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

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age19-75
SponsorOnconic Therapeutics Inc.

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • JP-1366 10 mg

    Drug

    Orally, once daily

  • Lansoprazole 15mg

    Drug

    Orally, once daily

Treatment groups

384 Participants
are divided into 2 treatment groups
Group A: JP-1366 10 mg, Lansoprazole 15 mg Placebo Orally, once dailyExperimental treatment 1 intervention
Group B: Lansoprazole 15mg, JP-1366 10 mg Placebo Orally, once dailyActive comparator 1 intervention

Trial outcomes

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

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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