H. Pylori Eradication TherapyPhase 3NCT07875933

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

A Phase 3 study of H. Pylori Eradication Therapy, run by Onconic Therapeutics Inc..

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Trial summary

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

Who is it for?: Ages 19 to 75 years
Conditions the study is for: H. Pylori Eradication Therapy
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 414 participants
Where: No sites listed yet
Study dates: 1 Nov 2026to 6 Oct 2028
Phase: Phase 3

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 19 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.)

Who cannot join

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)

About this study

Official title: A Multicenter, Randomized, Double-blind, Active-controlled, Parallel-group, Non-inferiority, Phase III Clinical Trial to Evaluate the Efficacy and Safety of JP-1366-based Triple Therapy in Helicobacter Pylori-positive Subjects

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

Read the detailed description

A Multicenter, Randomized, Double-blind, Active-controlled, Parallel-group, Non-inferiority, Phase III Study

Conditions: H. Pylori Eradication Therapy
Being tested: JP-1366 20 mg, Lansoprazole 30 mg Placebo, Clarithromycin 500mg, Amoxicillin 1000mg, Lansoprazole 30mg, JP-1366 20 mg Placebo, Clarithromycin 500mg, Amoxicillin 1000mg
Keywords: H. pylori

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

JP-1366 20 mg, Lansoprazole 30 mg Placebo, Clarithromycin 500mg, Amoxicillin 1000mgDrug
Orally, twice daily
Lansoprazole 30mg, JP-1366 20 mg Placebo, Clarithromycin 500mg, Amoxicillin 1000mgDrug
Orally, twice daily

Study groups in NCT07875933
Study group	Role	What they receive
Experimental Group	Experimental	Not described Receives: Drug: JP-1366 20 mg, Lansoprazole 30 mg Placebo, Clarithromycin 500mg, Amoxicillin 1000mg
Active Comparative Group	Active comparator	Not described Receives: Drug: Lansoprazole 30mg, JP-1366 20 mg Placebo, Clarithromycin 500mg, Amoxicillin 1000mg

What is being measured

The primary outcome is the main question the study is designed to answer.

H. pylori eradication rate after a minimum of 4 weeks from completion of Investigational product administration
Measured: at least 4 weeks after completion of administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Nov 20266 Oct 2028

First posted15 Oct 2026
Study start1 Nov 2026 (estimated)
Primary completion6 Sep 2028 (estimated)
Study completion6 Oct 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for H. Pylori Eradication TherapyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 414 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07875933
Sponsor's protocol ID: JP-1366-306
Status last verified: Oct 2026
First submitted: 1 Oct 2026
Last updated: 15 Oct 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No