Phase 3 Study of JP-1366: Efficacy and Safety of JP-1366 as Maintenance Therapy in Subjects With Healed Erosive Esophagitis

A Multicenter, Randomized, Double-blind, Active-controlled, Parallel, Non-inferiority Phase 3 Study to Evaluate the Efficacy and Safety of JP-1366 as Maintenance Therapy in Subjects With Healed Erosive Esophagitis

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07732075

Enrollment

384

Registered

2026-07-28

Start date

2026-08-01

Completion date

2028-10-30

Last updated

2026-07-28

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

Conditions

Maintenance of Healed Erosive Gastroesophageal Reflux Disease (ERD)

Keywords

Erosive gastroesophageal reflux disease (ERD)

Brief summary

This study aims to evaluate the Efficacy and Safety of JP-1366 as Maintenance Therapy in Subjects with Healed Erosive Esophagitis

Interventions

DRUGJP-1366 10 mg

Orally, once daily

DRUGLansoprazole 15mg

Orally, once daily

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

19 Years to 75 Years

Healthy volunteers

Inclusion criteria

1. Adult males or females aged ≥19 years and ≤75 years at the time of written informed consent 2. Subjects diagnosed with erosive esophagitis according to the LA classification based on upper gastrointestinal endoscopy performed within 12 weeks prior to the Randomization Visit 3. Subjects who have received a PPI or P-CAB for at least 4 weeks after diagnosis of erosive esophagitis confirmed by upper gastrointestinal endoscopy performed within 12 weeks prior to the Randomization Visit

Exclusion criteria

1. Subjects diagnosed with upper gastrointestinal bleeding or perforation, gastric or duodenal ulcer within 4 weeks prior to the Screening 2. Subjects who have alarm symptoms suggestive of gastrointestinal malignancy at the Screening, including odynophagia, severe dysphagia, bleeding, weight loss, anemia, or hematochezia 3. Subjects diagnosed with diseases affecting the esophagus identified by upper gastrointestinal endoscopy at the Screening, including Barrett's esophagus, esophageal dysplasia, esophageal stricture, ulcerative or pyloric stricture, gastroesophageal varices, malignancy, or viral or fungal infection

Design outcomes

Primary

Measure	Time frame
The proportion of subjects with maintained healing of erosive esophagitis confirmed by upper gastrointestinal endoscopy at Week 24	Week 24

Contacts

CONTACTOnconicTherapeutics

onconictherapeutics@gmail.com82-2-3454-0780

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 29, 2026