A Study in Adult Participants With EoE to Evaluate Vonoprazan 20 mg Compared to Placebo After 12 Weeks and to Evaluate Vonoprazan 20 mg Up to 24 Weeks

Part of paid clinical trials in Little Rock, Arkansas.

Sponsor
Phathom Pharmaceuticals, Inc.
Study ID
NCT06851559
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Vonoprazan — DRUG
    Vonoprazan will be administered orally as a tablet
  • Placebo — DRUG
    Placebo will be administered orally as tablet

Study Details

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.

Key Dates

Start date
Oct 30, 2025
Status verified
Apr 2026
Primary completion
Dec 31, 2026
Completion
Mar 31, 2027

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Number of Participants at Week 12 Achieving Peak Esophageal Intraepithelial Eosinophil Count <15 eos/hpf. [ Time Frame: Week 12 ]

Central Contacts

Locations (41)

FacilityCityStateZIPSite coordinators
Preferred Research Partners, IncLittle RockArkansas72211-
GW Research, IncChula VistaCalifornia91910-
Southern California Research Institute Medical GroupLos AngelesCalifornia90045-
Rocky Mountain GastroenterologyLakewoodColorado80228-
Western States Clinical Research, Inc.Wheat RidgeColorado80033-
Connecticut Clinical Research InstituteBristolConnecticut06010-
Nature Coast Clinical ResearchInvernessFlorida34452-
Encore Borland-Groover Clinical ResearchJacksonvilleFlorida32256-
International Center for ResearchTampaFlorida33614-
Gastroenterology Associates of Central Georgia, LLCMaconGeorgia31201-
Treasure Valley Medical ResearchBoiseIdaho83706-
Grand Teton Research GroupIdaho FallsIdaho83404-
Northwestern Medicine Digestive Health CenterChicagoIllinois60611-
GI Alliance - GurneeGurneeIllinois60031-
Combined Gastro, LLCLafayetteLouisiana70503-
Tandem Clinical Research GI, LLCMarreroLouisiana70072-
Woodholme Gastroenterology AssociatesGlen BurnieMaryland21061-
Boston SpecialistsBostonMassachusetts02111-
Brigham and Women's HospitalBostonMassachusetts02115-
Huron Gastroenterology AssociatesYpsilantiMichigan48197-
Advanced Research InstituteRenoNevada89511-
Weill Cornell Medicine, New York Presbyterian HospitalNew YorkNew York10065-
UNC Clinical & Translational Research CenterChapel HillNorth Carolina27514-
GCGA Physicians, LLC dba/Gastro Health ResearchCincinnatiOhio45219-
Great Lakes Gastroenterology Research LLCMentorOhio44060-
University of PennsylvaniaPhiladelphiaPennsylvania19104-
Galen Medical Group - Galen Digestive HealthChattanoogaTennessee37404-
Quality Medical ResearchNashvilleTennessee37211-
GI AllianceCedar ParkTexas78613-
The Hospitals of Providence Memorial CampusEl PasoTexas79902-
Texas Digestive SpecialistsHarlingenTexas78550-
Houston Endoscopy and Research CenterHoustonTexas77079-
Research Physicians Network, LLCHoustonTexas77089-
Biopharma Informatic, LLCMcAllenTexas78503-
Pearland PhysiciansPearlandTexas77581-
Gastroenterology Research of San AntonioSan AntonioTexas78229-
Texas Gastro ConsultantsTomballTexas73375-
Advanced Research InstituteOgdenUtah84405-
Care Access - OgdonOgdenUtah84403-
Advanced Research InstituteSandy CityUtah84070-
Blue Ridge Medical ResearchLynchburgVirginia25402-

Find similar trials in Little Rock, AR

By research site
Preferred Research Partners, Inc· Little Rock, ARGW Research, Inc· Chula Vista, CASouthern California Research Institute Medical Group· Los Angeles, CARocky Mountain Gastroenterology· Lakewood, COWestern States Clinical Research, Inc.· Wheat Ridge, COConnecticut Clinical Research Institute· Bristol, CT

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