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
Are there results?: Not yet: the study is under way

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

Interested in taking part?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingPhase 3
Keverprazan-Minocycline Dual Therapy of Different Durations Versus Bismuth Quadruple Therapy for Helicobacter Pylori Eradication.
Helicobacter Infection
RecruitingPhase 1
Impact of Eradication Therapy on Helicobacter Pylori Infection With Chronic Obstructive Pulmonary Disease:
Chronic Obstructive Pulmonary Disease (COPD), With Poitive H Pylori
RecruitingPhase 4
Efficacy and Safety of Linarazen Gluconate Capsules Combined With Amoxicillin (Dual-Drug Therapy) Versus Bismuth-Containing Quadruple Therapy for First-Line Eradication of Helicobacter Pylori Infection
HELICOBACTER PYLORI INFECTIONS
Not yet recruitingPhase 3
Personalized vs Standard of Care Treatment for Helicobacter Pylori Eradication Among Veterans
Helicobacter Pylori
Active, not recruiting
Efficacy and Safety of Second-Line Helicobacter Pylori Eradication
HELICOBACTER PYLORI INFECTIONS

All H. Pylori Eradication Therapy trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT07875933
Acronym / sponsor ID: JP-1366-306
Conditions: H. Pylori Eradication Therapy
Keywords: H. pylori
Phase: Phase 3
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 414 participants (estimated)
Lead sponsor: Onconic Therapeutics Inc.Industry (pharma, biotech, devices)
Study start: 1 Nov 2026 (estimated)
Primary completion: 6 Sep 2028 (estimated)
Study completion: 6 Oct 2028 (estimated)
First posted: 15 Oct 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
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

Who may qualify

Ages: 19 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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.)

Key exclusion criteria (4 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
JP-1366 20 mg, Lansoprazole 30 mg Placebo, Clarithromycin 500mg, Amoxicillin 1000mgOrally, twice daily	Drug	Experimental Group
Lansoprazole 30mg, JP-1366 20 mg Placebo, Clarithromycin 500mg, Amoxicillin 1000mgOrally, twice daily	Drug	Active Comparative Group

Primary outcome

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

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
Individual participant dataSharing planned: No

Related trials for H. Pylori Eradication Therapy

RecruitingPhase 3
Keverprazan-Minocycline Dual Therapy of Different Durations Versus Bismuth Quadruple Therapy for Helicobacter Pylori Eradication.
Helicobacter Infection
RecruitingPhase 1
Impact of Eradication Therapy on Helicobacter Pylori Infection With Chronic Obstructive Pulmonary Disease:
Chronic Obstructive Pulmonary Disease (COPD), With Poitive H Pylori
RecruitingPhase 4
Efficacy and Safety of Linarazen Gluconate Capsules Combined With Amoxicillin (Dual-Drug Therapy) Versus Bismuth-Containing Quadruple Therapy for First-Line Eradication of Helicobacter Pylori Infection
HELICOBACTER PYLORI INFECTIONS
Not yet recruitingPhase 3
Personalized vs Standard of Care Treatment for Helicobacter Pylori Eradication Among Veterans
Helicobacter Pylori
Active, not recruiting
Efficacy and Safety of Second-Line Helicobacter Pylori Eradication
HELICOBACTER PYLORI INFECTIONS

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

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

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

H. pylori eradication rate after a minimum of 4 weeks from completion of Investigational product administration (time frame: at least 4 weeks after completion of administration). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07875933.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.