Maintenance of Healed Erosive Gastroesophageal Reflux Disease (ERD)Phase 3NCT07732075
Phase 3 Study of JP-1366: Efficacy and Safety of JP-1366 as Maintenance Therapy in Subjects With Healed Erosive Esophagitis
A Phase 3 study testing JP-1366 10 mg and Lansoprazole 15mg in people with Maintenance of Healed Erosive Gastroesophageal Reflux Disease (ERD), run by Onconic Therapeutics Inc..
Trial summary
This study aims to evaluate the Efficacy and Safety of JP-1366 as Maintenance Therapy in Subjects with Healed Erosive Esophagitis Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- Maintenance of Healed Erosive Gastroesophageal Reflux Disease (ERD)
- What is being tested?
- JP-1366 10 mg and Lansoprazole 15mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 384 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2026to 30 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
- 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
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official 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
This study aims to evaluate the Efficacy and Safety of JP-1366 as Maintenance Therapy in Subjects with Healed Erosive Esophagitis
- Being tested
- JP-1366 10 mg, Lansoprazole 15mg
- Keywords
- Erosive gastroesophageal reflux disease (ERD)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JP-1366 10 mgDrug
Orally, once daily
Lansoprazole 15mgDrug
Orally, once daily
| Study group | Role | What they receive |
|---|---|---|
| JP-1366 10 mg, Lansoprazole 15 mg Placebo Orally, once daily | Experimental | Not described Receives: Drug: JP-1366 10 mg |
| Lansoprazole 15mg, JP-1366 10 mg Placebo Orally, once daily | Active comparator | Not described Receives: Drug: Lansoprazole 15mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of subjects with maintained healing of erosive esophagitis confirmed by upper gastrointestinal endoscopy at Week 24
Measured: Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2026
- Study start1 Aug 2026 (estimated)
- Primary completion30 Oct 2028 (estimated)
- Study completion30 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maintenance of Healed Erosive Gastroesophageal Reflux Disease (ERD)Studies 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
- 384 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Onconic Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07732075
- Sponsor's protocol ID
- JP-1366-302
- Status last verified
- Jul 2026
- First submitted
- 23 Jul 2026
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07732075
- Acronym / sponsor ID
- JP-1366-302
- Keywords
- Erosive gastroesophageal reflux disease (ERD)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 384 participants (estimated)
- Lead sponsor
- Onconic Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 30 Oct 2028 (estimated)
- Study completion
- 30 Oct 2028 (estimated)
- First posted
- 28 Jul 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 as Maintenance Therapy in Subjects with Healed Erosive Esophagitis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| JP-1366 10 mg, Lansoprazole 15 mg Placebo Orally, once daily | Experimental | Drug: JP-1366 10 mg |
| Lansoprazole 15mg, JP-1366 10 mg Placebo Orally, once daily | Active comparator | Drug: Lansoprazole 15mg |
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
- 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
Key exclusion criteria (3 listed)
- 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
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 10 mgOrally, once daily | Drug | JP-1366 10 mg, Lansoprazole 15 mg Placebo Orally, once daily |
| Lansoprazole 15mgOrally, once daily | Drug | Lansoprazole 15mg, JP-1366 10 mg Placebo Orally, once daily |
Primary outcome
The proportion of subjects with maintained healing of erosive esophagitis confirmed by upper gastrointestinal endoscopy at Week 24
Time frame: Week 24
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 28 Jul 2026.
- Individual participant dataSharing planned: No
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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing JP-1366 10 mg and Lansoprazole 15mg in people with Maintenance of Healed Erosive Gastroesophageal Reflux Disease (ERD), 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 3 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 28 Jul 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?
Contact OnconicTherapeutics (82-2-3454-0780, onconictherapeutics@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of subjects with maintained healing of erosive esophagitis confirmed by upper gastrointestinal endoscopy at Week 24 (time frame: Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jul 2026.