Iptacopan in Patients With ANCA Associated Vasculitis
Purpose
The purpose of this study is to evaluate the efficacy and safety of iptacopan compared to standard of care (SOC) to induce and maintain remission in study participants with active granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA), when used in combination with rituximab (RTX) induction. The trial will also assess the impact of iptacopan on disease relapses, evolution of renal function and proteinuria, GC side effects, patients' immune status, and QoL.
Condition
- Anti-Neutrophil Cytoplasm Antibodies (ANCA) Associated Vasculitis
Eligibility
- Eligible Ages
- Between 18 Years and 100 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Newly diagnosed or relapsed GPA and MPA (according to the 2022 ACR/EULAR classification criteria for GPA and MPA) requiring treatment with RTX and GC as per investigator's judgement. - BVAS assessment with ≥1 major item, or ≥3 minor items, or ≥2 renal items at Screening. - Positive antibody test for anti-proteinase 3 (PR3) or anti-myeloperoxidase (MPO) antibodies at Screening or with history of documented evidence of a positive antibody test.
Exclusion Criteria
- Other systemic disease which constitutes the primary illness, including but not limited to: eosinophilic granulomatosis with polyangiitis (EGPA), moderate to severe systemic lupus erythematosus, IgA vasculitis (Purpura Schönlein-Henoch), rheumatoid vasculitis, Sjögren's syndrome, anti-glomerular basement membrane (GBM) disease, cryoglobulinemic vasculitis, autoimmune hemolytic anemia, autoimmune lymphoproliferative syndrome or mixed connective tissue disease. - Alveolar hemorrhage requiring invasive pulmonary ventilation support at Screening. - Severe kidney disease defined as estimated glomerular filtration rate (eGFR) <15 mL/minute/1.73m2, or kidney failure defined as receiving renal replacement therapy such as hemo(dia)filtration, hemo-/peritoneal dialysis, or having received a kidney transplant. - Received plasma exchange/-pheresis within 12 weeks prior to Screening.
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Iptacopan |
LNP023 administered orally |
|
|
Placebo Comparator Control |
Matching placebo |
|
Recruiting Locations
Arizona Arthritis and Rheumatology Research PLLC
Mesa, Arizona 85202
Mesa, Arizona 85202
UCLA Medical Center
Los Angeles, California 90095
Los Angeles, California 90095
Mayo Clinic Rochester
Rochester, Minnesota 55905
Rochester, Minnesota 55905
Northwell Health
New York, New York 10028
New York, New York 10028
Contact:
516-708-2550
516-708-2550
More Details
- NCT ID
- NCT06388941
- Status
- Recruiting
- Sponsor
- Novartis Pharmaceuticals
Detailed Description
This is a randomized, controlled study to evaluate the efficacy and safety of iptacopan in combination with RTX induction therapy for the treatment of newly diagnosed or relapsed patients with active GPA or MPA.