Health Condition 1: M350- Sicca syndrome [Sjogren]
Conditions
Interventions
Intervention1: ianalumab: Patient will either receive 300 mg of ianalumab every three months for 3 years or they will receive 300 mg of ianalumab every month for 3 years.
Control Intervention1: placeb
Sponsors
Novartis Healthcare Pvt Ltd
Eligibility
Inclusion criteria
Inclusion 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 the core NEPTUNUS studies. 3.In the judgement of the Investigator, participants must be expected to clinically benefit from continued ianalumab therapy.
Exclusion criteria
Exclusion criteria: 1.Use of therapies excluded by the NEPTUNUS-1 and NEPTUNUS-2 study protocols (see NEPTUNUS studies protocols exclusion criteria in Section 5.2 for details). 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. Highly effective contraception methods include: â?¢Total abstinence (when this is in line with the preferred and usual lifestyle of the participant. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. â?¢Female bilateral tubal ligation, female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy) or total hysterectomy at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment. â?¢Male sterilization (at least 6 months prior to screening). For female participants on the study, the vasectomized male partner should be the sole partner for that participant. â?¢Use of oral (estrogen and progesterone), injected, or implanted hormonal methods of contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS), or other forms of hormonal contraception that have comparable efficacy (failure rate In case of use of oral contraception women should have been stable on the same pill for a minimum of 3 months before taking study treatment. Contraception should be used in accordance with locally approved prescribing information of concomitant medications administered. Women are considered post-menopausal if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g., age-appropriate history of vasomotor symptoms). Women are considered of not child-bearing potential if they are post-menopausal or have had surgical bilateral oophorectomy (with or without hysterectomy), total hysterectomy or bilateral tubal ligation at least six weeks ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow-up hormone level assessment is she considered not of child-bearing potential. If local regulations deviate from the contraception methods listed above to prevent pregnancy, local regulations apply and will be described in the informed consent form (ICF). 5.Sexually active males unless they agree to use barrier protection during intercourse while taking study treatment are excluded. As condom use alone has a reported failure rate exceeding 1% per year, it is recommended female partners of male study participants use a second method of birth control. Although ianalumab is not teratogenic and/or genotoxic, and not transferred to semen, male contraception is required, as requested by FDA.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of treatment-emergent AEs (TEAEs)/SAEsTimepoint: 4 week | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the long-term efficacy of VAY736 300 mg administered monthly or every 3 months To show comparability of ianalumab Ctrough between 2x 1mL PFS (from the NEPTUNUS core studies: CVAY736A2301 and CVAY736A2302) and 1x 2mL PFS for participants on continuous monthly treatment To further assess the pharmacokinetics of ianalumab. Timepoint: ESSDAI change from baseline Proportion of participants achieving ESSPRI â?¤ 3 AND â?¥ 1.5 points reduction from baseline Proportion of participants achieving meaningful improvement in the SSSD score over time up to Week 204 Ianalumab serum concentrations collected pre-dose (i.e., Ctrough) at Week 52 and Week 64 Ianalumab serum concentrations during treatment (e.g., Ctrough) and follow-up after last dose. | — |
Countries
Argentina, Australia, Austria, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czech Republic, France, Germany, Greece, Guatemala, Hungary, India, Israel, Japan, Lebanon, Mexico, Peru, Poland, Portugal, Republic of Korea, Singapore, Slovakia, South Africa, Spain, Taiwan, Turkey, United States of America
Contacts
Public ContactMurugananthan K
Novartis Healthcare Private Limited
Outcome results
None listed