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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.