A Phase III Clinical Trial and Extension Study to Evaluate the Efficacy and Safety of DWP14012 for Maintenance Therapy in Patients With Healed Erosive Esophagitis

NCT07746518 | Not Yet Recruiting Phase 3

• 1 other identifier: DW_DWP14012314
• Study Type: interventional
• Target: 420
• Locations: 0 countries
• Sites: N/A

Brief Summary

A Multi-center, Double-blind, Randomized, Active-controlled, Parallel-group, Phase III Clinical Trial and Open-label Extension Study to Evaluate the Efficacy and Safety of DWP14012 for Maintenance Therapy in Patients with Healed Erosive Esophagitis

Conditions

Healed Erosive Esophagitis

Outcome Measures

Primary Outcomes (1)

• Proportion (%) of subjects who maintain endoscopic remission* up to Week 24, as assessed by an independent central reader, after administration of the IP

  Week 24

Secondary Outcomes (2)

• Proportion (%) of subjects who maintain endoscopic remission* up to Week 24, as assessed by the investigator, after administration of the IP

  Week 24

• Proportion (%) of subjects who maintain endoscopic remission* up to Week 12, as assessed by an independent central reader and the investigator, after administration of the IP

  Week 12

Study Arms (4)

[Double-blind Treatment Period]Treatment group(DWP14012)

EXPERIMENTAL

Treatment group (DWP14012 20 mg group): 1 tablet of DWP14012 20 mg + 1 capsule of DWC202517 15 mg placebo for 24 weeks

Drug: DWP14012 20mg; Drug: DWC202517 15 mg placebo

[Double-blind Treatment Period]Control group(DWC202517)

ACTIVE COMPARATOR

1 tablet of DWP14012 20 mg placebo + 1 capsule of DWC202517 15 mg for 24weeks

Drug: DWP14012 20 mg placebo; Drug: DWC202517 15 mg

[Open-label Extension Period]Maintenance group (DWP14012 20 mg/DWP14012 20 mg group)

EXPERIMENTAL

1 tablet of DWP14012 20 mg for 28weeks after Double-blind Treatment Period

Drug: DWP14012 20mg

[Open-label Extension Period]Switch group (DWC202517 15 mg/DWP14012 20 mg group)

EXPERIMENTAL

1 tablet of DWP14012 20 mg for 28weeks after Double-blind Treatment Period

Drug: DWP14012 20mg

Interventions

DWP14012 20mg DRUG

20mg, 1 tablet, Orally, Once a day

[Double-blind Treatment Period]Treatment group(DWP14012); [Open-label Extension Period]Maintenance group (DWP14012 20 mg/DWP14012 20 mg group); [Open-label Extension Period]Switch group (DWC202517 15 mg/DWP14012 20 mg group)

DWP14012 20 mg placebo DRUG

1 tablet, Orally, Once a day

[Double-blind Treatment Period]Control group(DWC202517)

DWC202517 15 mg DRUG

15mg, 1 capsule, Orally, Once a day

[Double-blind Treatment Period]Control group(DWC202517)

DWC202517 15 mg placebo DRUG

1 capsule, Orally, Once a day

[Double-blind Treatment Period]Treatment group(DWP14012)

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 men and women aged 19 to 75 years at the time of written informed consent
• Diagnosed with EE on an upper gastrointestinal endoscopy prior to the initiation of standard therapy
• Healing of EE confirmed by upper gastrointestinal endoscopy performed prior to Visit 2 (Randomization), defined as the absence of mucosal breaks according to the LA Grade classification, after completion of standard therapy
• Able to understand the information provided and complete the questionnaire
• Has voluntarily decided to participate in this clinical trial and has provided written informed consent

You may not qualify if:

• Presence of heartburn or acid regurgitation within 7 days prior to Visit 2 (Randomization)
• On screening upper gastrointestinal endoscopy, presence of Barrett's esophagus (\>3 cm), esophageal varices, esophageal stricture, ulcer-related stricture, active peptic ulcer, acute gastrointestinal bleeding, or malignancy
• Patients with inflammatory bowel disease , irritable bowel syndrome, primary esophageal motility disorder, or pancreatitis
• History of gastric acid secretion-inhibiting surgery or surgery on the stomach/esophagus (e.g., gastrectomy, endoscopic mucosal resection) or total small bowel resection
• Presence of alarm symptoms suggestive of gastrointestinal malignancy
• Patients with Zollinger-Ellison syndrome
• Patients with eosinophilic esophagitis
• Subjects with diseases of the liver, kidney, nervous system, respiratory system, endocrine system, hematologic/oncologic system, cardiovascular system, or urinary system that, in the investigator's judgment, render them unsuitable for participation in this clinical trial
• Subjects with a history of malignancy within the past 5 years
• Subjects with a history of clinically significant psychiatric disorders.
• Subjects with a history of drug or alcohol abuse within the past year.
• Subjects diagnosed with Acquired Immune Deficiency Syndrome (AIDS).
• Subjects who test positive for either Hepatitis B surface antigen (HBsAg) or Hepatitis C virus antibody (anti-HCV)
• Subjects with hereditary disorders such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
• Subjects with hypersensitivity to any component of the IP or to benzimidazole-class drugs, or with a clinically significant history of hypersensitivity

Sponsors & Collaborators

• Daewoong Pharmaceutical Co. LTD.: lead

MeSH Terms

Interventions

fexuprazan

Central Study Contacts

Lee Coordinating Investigator

CONTACT

02)550-8800; 2220187@daewoong.co.kr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Part 1 (Double-blind Treatment Period) Multi-center, double-blind, randomized, active-controlled, parallel-group, Phase III clinical trial Part 2 (Open-label Extension Period) Open-label
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Part 1 (Double-blind Treatment Period) Multi-center, double-blind, randomized, active-controlled, parallel-group, Phase III clinical trial Part 2 (Open-label Extension Period) Open-label

Study Record Dates

• First Submitted: July 31, 2026
• First Posted: August 5, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): August 1, 2029
• Study Completion (Estimated): March 1, 2030
• Last Updated: August 5, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share