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Study to Evaluate Safety and Efficacy of Dexpramipexole (KNS-760704) in Subjects With Hypereosinophilic Syndrome

NCT02101138 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2017-12-07

No results posted yet for this study

Summary

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.

Conditions

  • Hypereosinophilic Syndrome

Interventions

DRUG

Dexpramipexole

Dexpramipexole (KNS 760704) is a synthetic amino-benzothiazole developed for use in amyotrophic lateral sclerosis (ALS)

Sponsors & Collaborators

  • Knopp Biosciences

    collaborator INDUSTRY

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Amy D Klion, M.D. · National Institute of Allergy and Infectious Diseases (NIAID)

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-14
Primary Completion
2016-12-30
Completion
2019-10-23

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02101138 on ClinicalTrials.gov