An open-label extension study to assess the efficacy and safety of ianalumab with or without study treatment withdrawal in adult participants with lupus nephritis who have completed study treatment in the CVAY736K12301 core study (SIRIUS-LN extension)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Novartis Pharma AG

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Immune System Diseases [C20]

Trial duration

29 May 2025 → ongoing

Decision date (initial)

2025-10-08

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

External identifiers

EU CT number

2024-515280-60-00

WHO UTN

U1111-1324-5224

ClinicalTrials.gov

NCT06711887

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Pharmacokinetic, Efficacy

Cohort1: To estimate the incidence of renal flare, escalation of immunosuppressive medication, or death following study treatment withdrawal in participants who completed the SIRIUS-LN core study on double-blind treatment and achieved CRR or PRR at Week 140 of the core study

Cohort2: To assess the safety and tolerability of ianalumab for participants who, at the end of the SIRIUS-LN core study, were either already receiving ianalumab open-label treatment or did not meet CRR/PRR criteria on double-blind treatment at the end of the SIRIUS-LN core study

Secondary objectives 3

1. To assess the safety and tolerability of ianalumab in Cohort 1
2. To assess immunogenicity to ianalumab
3. To assess pharmacokinetics of ianalumab

Conditions and MedDRA coding

Lupus nephritis

Regulatory references

Scientific advice from competent authorities

European Medicines Agency

Plan to share IPD

Yes

IPD plan description

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.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 2

1. Signed informed consent prior to participation in the extension study
2. Participants must have participated in the SIRIUS-LN core study and must have completed the entire treatment up to Week 144 on double-blind or open label study treatment.

Exclusion criteria 2

1. Use of prohibited therapies as defined in Section 6.5.2 of the protocol.
2. Pregnant or nursing (lactating) women

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. Incidence of renal flare, escalation of immunosuppressive medication, or death from Week 144E1 to Week 248
2. Incidence of TEAEs, SAEs, vital signs and clinical laboratory measurements from the start of treatment in the SIRIUS-LN core study up to EOS of the extension study

Secondary endpoints 3

1. Incidence of TEAEs, SAEs, vital signs and clinical laboratory measurements from the start of treatment in the SIRIUS-LN core study up to EOS of the extension study
2. Incidence and titer of anti-ianalumab antibodies in serum (ADA assay) from Week 144E1 up to Week 248
3. Ianalumab concentration in serum and calculated PK parameters from Week 144E1 up to Week 248

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Auxiliary 6

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Novartis Pharma AG

Sponsor organisation

Novartis Pharma AG

Address

Lichtstrasse 35

City

Basel

Postcode

4056

Country

Switzerland

Scientific contact point

Organisation

Novartis Pharma AG

Contact name

Novartis Pharma Arzneimittel GmbH

Public contact point

Organisation

Novartis Pharma AG

Contact name

Novartis Pharma Arzneimittel GmbH

Third parties 15

Locations

5 EU/EEA countries · 19 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 38 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

9 submissions — initial application plus substantial / non-substantial modifications