Efficacy and Safety of Vonoprazan Compared to Lansoprazole in Participants With Erosive Esophagitis

NCT04124926 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: EE-3012019-002579-33
• Study Type: interventional
• Target: 1,027
• Locations: 6 countries
• Sites: 157

Brief Summary

To evaluate the efficacy and safety of vonoprazan compared to lansoprazole in participants with erosive esophagitis.

Conditions

Erosive Esophagitis

Keywords

Erosive Esophagitis; Vonoprazan; Lansoprazole

Outcome Measures

Primary Outcomes (2)

• Healing Phase: Percentage of Participants Who Had Complete Healing of EE by Week 8

  A participant was considered to have complete healing of EE if healing was demonstrated during endoscopy.

  Week 8

• Maintenance Phase: Percentage of Participants Who Maintained Complete Healing of EE at Week 24

  A participant was considered to have complete healing of EE if healing was demonstrated during endoscopy.

  Week 24

Secondary Outcomes (7)

• Healing Phase: Percentage of 24-hour Heartburn-free Days

  Day 1 to Week 8

• Healing Phase: Percentage of Participants With Baseline LA Classification Grades C or D Who Had Complete Healing of EE at Week 2

  Week 2

• Healing Phase: Percentage of Participants With Onset of Sustained Resolution of Heartburn by Day 3

  Day 1 to maximum of Day 10 (inclusive of 7 day heartburn assessment)

• Healing Phase: Percentage of Participants With Baseline LA Classification Grades C or D Who Had Complete Healing of EE by Week 8

  Week 8

• Healing Phase: Percentage of Participants Who Had Complete Healing of EE at Week 2

  Week 2

Study Arms (5)

Healing Phase: Vonoprazan 20 mg

EXPERIMENTAL

Participants will receive oral vonoprazan 20 mg once per day (QD) for a maximum of 8 weeks.

Drug: Vonoprazan

Healing Phase: Lansoprazole 30 mg

ACTIVE COMPARATOR

Participants will receive oral lansoprazole 30 mg once per day (QD) for a maximum of 8 weeks.

Drug: Lansoprazole

Maintenance Phase: Vonoprazan 10 mg

EXPERIMENTAL

Participants will receive oral vonoprazan 10 mg once per day (QD) for a maximum of 24 weeks.

Drug: Vonoprazan

Maintenance Phase: Vonoprazan 20 mg

EXPERIMENTAL

Participants will receive oral vonoprazan 20 mg once per day (QD) for a maximum of 24 weeks.

Drug: Vonoprazan

Maintenance Phase: Lansoprazole 15 mg

ACTIVE COMPARATOR

Participants will receive oral lansoprazole 15 mg once per day (QD) for a maximum of 24 weeks.

Drug: Lansoprazole

Interventions

Vonoprazan DRUG

Over-encapsulated tablet administered orally with approximately 240 mL water, 30 minutes prior to the morning meal.

Healing Phase: Vonoprazan 20 mg; Maintenance Phase: Vonoprazan 10 mg; Maintenance Phase: Vonoprazan 20 mg

Lansoprazole DRUG

Over-encapsulated capsule administered orally with approximately 240 mL water, 30 minutes prior to the morning meal.

