Study to Evaluate the Efficacy and Safety of JP-1366 in the Prevention of NSAIDs-Induced Peptic Ulcers

A Multicenter, Parallel, Double-blind, Randomized, Active-controlled, Non-inferiority, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of JP-1366 Treatment in the Prevention of (NSAIDs)-Induced Peptic Ulcers

The sutdy aims to to demonstrate the non-inferiority of JP-1366 10 mg compared to Lanston Capsule 15 mg in preventing NSAIDs-induced peptic ulcers and to compare/evaluate the efficacy and safety of JP-1366 10 mg.

Study Overview

• Status: Recruiting
• Conditions: Peptic Ulcer
• Intervention / Treatment: Drug: JP-1366 10 mg; Drug: Lanston Capsule 15 mg placebo; Drug: Lanston Capsule 15 mg; Drug: JP-1366 10 mg placebo

• Study Type: Interventional
• Enrollment (Estimated): 364
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: John KIM; Phone Number: 0234540780; Email: onconictherapeutics@gmail.com

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Konkuk University Medical Center
    • Contact: Sang-Heon Lee; Phone Number: 0220305114

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Adult male/female aged 19 years or older as of the date of obtaining consent
2. Those who are diagnosed with musculoskeletal diseases such as rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, or other diseases at the time of screening and require continuous administration of NSAIDs for 24 weeks or more
3. Those with one or more of the following risk factors for ulcer development at the time of screening
4. Subjects who fully understand this study and voluntarily signed the informed consent form.

Exclusion Criteria:

1. Those who cannot undergo upper gastrointestinal endoscopy
2. At the time of screening, those who were confirmed to have active stage ulcers (A1, A2) or healing stage ulcers (H1, H2) in the stomach or duodenum according to the Sakita-Miwa Classification*
3. Those with a confirmed history of malignant tumor within 5 years
4. Those with a confirmed history of signal symptoms suggestive of malignant disease of the gastrointestinal tract
5. Those who need to continuously take corticosteroids, antiplatelet agents, and anticoagulants during this study (however, the following cases are permitted):
6. Pregnant and lactating women or those with a positive pregnancy test result at screening
7. Those who participated in another study and were administered investigational products or had medical devices applied at least once within 4 weeks from the screening visit(Visit 0)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: JP-1366 10 mg	Drug: JP-1366 10 mg; JP-1366 10 mg, tablet, orally once a day for up to 24 weeks; Drug: Lanston Capsule 15 mg placebo; Lanston Capsule 15 mg placebo, orally once a day for up to 24 weeks
Active Comparator: Lanston Capsule 15 mg	Drug: Lanston Capsule 15 mg; Lanston Capsule 15 mg orally once a day for up to 24 weeks; Drug: JP-1366 10 mg placebo; JP-1366 10 mg placebo, tablet, orally once a day for up to 24 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Cumulative proportion of subjects who developed peptic ulcers	at 24 weeks after administration of investigational products

Secondary Outcome Measures

Outcome Measure	Time Frame
Proportion of subjects with gastric or duodenal endoscopic bleeding	at 24 weeks after administration of investigational products

Collaborators and Investigators

• Sponsor: Onconic Therapeutics Inc.

Study record dates

Study Major Dates

• Study Start (Actual): October 22, 2024
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: May 22, 2024
• First Submitted That Met QC Criteria: May 29, 2024
• First Posted (Actual): June 3, 2024

Study Record Updates

• Last Update Posted (Estimated): November 1, 2024
• Last Update Submitted That Met QC Criteria: October 30, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Duodenal Diseases; Ulcer; Peptic Ulcer
• Other Study ID Numbers: JP-1366-304

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No