A Phase 2, Randomized, Double-Blind, Multi-Center Study in Adult Subjects With Eosinophilic Esophagitis (EoE) to Evaluate the Safety and Efficacy of Vonoprazan 20 mg Compared to Placebo After 12 Weeks and to Evaluate the Safety and Efficacy of Vonoprazan 20 mg Up to 24 Weeks

Status: Recruiting
Location: See all (25) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

The primary objective of this study is to assess the efficacy of vonoprazan 20 mg once daily (QD) compared to placebo QD in the number of participants with a peak eosinophilic histologic response \<15 eosinophils per high-power field (eos/hpf) after 12 weeks of therapy.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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, including completion and compliance with the electronic diary. The diary must be completed on at least 11 of the last 14 days in the 2 weeks prior to Visit 2 (Day -1).

• The participant signs and dates a written informed consent form (ICF) and any required privacy authorization prior to the initiation of any study procedures.

• The participant has a peak eosinophil count of at least 15 eos/hpf \[X 400\] from at least 2 of the 3 esophageal levels on screening endoscopy as measured in at least 6 biopsies, at least 2 each from the proximal, mid, and distal segments of the esophagus based on central reading.

• The participant has 4 or more days with dysphagia episodes documented via electronic diary in the 2 weeks prior to Visit 2 (Day -1).

• The participant must remain on a stable diet for at least 6 weeks prior to the Screening Period and is expected to remain on a stable diet during the course of the study; stable diet is defined as not initiating new elimination diets or reintroducing previously eliminated foods.

• A female participant of childbearing potential who is or may be sexually active with a non-sterilized male partner agrees to routinely use adequate contraception from the signing of informed consent until 4 weeks after the last dose of study drug.

Locations
United States
California
GW Research, Inc
RECRUITING
Chula Vista
Colorado
Rocky Mountain Gastroenterology
RECRUITING
Lakewood
Western States Clinical Research, Inc.
RECRUITING
Wheat Ridge
Connecticut
Connecticut Clinical Research Institute
RECRUITING
Bristol
Florida
Nature Coast Clinical Research
RECRUITING
Inverness
Encore Borland-Groover Clinical Research
RECRUITING
Jacksonville
International Center for Research
RECRUITING
Tampa
Georgia
Gastroenterology Associates of Central Georgia, LLC
RECRUITING
Macon
Idaho
Treasure Valley Medical Research
RECRUITING
Boise
Grand Teton Research Group
RECRUITING
Idaho Falls
Louisiana
Combined Gastro, LLC
RECRUITING
Lafayette
Massachusetts
Boston Specialists
RECRUITING
Boston
Michigan
Huron Gastroenterology Associates
RECRUITING
Ypsilanti
Nevada
Advanced Research Institute
RECRUITING
Reno
Ohio
Great Lakes Gastroenterology Research LLC
RECRUITING
Mentor
Tennessee
Galen Medical Group - Galen Digestive Health
RECRUITING
Chattanooga
Quality Medical Research
RECRUITING
Nashville
Texas
The Hospitals of Providence Memorial Campus
RECRUITING
El Paso
Texas Digestive Specialists
RECRUITING
Harlingen
Research Physicians Network, LLC
RECRUITING
Houston
Biopharma Informatic, LLC
RECRUITING
Mcallen
Pearland Physicians
RECRUITING
Pearland
Gastroenterology Research of San Antonio
RECRUITING
San Antonio
Utah
Advanced Research Institute
RECRUITING
Ogden
Advanced Research Institute
RECRUITING
Sandy City
Contact Information
Primary
Phathom Medical Information
medicalinformation@phathompharma.com
1-888-775-PHAT (7428)
Time Frame
Start Date: 2025-10-30
Estimated Completion Date: 2027-03
Participants
Target number of participants: 80
Treatments
Experimental: Vonoprazan 20 mg
Participants will be administered vonoprazan at a dose of 20 mg for 12 weeks. Participants will continue to receive the same dose for an additional 12 weeks.
Experimental: Placebo
Participants will be administered placebo for 12 weeks. Participants will then receive vonoprazan 20 mg for an additional 12 weeks.
Sponsors
Leads: Phathom Pharmaceuticals, Inc.

This content was sourced from clinicaltrials.gov