Healing Phase: Lansoprazole 30 mg; Maintenance Phase: Lansoprazole 15 mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The participant is ≥18 years of age at the time of informed consent signing.
• In the opinion of the investigator or subinvestigators, the participant is capable of understanding and complying with protocol requirements.
• The participant signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures. The participant is informed of the full nature and purpose of the study, including possible risks and side-effects. The participant has the ability to cooperate with the investigator. Ample time and opportunity should be given to read and understand verbal and/or written instructions.
• The participant is found to have endoscopically confirmed EE of LA Classification Grades A to D during the Screening Period (Visit 1) as assessed by a central adjudicator. The target number of participants with LA classification Grade C or D will be approximately 30% of the total number of participants (300 total). Enrollment of EE participants with Grade A or B will end when the number of participants with Grade A or B EE is approximately 700 or 70% of the total planned number of participants. Given the invasive nature of an endoscopy, any endoscopic confirmation performed in a routine clinical setting before signing the informed consent will be acceptable to use for the purpose of fulfilling the screening requirement if all of the following apply: (1) appropriate endoscopy pictures were taken; (2) appropriate gastric biopsy samples were taken; (3) the endoscopy pictures can be sent to the central adjudicator via the adjudication systems; and (4) all screening procedures (including the completion of adjudication) AND randomization can be completed within a 7-day period after the date of the endoscopy.
• A female participant of childbearing potential who is or may be sexually active with a nonsterilized male partner agrees to routinely use adequate contraception from the signing of informed consent until 4 weeks after the last dose of study drug.

You may not qualify if:

• The participant's endoscopic examination for entering this study fails to confirm EE within 7 days (no later than 10 days on rare occasion with sponsor approval) prior to randomization.
• The participant is determined to be positive for Helicobacter pylori (HP) or has had an HP infection within 45 days of randomization.
• The participant has endoscopic Barrett's esophagus (\>1 cm of columnar-lined esophagus) and/or definite dysplastic changes in the esophagus.
• The participant has any other condition affecting the esophagus, including eosinophilic esophagitis; esophageal varices; viral or fungal infection; esophageal stricture; a history of radiation therapy, radiofrequency ablation, endoscopic mucosal resection, or cryotherapy to the esophagus; or any history of caustic or physiochemical trauma (including sclerotherapy or esophageal variceal band ligation). However, participants diagnosed with Schatzki's ring (mucosal tissue ring around lower esophageal sphincter) are eligible to participate.
• The participant has scleroderma (systemic sclerosis).
• The participant has a history of surgery or endoscopic treatment affecting gastroesophageal reflux, including fundoplication and dilation for esophageal stricture (except Schatzki's ring) or a history of gastric or duodenal surgery (except endoscopic removal of benign polyps).
• The participant has an active gastric or duodenal ulcer at the start of the Screening Period. Additionally, participants with gastric or duodenal erosions are permitted to participate.
• The participant has received any investigational compound (including those in post marketing studies) within 30 days prior to the start of the Screening Period. A participant who has been screen failed from another clinical study and who has not been dosed may be considered for enrollment in this study.
• The participant is a study site employee, an immediate family member, or is in a dependent relationship with a study site employee who is involved in the conduct of this study (eg, spouse, parent, child, sibling) or who may have consented under duress.
• The participant has cutaneous lupus erythematosus or systemic lupus erythematosus.
• The participant has had clinically significant upper or lower gastrointestinal bleeding within 4 weeks prior to randomization.
• The participant has Zollinger-Ellison syndrome or other gastric acid hypersecretory conditions.
• The participant has a history of hypersensitivity or allergies to vonoprazan (including the formulation excipients: D-mannitol, microcrystalline cellulose, hydroxypropyl cellulose, fumaric acid, croscarmellose sodium, magnesium stearate, hypromellose, macrogol 8000, titanium oxide, or red or yellow ferric oxide), PPIs, or any excipients used in the 13C-urea breath test: mannitol, citric acid, or aspartame. Skin testing may be performed according to local standard practice to confirm hypersensitivity.
• The participant has a history of alcohol abuse, illegal drug use, or drug addiction within the 12 months prior to screening, or regularly consumes \>21 units of alcohol (1 unit = 12 oz/300 mL beer, 1.5 oz/25 mL hard liquor/spirits, or 5 oz/100 mL wine) per week based on self-report. Participants must have a negative urine drug screen at screening.
• The participant is taking any excluded medications or treatments.

Sponsors & Collaborators

• Phathom Pharmaceuticals, Inc.: lead

Study Sites (157)

Pinnacle Research Group

Anniston, Alabama, 36207, United States

Location

North Alabama Research Center LLC

Athens, Alabama, 35611, United States

Location

Synexus Clinical Research US, Inc.

