Clinical Trials List
Protocol NumberAR-DEX-22-04
Completed
2025-06-01 - 2028-07-31
Phase III
Recruiting3
An Open-Label Long-Term Phase III Extension Study to Assess the Long-Term Safety and Tolerability of Dexpramipexole in Participants with Severe Eosinophilic Asthma (EXHALE-5)
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Trial Applicant
WORLDWIDE CLINICAL TRIALS (TAIWAN) CO., LTD.
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Sponsor
Areteia Therapeutics, Inc.
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Trial scale
Multi-Regional Multi-Center
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Update
2026/03/01
Investigators and Locations
Principal Investigator
Pai-Chien Chou
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 莊政皓 無
- 鄭孟軒 無
- 鄭至宏 無
- Ming-Ju Tsai 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Severe Eosinophilic Asthma
Objectives
To assess the long-term safety of dexpramipexole 150 mg BID in participants
≥18 years of age who completed either of the Phase III studies EXHALE-2 or
EXHALE-3.
Test Drug
tablet
Active Ingredient
Dexpramipexole
Dosage Form
110
Dosage
150 mg
Endpoints
Assessment of treatment emergent AEs (TEAEs), clinical laboratory
parameters, vital signs, and 12-lead ECGs.
parameters, vital signs, and 12-lead ECGs.
Inclution Criteria
To be eligible to participate in this study, candidates must meet the following
eligibility criteria at Baseline/Day 1 of EXHALE-5 or at the timepoint specified in
the individual eligibility criterion listed below:
1. Participants ≥18 years of age who completed the double-blind study
intervention treatment period during either of the Phase III studies
EXHALE-2 or EXHALE-3.
Note: A “treatment completer” is defined as a participant who completed
the final treatment visit and has not permanently discontinued
investigational product in the previous study.
2. Signed informed consent form (ICF) and assent form as appropriate.
3. Negative urine pregnancy test for women of childbearing potential
(WOCBP; after menarche) at the Baseline Visit/Day 1.
4. WOCBP (after menarche) must use either of the following methods of
birth control, from the Baseline Visit/Day 1 through the End of Study
Visit:
a. A highly effective form of birth control (confirmed by the
investigator). Highly effective forms of birth control include: true
sexual abstinence, a vasectomized sexual partner, Implanon,
female sterilization by tubal occlusion, any effective intrauterine
device (IUD), IUD/intrauterine system, levonorgestrel intrauterine
system, or oral contraceptive.
Or
b. Two protocol acceptable methods of contraception in tandem.
Women not of childbearing potential are defined as women who are either
permanently sterilized (hysterectomy, bilateral oophorectomy, or bilateral
salpingectomy), or who are postmenopausal. Women will be considered
postmenopausal if they have been amenorrheic for ≥12 months prior to the
planned date of the Baseline Visit/Day 1 without an alternative medical
cause. The following age specific requirements apply:
c. Women <50 years old will be considered postmenopausal if they
have been amenorrheic for 12 months or more following cessation
of exogenous hormonal treatment and follicle stimulating hormone
levels in the postmenopausal range.
d. Women ≥50 years old will be considered postmenopausal if they
have been amenorrheic for 12 months or more following cessation
of all exogenous hormonal treatment.
eligibility criteria at Baseline/Day 1 of EXHALE-5 or at the timepoint specified in
the individual eligibility criterion listed below:
1. Participants ≥18 years of age who completed the double-blind study
intervention treatment period during either of the Phase III studies
EXHALE-2 or EXHALE-3.
Note: A “treatment completer” is defined as a participant who completed
the final treatment visit and has not permanently discontinued
investigational product in the previous study.
2. Signed informed consent form (ICF) and assent form as appropriate.
3. Negative urine pregnancy test for women of childbearing potential
(WOCBP; after menarche) at the Baseline Visit/Day 1.
4. WOCBP (after menarche) must use either of the following methods of
birth control, from the Baseline Visit/Day 1 through the End of Study
Visit:
a. A highly effective form of birth control (confirmed by the
investigator). Highly effective forms of birth control include: true
sexual abstinence, a vasectomized sexual partner, Implanon,
female sterilization by tubal occlusion, any effective intrauterine
device (IUD), IUD/intrauterine system, levonorgestrel intrauterine
system, or oral contraceptive.
Or
b. Two protocol acceptable methods of contraception in tandem.
Women not of childbearing potential are defined as women who are either
permanently sterilized (hysterectomy, bilateral oophorectomy, or bilateral
salpingectomy), or who are postmenopausal. Women will be considered
postmenopausal if they have been amenorrheic for ≥12 months prior to the
planned date of the Baseline Visit/Day 1 without an alternative medical
cause. The following age specific requirements apply:
c. Women <50 years old will be considered postmenopausal if they
have been amenorrheic for 12 months or more following cessation
of exogenous hormonal treatment and follicle stimulating hormone
levels in the postmenopausal range.
d. Women ≥50 years old will be considered postmenopausal if they
have been amenorrheic for 12 months or more following cessation
of all exogenous hormonal treatment.
Exclusion Criteria
Study participant candidates will be excluded from study entry if any of the
following exclusion criteria exist at Baseline/Day 1 of EXHALE-5 or at the
timepoint specified in the individual criterion listed below:
1. Clinically significant change in health status during either of the Phase III
studies EXHALE-2 or EXHALE-3 which in the opinion of the investigator
would make the participant unsuitable for participation in this study.
2. Participants with allergy/intolerance to dexpramipexole or any of its
excipients.
3. Participants who met permanent discontinuation criteria or permanently
discontinued study treatment for any reason in either of the Phase III
studies EXHALE-2 or EXHALE-3.
4. Treatment with selected drugs known to have a substantial risk of
neutropenia in the past 30 days (see Appendix A).
5. Pregnant or breastfeeding women.
6. Males who are unwilling to use an acceptable method of birth control
during the entire study period (ie, condom with spermicide).
following exclusion criteria exist at Baseline/Day 1 of EXHALE-5 or at the
timepoint specified in the individual criterion listed below:
1. Clinically significant change in health status during either of the Phase III
studies EXHALE-2 or EXHALE-3 which in the opinion of the investigator
would make the participant unsuitable for participation in this study.
2. Participants with allergy/intolerance to dexpramipexole or any of its
excipients.
3. Participants who met permanent discontinuation criteria or permanently
discontinued study treatment for any reason in either of the Phase III
studies EXHALE-2 or EXHALE-3.
4. Treatment with selected drugs known to have a substantial risk of
neutropenia in the past 30 days (see Appendix A).
5. Pregnant or breastfeeding women.
6. Males who are unwilling to use an acceptable method of birth control
during the entire study period (ie, condom with spermicide).
The Estimated Number of Participants
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Taiwan
20 participants
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Global
1600 participants
