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A randomized, double-blind 2-arm NEPTUNUS extension study to assess the long-term safety and efficacy of ianalumab in patients with Sjogren's syndrome (CVAY736A2301E1)

CVAY736A2301E1 Extension study (CVAY736A2301E1)

Maruyama Hideki

Novartis Pharma. K.K.

Toranomon Hills Mori Tower 23-1, Toranomon 1-chome Minato-ku, Tokyo 105-6333, Japan

rinshoshiken.toroku@novartis.com

Maruyama Hideki

Novartis Pharma. K.K.

Toranomon Hills Mori Tower 23-1, Toranomon 1-chome Minato-ku, Tokyo 105-6333, Japan

+81-120-003-293

rinshoshiken.toroku@novartis.com

Not Recruiting

Dec. 21, 2023

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

1.Signed informed consent prior to participation in the extension study.
2.Participants must have participated in either one of the two NEPTUNUS core studies, CVAY736A2301 or CVAY736A2302, and must have completed the entire treatment up to Week 48 without treatment discontinuation in core NEPTUNUS studies.
3.In the judgement of the Investigator, participants must be expected to clinically benefit from continued ianalumab therapy.

1.Use of therapies excluded by the NEPTUNUS-1 and NEPTUNUS-2 study protocols.
2.Plans for administration of live vaccines during the study period.
3.Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human Chorionic Gonadotropin (hCG) laboratory test.
4.Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception while taking study treatment during dosing and for 6 months after stopping of investigational drug.

Both

Sjogren's Syndrome

Regimen A - Continuous treatment of participants who were on 300 mg s.c. monthly treatment in either of the NEPTUNUS core studies, i.e., ianalumab 300 mg s.c. monthly.
Regimen B - Participants who were on placebo arm in either of the NEPTUNUS core studies randomize to ianalumab 300 mg s.c. monthly in the extension, the active treatment starts at Week 60.
Regimen C - Participants who were on placebo arm in either of the NEPTUNUS core studies randomize to ianalumab 300 mg s.c. every 3 months, the active treatment starts at Week 60.
Regimen D - Continuous treatment of participants who were on 300 mg s.c. every three months treatment, i.e., ianalumab 300 mg s.c. every three months. The first administration of active treatment in the extension study is at Week 60 to continue 3-monthly treatment cycle.

Incidence of treatment-emergent AEs (TEAEs)/SAEs

+81-52-691-7151

Oct. 30, 2023

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 expert 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 is currently available according to the process described on www.clinicalstudydatarequest.com.

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