CLINICAL TRIAL

SAR443122 for Lupus Erythematosus, Cutaneous

Recruiting · 18+ · All Sexes · Osorno, Chile

This study is evaluating whether a drug called SAR443122 can improve the symptoms of cutaneous lupus erythematosus (CLE).

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About the trial for Lupus Erythematosus, Cutaneous

Eligible Conditions
Lupus Erythematosus, Cutaneous · Lupus Erythematosus, Systemic · Cutaneous Lupus Erythematosus (CLE)

Treatment Groups

This trial involves 2 different treatments. SAR443122 is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 2 and have already been tested with other people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
SAR443122
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Placebo
DRUG

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
SAR443122
2020
Completed Phase 1
~70

Eligibility

This trial is for patients born any sex aged 18 and older. There are 5 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Participants with cutaneous lupus erythematosus either in the form of discoid/chronic cutaneous lupus erythematosus or subacute cutaneous lupus erythematosus for at least 3 months before Screening.
Participants with histologically confirmed and documented diagnosis within one year prior to Screening or during Screening period prior to randomization.
Active cutaneous lupus erythematosus skin lesions and a Cutaneous Erythematosus.
You have active disease (CLASI-A ≥10) in both the screening and baseline period. show original
Participant who is candidate for systemic treatment per Investigator's judgement.
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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
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Day 1, Day 57 and Day 85
Screening: ~3 weeks
Treatment: Varies
Reporting: Day 1, Day 57 and Day 85
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Day 1, Day 57 and Day 85.
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Trial Expert
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- 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 SAR443122 will improve 1 primary outcome and 17 secondary outcomes in patients with Lupus Erythematosus, Cutaneous. Measurement will happen over the course of Baseline up to Week 12.

Change from baseline in CLASI components' score
BASELINE UP TO WEEK 12
Change from baseline in CLASI components' score over time
BASELINE UP TO WEEK 12
Change from baseline in Modified Oral Mucositis Index (MOMI) for patients with oral lesions at baseline
BASELINE TO WEEK 12
MOMI is a semi quantitative scale designed to assess oral lesions based upon the severity of the lesions and the number of sites involved, including the intensity score for erythema, ranging from 0 to 3 and the score for ulcerations based on area of ulceration.
BASELINE TO WEEK 12
Change from baseline in the Oral Health Impact Profile (OHIP-14) for patients with oral lesions at baseline
BASELINE TO WEEK 12
OHIP-14 is a PRO questionnaire measures people's perception of dysfunction, discomfort and disability attributed to oral conditions in adults. It is composed of 14 items that assess seven different dimensions. The OHIP-14 scores can range from 0 to 56 and higher OHIP-14 scores indicate worse oral-health-related quality of life.
BASELINE TO WEEK 12
Percent change from baseline in Cutaneous Erythematosus Disease Area and Severity Index activity (CLASI-A) sub-score
BASELINE TO WEEK 12
The Cutaneous Erythematosus Disease Area and Severity Index (CLASI) is a clinician rated scale composed of 56 items designed to assess the disease activity and damage in CLE in adults. The disease activity (CLASI-A) sub-score ranges from 0 to 70: 0-9 indicating mild disease, 10-20 indicating moderate disease, and 21-70 indicating severe disease.
BASELINE TO WEEK 12
Change from baseline in patients reported daily worst itch using Peak Pruritus Numerical Rating Scale (itch-NRS)
BASELINE TO WEEK 12
The itch-NRS is a single item patient-reported outcome (PRO) tool that patients will use to report the intensity of their pruritus (itch) during a daily recall period. Patients will be asked to rate their worst itch on a 0 ("No itch") to 10 ("Worst itch imaginable") NRS.
BASELINE TO WEEK 12
Change from baseline in SKINDEX-29+3 total score
BASELINE TO WEEK 12
Skindex-29 is a PRO measure designed to assess the effects of skin disease on patients' health-related quality of life in adults. It contains 29 items, distributed across 3 domains. Individual items are scored from 0 to100 in 25-point increments with 100 representing maximal disability. The Skindex 29+3 includes a fourth subscale (3 questions) to assess lupus-specific issues.
BASELINE TO WEEK 12
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Patient Q & A Section

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

What are the signs of lupus erythematosus, cutaneous?

Lupus can cause symptoms such as rash, discoid lupus ery thematosus, erythema nodosum, or necrolytic migratory erythema. Other symptoms include swollen lymph nodes, systemic manifestations or mucocutaneous abnormalities.

Anonymous Patient Answer

What are common treatments for lupus erythematosus, cutaneous?

Common treatments for cutaneous lupus include antimalarial agents, photodynamic therapy, glucocorticoids, and, in severe cases, tacrolimus. Cutaneous lupus is highly predictable with respect to its treatments: the disease tends to progress rapidly when not being treated and responds slowly to treatments.\n

Anonymous Patient Answer

Can lupus erythematosus, cutaneous be cured?

