Study to Evaluate Safety and Efficacy of Dexpramipexole (KNS-760704) in Subjects With Hypereosinophilic Syndrome
Public ClinicalTrials.gov record NCT02101138. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
An Open-Label, Proof-of-Concept Study to Evaluate the Safety and Efficacy of Dexpramipexole (KNS-760704) in Subjects With Hypereosinophilic Syndrome
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Background: \- Eosinophils are white blood cells that fight infections. In people with hypereosinophilic syndrome (HES), eosinophil levels are too high and can damage their organs. HES is usually treated with steroids, but steroids can cause side effects and stop working over time. Researchers want to see if a drug called dexpramipexole, being developed by Knopp Pharmaceuticals, can help people with HES to reduce their steroid dose. Objective: \- To test whether dexpramipexole can reduce the steroid dose needed to control eosinophilia and HES symptoms. Eligibility: \- Adults 18 and older with HES who respond to steroids, but need more than 10 mg daily to control eosinophilia and symptoms. Design: * The study will last 9 months with 6 visits to NIH. * Participants will be screened with medical history, physical exam, and urine and blood samples. * Participants steroids will be tapered to the lowest effective dose. During this time, blood will be drawn weekly. Participants will take this dose for 2 weeks before starting the study drug. * Participants will take the study drug twice daily by mouth for 12 weeks along with steroids. The steroid dose will not be decreased during this time and participants will be seen monthly for a medical history, physical examination and blood work. * Just before and 12 weeks after starting the study drug, the following tests will be performed: * medical history and physical exam * blood and urine tests * lung function tests * electrocardiogram (measures heart electrical activity) * echocardiogram (takes pictures of the heart using sound waves) * bone marrow biopsy (a needle inserted into the hip bone that removes bone marrow cells for study) * After 12 weeks, the participants steroid dose will be tapered again to the lowest effective dose while on study drug. * Two weeks after the lowest effective dose is reached, participants will return for a medical history, physical examination, blood work, lung and heart tests. * Participants who respond to the study drug may be able to continue to receive the drug on a planned separate study. * Four weeks after stopping the study drug, participants will have medical history, physical exam, and blood tests.
Study identification
- NCT ID
- NCT02101138
- Recruitment status
- Not listed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 15 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 13, 2014
- Primary completion
- Dec 29, 2016
- Completion
- Oct 22, 2019
- Last update posted
- Dec 6, 2017
2014 – 2019
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland | 20892 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02101138, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 6, 2017 · Synced Sep 18, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02101138 live on ClinicalTrials.gov.