A randomized, double-blind, placebo-controlled, parallel-group study to assess the efficacy, safety, and tolerability of dexpramipexole administered orally for 24 weeks in participants with eosinophilic asthma (EXHALE-4)

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-509739-22-00

Acronym

AR-DEX-22-03

Enrollment

Registered

2024-08-28

Start date

2023-04-25

Completion date

2025-07-18

Last updated

2025-07-14

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

Conditions

Eosinophilic asthma

Brief summary

Pre-bronchodilator (pre-BD) FEV1, absolute change from baseline, averaged over Weeks 20 and 24.

Detailed description

Change from baseline in Asthma Control Questionnaire-6 (ACQ-6) averaged across visits at Weeks 20 and 24., Standardized version of the Asthma Quality of Life Questionnaire for 12 years and older (AQLQ+12) change from baseline to Week 24.

Interventions

DRUGDexpramipexole (KNS-760704)

DRUGPlacebo

Eligibility

Sex/Gender

All

Age

0 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Pre-bronchodilator (pre-BD) FEV1, absolute change from baseline, averaged over Weeks 20 and 24.	—

Secondary

Measure	Time frame
Change from baseline in Asthma Control Questionnaire-6 (ACQ-6) averaged across visits at Weeks 20 and 24., Standardized version of the Asthma Quality of Life Questionnaire for 12 years and older (AQLQ+12) change from baseline to Week 24.	—

Countries

Poland, Romania

Outcome results

None listed

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