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

NS Pharma

Status and phase: Enrolling; Phase 2

Conditions: Eosinophilic Granulomatosis With Polyangiitis; Churg-Strauss Syndrome

Treatments: Drug: Placebo; Drug: NS-229

Study type: Interventional

Funder types: Industry

Identifiers

NCT06046222

NS229-P2-01

Details and patient eligibility

About

This study will enroll male and female subjects who are 18 years of age or older with Eosinophilic Granulomatosis With Polyangiitis.

Full description

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.

Enrollment: 45 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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45 participants in 2 patient groups, including a placebo group

NS-229

Experimental group

Description:

Self-administer NS-229 in consecutive 28 weeks.

Treatment:

Drug: NS-229

Placebo

Placebo Comparator group

Description:

Self-administer matching placebo in consecutive 28 weeks.

Treatment:

Drug: Placebo