Sjogrens Syndrome Clinical Trial
Official title:
A Randomized, Double-blind 2-arm NEPTUNUS Extension Study to Assess the Long-term Safety and Efficacy of Ianalumab in Patients With Sjogrens Syndrome.
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 or CVAY736A2302). - The study treatment is ianalumab 300 mg in a 2 mL pre-filled syringe 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. Participants will be given the opportunity to self-inject at home on some visits after receiving training.
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. The Primary Objective is to assess the long-term safety and tolerability of ianalumab in participants with Sjogrens syndrome. Secondary objectives are as follows, 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. To assess the impact of long-term treatment on B-cell depletion. Trial Design: This is a multicenter, randomized, double-blind, phase 3b 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. Method of blinding: Double-blind 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. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01470638 -
A Study of Flt3-Ligand Levels in Sjögrens Syndrome
|