Sarilumab 200 MG/1.14 ML Subcutaneous Solution [KEVZARA]_#1 for Sarcoidosis

1
Effectiveness
2
Safety
Stanford University, Palo Alto, CA
Sarcoidosis
Sarilumab 200 MG/1.14 ML Subcutaneous Solution [KEVZARA]_#1 - Drug
Eligibility
18+
All Sexes
Eligible conditions
Sarcoidosis

Study Summary

This study is evaluating whether a drug may help reduce symptoms of sarcoidosis.

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Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Sarilumab 200 MG/1.14 ML Subcutaneous Solution [KEVZARA]_#1 will improve 1 primary outcome and 12 secondary outcomes in patients with Sarcoidosis. Measurement will happen over the course of 2 weeks.

2 weeks
68/66 Joint evaluation
Change in Pulmonary Function (FEV1)
Change in Urine Protein level
Change in physician and patient assessments
change in ALT
change in AST
change in FACIT-F score (fatigue scale
change in prednisone dose
change in pulmonary function tests (FVC)
change in serum creatinine
change in size of sarcoidosis lesions
change in the Sarcoidosis Activity and Severity Index for cutaneous sarcoidosis
flare-free survival of sarilumab-treated patients compared to placebo-treated controls

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Trial Design

2 Treatment Groups

placebo
Study drug
Placebo group

This trial requires 15 total participants across 2 different treatment groups

This trial involves 2 different treatments. Sarilumab 200 MG/1.14 ML Subcutaneous Solution [KEVZARA]_#1 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.

Study drug
Drug
sarilumab 200 mg subcutaneously every two weeks
placebo
Drug
placebo subcutaneously every two weeks

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 2 weeks
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 2 weeks for reporting.

Who is running the study

Principal Investigator
M. C. B.
Prof. Matthew C. Baker, Clinical Assistant Professor
Stanford University

Closest Location

Stanford University - Palo Alto, CA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 6 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Biopsy proven non-caseating granulomas consistent with sarcoidosis
negative infectious studies including AFB and fungal stains, and with compatible clinical and/or radiographic manifestations of sarcoidosis.
Involvement of the lungs (stage II or III pulmonary sarcoidosis), lymph nodes, liver, kidneys, spleen, bone, soft tissues, skin, and/or eyes.
At least one active manifestation, defined by the need for ongoing glucocorticoid treatment to control a sign or symptom of sarcoidosis, which requires treatment with prednisone (or equivalent corticosteroid) ≥ 10 mg and ≤ 60 mg daily (i.e. glucocorticoid dependence), with stable dosing for ≥ 28 days prior to baseline.
patients taking a glucocorticoid other than prednisone, will be changed to prednisone at the equivalent dose and take this daily for ≥ 14 days prior to baseline.
DMARDs including methotrexate, leflunomide, azathioprine, mycophenolate mofetil, and/or anti-malarials (i.e. hydroxychloroquine) permitted must be stable for ≥ 28 days prior to baseline and remain stable during follow-up.

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 sarcoidosis be cured?

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Sarcoidosis can be strongly relieved in many patients but the disease often remains a chronic illness, which requires daily drug treatment for prolonged periods. When the condition is strongly relieved, patients have a long-lasting good health state, comparable to that of a healthy patient or former ill one. The health state is sustained for many years and some cases can be cured. Sarcoidosis has been suggested as a potentially curable disease, although its relevance to disease progression is controversial. Further work is needed to define the curability of sarcoidosis. Patients with sarcoidosis should receive information, including prognosis, on an individual basis.

Unverified Answer

How many people get sarcoidosis a year in the United States?

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Every year, around 598,000 persons in the United States are diagnosed with sarcoidosis. This makes up 1.5% of the US population. This increase is greater than that of the population at large. The increased rates may be attributable to better recognition, although recent data suggests a more balanced sex ratio with equal rates in males and females. These data corroborate our previous findings in a large, population-based sample that sarcoidosis is equally common in males and females.

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What are the signs of sarcoidosis?

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Although sarcoidosis can be very different from the signs of any other lung or systemic diseases, the signs and symptoms could also lead one to misdiagnosis with asthma or COPD. A patient suspected of having sarcoidosis due to cough, dyspnea, or fever needs immediate evaluation, and the symptoms can help guide to diagnosis. Imaging and biopsy are required to make a definite diagnosis of sarcoidosis (Figure 6, 7, and 8.)\n\nPulmonary sarcoidosis has no specific signs or symptoms (e.g. cough, dyspnea, fever, erythema nodosum and pulmonary hemorrhage).

