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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
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:Select...
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
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
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.
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Who is running the clinical trial?
Novartis PharmaceuticalsLead Sponsor
2,913 Previous Clinical Trials
4,252,957 Total Patients Enrolled
14 Trials studying Sjogren's Syndrome
2,246 Patients Enrolled for Sjogren's Syndrome
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- The doctor believes that you will likely get better from the treatment with iscalimab.I have Sjögren's with another major autoimmune disease affecting my organs.I do not have any current severe infections requiring treatment.You cannot take any other experimental drugs during the main part of the study, except for iscalimab.I am a woman who can become pregnant and am using effective birth control.My rheumatoid arthritis affects my ability to move and use my joints.I have been diagnosed with systemic sclerosis.I do not have an active connective tissue disease needing treatment beyond this trial.
Research Study Groups:
This trial has the following groups:- Group 1: Arm 2
- Group 2: Arm 1
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Sjogren's Syndrome Patient Testimony for trial: Trial Name: NCT04541589 — Phase 2
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