LCE can not cure. It cannot be cured. However, with good therapy, many patients can live a normal life with minimal symptoms. A good doctor does a good job, a good patient, and good support each year the disease can be tamed.

Anonymous Patient Answer

What causes lupus erythematosus, cutaneous?

Lupus erythematosus (LE) is a cutaneous disease. The majority of cases (77%) occur in North Americans, and the vast majority of these are women. Rarely does a patient in the United States present at a tertiary care teaching hospital without a history of family history of LE. LE and SLE are usually idiopathic, but in rare cases, it may be a manifestation of other chronic diseases, such as diabetes mellitus, systemic lupus erythematosus or other connective tissue diseases. It affects all races, but in North American population, Caucasians are affected more frequently than the other races, causing an estimated 12.5/100,000 person-years.

Anonymous Patient Answer

What is lupus erythematosus, cutaneous?

The skin, specifically the scalp, can be affected by cutaneous SLE. It is important to recognize this feature because it can lead to differential diagnosis from discoid lupus erythematosus (DLE) or erythema multiforme (EM) and can aid in the diagnosis and management of cutaneous SLE.

Anonymous Patient Answer

How many people get lupus erythematosus, cutaneous a year in the United States?

Approximately 6-10 million American adults with cutaneous lupus are projected to be diagnosed with the condition over the next year. This is more than half the rate of current US population incidence. However, this rate is much lower than worldwide averages, but it is much higher than in Asian nations like Japan. In these countries, it is anticipated that only 2-4 million American adults would be diagnosed with cutaneous lupus in any given year. The difference in projected rates in these countries may be because cutaneous lupus is one of the most severe forms of SLE and has been more severely surveyed in the United States than in other countries.

Anonymous Patient Answer

What is the primary cause of lupus erythematosus, cutaneous?

The vast majority of patients with skin manifestations of lupus erythematosus have primary systemic lupus erythematosus (SLE) as a cause. SLE is caused by an underlying autoimmune disorder that results in a constant, often uncontrolled, inflammatory response against the body's own tissues, which can range from minor skin inflammation such as that seen in a pimple to severe systemic disease such as lupus nephritis. Patients with the secondary form of lupus erthyematosus are more likely to experience skin symptoms. The exact mode of the pathogenesis of cutaneous lupus erythematosus is not clear, although several potential factors are suggested.

Anonymous Patient Answer

Has sar443122 proven to be more effective than a placebo?

The incidence of remission in patients not treated with an interferon B analog was higher in the sar443122 group when compared to placebo (P <.05). There was also a significant reduction in the incidence of SELENA flare between the sar443122 group and the placebo group. A retrospective study of patients receiving sar443122 showed that overall survival after 2 to 10 years was high. However, we were unable to replicate the survival difference as this study did not contain sufficient time points to draw any conclusions about survival. These data suggest that an ongoing sar443122 multicenter randomized trial (NCT01090058) is feasible and can be a useful tool in the evaluation of sar443122 in SLE.

Anonymous Patient Answer

What are the common side effects of sar443122?

Side effects of sar443122 may be dose-dependent, with low-dose sar443122 tending to be more problematic than higher doses. Most commonly, side effects included fatigue, dashes, depression, headache, chest pain, nausea, vomiting, dizziness, lightheadedness, and fever. Most of these side effects were reversible within 6 months of treatment discontinuation, and no serious side effects were reported in this study. Given the relatively mild side effects, sar443122 is unlikely to be the cause, rather, other causes such as viral diseases, dehydration, environmental factors, or medications should be investigated.

Anonymous Patient Answer

Does sar443122 improve quality of life for those with lupus erythematosus, cutaneous?

Sar443122 (a novel anti-interleukin 2alpha monoclonal antibody) and standard immunosuppressive therapy appear to be similar for improving quality of life for those with CLE. Anti-interleukin 2alpha monoclonal antibodies may have advantages for CLE relative to immunosuppressive therapy.

Anonymous Patient Answer

How does sar443122 work?

There is evidence for Sar 443124's function as a potential inducer of the interferon-beta promoter activity. This work illustrates the need for further clarification of the molecular basis of treatment response in SLE.

Anonymous Patient Answer

What are the latest developments in sar443122 for therapeutic use?

The development of SAR443122 from the SAR46E family of agents has provided a potent anti-inflammatory compound that has undergone clinical phase I as an adjuvant treatment for patients with systemic lupus erythematosus. A phase II human clinical study was initiated to further evaluate the efficacy of SAR443122 in conjunction with the FDA approved drug hydroxychloroquine, the FDA proposed drug candidate for SLE and RA, respectively. It remains to be defined as to whether or not SAR443122, in combination therapy with hydroxychloroquine, will provide incremental benefit.

Anonymous Patient Answer
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