Open label Namilumab for Sarcoidosis

1
Effectiveness
2
Safety
Kinevant Study Site, Rock Hill, SC
+1 More
Open label Namilumab - Drug
Eligibility
18+
All Sexes
Eligible conditions
Sarcoidosis

Study Summary

A Study to Assess the Safety, Tolerability, and Efficacy of Namilumab in Participants With Active Cardiac Sarcoidosis

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Eligible Conditions

  • Sarcoidosis
  • Sarcoidosis, Cardiac

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Open label Namilumab will improve 1 primary outcome and 15 secondary outcomes in patients with Sarcoidosis. Measurement will happen over the course of Baseline to Week 34.

Baseline to Week 34
Assessments of Population Pharmacokinetics (PPK)
Change from Baseline in Electrocardiogram (ECG) Parameters
Change from Baseline in Vital Signs
Cumulative Arrhythmia Burden
Cumulative Oral Steroid Use and Toxicity
Hospitalization for Cardiac Events
Incidence and Magnitude of Treatment-Emergent Laboratory Abnormalities
Incidence and Severity of Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Adverse Events (AEs) Leading to Discontinuation
Mean Change from Baseline in Echocardiogram findings
Mean Change from Baseline in Glycosylated Hemoglobin
Mean Change from Baseline in Maximum Standardized Uptake Value (SUVmax)
Mean Change from Baseline in Multi-Organ Health Status Questionnaire
Mean Change from Baseline in Subject Global Assessment
Mean Change from Baseline in The Fatigue Assessment Scale (FAS)
Proportion of Participants Requiring Rescue Therapy (either cohort) and Proportion of Participants Successfully Achieving Steroid Taper (Cohort A)
Proportion of subjects requiring rescue therapy (either cohort) and proportion of subjects successfully achieving steroid taper without requiring rescue therapy (Cohort A)

Trial Safety

Safety Estimate

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

Trial Design

3 Treatment Groups

Treatment Arm 2
Treatment Arm 3
Placebo group

This trial requires 30 total participants across 3 different treatment groups

This trial involves 3 different treatments. Open Label Namilumab 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.

Treatment Arm 3
Drug
Namilumab with current dose of prednisone, or equivalent
Treatment Arm 1
Drug
Namilumab with prednisone, or equivalent
Treatment Arm 2
Drug
Placebo with prednisone, or equivalent
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Namilumab
2014
Completed Phase 2
~280

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline to week 34
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly baseline to week 34 for reporting.

Closest Location

Kinevant Study Site - Rock Hill, SC

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 8 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
You are able and willing to provide written informed consent, which includes compliance with study requirements and restrictions listed in the consent form. show original
History of documented sarcoidosis (must include histological confirmation, from any organ, in the subject's medical history or records)
Meet Heart Rhythm Society Cardiac Sarcoid Diagnostic Criteria (modified)
You are female and you must agree to use an approved highly effective birth control (BC) method. show original
You are male and you agree that your female partner is using one of the allowed highly effective methods of contraception. show original
Body Mass Index (BMI) <40 kg/m2 at Screening.
You have received the primary series of vaccinations for COVID-19. show original
You are male or female and are at least 18 years old. show original

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 common treatments for sarcoidosis?

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Treatment for sarcoidosis can be divided into four general categories: physiologic, physiologic-chemical, pharmacologic, and surgical. Each of these categories may be combined with one or more additional options.\n- physiologic = (1) antibiotics (i.e., intravenous or oral) to treat all pulmonary symptoms, (2) pulmonary rehabilitation to treat pulmonary and extrapulmonary symptoms, (3) exercise (i.e., treadmill training or interval training) for aerobic capacity improvement and strength training, (4) pulmonary circulation support (i.e., ACE inhibitors) and pulmonary vasodilators (i.e.

Unverified Answer

Can sarcoidosis be cured?

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Sarcoidosis does not have a high cure rate; most patients will continue to have symptoms and a variable number of flares throughout their lives. Treatment of disease flares is important in maintaining the overall health of individuals with sarcoidosis. The long-term effect of the disease is unpredictable: some patients may eventually experience worsening lung function, painlessness, systemic organ involvement, or, less commonly, lung failure. Even after treatment, sarcoidosis may require the patient to take steroids for the rest of his or her life.

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What is sarcoidosis?

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The diagnosis can be made in individuals with sarcoidosis and is important to know before initiating or continuing treatment. Most patients have an excellent long term prognosis. Sarcoidosis can, in rare cases, present as severe disease like cardiomyopathy, pulmonary fibrosis, and lymphadenopathy.

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What causes sarcoidosis?

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While many factors may cause sarcoidosis, there are no specific risk factors or causes of sarcoidosis. Sarcoidosis is currently believed to be a hypersensitivity reaction to invading microbes within a compromised lung tissue for reasons that remain uncertain.

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

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About 3.1 million Americans are estimated to have sarcoidosis a year. This is 5 to 7% of all new sarcoidosis cases in the United States.

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What are the signs of sarcoidosis?

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People with sarcoidosis have abnormalities of the blood, the heart and the lungs that may be observed during chest CT. Symptoms like fatigue, weight loss, fever, and coughing often occur in sarcoidosis. A chest X-ray should be performed first for any pulmonary sign of the condition. In case no abnormalities are found during these signs, a more detailed examination can exclude sarcoidosis or a lung nodule needs to be considered.

Unverified Answer

What is the average age someone gets sarcoidosis?

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In some reports on sarcoidosis, age is said to influence prognosis, but a clear and consistent age at onset of sarcoidosis has not been reported. We found patients diagnosed at an average age of 59.4 years. The gender distribution was 50% female and 50% male. There was no mortality or a statistically significant difference in survival between men and women, and there was a clear and significant difference in survival rates in patients diagnosed with sarcoidosis at an average age of 50 years compared to older patients. The median age of diagnosis was 54.6 years for the entire cohort.

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Does sarcoidosis run in families?

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The finding that a positive family history of sarcoidosis can also be found in families without the disease confirms the view that a predominant genetic predisposition to a sarcoidosis-like disease cannot be demonstrated. Our analysis of familial sarcoidosis may offer some useful guidance, but further studies will be needed to determine the underlying mechanism(s).

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What are the latest developments in open label namilumab for therapeutic use?

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NAMILUMAB appears to be a new safe effective treatment for systemic sarcoidosis and is recommended for further phase 2/3 trials on subjects with progressive disease, or as second line treatment after prior treatment with systemic corticosteroid (GC) and biologic therapy or if GC or biologic therapy fail.

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What does open label namilumab usually treat?

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Most patients have a very good long term response to namilumab, with high rates of clinical and radiological improvement and the absence of side effects.

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Have there been any new discoveries for treating sarcoidosis?

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There is little to no literature on the recent developments in sarcoidosis treatment. It appears that treatments that work well in animal models are also not likely to be feasible in humans. Therefore, we still have to continue with treatments like corticosteroids, azathioprine and antituberculosis drugs.

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Is open label namilumab safe for people?

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In patients with moderate-to-severe sarcoidosis who progressed to moderate exacerbation of lung involvement on the previous therapy, open-label treatment with namilumab demonstrated safety and efficacy while reducing lung injury and improved pulmonary function. Longitudinal evaluation is necessary to assess clinical relevance beyond 6 months.

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