Efficacy and Safety of JP-1366-based Triple Therapy in Helicobacter Pylori-positive Subjects

NCT07875933 | Not Yet Recruiting Phase 3

• 1 other identifier: JP-1366-306
• Study Type: interventional
• Target: 414
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aims to evaluate the Efficacy and Safety of JP-1366-based Triple-Therapy in H. pylori-positive Subjects

Conditions

H. Pylori Eradication Therapy

Keywords

H. pylori

Outcome Measures

Primary Outcomes (1)

• H. pylori eradication rate after a minimum of 4 weeks from completion of Investigational product administration

  at least 4 weeks after completion of administration

Study Arms (2)

Experimental Group

EXPERIMENTAL

Drug: JP-1366 20 mg, Lansoprazole 30 mg Placebo, Clarithromycin 500mg, Amoxicillin 1000mg

Active Comparative Group

ACTIVE COMPARATOR

Drug: Lansoprazole 30mg, JP-1366 20 mg Placebo, Clarithromycin 500mg, Amoxicillin 1000mg

Interventions

JP-1366 20 mg, Lansoprazole 30 mg Placebo, Clarithromycin 500mg, Amoxicillin 1000mg DRUG

Orally, twice daily

Experimental Group

Lansoprazole 30mg, JP-1366 20 mg Placebo, Clarithromycin 500mg, Amoxicillin 1000mg DRUG

Orally, twice daily

Active Comparative Group

Eligibility Criteria

• Age: 19 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult males or females aged ≥19 years and ≤75 years at the time of written informed consent
• Participants with a confirmed positive result for 13C-UBT performed at the Screening Visit (Visit 1)
• Participants with a confirmed positive result for H. pylori in the CLO test performed at the Screening Visit (Visit 1) (If test results obtained at the same study site within 12 weeks prior to the Screening Visit (Visit 1) are available, those results may be used.)

You may not qualify if:

• Participants diagnosed with significant acute upper gastrointestinal bleeding within 4 weeks prior to the Screening Visit (Visit 1)
• Participants with a procedural history that affects gastric acid secretion (partial gastrectomy, vagotomy, etc.) prior to the Screening Visit (Visit 1)
• Participants with Zollinger-Ellison syndrome or other hyperchlorhydria disorders at the Screening Visit (Visit 1)
• Participants who have had H. pylori eradication therapy at least once before the Screening Visit (Visit 1)

Sponsors & Collaborators

• Onconic Therapeutics Inc.: lead

MeSH Terms

Interventions

Lansoprazole; Clarithromycin; Amoxicillin

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Erythromycin; Macrolides; Polyketides; Lactones; Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double-blinded (Participant, Investigator)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2026
• First Posted: October 15, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): September 6, 2028
• Study Completion (Estimated): October 6, 2028
• Last Updated: October 15, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share