Clinical trial NCT06046222: Trial of Efficacy and Safety of NS-229 Versus Placebo in Patients With Eosinophilic Granulomatosis With Polyangiitis
Official title: A Phase 2, Double-blind, Randomized, Placebo-controlled Study to Investigate the Efficacy and Safety of NS-229 in the Treatment of Eosinophilic Granulomatosis With Polyangiitis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Eosinophilic Granulomatosis With Polyangiitis
Churg-Strauss Syndrome
Lead sponsor: NS Pharma, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Nippon Shinyaku Co., Ltd.
First posted: 2023-09-21
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility 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.

Primary outcomes:
measure: The proportion of subjects in remission [OGC 4.0]
timeFrame: From Baseline to week 28
Secondary outcomes:
measure: The proportion of subjects in remission [OGC 7.5]
timeFrame: From Baseline to week 28
measure: Time to first relapse of EGPA
timeFrame: Up to Week 28
measure: Time to first worsening of EGPA
timeFrame: Up to Week 28
Other outcomes:
Locations:
city: Denver
country: United States
facility: National Jewish Health
state: Colorado
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center
state: Ohio
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
city: Hamilton
country: Canada
facility: St Joseph's Healthcare Hamilton
state: Ontario
city: Toronto
country: Canada
facility: University of Toronto
state: Ontario
city: Nice
country: France
facility: CHU Nice
city: Paris
country: France
facility: Hopital Cochin
city: Toulouse
country: France
facility: Chu Rangueil
city: Kirchheim Unter Teck
country: Germany
facility: Medius Kliniken gGmbh
state: Studienzentrale
city: Milan
country: Italy
facility: Istituto Auxologico Italiano IRCCS
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Campus Bio-Medico
city: Trento
country: Italy
facility: Azienda Provinciale per i Servizi Sanitari Provincia Autonoma Trento
city: Verona
country: Italy
facility: Azienda Ospedaliera Universitaria Integrata Verona
city: Chuo-ku, Chiba-shi
country: Japan
facility: Chiba University Hospital
state: Chiba
city: Kitakyushu
country: Japan
facility: Hospital of the University of Occupational and Environmental Health, Japan
state: Fukuoka
city: Sapporo
country: Japan
facility: Hokkaido University Hospital
state: Hokkaido
city: Sagamihara
country: Japan
facility: NHO Sagamihara National Hospital
state: Kanagawa
city: Yokohama
country: Japan
facility: National Hospital Organization Yokohama Medical Center
state: Kanagawa
city: Sendai
country: Japan
facility: Tohoku University Hospital
state: Miyagi
city: Habikino
country: Japan
facility: Osaka Habikino Medical Center
state: Osaka
city: Kawagoe
country: Japan
facility: Saitama Medical Center
state: Saitama
city: Bunkyo-ku
country: Japan
facility: Juntendo University Hospital
state: Tokyo
city: Mitaka
country: Japan
facility: Kyorin University Hospital
state: Tokyo
city: Ota-ku
country: Japan
facility: Toho University Omori Medical Center
state: Tokyo
city: Santiago de Compostela
country: Spain
facility: Complejo Hospitalario Universitario de Santiago de Compostela
state: A Coruna
city: Pamplona
country: Spain
facility: Complejo Hospitalario de Navarra
city: Edgbaston
country: United Kingdom
facility: Queen Elizabeth Hospital Birmingham
state: Birmingham
city: Cambridge
country: United Kingdom
facility: Addenbrookes Hospital
city: Reading
country: United Kingdom
facility: Royal Berkshire NHS Foundation Trust
Study officials:
References: