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-3)

Status

Withdrawn

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-503693-20-00

Acronym

AR-DEX-22-02

Enrollment

Registered

2023-09-12

Start date

Unknown

Completion date

Unknown

Last updated

2023-09-12

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

DRUGBudesonide/Formoterol Teva Pharma B.V. 160 micrograms / 4.5 micrograms inhalation powder

DRUGVentolin 100 microgramos/inhalación suspensión para inhalación en envase a presión* (*) sin CFC

DRUGPlacebo

DRUGDexpramipexole (KNS-760704)

DRUGVentolin 100 mikrogramų/išpurškime suslėgtoji įkvepiamoji suspensija

DRUGVentolin Inhaler N Suspenze k inhalaci v tlakovém obalu

DRUGSultanol Dosier-Aerosol 100 Mikrogramm/Dosis Druckgasinhalation

DRUGSuspension

DRUGVentolin Evohaler túlnyomásos inhalációs szuszpenzió

DRUGNovolizer Salbutamol Meda 100 Mikrogramm/Dosis Pulver zur Inhalation

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

Czechia

Outcome results

None listed

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