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Trial of Efficacy and Safety of NS-229 Versus Placebo in Patients With Eosinophilic Granulomatosis With Polyangiitis
Study Purpose
This study will enroll male and female subjects who are 18 years of age or older with
Eosinophilic Granulomatosis With Polyangiitis.
Recruitment Criteria
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
No
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
Interventional
Eligible Ages
18 Years and Over
Gender
All
More Inclusion & Exclusion Criteria
Inclusion Criteria:
- Ability to provide written informed consent prior to participation in the study.
- Male or female subjects aged ≥18 years at the time the informed consent form is
signed.
- Diagnosis of EGPA: Subjects who have been diagnosed with EGPA based on the history or
presence of eosinophilia plus at least a history or presence of 2 of additional
features of EGPA.
- Use of adequate contraception.
- Other inclusion criteria may apply.
Exclusion Criteria:
- Current diagnosis of either granulomatosis with polyangiitis or microscopic
polyangiitis.
- Imminently life-threatening EGPA at the time of screening.
- History or presence of any form of cancer within 5 years prior to screening.
- Serious liver, renal, blood, or psychiatric disease.
- Severe or clinically significant cardiovascular disease uncontrolled with standard
treatment.
- Active systemic infections (including TB, pneumonia, Pneumocystis pneumonia, sepsis,
and opportunistic infections)
- Parasitic infection: Subjects with a known parasitic infestation within 6 months prior
to screening.
- HIV positive status.
- Active hepatitis due to hepatitis B virus or hepatitis C virus.
- Known history or presence of venous thromboembolism/venous thrombotic events (deep
vein thrombosis and/or pulmonary embolus)
- laboratory parameter exclusions:
1.
- Subjects who are pregnant, breastfeeding, or planning to become pregnant during the
time of study participation.
- History of clinically significant drug or alcohol abuse within the last 6 months.
- Other exclusion criteria may apply.
Trial Details
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Phase 2
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
NS Pharma, Inc.
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study.
N/A
Principal Investigator Affiliation
N/A
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
Industry
Overall Status
Recruiting
Countries
Japan, United States
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied.
Eosinophilic Granulomatosis With Polyangiitis, Churg-Strauss Syndrome
Additional Details
The purpose of this randomized, double-blind study is to investigate the efficacy and safety
of NS229 compared with placebo over a 28-week study treatment period in subjects with
Eosinophilic Granulomatosis with Polyangiitis (EGPA) receiving background corticosteroid
therapy with or without mepolizumab therapy. During the treatment period corticosteroid dose
will be tapered.
The key outcomes in the study focus on evaluation of clinical remission, defined as
Birmingham Vasculitis Activity Score (BVAS)=0 with a corticosteroid dose of <=4 mg/day
prednisolone/prednisone.
Arms & Interventions
Arms
Experimental: NS-229
Self-administer NS-229 in consecutive 28 weeks.
Placebo Comparator: Placebo
Self-administer matching placebo in consecutive 28 weeks.
Interventions
Drug: - NS-229
Experimental
Drug: - Placebo
Placebo comparator
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
