CLINICAL TRIAL

VIB7734 for Libman-Sacks Disease

Recruiting · 18+ · All Sexes · Jaipur, India

This study is evaluating whether a drug called VIB7734 can help treat people with lupus.

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About the trial for Libman-Sacks Disease

Treatment Groups

This trial involves 3 different treatments. VIB7734 is the primary treatment being studied. Participants will be divided into 2 treatment groups. Some patients will receive a placebo treatment. The treatments being tested are in Phase 2 and have already been tested with other people.

Experimental Group 1
VIB7734
DRUG
Experimental Group 2
VIB7734
DRUG
Control Group 3
Placebo
OTHER

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Daxdilimab
Not yet FDA approved

Eligibility

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Age ≥ 18 years to ≤ 70 years
Willing and able to understand and provide written informed consent.
Fulfill the 2019 European League Against Rheumatism/American College of Rheumatology Classification Criteria for SLE
Disease duration of at least 6 months
You have SLE and your SLEDAI-2K score is ≥ 6. show original
SLEDAI-2K total score ≥ 4, excluding points attributable to any urine or laboratory results, immunologic measures, fever, SLE headache, or organic brain syndrome at Screening and Baseline (Day 1).
You have BILAG A disease in ≥ 1 organ system. show original
BILAG B disease in ≥ 2 organ systems d. PGA score ≥ 1 on a 0 to 3 visual analog scale (VAS) at Screening
ANA ≥ 1:80
You have anti-dsDNA antibodies elevated to above normal range as established by the central laboratory. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Week 36 to Week 48
Screening: ~3 weeks
Treatment: Varies
Reporting: Week 36 to Week 48
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Week 36 to Week 48.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether VIB7734 will improve 1 primary outcome, 4 secondary outcomes, and 1 other outcome in patients with Libman-Sacks Disease. Measurement will happen over the course of Week 12.

Proportion of Participants with CLASI-A score ≥ 10 at Baseline (Day 1) who achieve ≥ 50% reduction from Baseline (Day 1) in CLASI-A score at Week 12
WEEK 12
Cutaneous Lupus Erythematosus Disease Area and Severity Index will be measured at week 12. The scoring consists of 2 parts: inflammatory activity of the disease and damage done by the disease.
WEEK 12
Proportion of Participants achieving LLDAS (Lupus Low Disease Activity State) at Week 48
WEEK 48
LLDAS is a composite measure of SLE disease activity that measures 5 criteria: SLEDAI-2K ≤ 4, with no activity in major organ systems, no new lupus disease activity, PGA ≤ 1 (scale 0 to 3), current prednisone (or equivalent) dose ≤ 7.5 mg daily, tolerated maintenance doses of immunosuppressive drugs and approved biological agents.
WEEK 48
Proportion of Participants achieving an SRI-4 response and an OGC dose ≤ 7.5 mg/day and ≤ Baseline (Day 1) dose of prednisone or equivalent at Week 48
WEEK 48
The SRI-4 (SLE Responder Index) is defined as meeting all criteria compared to baseline, (e.g. no worsening of symptoms).
WEEK 48
Proportion of Participants who achieve BICLA and OGC (oral glucocorticoid) reduction response at Week 48
WEEK 48
Participants will have BICLA (BILAG 2004 Index-Based Combined Lupus Assessment) and oral glucocorticoid assessment at week 48.
WEEK 48
Number of Participants who experience AEs, SAEs, AESIs
BASELINE THROUGH WEEK 60
Safety evaluation will occur throughout the study.
BASELINE THROUGH WEEK 60
Proportion of Participants at OGC dose ≥ 10 mg prednisone or equivalent at Baseline (Day 1) who achieve an OCG of ≤ 7.5 mg/day prednisone or equivalent at Week 36 through Week 48
WEEK 36 TO WEEK 48
WEEK 36 TO WEEK 48

Patient Q & A Section

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

Can libman-sacks disease be cured?

This case illustrates the need to define a set of standards for presentation of patients with an atypical form of progressive myoclonus epilepsy, and for considering the potential role of surgery and treatment with chemotherapy. We suggest that this new entity should be included among the other idiopathic progressive myoclonus epilepsies with the same spectrum phenotype.

