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A randomized, phase 3, double-blind, double-dummy, active comparator-controlled multicenter clinical trial to evaluate the efficacy and safety of linaprazan glurate compared to lansoprazole in maintenance of healing in participants with healed erosive esophagitis (EE) due to gastroesophageal reflux disease (GERD) of Los Angeles (LA) grades A to D

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-522750-39-00
Enrollment
12
Registered
2026-04-28
Start date
Unknown
Completion date
Unknown
Last updated
2026-04-29

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

1.Maintained healing of EE after 24 weeks as assessed by central reading of endoscopy.

Detailed description

1. Maintained healing of EE after 24 weeks as assessed by central reading of endoscopy, 2. Maintained healing from EE as assessed by central reading of endoscopy after 24 weeks in participants with Baseline EE due to GERD of LA grades C/D., 3. Percentage of heartburn-free days from Baseline to Week 24 based on electronic Diary, 4. Maintained healing of EE comparing linaprazan glurate ‘high dose’ with lansoprazole after 52 weeks as assessed by central reading of endoscopy., 5. Maintained healing of EE comparing linaprazan glurate ‘low dose’ with lansoprazole after 52 weeks as assessed by central reading of endoscopy

Interventions

DRUGLANSOPRAZOLE
DRUGPlacebo to match lansoprazole high dose
DRUGLinaprazan glurate
DRUGPlacebo to match Lansoprazole low dose
DRUGPlacebo to match Linaprazan Glurate

Sponsors

Cinclus Pharma Holding AB (publ)
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
1.Maintained healing of EE after 24 weeks as assessed by central reading of endoscopy.—

Secondary

MeasureTime frame
1. Maintained healing of EE after 24 weeks as assessed by central reading of endoscopy, 2. Maintained healing from EE as assessed by central reading of endoscopy after 24 weeks in participants with Baseline EE due to GERD of LA grades C/D., 3. Percentage of heartburn-free days from Baseline to Week 24 based on electronic Diary, 4. Maintained healing of EE comparing linaprazan glurate ‘high dose’ with lansoprazole after 52 weeks as assessed by central reading of endoscopy., 5. Maintained healing of EE comparing linaprazan glurate ‘low dose’ with lansoprazole after 52 weeks as assessed by central reading of endoscopy—

Outcome results

None listed

Source: EU CTIS · Data processed: Apr 30, 2026