NCT05055128

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

A Randomized Double-blind, Double Dummy, Active Comparator-controlled Dose-finding Study in Patients With Erosive Esophagitis Due to Gastro-esophageal Reflux Disease (GERD) Los Angeles Grade C or D, and Patients With at Least Partial Symptom Response But Endoscopically Still Unhealed After 8 Weeks History of Standard Treatment Healing Course With Proton-pump Inhibitor (PPI), 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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 248 (actual)
• Sponsor: Cinclus Pharma AG · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	X842	Patients will receive X842 tablets.
DRUG	X842 Dummy	Patients will receive matching placebo tablets for X842.
DRUG	Lansoprazole	Patients will receive Lansoprazole capsule.
DRUG	Lansoprazole Dummy	Patients will receive matching placebo capsules for Lansoprazole.

Timeline

• Start date: 2021-08-11
• Primary completion: 2022-09-01
• Completion: 2022-09-01
• First posted: 2021-09-24
• Last updated: 2023-11-01
• Results posted: 2023-11-01

Locations

42 sites across 8 countries: United States, Bulgaria, Czechia, Georgia, Hungary, Poland, Serbia, Ukraine

Regulatory

• FDA-regulated drug study