Trial of Efficacy and Safety of NS-229 Versus Placebo in Patients With Eosinophilic Granulomatosis With Polyangiitis

Overview

About this study

The purpose of this study is to investigate the efficacy of NS-229 compared with placebo in subjects with eosinophilic granulomatosis with polyangiitis (EGPA).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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. Estimated glomerular filtration rate of < 30 mL/min/1.73 m^2 by Chronic Kidney
Disease Epidemiology Collaboration equations;

2. WBC count < 4 × 10^9/L;

3. Absolute lymphocyte count < 500 cells/mm^3;

4. Absolute neutrophil count < 500 cells/mm^3;

5. Platelet count < 120,000/mm^3

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.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 10/24/23. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Ulrich Specks, M.D.

Open for enrollment

Contact information:

Michael Stachowitz

(507) 284-4862

Stachowitz.Michael@mayo.edu

More information

Publications

Publications are currently not available
.
CLS-20559960

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