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Clinical Trials List

Protocol NumberAR-DEX-22-03
Completed

2024-01-01 - 2025-12-31

Phase III

Recruiting9

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)

  • Trial Applicant

    WORLDWIDE CLINICAL TRIALS (TAIWAN) CO., LTD.

  • Sponsor

    Areteia Therapeutics, Inc

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator Liang-wen Hang

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Pin-Kuei Fu

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Pai-Chien Chou

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 曾敬閔

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Wei-Zhi Chen

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 鄭世隆

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Ping-Hung Kuo

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

eosinophilic asthma (EXHALE-4)

Objectives

To evaluate the efficacy of dexpramipexole on pulmonary function

Test Drug

tabltes

Active Ingredient

Dexpramipexole

Dosage Form

110

Dosage

75 mg/ 150 mg

Endpoints

To evaluate the efficacy of dexpramipexole on pulmonary function.

Inclution Criteria

To be eligible to participate in this study, candidates must meet the following
eligibility criteria at Screening Visit 1 or at the time point specified in the individual
eligibility criterion listed below:
1. Signed informed consent form and assent form, as appropriate.
2. Male or female ≥12 years of age at Screening Visit 1. Sites in Poland will
only include participants aged ≥18 years.

Exclusion Criteria

Study participant candidates will be excluded from study entry if any of the
following exclusion criteria exist at Screening Visit 1 or at the timepoint specified in
the individual criterion listed below:

The Estimated Number of Participants

  • Taiwan

    40 participants

  • Global

    550 participants