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NCT Number: NCT07732075

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

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

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Key information

Age range

19 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult males or females aged ≥19 years and ≤75 years at the time of written informed consent
  • Subjects diagnosed with erosive esophagitis according to the LA classification based on upper gastrointestinal endoscopy performed within 12 weeks prior to the Randomization Visit
  • 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

  • Subjects diagnosed with upper gastrointestinal bleeding or perforation, gastric or duodenal ulcer within 4 weeks prior to the Screening
  • Subjects who have alarm symptoms suggestive of gastrointestinal malignancy at the Screening, including odynophagia, severe dysphagia, bleeding, weight loss, anemia, or hematochezia
  • 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

Treatment and study plan

JP-1366 10 mg

Drug

Orally, once daily

Lansoprazole 15mg

Drug

Orally, once daily

Primary outcomes

  1. The proportion of subjects with maintained healing of erosive esophagitis confirmed by upper gastrointestinal endoscopy at Week 24

    Time frame: Week 24

Study contacts

Contact information is provided by the study sponsor or research team.

OnconicTherapeutics

CONTACT

[email protected]

82-2-3454-0780

Sponsors and collaborators

Lead sponsor

Onconic Therapeutics Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jul 28, 2026
Registry last updated
Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.