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Monoclonal Antibodies

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 (e.g., ctrough) i.e. from week 52 to week 204 and follow-up i.e. 304, after last dose.

Awards & highlights

NEPTUNUS-Ext 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.Check my eligibility

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.See study design

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.

NEPTUNUS-Ext Trial 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.

NEPTUNUS-Ext Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ during treatment (e.g., ctrough) i.e. from week 52 to week 204 and follow-up i.e. 304, after last dose.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~during treatment (e.g., ctrough) i.e. from week 52 to week 204 and follow-up i.e. 304, after last dose.

This trial's timeline: 3 weeks for screening, Varies for treatment, and during treatment (e.g., ctrough) i.e. from week 52 to week 204 and follow-up i.e. 304, after last dose. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Treatment-emergent AEs (TEAEs)/SAEs

Secondary outcome measures

B-cell count measurement

ESSDAI change from baseline

On-treatment Ianalumab serum concentrations

+3 more

NEPTUNUS-Ext Trial Design

2Treatment groups

Experimental Treatment

Group I: Ianalumab MonthlyExperimental Treatment1 Intervention

ianalumab 300 mg s.c. monthly

Group II: Ianalumab 3 MonthlyExperimental Treatment2 Interventions

ianalumab 300 mg s.c. every three months

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor

2,860 Previous Clinical Trials

4,197,709 Total Patients Enrolled

6 Trials studying Sjögren's Syndrome

1,154 Patients Enrolled for Sjögren's Syndrome

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the trial restrict participation to persons of a particular age bracket?

"According to the requirements set out by this medical trial, only patients aged 18-75 are eligible for enrollment. There are 377 studies currently running that accommodate those under 18 and 1030 trials available for seniors over 65 years of age."

Answered by AI

Which patient demographics are able to partake in this research?

"To be eligible for this research, individuals must possess sjögren's syndrome and fall within the 18-75 age bracket. Aspiring participants should also note that the trial needs to recruit a total of 600 patients."

Answered by AI

Are participants being accepted for enrollment in this trial presently?

"The trial is currently recruiting, with the initial post appearing on October 27th 2023 and last updated November 30th 2023. Data can be found on clinicaltrials.gov."

Answered by AI

What degree of protection does Ianalumab 3 Monthly provide to users?

"Our research team at Power assigned ianalumab 3 Monthly a rating of three due to its Phase 3 status, which signifies the presence of data attesting to both efficacy and safety."

Answered by AI

What is the uppermost capacity of participants for this clinical experiment?

"Affirmative. Evidenced on the clinicaltrials.gov webpage, this medical study is presently searching for participants as of November 30th 2023. This research project was initially posted on October 27th 2023 and necessitates 600 recruits from 12 different sites."

Answered by AI

How many healthcare sites are currently engaged in this experimental research?

"At the present time, patients are being recruited from 12 different locations. These include Oklahoma City, Bydgoszcz and Nagoya among others. It is advisable to choose a clinic that is close by so as to minimize any travel requirements for those who participate in this trial."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "A Randomized, Double-blind 2-arm NEPTUNUS Extension Study to Assess the Long-term Safety and Efficacy of Ianalumab in Patients With Sjogrens Syndrome.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05985915.

All > Sjogrens Syndrome