CDX0159-08: A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Barzolvolimab (CDX-0159) in Adults with Active Eosinophilic Esophagitis (The “EvolvE” Study)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-512767-30-00

Acronym

CDX0159-08

Enrollment

Registered

2024-07-16

Start date

2023-09-28

Completion date

2025-09-17

Last updated

2025-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Eosinophilic Esophagitis

Brief summary

Absolute change from baseline to Week 12 in the PMC/high power field (hpf)

Detailed description

1 - Absolute changes from baseline to Week 12 in DSQ, 2 - Absolute change from baseline to Week 12 in PMC/hpf among patients with baseline PMC ≥ 12/hpf, 3 - Absolute change from baseline to Week 12 in PEC/hpf, 4 - Percent (%) change from baseline to week 12 in PMC/hpf, 5 - Incidence of TEAEs

Interventions

DRUGFASTJEKT 300 Mikrogramm

DRUGInjektionslösung im Fertigpen

DRUGBARZOLVOLIMAB

DRUGPlacebo matching CDX-0159

DRUGsolution for injection

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Absolute change from baseline to Week 12 in the PMC/high power field (hpf)	—

Secondary

Measure	Time frame
1 - Absolute changes from baseline to Week 12 in DSQ, 2 - Absolute change from baseline to Week 12 in PMC/hpf among patients with baseline PMC ≥ 12/hpf, 3 - Absolute change from baseline to Week 12 in PEC/hpf, 4 - Percent (%) change from baseline to week 12 in PMC/hpf, 5 - Incidence of TEAEs	—

Countries

Germany, Italy, Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026