A randomized, double-blind, placebo-controlled, parallel-group study to assess the efficacy, safety, and tolerability of dexpramipexole administered orally for 52 weeks in participants with severe eosinophilic asthma (EXHALE-2)

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-507665-25-00

Acronym

AR-DEX-22-01

Enrollment

430

Registered

2024-09-23

Start date

2023-04-25

Completion date

2025-11-05

Last updated

2025-09-19

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

Annualized rate of severe asthma exacerbations (AAER) over 52 weeks.

Detailed description

Pre-BD FEV1, absolute change from baseline, averaged across visits at Weeks 36, 44, and 52., Asthma Control Questionnaire-6 (ACQ-6), change from baseline, averaged across visits at Weeks 36, 44, and 52., Standardized version of the Asthma Quality of Life Questionnaire for 12 years and older (AQLQ+12) change from baseline to Week 52.

Interventions

DRUGDexpramipexole (KNS-760704)

DRUGPlacebo

Eligibility

Sex/Gender

All

Age

0 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Annualized rate of severe asthma exacerbations (AAER) over 52 weeks.	—

Secondary

Measure	Time frame
Pre-BD FEV1, absolute change from baseline, averaged across visits at Weeks 36, 44, and 52., Asthma Control Questionnaire-6 (ACQ-6), change from baseline, averaged across visits at Weeks 36, 44, and 52., Standardized version of the Asthma Quality of Life Questionnaire for 12 years and older (AQLQ+12) change from baseline to Week 52.	—

Countries

Bulgaria, Poland, Romania

Outcome results

None listed

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