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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 60 weeks
Awards & highlights

TWINSS Extn Trial Summary

This trial will study the safety and effectiveness of a potential new drug for Sjögren's Syndrome.

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.Check my eligibility
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.See study design
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.

TWINSS Extn Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of Treatment-emergent adverse events (TEAEs)
Secondary outcome measures
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

TWINSS Extn 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

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,856 Previous Clinical Trials
4,197,499 Total Patients Enrolled
13 Trials studying Sjogren's Syndrome
2,212 Patients Enrolled for Sjogren's Syndrome

Media Library

CFZ533 (iscalimab) (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04541589 — Phase 2
Sjogren's Syndrome Research Study Groups: Arm 2, Arm 1
Sjogren's Syndrome Clinical Trial 2023: CFZ533 (iscalimab) Highlights & Side Effects. Trial Name: NCT04541589 — Phase 2
CFZ533 (iscalimab) (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04541589 — Phase 2
Sjogren's Syndrome Patient Testimony for trial: Trial Name: NCT04541589 — Phase 2

Frequently Asked Questions

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

To whom is eligibility for this experiment open?

"In order to be qualified for participation in this trial, applicants should have the condition and must fall between 18-90 years of age. Approximately 214 individuals will benefit from being a part of this study."

Answered by AI

Are there current openings available to participants in this research endeavor?

"As per the clinicaltrials.gov record, this trial is currently enrolling participants. It was initially posted on May 1st 2021 and received its most recent update in October 14th 2022."

Answered by AI

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

"Affirmative. Information hosted on clinicaltrials.gov indicates that this medical experiment is actively recruitment patients; it was initially posted in the beginning of 2021 and most recently modified at the end of October 2022. In total, 214 participants are needed from 4 distinct clinical sites."

Answered by AI

What is the geographic reach of this trial's implementation?

"Currently, 4 locations across the United States are accepting patients for this study. These sites include Baton Rouge, Duluth and Baltimore as well as other various locales. It is recommended that prospective participants select the most proximal clinic to minimize their travel requirements should they choose to join in on this trial."

Answered by AI

Has Arm 2 received the green light from the FDA?

"Having reviewed available safety data, Arm 2 was assigned a rating of 2 on our 1 to 3 scale. This is because this trial has reached Phase 2 status, meaning some evidence exists in support of its security but no proof for efficacy yet."

Answered by AI

Are participants of legal age accepted into this research trial?

"For this clinical trial, only participants aged 18 and above but below 90 years old are being considered."

Answered by AI

What precedent has been established by prior assessments of Arm 2?

"Arm 2 was initially researched at Novartis Investigative Site in 2019, with no completed studies since then. At present, 3 clinical trials are ongoing and many of them originate from Baton Rouge, Louisiana."

Answered by AI

Is this experimental protocol a pioneering attempt?

"Since 2019, Arm 2 has been under the microscope of medical science. Funded by Novartis Pharmaceuticals and with a Phase 2 drug approval in hand, it is currently being studied across 47 cities and 26 countries worldwide."

Answered by AI

Who else is applying?

What state do they live in?
California
Florida
Pennsylvania
What site did they apply to?
Novartis Investigative Site
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I have been in trials before and am always trying to improve my condition as well as hoping I can help others.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Study of Safety and Tolerability of CFZ533 in Patients With Sjögren's Syndrome
2021. "Study of Safety and Tolerability of CFZ533 in Patients With Sjögren's Syndrome". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04541589.
All > Autoimmune Hemolytic Anemia > Sjogrens Syndrome
~15 spots leftby Jul 2024
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