A Study to Assess the Effect of Dexpramipexole in Adolescents and Adults With Severe Eosinophilic Asthma.

Conditions

• Asthma
• Asthma; Eosinophilic
• Eosinophilic Asthma

Eligibility Criteria

Sex

ALL

Age

12 Years - 99 Years

Healthy Volunteers

Not accepted

Interventions

• Dexpramipexole Dihydrochloride — DRUG
  oral administration of dexpramipexole tablet
• Placebo — DRUG
  oral administration of placebo tablet

Study Details

This study will assess the efficacy and safety of dexpramipexole as an adjunctive oral therapy in participants with inadequately controlled asthma with an eosinophilic phenotype and a history of asthma exacerbations.

Key Dates

First listed

Mar 10, 2023

Start date

Jan 30, 2023

Status verified

Dec 2025

Primary completion

Dec 8, 2025

Completion

Dec 8, 2025

Study Design

Enrollment

1,061 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: 150 mg BID
  Dexpramipexole 150 mg oral tablet taken twice a day
• Experimental: 75 mg BID
  Dexpramipexole 75 mg oral tablet taken twice a day
• Placebo Comparator: Placebo
  Placebo oral tablet taken twice a day

Primary Outcome Measure

Annualized rate of severe asthma exacerbations over 52 weeks. [ Time Frame: Day 1 (baseline, pre-dose) through Week 52 ]

Locations (89)

Find similar trials in Bakersfield, CA

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