Birmingham, Alabama, 35211, United States

Location

Medical Affiliated Research Center Inc

Huntsville, Alabama, 35801, United States

Location

Synexus Clinical Research US, Inc. - East Valley Family Physicians, PLC

Chandler, Arizona, 85224, United States

Location

Synexus Clinical Research US, Inc. - Central Arizona Medical Associates, PC

Mesa, Arizona, 85206, United States

Location

Synexus Clinical Research US, Inc. - Desert Clinical Research, LLC

Mesa, Arizona, 85213, United States

Location

Elite Clinical Studies - Phoenix - BTC - PPDS

Phoenix, Arizona, 85018, United States

Location

Hope Research Institute LLC

Phoenix, Arizona, 85018, United States

Location

Del Sol Research Management - BTC - PPDS

Tucson, Arizona, 85712, United States

Location

Preferred Research Partners - ClinEdge - PPDS

Little Rock, Arkansas, 72211, United States

Location

Applied Research Center of Little Rock

Little Rock, Arkansas, 72212, United States

Location

Arkansas Gastroenterology

North Little Rock, Arkansas, 72117, United States

Location

Atria Clinical Research - BTC - PPDS

North Little Rock, Arkansas, 72117, United States

Location

Anaheim Clinical Trials LLC

Anaheim, California, 92801, United States

Location

GW Research, Inc. - ClinEdge - PPDS

Chula Vista, California, 91910, United States

Location

eStudySite - Chula Vista - PPDS

Chula Vista, California, 91911, United States

Location

Kindred Medical Institute for Clinical Trials, LLC

Corona, California, 92879, United States

Location

HB Clinical Trials, Inc.

Fountain Valley, California, 92708-7510, United States

Location

OM Research LLC

Lancaster, California, 93534, United States

Location

Torrance Clinical Research Institute

Lomita, California, 90717, United States

Location

LA County + USC Medical Center

Los Angeles, California, 90033, United States

Location

Southern California Research Institute Medical Group, Inc.

Los Angeles, California, 90045, United States

Location

Facey Medical Foundation

Mission Hills, California, 91345, United States

Location

Palmtree Clinical Research

Palm Springs, California, 92262, United States

Location

Precision Research Institute

San Diego, California, 92114, United States

Location

Medical Associates Research Group, Inc.

San Diego, California, 92123, United States

Location

Paragon Rx Clinical, Inc.

Santa Ana, California, 92703, United States

Location

Synexus Clinical Research US, Inc. - Colorado Springs Family Practice

Colorado Springs, Colorado, 80909, United States

Location

Western States Clinical Research, Inc.

Wheat Ridge, Colorado, 80033, United States

Location

Gastroenterology Associates of Fairfield County

Bridgeport, Connecticut, 06606, United States

Location

Connecticut Clinical Research Foundation

Bristol, Connecticut, 06010, United States

Location

Riverside Clinical Research

Edgewater, Florida, 32132, United States

Location

Research Centers of America - ERG

Hollywood, Florida, 33024, United States

Location

Nature Coast Clinical Research

Inverness, Florida, 34452, United States

Location

ENCORE Borland-Groover Clinical Research - ERN - PPDS

Jacksonville, Florida, 32256, United States

Location

Columbus Clinical Services LLC

Miami, Florida, 33125, United States

Location

Jesscan Medical Research

Miami, Florida, 33134, United States

Location

Nuren Medical and Research Center

Miami, Florida, 33144, United States

Location

Premier Research Associate, Inc.

