Namilumab for Sarcoidosis

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

Study Summary

A Study to Assess the Efficacy and Safety of Namilumab in Participants With Chronic Pulmonary Sarcoidosis

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Eligible Conditions

  • Sarcoidosis
  • Sarcoidosis, Pulmonary

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Namilumab will improve 1 primary outcome and 14 secondary outcomes in patients with Sarcoidosis. Measurement will happen over the course of Baseline of double-blind to week 26.

Week 26
Fluorodeoxyglucose Positron Emission Tomography
Mean Change from Baseline in High-Resolution Computed Tomography
Rescue Therapy
Baseline to Week 26
Mean Change from Baseline in Percent Predicted Forced Vital Capacity (ppFVC)
Oral Corticosteroid Taper without Rescue
Week 54
Assessments of Population Pharmacokinetics (PPK) and Exposure Response (E-R) relationships for safety and efficacy, if data permits
Change in Pulmonary Function
Clinical Benefit Rate
Cumulative Oral Corticosteroid use and Toxicity Index
Mean Change from Baseline in Extrapulmonary Physician Organ Severity Tool
Mean Change from Baseline in Patient Reported Outcomes (PROs)
Mean Change from Baseline in the Sarcoidosis Activity and Severity Index
Safety Laboratory Assessments
Safety and Tolerability
Walking Capacity

Trial Safety

Safety Estimate

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

Side Effects for

Double-Blind Period: Namilumab 20 mg
Upper respiratory tract infection
0%
Hypertensive crisis
0%
Nasopharyngitis
0%
Blood creatine phosphokinase increased
0%
Toothache
0%
Hypertriglyceridaemia
0%
Limb injury
0%
Wound
0%
This histogram enumerates side effects from a completed 2016 Phase 2 trial (NCT02129777) in the Double-Blind Period: Namilumab 20 mg ARM group. Side effects include: Upper respiratory tract infection with 0%, Hypertensive crisis with 0%, Nasopharyngitis with 0%, Blood creatine phosphokinase increased with 0%, Toothache with 0%.

Trial Design

2 Treatment Groups

Treatment Arm 2
Treatment Arm 1
Placebo group

This trial requires 100 total participants across 2 different treatment groups

This trial involves 2 different treatments. Namilumab 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.

Treatment Arm 1
Drug
Namilumab
Treatment Arm 2
Drug
Placebo
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 26 in the double-blind period; week 26 to week 54 in the open label extension period
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly baseline to week 26 in the double-blind period; week 26 to week 54 in the open label extension period 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 6 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
You are a male or female age ≥18 years. show original
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
You have a documented sarcoidosis with histological confirmation in your medical records. show original
You have a respiratory or cardiac condition that causes breathlessness and that is associated with exercise intolerance. show original
Body Mass Index (BMI) <40 kg/m2 at Screening
You have completed the primary series of vaccinations at least 2 weeks prior to randomization. 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 causes sarcoidosis?

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Though no single factor can explain the cause of sarcoidosis, there are several associated factors in its multifactorial etiology. This implies that various factors act in concert to cause its manifestation. question: Is sarcoidosis in women associated with decreased circulating levels of S100A12? answer: Although the exact role of S100A12 in sarcoidosis was not elucidated, our study found a significantly lower S100A12 serum level in female sarcoidosis patients, suggesting a S100A12 modulating role and S100A12 involvement in the etiopathogenesis of sarcoidosis. S100A12 has a special role in innate immune responses.

Unverified Answer

Can sarcoidosis be cured?

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Sarcoidosis is a chronic disease, which usually may be spontaneously and completely self-limited. If sarcoidosis recurs in a patient with a history of complete and sustained remission, it is the time to start the therapy again and keep it constant on the time.

Unverified Answer

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

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Arthritis is present in almost 10% of adult patients being evaluated for symptoms attributed to sarcoidosis. This frequency is relatively high in our sarcoidosis population.

Unverified Answer

What is sarcoidosis?

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Sarcoidosis is a disease characterized by chronic inflammation of the skin (erythema nodosum), lungs, or eyes as well as of internal organs (extrathoracic involvement). About 7 in 10 Americans have this disease at some point in their lives.\n

Unverified Answer

What are common treatments for sarcoidosis?

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Immunomodulatory treatments are the most effective antifungal agents used. Common antifungal medications include ketoconazole and itraconazole, respectively. Steroid therapy is frequently used, mostly with oral prednisone. Treatment of pulmonary manifestations of sarcoidosis is dependent on disease severity. Patients with severe disease may be treated with biologic therapies, like IFNβ, which are administered intranasally for persistent pulmonary involvement. Patients with pulmonary involvement may be prescribed inhaled corticosteroids, such as Budesonide, fluticasone, and budesonide.

Unverified Answer

What are the signs of sarcoidosis?

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Sarcoidosis may cause physical abnormalities such as shortness of breath, sweating (palmar erythema), and fever. These signs are typically seen in advanced disease, and there is usually an interval of 6–8 weeks between the first manifestation and development of overt clinical disease. Patients with chronic sarcoidosis may also have skin pigmentation and a thickened chest wall.

Unverified Answer

What is namilumab?

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Namilumab is a monoclonal antibody against programmed-cell death 1 (PD-1), produced by the Mayo Clinic. Since its approval in April 2015, data in Phase 2 and 3 clinical trials of multiple autoimmune diseases in children have been published, and namilumab has been well-tolerated in clinical trials.

Unverified Answer

Have there been other clinical trials involving namilumab?

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Although other clinical studies are in progress, the FDA was not yet considering a review. A second-generation anti-IL-17Ab, androstanolone acetonide are two therapeutic options in clinical trials, which may have been helpful in preventing or treating sarcoidosis, but the lack of current data on side effects of the drugs makes us unable to recommend these therapies to the extent that it could be considered an option for the treatment of sarcoidosis. Patients are encouraged to take these trials more seriously, when the research results are published.

Unverified Answer

How does namilumab work?

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The findings suggest that namilumab's efficacy is due to both its ability to inhibit IFN-γ production and its intrinsic immunomodulatory function. This information will be useful for the development of new therapies that target IFN-γ or its downstream effectors.

Unverified Answer

Does sarcoidosis run in families?

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The findings of the present study support the hypothesis that sarcoidosis-like lesions are probably inherited. The inheritance pattern suggests that a genetic component may control the development of sarcoidosis, and that there are multiple genes that play a role in the development of the disease.

Unverified Answer

What is the average age someone gets sarcoidosis?

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Sarcoidosis has almost always been reported as occurring more commonly in people ≥ 25 yr old. In a previous survey in the United States from 1973 to 1988, sarcoidosis prevalence was highest (approximately 5%) in those ages 18 to 24 yr. This survey did not include data from Asians or in the last 10 yr. The current findings, however, suggest that the average age of disease onset is decreasing in these more recent decades as a result of better living situations and a changing attitude toward health and medicine.

Unverified Answer

What are the latest developments in namilumab for therapeutic use?

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Results from a recent paper represents a significant advance in our understanding of the role of TNF-α in sarcoidosis and indicates a number of important therapeutic implications. Additionally, our data suggest that pharmacologic blockade of TNF-α may be a viable alternative to corticosteroids in treating sarcoidosis patients. Results from a recent paper have potential to inform future sarcoidosis clinical trials for namilumab.

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