A randomized, controlled study to evaluate LNP023 (iptacopan) in patients with active ANCA-associated vasculitis.
EU CTIS ID: 2023-510525-15-00
What this study is testing
To assess the effect of iptacopan in achieving sustained remission compared to standard of care (SOC)
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Signed informed consent obtained prior to participation in the study.
- 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.
- Male or female subjects ≥18 years at Screening.
You likely can't join if
- 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 <15 mL/min/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.
- Received any of the following immunosuppressive, cell depleting or biological therapy (any other immunosuppressive, cell depleting, or biological therapy not listed here must be discussed with the Sponsor): • Received RTX or other B-cell depleting agent within 16 weeks prior to Screening. • Received any of the following biological or alkylating immunosuppressive medications within 12 weeks before screening, including but not limited to: • cyclophosphamide (CYC) • complement inhibitor (such as eculizumab, ravulizumab, avacopan) • anti-tumor necrosis factor • abatacept • tocilizumab • intravenous immunoglobulins • Received any of the following cell depleting agents within 24 weeks before Screening, including but not limited to: • alemtuzumab • antithymocyte globulin • Received azathioprine (AZA), methotrexate (MTX), or mycophenolate (MMF), or any other immunosuppressants with similar half-life within 1 week prior to Day 1. • Received leflunomide (LEF) within 6 weeks prior to Day 1.
The study team makes the final eligibility decision.
Where it's taking place
- Canada
- Argentina
- Turkey
- China
- Australia
- United Kingdom
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Canada; Argentina; Turkey; China; Australia; United Kingdom and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.