Miami, Florida, 33165, United States

Location

Gutierrez Medical Center

Orlando, Florida, 32807, United States

Location

Advanced Gastroenterology Associates, LLC

Palm Harbor, Florida, 34684, United States

Location

Innovation Medical Research Center

Palmetto Bay, Florida, 33157, United States

Location

Synexus Clinical Research US, Inc. - St. Petersburg

Pinellas Park, Florida, 33781, United States

Location

Precision Clinical Research, LLC

Sunrise, Florida, 33351, United States

Location

Guardian Angel Research Center

Tampa, Florida, 33614, United States

Location

Atlanta Gastroenterology Associates

Atlanta, Georgia, 30342, United States

Location

Nexgen Research Center

Atlanta, Georgia, 30345, United States

Location

Gastroenterology Associates of Central Georgia, LLC

Macon, Georgia, 31201, United States

Location

In-Quest Medical Research, LLC

Peachtree Corners, Georgia, 30071, United States

Location

Illinois Gastroenterology Group

Gurnee, Illinois, 60031, United States

Location

Summit Digestive & Liver Disease Specialists State Street Clinic

Oakbrook Terrace, Illinois, 60181, United States

Location

MediSphere Medical Research Center, LLC

Evansville, Indiana, 47714, United States

Location

Gastroenterology Health Partners, PLLC

New Albany, Indiana, 47150, United States

Location

Iowa Digestive Disease Center

Clive, Iowa, 50325, United States

Location

Clinical Trials Management LLC

Covington, Louisiana, 70433, United States

Location

CroNOLA, LLC.

Houma, Louisiana, 70360, United States

Location

Clinical Trials Management LLC

Metairie, Louisiana, 70006, United States

Location

Louisiana Research Center, LLC

Shreveport, Louisiana, 71105, United States

Location

Meridian Clinical Research

Rockville, Maryland, 20854, United States

Location

Clinical Associates Research

Towson, Maryland, 21286, United States

Location

Oakland Medical Research Center

Troy, Michigan, 48085, United States

Location

Gastroenterology Associates of Western Michigan, PLC

Wyoming, Michigan, 49519, United States

Location

The Alliance for Multispecialty Research, LLC

Kansas City, Missouri, 64114, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Heartland Clinical Research, Inc

Omaha, Nebraska, 68134, United States

Location

Synexus Clinical Research US, Inc. Site 1

Henderson, Nevada, 89052, United States

Location

Synexus Clinical Research US, Inc. Site 2

Henderson, Nevada, 89052, United States

Location

Sierra Clinical Research - ClinEdge - PPDS

Las Vegas, Nevada, 89106, United States

Location

Site 2

Las Vegas, Nevada, 89119, United States

Location

Las Vegas - Site 1

Las Vegas, Nevada, 89128, United States

Location

Advanced Research Institute

Reno, Nevada, 89511, United States

Location

Drug Trials America - ClinEdge

Hartsdale, New York, 10530, United States

Location

Southtowns Gastroenterology, PLLC

Orchard Park, New York, 14127, United States

Location

Carolinas Research Center

Charlotte, North Carolina, 28215, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Medication Management LLC

Greensboro, North Carolina, 27408, United States

Location

Carolina Research

Greenville, North Carolina, 27834, United States

Location

Peters Medical Research, LLC - ClinEdge - PPDS

High Point, North Carolina, 27262, United States

Location

Carolina's GI Research, LLC

Raleigh, North Carolina, 27607, United States

Location

Dayton Gastroenterology, Inc

Dayton, Ohio, 45415, United States

Location

Prestige Clinical Research

Franklin, Ohio, 45005, United States

Location

Central Sooner Research

Norman, Oklahoma, 73071, United States

Location

Synexus Clinical Research US, Inc.

Anderson, South Carolina, 29621, United States

Location

Clinical Trials of South Carolina

Charleston, South Carolina, 29406, United States

Location

Coastal Carolina Research Center

Mt. Pleasant, South Carolina, 29464, United States

Location

Rapid City Medical Center LLP

Rapid City, South Dakota, 57701, United States

Location

Multi Specialty Clinical Research

Johnson City, Tennessee, 37601, United States

Location

Clinical Research Associates Inc

Nashville, Tennessee, 37203, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

Location

Inquest Clinical Research

Baytown, Texas, 77521, United States

Location

Synexus Clinical Research US, Inc. - Dallas

Dallas, Texas, 75234, United States

Location

Texas Tech University Health Sciences Center El Paso

El Paso, Texas, 79905, United States

Location

Precision Research Institute, LLC

Houston, Texas, 77036, United States

Location

Biopharma Informatic, LLC

Houston, Texas, 77084, United States

Location

Rio Grande Gastroenterology

McAllen, Texas, 78503, United States

Location

Digestive System Healthcare

Pasadena, Texas, 77505, United States

Location

Pearland Physicians

Pearland, Texas, 77581, United States

Location

Synexus Clinical Research US, Inc.