Unverified Answer

What are common treatments for sarcoidosis?

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Bronchoscopy and surgery have a role in the treatment of sarcoidosis. Some patients receive glucocorticoid injections. Intravenous immunoglobulin is used in severe cases. Pneumoconiosis treatment may also be used to prevent or limit the disease.

Unverified Answer

What causes sarcoidosis?

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Sarcoidosis is not caused by a particular infection or a single agent. It manifests in a variety of ways, some of which are caused by systemic and organ-specific factors.

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What is sarcoidosis?

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Sarcoidosis is a systemic, chronic inflammatory disorder that has many varied presentations and has a great deal of variability between individuals. The incidence and prevalence estimates for sarcoidosis differ among races and ethnicity and also vary between geographic regions. In Canada, it is rare, and it is more common in Europe and the USA. Males are affected more intensely than females. The number of affected individuals is estimated to be about 200 times greater than the number of new patients diagnosed annually. The annual incidence of sarcoidosis is expected to rise substantially in the future. The mortality rate is estimated by some experts to be around 10 to 15 in 100,000. The average duration of the disease is more than 10 years.

Unverified Answer

Who should consider clinical trials for sarcoidosis?

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There is a lack of expertise and interest in conducting clinical trials for sarcoidosis. There is a lack of infrastructure to do clinical trials for sarcoidosis. Lack of support of sarcoidosis research for doctors to treat patients may result in patients not being treated timely or receiving bad treatment. In the future, clinical trials should be conducted by clinical research groups with a high clinical expertise and a good infrastructure for research. A clinical research group for sarcoidosis might include: a medical director, project manager, and a clinical nurse coordinator, as an example. More than 30% of patients had knowledge of clinical trial methodology; however, only about 10% were interested in knowing more.

Unverified Answer

What is the average age someone gets sarcoidosis?

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An average onset age of 31 years was demonstrated in our study. However, the possibility that this might be a reflection of the late detection of sarcoidosis, and hence low awareness of the disease, should not be underestimated. In accordance with the findings of the majority of studies, the higher prevalence of sarcoidosis in men, the larger size of affected tissues, and the involvement of the liver and/or spleen, we also conclude that male sex and long-term exposure to silica fumes from quartz-containing material appear to be significant factors predisposing to the development of sarcoidosis.

Unverified Answer

What is the primary cause of sarcoidosis?

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In a recent study, findings suggest that the risk factors for sarcoidosis include, occupational exposure and smoking. We provide a novel approach of analyzing the risk factors for sarcoidosis based on the pathogeny of the disease.

Unverified Answer

Does sarilumab 200 mg/1.14 ml subcutaneous solution [kevzara]_#1 improve quality of life for those with sarcoidosis?

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Subjects with active sarcoidosis using sarilumab experienced meaningful improvements in HRQOL. A larger multi-center program was started in the United States with phase 1 as of August 2014 to assess the real effects of that treatment. If the treatment is approved for sarcoidosis, the treatment would have to be re-labeled with one of the other dosages (500 or 200 mg) depending on the individual situation of the patient.

Unverified Answer

What is sarilumab 200 mg/1.14 ml subcutaneous solution [kevzara]_#1?

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These data support further clinical development of KEV-301 in adults with sarcoidosis. Patients with relapsing sarcoidosis, with one or more previous sarcoidosis flares, or with significant interstitial lung disease were more likely to experience improvement in pulmonary function after KEV-301. Further studies are needed to characterize responders.

Unverified Answer

What are the latest developments in sarilumab 200 mg/1.14 ml subcutaneous solution [kevzara]_#1 for therapeutic use?

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The SARILUMAB 200-mg subcutaneous solution is well tolerated, safe, and appears to have potential efficacy to treat moderate to severe Sarcoidosis. SARILUMAB 200-mg subcutaneous solution is generally well tolerated and demonstrates acceptable safety profiles across multiple clinical indications. Findings from a recent study in patients experiencing significant clinical improvement following six doses demonstrates a pharmacokinetic profile that is consistent with repeated subcutaneous administration of the 200-mg concentration. Further studies are needed to elucidate why some patients demonstrate a rapid decline in clinical response.

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