Phase 3 extension study to evaluate long-term safety of two regimens of ianalumab in participants with systemic lupus erythematosus (SIRIUS-SLE 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

21 May 2024 → ongoing

Decision date (initial)

2024-11-07

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Novartis Pharma AG

External identifiers

EU CT number

2023-505929-14-00

ClinicalTrials.gov

NCT06133972

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacodynamic, Therapy, Dose response, Safety, Pharmacokinetic, Efficacy

To evaluate long-term safety and tolerability of ianalumab XXX mg administered XXX XXX or XXX in participants with active systemic lupus erythematosus (SLE)

Secondary objectives 6

1. To evaluate the long-term efficacy of ianalumab XXX mg administered XXX XXX or XXX
2. To evaluate the effect of ianalumab XXX mg administered XXX XXX or XXX on Systemic Lupus International Collaborating Clinics (SLICC)/American College of Rheumatology (ACR) Damage Index
3. To evaluate the effect of ianalumab XXX mg administered XXX XXX or XXX on corticosteroids intake
4. To evaluate the effect of ianalumab XXX mg administered XXX XXX or XXX on British Isles Lupus Assessment Group (BILAG) flares
5. To characterize the Pharmacokinetics (PK) of ianalumab
6. To characterize the immunogenicity of ianalumab

Conditions and MedDRA coding

Systemic Lupus Erythematosus

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 3

1. Signed informed consent prior to participation in the extension study. Parent or legal guardian's signed informed consent and child's assent, if appropriate, are required before any assessment is performed for participants below18 years of age. Of note, if the participant reaches age of consent (age as per local law) during the study, they will also need to sign the corresponding study Informed Consent Form (ICF) at the next study visit.
2. Participants must have participated in either one of the two SIRIUS-SLE core studies, CVAY736F12301 or CVAY736F12302, and have completed the treatment period through Week 60 without treatment discontinuation.
3. In the judgement of the investigator, participants must be expected to clinically benefit from continued study treatment.

Exclusion criteria 6

1. Use of prohibited therapies
2. Active viral, bacterial or other infections requiring intravenous or intramuscular treatment for clinically significant infection which in the opinion of the investigator will place the participant at risk for participation.
3. Plans for administration of live vaccines during the study period.
4. Pregnant or nursing (breastfeeding) women.
5. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, refusing or unable to use highly effective methods of contraception while on study treatment and for 6 months after stopping of study drug (or longer if required by concomitant medications).
6. United States (and other countries, where male contraception is locally required): sexually active males, unless they agree to use barrier protection during intercourse with women of child-bearing potential while taking study treatment.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Incidence of treatment-emergent AEs (TEAEs)/SAEs

Secondary endpoints 6

1. Proportion of participants who achieved SRI-4 response up to Week 216
2. Change from baseline in SLICC/ACR Damage Index up to Week 216
3. Average daily dose of oral corticosteroids administered up to Week 216
4. Annualized BILAG moderate or severe flare rate up to Week 216
5. Ianalumab serum concentrations during treatment and follow-up after last dose
6. Incidence and titer of anti-ianalumab antibodies in serum (ADA assay) over time

Investigational products

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

Test 2

Placebo 2

Auxiliary 4

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Novartis Pharma AG

Sponsor organisation

Novartis Pharma AG

Address

Lichtstrasse 35

City

Basel Town

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 13

Locations

11 EU/EEA countries · 66 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 83 files

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

Application history

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