Overview Study details Eligibility Things to know Research Study plan

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Overview Study details Eligibility Things to know Research Study plan

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Iptacopan in Patients With ANCA Associated Vasculitis

PHASE2ACTIVE_NOT_RECRUITING

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.

Study details:

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.

Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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.

Eligibility

Age eligible for study : NA

Healthy volunteers accepted : No

Gender eligible for study: ALL

Things to know

Study dates

Study start:

Primary completion:

Study completion finish:

Study type

TREATMENT

Phase

PHASE2

Study ID

NCT06388941

Intervention or treatment

DRUG: Iptacopan

DRUG: Placebo

DRUG: Rituximab

Conditions

Anti-Neutrophil Cytoplasm Antibodies (ANCA) Associated Vasculitis

Condition: Anti-Neutrophil Cytoplasm Antibodies (ANCA) Associated Vasculitis
DRUG: Iptacopan and other drugs
Concord, New South Wales, Australia and more
Sponsor: Novartis Pharmaceuticals

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Are you running this trial?

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Research sites nearby

Closest Location:

Novartis Investigative Site

Select from list below to view details:

Novartis Investigative Site
Concord, New South Wales, Australia
Novartis Investigative Site
Westmead, New South Wales, Australia
Novartis Investigative Site
Adelaide, South Australia, Australia
Novartis Investigative Site
Clayton, Victoria, Australia

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Who is running the clinical trial?

Novartis Pharmaceuticals

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Iptacopan LNP023 administered orally	Drug: Iptacopan, Drug: Rituximab
PLACEBO_COMPARATOR: Control Matching placebo	Drug: Placebo, Drug: Rituximab

What is the study measuring?

Primary Outcome

Measure	Description	Time Frame
Sustained remission through Week 48 defined as complete remission at Week 24 without major relapse up to Week 48.	To assess the effect of iptacopan in achieving sustained remission compared to standard of care (SOC)	At Week 48

Secondary Outcome

Measure	Description	Time Frame
B cell counts	To assess participant's immune status	At Week 48
Total IgG levels	To assess participant's immune status	At Week 48
Complete remission at week 24	Remission is defined as Birmingham Vasculitis Activity Score (BVAS) equal zero. BVAS captures various vasculitis organ manifestations as weighted score describing persistent and new symptoms with higher scores indicating more severe disease.	At week 24
Time to reach BVAS=0	To assess time to remission through Week 24	At Week 24
Time to major relapse	To assess the effect of iptacopan on disease relapse	At Week 48
Estimated glomerular filtration rate (eGFR) using the CKD-EPI formula, urinary protein excretion and hematuria over 48 weeks	To assess the effect of iptacopan on renal function	At Week 48
Cumulative dose of glucocorticoid (GC)	To assess the effect of iptacopan on GC sparing	At Week 48

Are you running this trial?If you're a clinic or sponsor, you can claim this study.

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References

Clinical Trials Gov: Iptacopan in Patients With ANCA Associated Vasculitis

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