A Randomized, Double-blind 2-arm NEPTUNUS Extension Study to Assess the Long-term Safety and Efficacy of Ianalumab in Patients With Sjogrens Syndrome.

Last updated: March 5, 2025
Sponsor: Novartis Pharmaceuticals
Overall Status: Active - Recruiting

Phase

3

Condition

Dermatomyositis (Connective Tissue Disease)

Sjogren's Syndrome

Treatment

Ianalumab (VAY736)

Placebo

Clinical Study ID

NCT05985915
CVAY736A2301E1
2022-502966-26
2022-502966-26-01
  • Ages 18-75
  • All Genders

Study Summary

The purpose of this study is to measure the long-term safety and tolerability of ianalumab in participants with Sjogrens syndrome who have previously completed treatment from one of two NEPTUNUS 1 year core studies (CVAY736A2301 [NCT05350072] or CVAY736A2302 [NCT05349214]).

  • The study treatment is ianalumab 300 mg in a 2 mL pre-filled syringe (PFS) or in a 2 mL autoinjector (AI) for injection. All participants will receive ianalumab either monthly or every 3 months.

  • The treatment duration will be 3 years with an additional up to 2-year safety follow-up. The total duration of this extension study will be up to 5 years.

  • The visit frequency will be monthly during both the treatment period and mandatory follow-up, and then less frequently during the subsequent conditional follow-up.

Treatment of interest: The randomized treatment (ianalumab) will be received monthly or every 3 months. Participants assigned to treatment every 3 months will receive placebo every month between the ianalumab doses to maintain blinding.

Number of Participants: Approximately 600 participants from the NEPTUNUS core studies will be rolled over into the extension study.

Treatment Groups:There will be no screening period in this trial. From Week 48 of the NEPTUNUS core study, participants will be given the opportunity to consent to this extension study. From Week 52 of the NEPTUNUS core studies (i.e., Day 1 in the extension study), eligible participants will be assigned to either one of the treatment regimens:

  • ianalumab 300 mg monthly or

  • ianalumab 300 mg once every 3 months

Participants receiving placebo in either of the NEPTUNUS core studies will be randomized 1:1 to receive ianalumab 300 mg monthly or every 3 months starting from Week 60 and participants receiving ianalumab in either of the NEPTUNUS core studies will continue the same treatment in the extension study.

Ianalumab will be given as a subcutaneous injection from a 2 mL pre-filled syringe or a 2 mL autoinjector. Participants will be given the opportunity to self-inject at home on some visits after receiving training.

Eligibility Criteria

Inclusion

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 toWeek 48 without treatment discontinuation in core NEPTUNUS studies.

  3. In the judgement of the Investigator, participants must be expected to clinicallybenefit from continued ianalumab therapy.

Exclusion

Exclusion Criteria:

  1. Use of therapies excluded by the NEPTUNUS-1 and NEPTUNUS-2 study protocols (seeNEPTUNUS 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 afemale after conception and until the termination of gestation, confirmed by apositive human Chorionic Gonadotropin (hCG) laboratory test.

  4. Women of child-bearing potential (WOCBP), defined as all women physiologicallycapable of becoming pregnant, unless they are using highly effective methods ofcontraception while taking study treatment during dosing and for 6 months afterstopping of investigational drug. Highly effective contraception methods include:

  • Total abstinence (when this is in line with the preferred and usual lifestyleof the participant. Periodic abstinence (e.g., calendar, ovulation,symptothermal, post-ovulation methods) and withdrawal are not acceptablemethods of contraception.

  • Female bilateral tubal ligation, female sterilization (have had surgicalbilateral oophorectomy with or without hysterectomy) or total hysterectomy atleast six weeks before taking study treatment. In case of oophorectomy alone,only when the reproductive status of the woman has been confirmed by follow uphormone level assessment.

  • Male sterilization (at least 6 months prior to screening). For femaleparticipants on the study, the vasectomized male partner should be the solepartner for that participant.

  • Use of oral (estrogen and progesterone), injected, or implanted hormonalmethods of contraception or placement of an intrauterine device (IUD) orintrauterine system (IUS), or other forms of hormonal contraception that havecomparable efficacy (failure rate < 1%), for example hormone vaginal ring ortransdermal hormone contraception. In case of use of oral contraception women should have been stable on the same pillfor a minimum of 3 months before taking study treatment. Contraception should be used in accordance with locally approved prescribinginformation 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-appropriatehistory of vasomotor symptoms). Women are considered of not child-bearing potentialif they are post-menopausal or have had surgical bilateral oophorectomy (with orwithout hysterectomy), total hysterectomy or bilateral tubal ligation at least sixweeks ago. In the case of oophorectomy alone, only when the reproductive status ofthe woman has been confirmed by follow-up hormone level assessment is she considerednot of child-bearing potential. If local regulations deviate from the contraception methods listed above to preventpregnancy, local regulations apply and will be described in the informed consentform (ICF).

  1. United States (and other countries, if male contraception is locally required):Sexually active males, unless they agree to use barrier protection duringintercourse with a woman of child-bearing potential, while taking study treatment.As condom use alone has a reported failure rate exceeding 1% per year, it isrecommended that female partners of male study participants use a second method ofbirth control. Although ianalumab is not teratogenic and/or genotoxic, and nottransferred to semen, male contraception is required, as requested by FDA.

Globally, for all sexually active males, contraception should be used in accordance with the locally approved prescribing information of concomitant medications administered.

Study Design

Total Participants: 600
Treatment Group(s): 2
Primary Treatment: Ianalumab (VAY736)
Phase: 3
Study Start date:
October 27, 2023
Estimated Completion Date:
July 18, 2030

Study Description

The primary purpose of this 3-year treatment extension study is the continued evaluation of the safety and tolerability of treatment with ianalumab 300 mg monthly or every 3 months. An additional purpose is to explore the long-term efficacy of both dosing regimens of ianalumab 300 mg.

Trial Design: This is a multicenter, randomized, double-blind, phase 3 study to assess the long-term safety and tolerability of four treatment regimens of ianalumab in participants with Sjogrens syndrome who have taken part in and completed one of two NEPTUNUS core studies, NEPTUNUS-1 (CVAY736A2301) or NEPTUNUS-2 (CVAY736A2302). There will be no screening period in this trial. From week 48 of the NEPTUNUS core study, participants will be given the opportunity to consent to this extension study. Eligible participants will continue their assigned treatment to receive ianalumab 300 mg either monthly or every 3 months for up to 3 additional years of treatment beyond the 1-year core study period. After the treatment period, all participants will enter a follow-up period to be monitored for at least 20 weeks and then a conditional (if B-cell recovery criteria have not been met) follow-up period. The total post treatment follow-up period is up to 2 years.

Study Population: Participants with Sjogrens syndrome who have completed treatment in one of two NEPTUNUS core studies.

Study treatment assignment method: Participants randomized to ianalumab 300 mg monthly or every 3 months in one of the NEPTUNUS core studies will continue their assigned treatment. Participants randomized to placebo in the NEPTUNUS core studies will be randomized in a 1:1 ratio to either ianalumab 300 mg monthly or every 3 months.

Participants randomized to ianalumab 300 mg every 3 months will receive placebo (a dummy treatment) once monthly between doses.

Committees: An independent Data Monitoring Committee (DMC) will be utilized for safety review throughout the study. A steering committee will be formed to ensure overview of the study conduct.

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