Clinical trial NCT06388889: Phase III Long-Term Extension Study With Dexpramipexole
Official title: 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
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE3
Conditions: Eosinophilic Asthma
Keywords: Exacerbations
Severe Asthma
EXHALE-2
EXHALE-3
EXHALE-4
Uncontrolled Asthma
Asthma Attack
Lead sponsor: Areteia Therapeutics
Sponsor class: INDUSTRY
First posted: 2024-04-29
Enrollment: 1600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

1. Participants who completed the double-blind study intervention treatment period during either of the Phase III studies EXHALE-2 or EXHALE-3.
2. Participants capable of giving signed informed consent/assent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
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:

   1. 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-
   2. 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:
   3. 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.
   4. 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:

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.
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).

Primary outcomes:
measure: Number and Percentage of Participants with a Treatment Emergent Adverse Event
timeFrame: 52 weeks
measure: Number and Percentage of Participants with Potentially Clinically Significant Postbaseline Changes in Clinical Laboratory Evaluations
timeFrame: 52 weeks
measure: Number and Percentage of Participants with Potentially Clinically Significant Postbaseline Changes in Vital Signs and Body Weight
timeFrame: 52 weeks
measure: Number and Percentage of Participants with Potentially Significant Postbaseline Changes in Electrocardiogram Parameters
timeFrame: 52 weeks
Secondary outcomes:
measure: Severe Asthma Exacerbations
timeFrame: Averaged across 52 weeks
measure: Change in Asthma Control Questionnaire-6 (ACQ-6)
timeFrame: Day 1 (baseline), Weeks 16, 32, and 52
measure: Change in absolute eosinophil counts (AEC)
timeFrame: Day 1 (baseline), Weeks 16, 32, and 52
Other outcomes:
Locations:
city: Northridge
country: United States
facility: Research Site 20001-376
state: California
city: Jacksonville
country: United States
facility: Research Site 30001-291
state: Florida
city: Miami
country: United States
facility: Research Site 20001-066
state: Florida
city: Miami
country: United States
facility: Research Site 20001-311
state: Florida
city: Miami
country: United States
facility: Research Site 20001-026
state: Florida
city: Miami
country: United States
facility: Research Site 30001-082
state: Florida
city: Miami
country: United States
facility: Research Site 20054-024
state: Florida
city: Tampa
country: United States
facility: Research Site 20001-004
state: Florida
city: Elwood
country: United States
facility: Research Site 20001-036
state: Indiana
city: Evansville
country: United States
facility: Research Site 20001-044
state: Indiana
city: Flint
country: United States
facility: Research Site 20001-006
state: Michigan
city: Saint Louis
country: United States
facility: Research Site 20001-046
state: Missouri
city: St Louis
country: United States
facility: Research Site 20001-046
state: Missouri
city: Hawthorne
country: United States
facility: Research Site 20001-047
state: New York
city: Toledo
country: United States
facility: Research Site 20001-063
state: Ohio
city: Buenos Aires
country: Argentina
facility: Research Site 20054-017
city: Buenos Aires
country: Argentina
facility: Research Site 20054-015
city: Buenos Aires
country: Argentina
facility: Research Site 20054-022
city: Buenos Aires
country: Argentina
facility: Research Site 20054-024
city: Buenos Aires
country: Argentina
facility: Research Site 20054-008
city: Cordoba
country: Argentina
facility: Research Site 20054-005
city: Mendoza
country: Argentina
facility: Research Site 20054-019
city: Mendoza
country: Argentina
facility: Research Site 20054-016
city: Mendoza
country: Argentina
facility: Research Site 20054-010
city: Tucuman
country: Argentina
facility: Research Site 20054-002
city: Blumenau
country: Brazil
facility: Research Site 20055-007
city: Porto Alegre
country: Brazil
facility: Research Site 20055-004
city: Sao Bernardo
country: Brazil
facility: Research Site 20055-001
city: Sao Paulo
country: Brazil
facility: Research Site 20055-008
city: Montana
country: Bulgaria
facility: Research Site 20359-008
city: Pernik
country: Bulgaria
facility: Research Site 20359-010
city: Ruse
country: Bulgaria
facility: Research Site 20359-005
city: Sliven
country: Bulgaria
facility: Research Site 20359-009
city: Vidin
country: Bulgaria
facility: Research Site 20359-016
city: Kutaisi
country: Georgia
facility: Research Site 20995-001
city: Tbilisi
country: Georgia
facility: Research Site 20995-005
city: Tbilisi
country: Georgia
facility: Research Site 20995-006
city: Tbilisi
country: Georgia
facility: Research Site 20995-002
city: Tbilisi
country: Georgia
facility: Research Site 20995-003
city: Tbilisi
country: Georgia
facility: Research Site 20995-004
city: Anyang-si
country: Korea, Republic of
facility: Research Site 20082-003
city: Daegu
country: Korea, Republic of
facility: Research Site 20082-009
city: Jeonju
country: Korea, Republic of
facility: Research Site 20082-006
city: Seoul
country: Korea, Republic of
facility: Research Site 20082-008
city: Bialystok
country: Poland
facility: Research Site 20048-018
city: Gizycko
country: Poland
facility: Research Site 20048-006
city: Krakow
country: Poland
facility: Research Site 20048-008
city: Piaseczno
country: Poland
facility: Research Site 20048-010
city: Poznan
country: Poland
facility: Research Site 20048-016
city: Brasov
country: Romania
facility: Research Site 20040-002
city: Brasov
country: Romania
facility: Research Site 20040-004
city: Belgrade
country: Serbia
facility: Research Site 20381-002
city: Belgrade
country: Serbia
facility: Research Site 20381-007
city: Valjevo
country: Serbia
facility: Research Site 20381-003
city: Durban
country: South Africa
facility: Research Site 30027-010
state: Kwa-ZuIu Natal
city: Durban
country: South Africa
facility: Research Site 30027-008
state: Kwa-Zulu Natal
city: Cape Town
country: South Africa
facility: Research Site 30027-009
state: Western Cape
city: Kyiv
country: Ukraine
facility: Research Site 20380-007
city: Kyiv
country: Ukraine
facility: Research Site 20380-010
city: Kyiv
country: Ukraine
facility: Research Site 20380-012
city: Kyiv
country: Ukraine
facility: Research Site 20380-013
city: Vinnytsia
country: Ukraine
facility: Research Site 20380-003
city: Zhytomyr
country: Ukraine
facility: Research Site 20380-005
city: Manchester
country: United Kingdom
facility: Research Site 20044-020
city: Rochdale
country: United Kingdom
facility: Research Site 20044-026
Study officials:
affiliation: Clinical Research Trials of Florida, Inc.
name: Sady Alpizar, MD
role: PRINCIPAL_INVESTIGATOR
References: