Dexpramipexole Dose-Ranging Biomarker Study in Subjects With Eosinophilic Asthma
NCT ID: NCT04046939
Last Updated: 2023-04-13
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
534 participants
INTERVENTIONAL
2019-08-15
2021-03-02
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study to Evaluate Safety and Efficacy of Dexpramipexole (KNS-760704) in Subjects With Hypereosinophilic Syndrome
NCT02101138
A Study to Assess the Effect of Dexpramipexole in Adolescents and Adults With Severe Eosinophilic Asthma (EXHALE-3)
NCT05813288
A Study to Evaluate the Long-term Safety, Pharmacodynamics and Efficacy of SHR-1703 in Eosinophilic Asthma Patients
NCT06441812
A Multi-centered，Randomized，Double-blind，Placebo-controlled Study to Evaluate the Efficacy and Safety of SHR-1703 in Eosinophilic Asthma
NCT06653322
Efficacy/ Safety of Omalizumab in Patients With Seasonal Allergic Asthma and Seasonal Allergic Rhinoconjunctivitis
NCT00396409
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
placebo BID
Following a 2-4 week placebo run-in, randomized subjects received 1 tablet placebo twice daily for 12 weeks.
Placebo
placebo twice daily oral dosing for up to 12 weeks
37.5 mg BID dexpramipexole
Following a 2-4 week placebo run-in, randomized subjects received 1 tablet of 37.5 mg dexpramipexole twice daily for 12 weeks.
Dexpramipexole
dexpramipexole twice daily oral dosing for up to 12 weeks
75 mg BID dexpramipexole
Following a 2-4 week placebo run-in, randomized subjects received 1 tablet of 75 mg dexpramipexole twice daily for 12 weeks.
Dexpramipexole
dexpramipexole twice daily oral dosing for up to 12 weeks
150 mg BID dexpramipexole
Following a 2-4 week placebo run-in, randomized subjects received 1 tablet of 150 mg dexpramipexole twice daily for 12 weeks.
Dexpramipexole
dexpramipexole twice daily oral dosing for up to 12 weeks
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Dexpramipexole
dexpramipexole twice daily oral dosing for up to 12 weeks
Placebo
placebo twice daily oral dosing for up to 12 weeks
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Physician diagnosis of asthma for ≥12 months (relative to Baseline) based on Global Initiative for Asthma (GINA) 2018 Guidelines
* Asthma requiring treatment with, at a minimum, low dose inhaled corticosteroids in combination with a long-acting β2 agonist, on a stable dose for at least 1 month before Screening
* Bronchodilator reversibility, as evidenced by ≥12% and ≥200 mL improvement in FEV1 15 to 25 minutes following inhalation of albuterol at Screening
* Pre-bronchodilator FEV1 ≥40% and \<80% of predicted at Screening and Baseline
* AEC ≥0.30 x10\^9/L at the Screening visit
* ACQ-7 ≥1.5 at Screening
* Negative pregnancy test at Baseline
* Adherence ≥85% with twice-daily placebo taken during the Run-in Period
Exclusion Criteria
* Treatment with systemic corticosteroids in the 8 weeks prior to Screening
* Treatment with monoclonal antibody therapy, within 5-half-lives prior to Baseline
* Treatment with selected drugs known to have a substantial risk of neutropenia
* Absolute neutrophil count \<2.0x10\^9/L at Screening, or any documented history of absolute neutrophil count \<2.0x10\^9/L.
* Renal dysfunction, defined as an estimated glomerular filtration rate (eGFR) \<60 mL/min/1.73m\^2 at Screening
* Clinically significant abnormal laboratory or ECG values
* Other medically significant illness
* Use of any smoke or inhaled nicotine delivery device within 1 year prior to Screening
* Pregnant women or women breastfeeding
* Currently taking pramipexole or other dopamine agonists
18 Years
74 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Knopp Biosciences
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Research Site
Los Angeles, California, United States
Research Site
Mission Viejo, California, United States
Research Site
Westminster, California, United States
Research Site
Denver, Colorado, United States
Research Site
Daytona Beach, Florida, United States
Research Site
Miami, Florida, United States
Research Site
Orlando, Florida, United States
Research Site
Tampa, Florida, United States
Research Site
Tampa, Florida, United States
Research Site
Lawrenceville, Georgia, United States
Research Site
Winder, Georgia, United States
Research Site
Boise, Idaho, United States
Research Site
Farmington Hills, Michigan, United States
Research site
Plymouth, Minnesota, United States
Research Site
St Louis, Missouri, United States
Research Site
St Louis, Missouri, United States
Research Site
Las Vegas, Nevada, United States
Research Site
New Brunswick, New Jersey, United States
Research Site
Corning, New York, United States
Research Site
New Hyde Park, New York, United States
Research Site
Raleigh, North Carolina, United States
Research Site
Winston-Salem, North Carolina, United States
Research Site
Cincinnati, Ohio, United States
Research Site
Cincinnati, Ohio, United States
Research Site
Columbus, Ohio, United States
Research Site
Dublin, Ohio, United States
Research Site
Edmond, Oklahoma, United States
Research Site
Medford, Oregon, United States
Research Site
Portland, Oregon, United States
Research Site
Pittsburgh, Pennsylvania, United States
Research Site
Anderson, South Carolina, United States
Research Site
North Charleston, South Carolina, United States
Research Site
Allen, Texas, United States
Research Site
Boerne, Texas, United States
Research Site
Dallas, Texas, United States
Research Site
El Paso, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
KNS-760704-AS201
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.