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Phase III Long-Term Extension Study With Dexpramipexole

NCT06388889 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 509

Last updated 2025-12-15

No results posted yet for this study

Summary

The goal of this clinical trial\] is to evaluate the long term safety of dexpramipexole treatment in participants with severe asthma, aged ≥18 years, on Global Initiative for Asthma (GINA) 2021 \[GINA, 2021\] Step 4 or 5 therapy and who completed either of the Phase III studies EXHALE-2 or EXHALE-3.

Conditions

Interventions

DRUG

Dexpramipexole Dihydrochloride

Oral administration of dexpramipexole tablet

Sponsors & Collaborators

  • Areteia Therapeutics

    lead INDUSTRY

Principal Investigators

  • Sady Alpizar, MD · Clinical Research Trials of Florida, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-12
Primary Completion
2025-12-08
Completion
2025-12-08
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Brazil
  • Bulgaria
  • Georgia
  • Japan
  • Mexico
  • North Macedonia
  • Poland
  • Romania
  • Serbia
  • South Africa
  • South Korea
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06388889 on ClinicalTrials.gov