Under Evaluation Therapeutic confirmatory (Phase III) Severe eosinophilic asthma

An Open-Label Extension to Study the Long-Term Effect of Dexpramipexole in Participants with Severe Eosinophilic Asthma (EXHALE-5)

EU CTIS ID: 2024-510810-33-00

What this study is testing

To assess the long-term safety of dexpramipexole 150 mg BID in participants who completed either of the Phase III studies EXHALE-2 or EXHALE-3.

  • Therapeutic confirmatory (Phase III)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • Participants who completed the double-blind study intervention treatment period during either of the Phase III studies EXHALE-2 or EXHALE-3.
  • Signed informed consent form (ICF) and assent form as appropriate.
  • Negative urine pregnancy test for women of childbearing potential (WOCBP; after menarche) at the Baseline Visit/Day 1.
  • 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.

You likely can't join if

  • 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.
  • Participants with allergy/intolerance to dexpramipexole or any of its excipients.
  • 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.
  • Treatment with selected drugs known to have a substantial risk of neutropenia in the past 30 days
  • Pregnant or breastfeeding women.
  • Males who are unwilling to use an acceptable method of birth control during the entire study period (ie, condom with spermicide).

The study team makes the final eligibility decision.

Where it's taking place

  • Georgia
  • Argentina
  • Chile
  • China
  • Ukraine
  • North Macedonia
  • Serbia
  • South Africa
  • Japan
  • United States
  • Canada
  • Puerto Rico
  • Turkey
  • Taiwan
  • Israel
  • Mexico
  • United Kingdom
  • Brazil
  • Korea, Democratic People's Republic of
  • Peru

+ 2 more site(s).

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18-64 years, 0-17 years, 65+ years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Georgia; Argentina; Chile; China; Ukraine; North Macedonia and 16 more location(s). Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.