Anti-Neutrophil Cytoplasm Antibodies (ANCA) Associated VasculitisPhase 2NCT06388941
Iptacopan in Patients With ANCA Associated Vasculitis
A Phase 2 study testing Iptacopan and Rituximab in people with Anti-Neutrophil Cytoplasm Antibodies (ANCA) Associated Vasculitis, run by Novartis Pharmaceuticals at 40 sites in 15 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anti-Neutrophil Cytoplasm Antibodies (ANCA) Associated Vasculitis
- What is being tested?
- Iptacopan and Rituximab
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 40 sitesin 15 countries
- Study dates
- 5 Aug 2024to 30 Dec 2026
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
40 sites in 15 countries.
40 sites in 15 countries
France6 sites
Novartis Investigative Site
Angers, France, 49933
Novartis Investigative Site
Brest, 29200
Novartis Investigative Site
Dijon, 21000
Novartis Investigative Site
Marseille, 13005
Novartis Investigative Site
Paris, 75014
Novartis Investigative Site
Toulouse, 31054
Germany5 sites
Novartis Investigative Site
Berlin, 13353
Novartis Investigative Site
Kirchheim unter Teck, Baden-Wurttemberg, 73230
Novartis Investigative Site
Ludwigshafen, Germany, 67063
Novartis Investigative Site
Mainz, 55131
Novartis Investigative Site
Munich, Bavaria, 81377
Canada4 sites
Novartis Investigative Site
Fleurimont, Quebec, J1H 5N4
Novartis Investigative Site
London, Ontario, N6A 5W9
Novartis Investigative Site
Montreal, Quebec, H2X 1R9
Novartis Investigative Site
Québec, Quebec, G1R 2J6
Argentina3 sites
Novartis Investigative Site
CABA, Buenos Aires, C1180AAX
Novartis Investigative Site
CABA, C1181ACH
Novartis Investigative Site
La Plata, Buenos Aires, B1900AWT
Austria3 sites
Novartis Investigative Site
Graz, 8036
Novartis Investigative Site
Innsbruck, Tyrol, 6020
Novartis Investigative Site
Vienna, 1090
China3 sites
Novartis Investigative Site
Beijing, 100034
Novartis Investigative Site
Shijiazhuang, Hebei, 050000
Novartis Investigative Site
Zhengzhou, Henan, 450003
Spain3 sites
Novartis Investigative Site
Madrid, 28046
Novartis Investigative Site
Pamplona, Navarre, 31008
Novartis Investigative Site
Plasencia, Caceres, 10600
United States2 sites
Arizona Arthritis and Rheumatology Research PLLC
Mesa, Arizona, 85202
Mayo Clinic Rochester
Rochester, Minnesota, 55905
Australia2 sites
Novartis Investigative Site
Clayton, Victoria, 3168
Novartis Investigative Site
Concord, New South Wales, 2139
Denmark2 sites
Novartis Investigative Site
Aarhus N, 8200
Novartis Investigative Site
Herlev, 2730
Hungary2 sites
Novartis Investigative Site
Budapest, 1083
Novartis Investigative Site
Szeged, 6725
Turkey (Türkiye)2 sites
Novartis Investigative Site
Ankara, Sihhiye Altindag, 06230
Novartis Investigative Site
Istanbul, Pendik, 34899
About this study
Official title: A Randomized, Controlled Study to Evaluate LNP023 (Iptacopan) in Patients With Active ANCA-associated Vasculitis
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.
Read the 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.
- Being tested
- Iptacopan, Placebo, Rituximab
- Keywords
- ANCA-associated vasculitis;, granulomatosis with polyangiitis (GPA);, microscopic polyangiitis (MPA);, LNP023 (iptacopan).
- Medical subject headings
- Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis, Granulomatosis with Polyangiitis, Microscopic Polyangiitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IptacopanDrug
Also called LNP023
LNP023 administered orally
PlaceboDrug
Matching placebo administered orally
RituximabDrug
Standard of care
| Study group | Role | What they receive |
|---|---|---|
| Iptacopan | Experimental | LNP023 administered orally Receives: Drug: Iptacopan; Drug: Rituximab |
| Control | Placebo comparator | Matching placebo Receives: Drug: Placebo; Drug: Rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: At Week 48
Secondary outcomes (7)
B cell counts
To assess participant's immune status
Measured: At Week 48
Total IgG levels
To assess participant's immune status
Measured: 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.
Measured: At week 24
Time to reach BVAS=0
To assess time to remission through Week 24
Measured: At Week 24
Time to major relapse
To assess the effect of iptacopan on disease relapse
Measured: 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
Measured: At Week 48
Cumulative dose of glucocorticoid (GC)
To assess the effect of iptacopan on GC sparing
Measured: At Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2024
- Study start5 Aug 2024
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anti-Neutrophil Cytoplasm Antibodies (ANCA) Associated VasculitisStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06388941
- Sponsor's protocol ID
- CLNP023R12201
- Other IDs
- 2023-510525-15-00, 2023
- Status last verified
- Oct 2026
- First submitted
- 17 Apr 2024
- Last updated
- 15 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.
Publications
Brilland B, Riou J, Quemeneur T, Vandenbussche C, Merillon N, Boizard-Moracchini A, Roy M, Despre M, Piccoli GB, Djema A, Henry N, Preisser L, Blanchet O, Gnemmi V, Copin MC, Langlais D, Jeannin P, Blanco P, Delneste Y, Augusto JF; Maine-Anjou Registry Research Group. Identification of Renal Transcripts Associated with Kidney Function and Prognosis in ANCA-Associated Vasculitis. J Am Soc Nephrol. 2026 Jan 1;37(1):131-149. doi: 10.1681/ASN.0000000779. Epub 2025 Jul 9.
PubMed 40632630