Your session is about to expire
← Back to Search
Monoclonal Antibodies
VAY736 + CFZ533 for Lupus
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
Elevated serum titers at screening of ANA (≥1:80) of a pattern consistent with an SLE diagnosis, including at a minimum either anti-double stranded DNA (anti-ds DNA) or anti-Ro (SSA) or anti-La (SSB) or anti-nuclear ribonucleoprotein (anti-RNP) or anti-Smith (anti-Sm)
BILAG 2004 score of one 'A' score either in the mucocutaneous or in the musculoskeletal domain or one 'B' score in either the mucocutaneous or musculoskeletal domain and at least one 'A' or 'B' score in a second domain at screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 months
Awards & highlights
Study Summary
This trial is testing two possible treatments for lupus in order to see if they are safe and effective.
Who is the study for?
This trial is for SLE patients with certain autoantibodies, meeting at least 4 of the ACR's criteria, diagnosed for 6+ months, on stable meds, and have active disease. Excluded are those with recent potent treatments or B-cell depleting therapies, infections like HIV/TB/Hepatitis, severe diseases or organ dysfunction.Check my eligibility
What is being tested?
The study tests VAY736 and CFZ533 against placebos to assess their safety and effectiveness in treating SLE. It involves monitoring how the body processes these drugs and their impact on disease symptoms over time.See study design
What are the potential side effects?
Potential side effects aren't specified but may include typical drug reactions such as allergic responses, infection risks due to immune system suppression by the medications being tested.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My blood test shows high levels of antibodies linked to lupus.
Select...
My lupus affects my skin, joints, or another area severely.
Select...
I weigh at least 40 kg.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 18 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
SRI-4 response status
Secondary outcome measures
Flare rate and time to first flare
PD Cohort 2 (CFZ533): total soluble CD40
PGA VAS - global disease activity
+6 moreSide effects data
From 2018 Phase 2 trial • 27 Patients • NCT0214942075%
Infusion related reaction
33%
Nasopharyngitis
17%
Headache
8%
Fatigue
8%
Cystitis
8%
Rash
8%
Sinusitis
8%
Iron deficiency anaemia
8%
Back pain
8%
Conjunctivitis
8%
Myalgia
8%
Gastroenteritis
8%
Gastrointestinal infection
8%
Influenza
100%
80%
60%
40%
20%
0%
Study treatment Arm
VAY736 10mg/kg
VAY736 3mg/kg
Placebo
Open Label VAY736 10mg/kg
Trial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: Cohort 2 CFZ533Experimental Treatment1 Intervention
multiple doses of CFZ533, i.v.
Group II: Cohort 1 VAY736Experimental Treatment1 Intervention
multiple doses of VAY736, s.c.
Group III: Cohort 2 CFZ533 PlaceboPlacebo Group1 Intervention
multiple doses of matching placebo i.v. until week 29. Multiple doses of CFZ533, i.v. from week 29 until week 53.
Group IV: Cohort 1 VAY736 PlaceboPlacebo Group1 Intervention
multiple doses of matching placebo s.c. until week 29. Multiple doses of VAY736, s.c from week 29 until week 53.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
VAY736
2014
Completed Phase 2
~290
CFZ533
2013
Completed Phase 2
~660
Find a Location
Who is running the clinical trial?
Novartis PharmaceuticalsLead Sponsor
2,856 Previous Clinical Trials
4,197,598 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have active hepatitis B or C.I have been diagnosed with lupus for at least 6 months.My blood test shows high levels of antibodies linked to lupus.I am at high risk for blood clots due to my medical history or conditions.I am HIV positive.My kidney disease is severe with high protein in urine or high creatinine levels, or requires strong immune suppressive treatment.I do not have any active infections.My lupus affects my skin, joints, or another area severely.I do not have severe organ dysfunction or a life-threatening disease.I am on a stable dose of corticosteroids, anti-malarial, thalidomide, or another DMARD.I haven't had certain immune system treatments in the past year.I have not received a live vaccine in the last 2 months.I do not have any serious, uncontrolled diseases like high blood pressure or heart failure.I weigh at least 40 kg.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 2 CFZ533
- Group 2: Cohort 2 CFZ533 Placebo
- Group 3: Cohort 1 VAY736 Placebo
- Group 4: Cohort 1 VAY736
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What sort of risks have been associated with VAY736?
"A score of 2 was assigned to the safety profile of VAY736, as clinical data confirms its security but no proof exists for its efficacy."
Answered by AI
Am I eligible to join this research endeavor?
"This clinical trial is recruiting 107 individuals with libman-sacks disease aged between 18 and 75. Those who meet these criteria are eligible for enrollment."
Answered by AI
Is this trial still available to enroll new participants?
"This particular clinical trial, initially posted on December 19th 2018 and edited as recently as September 19th 2022, is not currently enrolling patients. Nonetheless, 131 other trials are actively recruiting at this moment in time."
Answered by AI
Is this an unprecedented medical study?
"Currently, Novartis Pharmaceuticals is running 7 separate trials for its drug VAY736 across 28 countries and 66 cities. The inaugural study commenced in 2018 with 65 patients taking part in Phase 2 & 3 clinical stages before completion. As of now, 8 such experiments have been conducted since the initial trial."
Answered by AI
Does this experiment permit the enrollment of individuals aged over 25?
"Patients aged between 18 and 75 are being sought for enrollment in this clinical trial."
Answered by AI
Has VAY736 been the focus of any prior research?
"Presently, VAY736 is being researched in 7 clinical trials with 2 of them reaching the Phase 3 stage. While a couple are situated near Aachen, Michigan, the drug's evaluation spans 153 different sites around the country."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger