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.

- Subjects receive background OGC dose of ≥7.5 mg/day with or without stable treatment with Mepolizumab/Benralizumab.

- 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.

Estimated glomerular filtration rate of <30 mL/min/1.73 m2 by Chronic Kidney Disease Epidemiology Collaboration equations. 2. WBC count <4 × 109/L. 3. Absolute lymphocyte count <500 cells/mm3. 4. Absolute neutrophil count <1000 cells/mm3. 5. Platelet count <120,000/mm3. 6. Hemoglobin <8 g/dL (<80 g/L)

- 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.	NCT06046222
Phase 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	Canada, France, Germany, Italy, Japan, Spain, United Kingdom, 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/Benralizumab 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.

National Jewish Health, Denver 5419384, Colorado 5417618

Status

Recruiting

Address

National Jewish Health

Denver 5419384, Colorado 5417618, 80206

Site Contact

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