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A randomized, phase 3, double-blind, double-dummy, active comparator-controlled multicenter study to evaluate the efficacy and safety of 2 doses of linaprazan glurate compared to lansoprazole in 4 or 8 weeks healing in participants with erosive esophagitis (EE) due to gastroesophageal reflux disease (GERD) of Los Angeles (LA) grades A to D

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-518714-31-00
Acronym
CX842A2301
Enrollment
382
Registered
2025-08-22
Start date
2025-10-03
Completion date
Unknown
Last updated
2025-11-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Erosive esophagitis (EE) due to gastroesophageal reflux disease (GERD)

Brief summary

Healing of EE at Week 4 as assessed by endoscopy in participants with Baseline EE LA grades C/D.

Detailed description

1. Cumulative healing of EE at Week 8 as assessed by endoscopy at 4 and 8 weeks., 2. Healing of EE at Week 4 as assessed by endoscopy., 3. Percentage of 24-hour heartburn-free days from Baseline to Week 8 based on the electronic Diary., 4. Percentage of 24-hour heartburn-free days from Baseline to Week 4 based on the electronic Diary., 5. Cumulative healing of EE at Week 8 as assessed by endoscopy at 4 and 8 weeks in participants with Baseline EE LA grades C/D., 6. Healing of EE at Week 4 as assessed by endoscopy in participants with Baseline EE LA grades C/D., 7. Change in weekly mean 24-hour heartburn severity from Baseline to Week 1, Week 4, and Week 8 based on electronic Diary., 8. Safety analysis based on frequency and severity of adverse events (AEs) and any other safety signals detected.

Interventions

DRUGPlacebo to match Linaprazan glurate 50mg
DRUGLinaprazan glurate
DRUGPlacebo to match Lansoprazole 30 mg
DRUGLANSOPRAZOLE

Sponsors

Cinclus Pharma Holding AB (publ)
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Healing of EE at Week 4 as assessed by endoscopy in participants with Baseline EE LA grades C/D.—

Secondary

MeasureTime frame
1. Cumulative healing of EE at Week 8 as assessed by endoscopy at 4 and 8 weeks., 2. Healing of EE at Week 4 as assessed by endoscopy., 3. Percentage of 24-hour heartburn-free days from Baseline to Week 8 based on the electronic Diary., 4. Percentage of 24-hour heartburn-free days from Baseline to Week 4 based on the electronic Diary., 5. Cumulative healing of EE at Week 8 as assessed by endoscopy at 4 and 8 weeks in participants with Baseline EE LA grades C/D., 6. Healing of EE at Week 4 as assessed by endoscopy in participants with Baseline EE LA grades C/D., 7. Change in weekly mean 24-hour heartburn severity from Baseline to Week 1, Week 4, and Week 8 based on electronic Diary., 8. Safety analysis based on frequency and severity of adverse events (AEs) and any other safety signals detected.—

Countries

Bulgaria, Czechia, Germany, Hungary, Poland, Romania

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026