Ianalumab for Sjogren's Syndrome (NEPTUNUS-Ext Trial)

Phase 3

Recruiting

Research Sponsored by Novartis Pharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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.

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up during treatment (from week 52 to week 204) and follow-up (from week 208 to week 304)

Awards & highlights

Pivotal Trial

Summary

This trial is to measure long-term safety of ianalumab in participants with Sjogrens syndrome for up to 5 years; ianalumab will be given monthly or every 3 months (w/placebo in between). 600 participants will be enrolled. Some may self-inject at home.

Who is the study for?

This trial is for people with Sjogren's Syndrome who finished a year of treatment in one of the NEPTUNUS core studies without stopping early. They should be able to keep taking ianalumab, as judged by their doctor, and have agreed to join this extension study.

What is being tested?

The trial tests the long-term safety and effectiveness of ianalumab given monthly or every three months for up to five years. Participants will either continue their current regimen from previous studies or be randomly assigned a new schedule while maintaining blinding with placebo injections.

What are the potential side effects?

While specific side effects are not listed here, participants will monitor any adverse reactions over the course of treatment with ianalumab, which may include typical drug-related side effects such as injection site reactions, allergies, or other immune responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I completed one of the NEPTUNUS studies without stopping the treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ during treatment (from week 52 to week 204) and follow-up (from week 208 to week 304)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~during treatment (from week 52 to week 204) and follow-up (from week 208 to week 304)

This trial's timeline: 3 weeks for screening, Varies for treatment, and during treatment (from week 52 to week 204) and follow-up (from week 208 to week 304) for reporting.