An Open-Label Long-Term Phase III Extension Study to Assess the Long-Term Safety and Tolerability of Dexpramipexole in Participants with Severe Eosinophilic Asthma (EXHALE-5)

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-510810-33-00

Acronym

AR-DEX-22-04

Enrollment

Registered

2024-09-22

Start date

2024-10-14

Completion date

Unknown

Last updated

2025-11-03

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

Conditions

Severe eosinophilic asthma

Brief summary

Assessment of treatment emergent AEs (TEAEs), clinical laboratory parameters, vital signs, and 12-lead ECGs.

Detailed description

Annualized rate of severe asthma exacerbations over 52 weeks., Asthma Control Questionnaire-6 (ACQ-6), change from baseline, at Weeks 16, 32, and 52., Absolute eosinophil counts (AEC), change from baseline, at Weeks 16, 32, and 52.

Interventions

DRUGDexpramipexole (KNS-760704)

Eligibility

Sex/Gender

All

Age

0 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Assessment of treatment emergent AEs (TEAEs), clinical laboratory parameters, vital signs, and 12-lead ECGs.	—

Secondary

Measure	Time frame
Annualized rate of severe asthma exacerbations over 52 weeks., Asthma Control Questionnaire-6 (ACQ-6), change from baseline, at Weeks 16, 32, and 52., Absolute eosinophil counts (AEC), change from baseline, at Weeks 16, 32, and 52.	—

Countries

Bulgaria, Czechia, Germany, Italy, Poland, Romania, Spain

Outcome results

None listed

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