Plano, Texas, 75093, United States

Location

Quality Research Inc

San Antonio, Texas, 78209, United States

Location

Gastroenterology Research of San Antonio (GERSA)

San Antonio, Texas, 78229, United States

Location

Southern Star Research Institute, LLC

San Antonio, Texas, 78229, United States

Location

Synexus Clinical Research US, Inc.

Layton, Utah, 84041, United States

Location

Advanced Research Institute

Ogden, Utah, 84405, United States

Location

New River Valley Research Institute

Christiansburg, Virginia, 24073, United States

Location

Verity Research, Inc.

Fairfax, Virginia, 22031, United States

Location

Blue Ridge Medical Research

Lynchburg, Virginia, 24502, United States

Location

Washington Gastroenterology

Bellevue, Washington, 98004, United States

Location

Harborview Medical Center, University of Washington Medical Center

Seattle, Washington, 98104, United States

Location

Fourth Multiprofile Hospital for Active Treatment

Sofia, Sofia-Grad, 1606, Bulgaria

Location

Multiprofile Hospital for Active Treatment Puls AD - PPDS

Blagoevgrad, 2700, Bulgaria

Location

University Multiprofile Hospital for Active Treatment

Pleven, 5800, Bulgaria

Location

Second Multiprofile Hospital for Active Treatment Sofia

Sofia, 1202, Bulgaria

Location

Medical Center Excelsior OOD - PPDS

Sofia, 1407, Bulgaria

Location

Diagnostic-Consultative Center Aleksandrovska EOOD

Sofia, 1431, Bulgaria

Location

Synexus - Medical Center Synexus Sofia EOOD

Sofia, 1784, Bulgaria

Location

Synexus - Medical Centre Synexus Sofia EOOD

Stara Zagora, 6003, Bulgaria

Location

Nemocnice Pardubickeho kraje, a.s. Orlickoustecka nemocnice, Interni oddeleni, Cs.

Ústí nad Orlicí, Pardubice, 562 18, Czechia

Location

MEDIC KRAL s.r.o.

Prague, Prague, 190 00, Czechia

Location

PreventaMed s.r.o.

Olomouc, 779 00, Czechia

Location

Synexus Czech s.r.o.

Prague, 120 00, Czechia

Location

Krajska zdravotni, a.s. - Masarykova nemocnice v Usti nad Labem, o.z. Oddeleni gastroenterolgie

Ústí nad Labem, 401 13, Czechia

Location

Debreceni Egyetem Klinikai Kozpont Nagyerdei Krt. 98, Belgyogyaszati Klinika

Debrecen, Hajdú-Bihar, 4032, Hungary

Location

Synexus Affiliate BKS Research Kft. Hatvan

Hatvan, Heves County, 3000, Hungary

Location

Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz

Nyíregyháza, Szabolcs-Szatmár-Bereg, 4400, Hungary

Location

Synexus (DRS) - Synexus Magyarország Kft. Budapest

Budapest, 1036, Hungary

Location

Synexus Affiliate - Synexus Magyarorszag Kft. Debrecen

Debrecen, 4025, Hungary

Location

Synexus (DRS) - Synexus Magyarorszag Kft. Gyula

Gyula, 5700, Hungary

Location

Synexus (DRS) - Synexus Magyarország Kft. Zalaegerszeg

Zalaegerszeg, 8900, Hungary

Location

Szpital Uniwersytecki Nr 2 im. Dr Jana Biziela w Bydgoszczy Centrum Endoskopii Zabiegowej - Poradnia Chorob Jelitowych

