What side effects are associated with this type of intervention?

Common treatments for Sjögren's Syndrome include biologic agents like rituximab, abatacept, and belimumab, as well as conventional immunosuppressive drugs such as hydroxychloroquine and methotrexate. Rituximab can cause infusion reactions, serum-sickness-like reactions, and interstitial lung disease. Abatacept has shown mixed efficacy and may cause infections and infusion-related reactions. Belimumab may lead to modest symptom reduction but can also cause infections and infusion reactions. Hydroxychloroquine and methotrexate are generally well-tolerated but can cause gastrointestinal upset, liver toxicity, and bone marrow suppression. These treatments share some similarities with iscalimab in terms of targeting immune pathways and potential side effects like infusion reactions and increased infection risk.

What prior FDA approvals exist?

As of now, there are no FDA-approved treatments specifically for Sjögren's Syndrome. However, several biologic agents and immunosuppressive therapies have been studied for their efficacy in treating the disease. These include rituximab, a monoclonal antibody targeting CD20 on B cells, and belimumab, which inhibits B-cell activating factor (BAFF). Both have shown varying degrees of success in clinical trials. Iscalimab (CFZ533), which targets CD40 inhibition, is currently under investigation and represents a novel approach in the treatment of Sjögren's Syndrome.

What other types of research exist?

Promising novel alternatives to Iscalimab for Sjogren's Syndrome patients in 2024 include therapies targeting B-cells such as ocrelizumab, veltuzumab, tabalumab, and atacicept. Additionally, novel strategies for regulatory T-cell modulation, including low-dose IL-2 therapy and Tregitopes, are also being explored.

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Monoclonal Antibodies

CFZ533 for Sjögren's Syndrome (TWINSS Extn Trial)

Phase 2

Waitlist Available

Research Sponsored by Novartis Pharmaceuticals

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Must not have

Sjögren's Syndrome overlap syndromes where another autoimmune rheumatic disease constitutes the principle illness, specifically: Moderate-to-severe active systemic lupus erythematosus (SLE) with anti-dsDNA positivity and renal involvement, or other organ involvement that impedes on ability to score ESSDAI domains

Active uncontrolled viral, bacterial or other infections requiring systemic treatment at the time of enrollment, or history of recurrent clinically significant infection or of bacterial infections with encapsulated organisms

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 60 weeks

Awards & highlights

Summary

This trial tests iscalimab, an injectable medication, on patients with Sjögren's Syndrome. It works by adjusting the immune system to help manage the disease.

Who is the study for?

This trial is for patients with Sjögren's Syndrome who completed the TWINSS core study. They must have finished treatment up to Week 48 and follow-up until Week 60, consent to continue, and are expected to benefit from further iscalimab therapy. Excluded are those on other investigational drugs, pregnant or nursing women, women not using effective contraception, and individuals with certain overlapping autoimmune conditions or uncontrolled infections.

What is being tested?

The trial tests the safety and tolerability of two dose levels of a drug called iscalimab (CFZ533) in people with Sjögren's Syndrome. It extends from a previous study (TWINSS), aiming also to understand how the body processes the drug over time and its continued effectiveness.

What are the potential side effects?

While specific side effects for CFZ533 (iscalimab) aren't listed here, similar medications can cause immune system changes leading to increased infection risk, infusion reactions like fever or chills, potential organ inflammation, fatigue, headaches or allergic responses.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have Sjögren's with another major autoimmune disease affecting my organs.

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I do not have any current severe infections requiring treatment.

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My rheumatoid arthritis affects my ability to move and use my joints.

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I have been diagnosed with systemic sclerosis.

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I do not have an active connective tissue disease needing treatment beyond this trial.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 60 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~60 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 60 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of Treatment-emergent adverse events (TEAEs)

Secondary study objectives

Free iscalimab concentration in plasma during the treatment (Ctrough) and follow-up (up to end of study) periods

Incidence of anti-iscalimab antibodies in plasma at analysis visits up to end of study

Trial Design

2Treatment groups

Active Control

Group I: Arm 2Active Control2 Interventions

Arm 2 - Iscalimab Dose 2 and Placebo

Group II: Arm 1Active Control1 Intervention

Arm 1 - Iscalimab Dose 1

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Sjögren's Syndrome, such as immunosuppressive and biologic agents, work by modulating the immune system to reduce inflammation and autoimmunity. Iscalimab, which targets CD40, inhibits the CD40-CD40L interaction crucial for B-cell activation and antibody production. This mechanism is significant for Sjögren's Syndrome patients as it helps to control the overactive immune response that leads to glandular dysfunction and systemic symptoms. Other treatments like rituximab target CD20 on B cells, reducing their numbers and activity, which can alleviate symptoms and prevent disease progression. These therapies are essential as they address the underlying immune dysregulation, offering relief from symptoms and potentially improving quality of life.