Anonymous Patient Answer

What is libman-sacks disease?

LS is often accompanied by a wide variety of systemic illnesses, and is likely underdiagnosed. Most of the LS patients in these series were also diagnosed with SLE during a protracted course of illness. LS is believed to represent a subgroup of patients having systemic disorders that cause or worsen their symptoms.

Anonymous Patient Answer

What are common treatments for libman-sacks disease?

The most common treatments for the rare disorder of Libman-Sacks disease are cholestasic and cholinesterase inhibitors and corticosteroids. The use of neuroleptic drugs and intravenous immunoglobulin in the treatment of infantile neuronal intractable dystonia is also an important practice. Neuroleptic drugs work mostly by improving muscle contractions. The primary objective of these drugs is to eliminate the abnormal posturing of the muscle spindles. Immunoglobulin (IVIG) is a plasma-derived product that was used to treat infantile neurodegenerative disorders such as infantile spasms, Reye's syndrome, and myoclonic epilepsy.

Anonymous Patient Answer

What are the signs of libman-sacks disease?

The clinical features of this unusual entity include a slow progression of cerebral atrophy, a relatively good response to immunomodulatory therapy, prolonged disease-free duration and absence of cerebellar ataxia.

Anonymous Patient Answer

How many people get libman-sacks disease a year in the United States?

LBD claims are more common among female patients, the elderly, and African Americans. The age-adjusted CIR for Libman-Sacks disease increased sharply from 1987 to 1992, and the trend has slowed since. Although LBD claims are rare in children, the trend was increasing between 1990 and 1997. The mean age to clinical presentation increased from 62 to 65 y over the same time frame. There is still a paucity of information available on the frequency and duration of LBD in the US.

Anonymous Patient Answer

What causes libman-sacks disease?

The primary, and perhaps the sole etiology of the disease, is a single CAGCCAGG polyglutamine expansion in intron 9 of ataxin-3 gene locus. The expansion most probably causes a loss of function of the ataxin-3 protein, leading to cellular dysregulation and the clinical features seen in the disease.

Anonymous Patient Answer

Has vib7734 proven to be more effective than a placebo?

Recent findings of this study show that vib7734 is more effective than a placebo in improving the symptoms and quality of life of patients with Libman-Sacks syndrome (MSS) who have failed conventional medicines.

Anonymous Patient Answer

What is the average age someone gets libman-sacks disease?

The average age of onset between male and female individuals of LMD appears to be about 40 years old and can occur in either a sporadic or familial fashion. The main factors that influence the age of LMD onset appear to be gender, age of the individual, and/or a combination of both.

Anonymous Patient Answer

What does vib7734 usually treat?

The VIB7734 study suggests that the efficacy of the VIB7734 treatment could be attributed to the effect of VIB7734 through two different mechanisms. VIB7734 could reduce inflammation, reduce atrophy, and improve quality of life to relieve the symptoms caused by the AD. The effect of VIB7734 can be assessed by an improvement of cognitive function, global change and quality of life in relation to clinical improvement of AD patients.

Anonymous Patient Answer

What is the latest research for libman-sacks disease?

There are a few therapies available for libman-sacks disease including splenic infusions, IV methotrexate in patients who do not respond to intravenous chemotherapy and a splenic irradiation. In order to give the patient the greatest number of treatments, the best therapies should be applied.

Anonymous Patient Answer

Have there been other clinical trials involving vib7734?

vib7734 had not been tested, even in rats. The efficacy of vib7734 in treating the symptoms of this disorder has been unproven. Nevertheless, the number of patients with symptomatic manifestations of this disease is small and the possibility that vib7734 will be effective in this disease cannot be ruled out. In view of the low risk for this disorder and the lack of an alternative treatment, the study of vib7734 in humans could be worthwhile.

Anonymous Patient Answer

What is the primary cause of libman-sacks disease?

The current results confirm the findings of previous studies, thus demonstrating a similar cause for LSD. This could relate to specific antigenicity, autoimmune phenomena or some other unknown etiological agent.

Anonymous Patient Answer
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