CVAY736A2301E1 Extension study

JRCT ID: jRCT2041240054

Registered date:03/07/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Sjogren's Syndrome
• Date of first enrollment: 21/12/2023
• Target sample size: 36
• Countries of recruitment: Argentina,Japan,Australia,Japan,Brazil,Japan,Bulgaria,Japan,Canada,Japan,Chile,Japan,China,Japan,Colombia,Japan,France,Japan,Germany,Japan,Greece,Japan,Hungary,Japan,Iceland,Japan,India,Japan,Israel,Japan,Italy,Japan,Lebanon,Japan,Mexico,Japan,Peru,Japan,Poland,Japan,Romania,Japan,Russia,Japan,Slovakia,Japan,South Africa,Japan,Spain,Japan,Sweden,Japan,Taiwan,Japan,United Kingdom,Japan,United States,Japan
• Study type: Interventional

Intervention(s)

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.

Outcome(s)

• Primary Outcome: Incidence of treatment-emergent AEs (TEAEs)/SAEs

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

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.

Exclude criteria

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.

Related Information

• Primary Sponsor: Maruyama Hideki
• Secondary ID(s): NCT05985915