Churg-Strauss Syndrome, Eosinophilic Granulomatosis With Polyangiitis
Conditions
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.
Interventions
DRUGNS-229
Experimental
DRUGPlacebo
Placebo comparator
Sponsors
NS Pharma, Inc.
Nippon Shinyaku Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The proportion of subjects in remission [OGC 4.0] | From Baseline to week 28 | The proportion of subjects in remission (oral glucocorticoid \[OGC\] 4.0) at Week 28 of the study treatment period. Definition of remission (OGC 4.0): BVAS of 0 AND OGC dose of prednisolone/prednisone ≤4 mg/day |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The proportion of subjects in remission [OGC 7.5] | From Baseline to week 28 | The proportion of subjects in remission (OGC 7.5) at Week 28 of the study treatment period Definition of remission (OGC 7.5): BVAS of 0 AND OGC dose of prednisolone/prednisone ≤7.5 mg/day |
| Time to first relapse of EGPA | Up to Week 28 | Relapse of EGPA will be defined as active disease since the last visit after remission (OGC 4.0) was achieved, characterized by: 1. Active vasculitis (BVAS of \>0); OR 2. Signs and/or symptoms of active asthma with a corresponding worsening in answers on the 6-item Asthma Control Questionnaire (compared with the most recent previous results); OR 3. Active nasal and/or sinus disease (attributable to EGPA) with a corresponding worsening in at least 1 of the answers on the sinonasal symptom questionnaire (compared with the most recent previous assessment). |
| Time to first worsening of EGPA | Up to Week 28 | Worsening of EGPA will be defined as worsening of active disease since the last visit, characterized by: 1. Active vasculitis (BVAS \>0) and the score greater than the previous visit; OR 2. Signs and/or symptoms of active asthma with a corresponding worsening in answers on the 6-item Asthma Control Questionnaire (compared to the most recent previous score); OR 3. Active nasal and/or sinus disease (attributable to EGPA) with a corresponding worsening in at least 1 of the answers on the sinonasal symptom questionnaire (compared to the most recent previous assessment). |
Countries
Canada, France, Germany, Italy, Japan, Spain, United Kingdom, United States
Outcome results
None listed