Efzofitimod 3 mg/kg for Sarcoidosis, Pulmonary

2
Effectiveness
3
Safety
aTyr Investigative Site, Cleveland, OH
+1 More
Efzofitimod 3 mg/kg - Drug
Eligibility
18+
All Sexes
Eligible conditions
Sarcoidosis, Pulmonary

Study Summary

Efficacy and Safety of Intravenous Efzofitimod in Patients With Pulmonary Sarcoidosis

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Eligible Conditions

  • Sarcoidosis, Pulmonary
  • Sarcoidosis

Treatment Effectiveness

Effectiveness Estimate

2 of 3
This is better than 85% of similar trials

Study Objectives

This trial is evaluating whether Efzofitimod 3 mg/kg will improve 1 primary outcome and 3 secondary outcomes in patients with Sarcoidosis, Pulmonary. Measurement will happen over the course of Baseline to Week 48.

Baseline to Week 48
Annual rate of change in absolute value of Forced vital capacity (FVC)
Change from baseline in King's Sarcoidosis Questionnaire (KSQ)-Lung score
Change from baseline in mean daily OCS dose post-taper
Percent change from baseline in mean daily OCS dose post-taper

Trial Safety

Safety Estimate

3 of 3
This is better than 85% of similar trials

Trial Design

3 Treatment Groups

Placebo
Efzofitimod 3 mg/kg
Placebo group

This trial requires 264 total participants across 3 different treatment groups

This trial involves 3 different treatments. Efzofitimod 3 Mg/kg 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 3 and have had some early promising results.

Efzofitimod 3 mg/kg
Drug
Efzofitimod 5 mg/kg
Drug
Placebo
Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline to week 48
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly baseline to week 48 for reporting.

Closest Location

aTyr Investigative Site - Cleveland, OH

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 4 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Confirmed diagnosis of pulmonary sarcoidosis for at least 6 months, defined by the following criteria: documented histologically proven diagnosis of sarcoidosis by tissue biopsy and documented evidence of parenchymal lung involvement by historical radiological evidence
Patients must be receiving treatment with OCS of ≥ 3 months with a starting dose between ≥ 7. show original
You have body weight ≥ 40 kg and < 160 kg. show original
You have symptomatic pulmonary sarcoidosis, as demonstrated by the following criteria: Modified Medical Research Council (MRC) dyspnea scale grade of at least 1 and KSQ-Lung score ≤70. 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.

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

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The American Society of Clinical Oncology estimates 1,500 new cases of sarcoidosis, pulmonary will be reported annually in the U.S. in the coming years. However, an estimated 300,000 new cases will occur annually. These people are, however, likely to go undetected.

Unverified Answer

What is sarcoidosis, pulmonary?

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Sarcoidosis is more common than generally thought. If sarcoidosis is diagnosed, lung involvement and damage to lung tissue must be ruled out to rule out a more serious disorder. The presentation of sarcoidosis has a great variety, including pulmonary disease and cutaneous disease. A number of radiographic abnormalities may be seen, but only about 30% of people with pulmonary sarcoidosis have lung nodules, and only 50% have hilar adenopathy on the chest radiograph. Sarcoid nodules are hard and dense and do not cause significant symptoms; they are most noticeable on CT scans.

Unverified Answer

What causes sarcoidosis, pulmonary?

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Sarcoidosis is an immune system disorder of unknown cause. Genetic factors have been suggested. The cause of sarcoidosis is unknown, but the lungs are damaged by cell-mediated mechanisms. This damage is similar to that seen in drug or radiation-induced lung diseases.

Unverified Answer

What are the signs of sarcoidosis, pulmonary?

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What are the signs of sarcoidosis, Pulmonary (SSP)? SSP is characterized by persistent cough, shortness of breath, chest pain and weight loss. SSP is characterized by shortness of breath, chest pain, weight loss and fever. SPS is characterized by persistent cough, shortness of breath, night sweats, weight loss and jaundice. SOD is characterized by cough and swollen lymph nodes. Symptoms of SOD may be the same as pneumoconiosis. SLD is characterized by cough, weight loss and night sweats. Symptoms of SLD may be the same as sarcoidosis. SLE is characterized by arthritis, skin changes, fever and night sweats.

Unverified Answer

Can sarcoidosis, pulmonary be cured?

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A significant number of patients with sarcoidosis, pulmonary can be cured spontaneously in 1-3% of the cases. This observation is in complete agreement with one reported meta-analysis where a cure of sarcoidosis the pulmonary was observed in 2 out of 5 patients. Treatment of sarcoidosis patients with corticosteroids alone or in combination with Immunosuppressant drugs has been a subject of an intense search in the literature. Corticosteroids used in combination with Immunosuppressants are known to increase the risks of sarcoidosis, and are thus always to be used with caution.

Unverified Answer

What are common treatments for sarcoidosis, pulmonary?

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The treatment of primary Sjögren's syndrome remains an interesting case of an orphan disease. The use of tacrolimus in Sjögren's syndrome patients with autoimmune polyendocrine syndrome type 1 has been studied in several clinical trials. The treatment of systemic juvenile idiopathic arthritis (systemic JIA) with tacrolimus has been studied in one or a few small clinical trials. The use of the medication's immunosuppressive effect against the sarcoidosis remains to be established.

Unverified Answer

What is the primary cause of sarcoidosis, pulmonary?

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Pulmonary sarcoidosis is caused by a foreign trigger factor. An aberrant immune system response against dead organisms results in a granulomatous inflammatory process that causes a fibrotic process with obliteration of the lung and heart. The primary source of infection may be the lungs.

Unverified Answer

Is efzofitimod 5 mg/kg typically used in combination with any other treatments?

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When evaluated in clinical trials of sarcoidosis and pulmonary MLC, efzofimod may typically be administered with prednisone and/or albuterol. A number of other drugs are reported to be effective in treating sarcoidosis and pulmonary MLC, but their typical use combinations with efzofirmod are not well known. Clinical trials evaluating efzofirmod should examine combinations of it with albuterol and/or prednisone. Trials should also evaluate the use of efzofirmod in conjunction with other therapies, such as methotrexate.

Unverified Answer

Have there been any new discoveries for treating sarcoidosis, pulmonary?

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There have been no new drugs prescribed for sarcoidosis in over 15 years. No study has shown an improvement. The studies are too limited and can't be conclusive about the best course of treatment for sarcoidosis. The treatments are supportive with no new insights. Currently, the most effective treatment is supportive. There have not been any new findings, but there could be a better way of managing patients in the emergency department. It would be better than the current emergency room management.

Unverified Answer

Have there been other clinical trials involving efzofitimod 5 mg/kg?

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This is the first real world report of efzofitimod 5mg/kg in patients with sarcoidosis. Long-term data from placebo-controlled trials, a similar safety profile, and a positive response rate of 67% with efzfictimod 5mg/kg treatment will add to this body of evidence. The optimal timing and duration of treatment remain open.

Unverified Answer

Who should consider clinical trials for sarcoidosis, pulmonary?

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Sarcoidosis is a chronic systemic disease. Many patients have profound functional impairment. Clinical trials for lung parenchymal disease (Sarcoidosis Lung Disease) address the treatment goals of significant improvement in pulmonary function, exercise tolerance, dyspnea, and HRQL.

Unverified Answer
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