Recruitment Complete
Sponsor ID
D5244C00001

Efficacy and Safety of Tezepelumab in Patients With Eosinophilic EsophagitisCROSSING

Sponsor ID
D5244C00001
Clinicaltrials.gov ID
NCT05583227
EUCTIS ID
N/A
EudraCT ID
2022-001294-31

Study Details

A randomized, double-blind, placebo-controlled multicenter, phase 3 study to evaluate the efficacy and safety of tezepelumab administered subcutaneously (SC) using an accessorized pre-filled syringe (APFS) versus placebo in adult and adolescent patients with eosinophilic esophagitis (EoE).

Additional Study Details

Phase
Phase 3
Product
N/A
Type
Interventional
Masking
N/A
Enrollment
368
Additional Study Details

Protocol Summary

Primary Outcome Measures

Histologic response of peak esophageal eosinophil per HPF count of ≤ 6 across all available esophageal levels

Timeframe: Week 24

Change from baseline in DSQ (Dysphagia Symptom Questionnaire) score

Timeframe: Week 24

Secondary Outcome Measures

Change from baseline in EoE EREFS (Endoscopic reference score )

Timeframe: Week 24, Week 52

Change from baseline in EoE-HSS (Histologic scoring system) grade score

Timeframe: Week 24

Change from baseline in EoE-HSS (Histologic scoring system) stage score

Timeframe: Week 24

Histologic response of peak esophageal eosinophil per HPF count of ≤ 6 across all available esophageal levels

Timeframe: Week 52

Change from baseline in DSQ (Dysphagia Symptom Questionnaire) score

Timeframe: Week 52

Endoscopic response of total EREFS score of 0 to ≤2 with no score > 1 for any of the components and no worsening in any individual component from baseline accross all esophageal levels

Timeframe: Week 52

Endoscopic inflammatory remission of EREFS inflammatory subscore (including edema, exudate, and furrows components) of 0 with no worsening in rings or stricture from baseline across all esophageal levels)

Timeframe: Week 52

Total endoscopic remission of total EREFS score of 0 across all esophageal levels

Timeframe: Week 52

Locations

Location
Status
Contact Us
Location
Research Site
Phoenix, Arizona, United States, 85016
Status
N/A
Location
Research Site
Little Rock, Arkansas, United States, 72202
Status
N/A
Location
Research Site
Los Angeles, California, United States, 90033
Status
N/A
Location
Research Site
Aurora, Colorado, United States, 80045
Status
N/A
Location
Research Site
Inverness, Florida, United States, 34452
Status
N/A
Location
Research Site
Jacksonville, Florida, United States, 32256
Status
N/A
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