; 69.7; 63.1; 98.5 | — |
| SECONDARY Investigator Assessment of Symptoms by Frequency and Severity |
0; 2; 0; 1; 0; 14 | — |
| SECONDARY Change From Baseline in Quality of Life in Reflux and Dyspepsia (QOLRAD) Score |
1.69; 1.55; 1.14; 1.54; 1.34; 2.76 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT05055128). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.