Bydgoszcz, 85-168, Poland

Location

Gabinet Lekarski-Janusz Rudzinski ul. Powstancow Warszawy 5

Bydgoszcz, 85-681, Poland

Location

Synexus - Czestochowa

Częstochowa, 42-202, Poland

Location

Synexus - Gdansk

Gdansk, 80-382, Poland

Location

Synexus - Gdynia

Gdynia, 81-537, Poland

Location

Synexus - Katowice

Katowice, 40-040, Poland

Location

Synexus Affiliate - Krakowskie Centrum Medyczne

Krakow, 31-501, Poland

Location

Centrum Opieki Zdrowotnej Orkan-Med Stec-Michalska Sp. J.

Ksawerów, 95-054, Poland

Location

Synexus - Lodz

Lodz, 90-127, Poland

Location

Santa Familia Centrum Badań Profilaktyki i Leczenia

Lodz, 90-302, Poland

Location

GASTRO MED Zaklad Opieki Zdrowotnej

Lublin, 20-582, Poland

Location

Synexus - Poznan

Poznan, 60-702, Poland

Location

Korczowski Bartosz, Gabinet Lekarski

Rzeszów, 35-302, Poland

Location

Twoja Przychodnia - Szczecińskie Centrum Medyczne

Szczecin, 71-434, Poland

Location

Gastromed Specjalistyczne Centrum Gastrologii i Endoskopii

Torun, 87-100, Poland

Location

REUMATIKA - Centrum Reumatologii NZOZ

Warsaw, 0-691, Poland

Location

Synexus - Warszawa

Warsaw, 01-192, Poland

Location

Synexus - Wroclaw

Wroclaw, 50-381, Poland

Location

Melita Medical

Wroclaw, 50-449, Poland

Location

Synexus Thames Valley Clinical Research Centre

Reading, Berkshire, RG2 0TG, United Kingdom

Location

Synexus - Midlands Clinical Research Centre

Edgbaston, West Midlands, B15 2SQ, United Kingdom

Location

Synexus - Wales Clinical Research Centre

Cardiff, CF15 9SS, United Kingdom

Location

Synexus - Lancashire Clinical Research Centre

Chorley, PR7 7NA, United Kingdom

Location

CPS Research

Glasgow, G20 0XA, United Kingdom

Location

Synexus - Hexham Clinical Research Centre

Hexham, NE46 1QJ, United Kingdom

Location

Synexus - Merseyside Clinical Research Centre

Liverpool, L22 0LG, United Kingdom

Location

Synexus - Manchester Clinical Research Centre

Manchester, M15 6SE, United Kingdom

Location

Synexus - North Tees Clinical Research Centre

Stockton-on-Tees, TS19 8PE, United Kingdom

Location

Related Publications (1)

• Laine L, DeVault K, Katz P, Mitev S, Lowe J, Hunt B, Spechler S. Vonoprazan Versus Lansoprazole for Healing and Maintenance of Healing of Erosive Esophagitis: A Randomized Trial. Gastroenterology. 2023 Jan;164(1):61-71. doi: 10.1053/j.gastro.2022.09.041. Epub 2022 Oct 10.

  PMID: 36228734 DERIVED

MeSH Terms

Interventions

1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)-N-methylmethanamine; Lansoprazole

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Phathom Medical Information
• Organization: Phathom Pharmaceuticals, Inc.

medicalinformation@phathompharma.com

1-888-775-PHAT (7428)

Study Officials

• Medical Director

  Phathom Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2019
• First Posted: October 14, 2019
• Study Start: October 28, 2019
• Primary Completion: July 29, 2021
• Study Completion: August 24, 2021
• Last Updated: July 29, 2022
• Results First Posted: July 29, 2022

Record last verified: 2022-07

Locations

CZ (5); HU (7); US (109); BU (8); PL (19); GB (9)