May 20th is National Clinical Trials Day. This day is celebrated around the world in May to recognize the day that what is often considered the first randomized clinical trial started aboard a British Naval ship that had been struck with scurvy. The date of this first “trial” was May 20, 1747. Now, well over 200 years later, clinical trials are a highly complex and well-oiled part of medical science, serving as a critical component in drug development.
Clinical trials are central to advancements in clinical care and medicine, and are the future of finding a cure for sarcoidosis. They provide data for new treatments, diagnosis, identification of potential shortcomings in the understanding of a disease, and chance of decreasing the rate of development of a disease all together.There are many different types of clinical trials, from ones that look at an experimental or new drug, to a new diagnostic test. While other trials are just observing patients during a certain period of time. The most important aspect of clinical trials is patient involvement. Trials are focused around the patient and their experience.
The key to clinical trials is data. Before a trial can be designed, researchers need to compile data to determine everything they need to know- from what to study to how best to study it. Data allows researchers to see what areas of a disease space need improvement and can assert different patterns from patient data. In a rare disease like sarcoidosis, it is extremely important for patients to participate in trials and contribute their unique disease experience, as its extremely valuable to help advance knowledge and interest in the disease, since there is not a large number of patients.
The main struggle in sarcoidosis clinical trials is finding enough eligible patients to fill a clinical trial. Since trials sometimes have strict inclusion criteria and sarcoidosis patients are already a small pool of candidates it can be tough to find enough people who qualify and are willing to participate. This makes is risky for new companies to consider investing in the search for a new treatment for sarcoidosis, which is why FSR is doing all we can to help ensure patients are well-informed about clinical trial opportunities in their area.
FSR offers several ways to keep patients informed about these opportunities. We share them across our website and social media, but we also offer more proactive ways for patients to stay informed about research- our Patient Registry and our Clinical Trial Interest Indicator. Learn more about each at the links below and choose your preferred method of being informed on ongoing and upcoming sarcoidosis research opportunities.
If you are interested in joining a clinical trial, there are many ways to get involved. Be sure to talk to your sarcoidosis specialist for possible studies that you might qualify for, or reach out to FSR for more information about clinical trials that you can participate in. Check out the clinical trials that are currently recruiting for sarcoidosis below:
PAPLAND
- PAPLAND Study is looking to see if there is any benefit using more advanced screening methods to diagnose cardiac sarcoidosis.
- This trial is currently recruiting. Eligible candidates must be over 18 and not have not undergone cardiac sarcoidosis screening yet. This trial is taking place at all 12 CSN sites. You can find more information on this trial on clinicaltrials.gov and on stopsarcoidosis.org
Study of Intravenous ATYR1923 for Pulmonary Sarcoidosis
- FSR is running its first industry-led trial through the CSN this year. This aTyr trial is a Phase 1b/2a trial by aTyr Pharma, Inc. looking at their ATYR1923 drug.
- Phase 1b is a phase of a clinical trial that is looking at the safety and tolerability of multiple doses of a drug. Phase 2a is looking at the clinical efficacy or biological activity of the drug.
- This trial is focusing on the drug ATYR1923, an immune modulator, and its therapeutic effects for patients with pulmonary sarcoidosis.
- This trial is currently RECRUITING
- To be eligible, patients must be diagnosed with pulmonary sarcoidosis for over one year and have symptomatic and/or active pulmonary sarcoidosis, and must also be receiving treatment with oral prednisone for 4 weeks prior to joining the trial.
Sites
- University of Cincinnati
- Cleveland Clinic
- Albany Medical Center
- National Jewish Hospital
- University of Washington
- Northwestern University
- UIC
- University of South Carolina
- University of Iowa
- To find out more about this trial, visit this page or www.clinicaltrials.gov
PULSAR Study
- PulSar is a pilot trial to assess the efficacy and safety of Acthar Gel in participants with Pulmonary Sarcoidosis.
- To be eligible you must meet the following criteria:
- Be between 18 and 90 years of age
- Have biopsy-confirmed sarcoidosis for >1 year prior to initial visit
- Be on a stable prednisone dose for at least 4 weeks prior to initial visit
- To find out more about the PulSar trial and find the trial site nearest you, please visit pulsarstudy.com
- This trial is currently RECRUITING!
Registry for Advanced Sarcoidosis (ReAS)
- This registry aims to chart the clinical course of patients diagnosed with advanced sarcoidosis. This trial was a part of FSR’s CSN in 2018.
- This trial is currently recruiting.
- Sites participating in this trial include:
- University of Cincinnati
- Johns Hopkins Medicine
- Cleveland Clinic
- National Jewish Health
- Albany Medical Center
- University of Illinois College of Medicine at Chicago
- To find out more about this trial, including recruitment status, please visit clinicaltrials.gov
CLEAR Trial
- CLEAR is an acronym used to describe treatment with Combination Levofloxacin, Ethambutol, Azithromycin, and Rifampin, four medications being studied because of the thought that sarcoidosis might be influenced or caused by a type of bacteria. Researchers suspect that the CLEAR regimen will improve the forced vital capacity (FVC) or the amount of air that can be exhaled after taking the deepest breath possible in chronic pulmonary sarcoidosis participants.
- This trial is sponsored by Vanderbilt University and is a collaboration with the National Heart, Lung, and Blood Institute.
- Criteria that may make you able to participate in this trial include:
Patients must be at least 18 years old, diagnosed with pulmonary sarcoidosis via biopsy demonstrating granulomas and no alternative cause for granulomas, such as tuberculosis for at least one year before joining this trial, evidence of disease progression, evidence of disease in lung and lymph node tissue in chest x-ray.
- Locations currently recruiting:
- Albany, New York, USA – Albany Medical Center
- Cincinnati, Ohio, USA – University of Cincinnati
- Cleveland, Ohio, USA – Cleveland Clinic
- Columbus, Ohio, USA – Ohio State University
- Charleston, South Carolina, USA – Medical University of South Carolina
- Nashville, Tennessee, USA – Vanderbilt University
- To find out more about this trial, please visit www.stopsarcoidosis.org/clear-trial/
Nicotine Treatment for Pulmonary Sarcoidosis: A Clinical Trial Pilot Study
- The purpose of this trial is to determine if nicotine treatment is beneficial for the treatment of sarcoidosis.
- This trial is interesting because a small initial trial of nicotine patches showed some benefit, and now Dr. Crouser of Cleveland Clinic, is conducting a larger trial. The Ohio State University is also participating in the trial. This is also the FIRST trial to be funded by the NIH. This is an important step because this shows that sarcoidosis research is beginning to gain attention.
- Inclusion Criteria:
– 18 Years to 75 Years
– Sarcoidosis, diagnosed at least 2 months before screening
– Must be on a stable treatment regimen for sarcoidosis for a least one month prior to enrollment in trial OR on no treatment for the condition - To find out more about this trial, please visit https://www.stopsarcoidosis.org/nicotine-trial/
WISE Study
- The WISE study, also known as the Worldwide Sarcoidosis Research Study, aims to collect information about the clinical course and characteristics of sarcoidosis patients around the world through web-based surveys. Recruitment is directed at and driven by patients in the sarcoidosis community. After agreeing to participate in further research studies through the website, participants will also have the opportunity to provide a DNA sample.
- The trial’s main site is University of Iowa, and if you have any questions or would like to participate please visit: https://www.sarcoidstudy.org/
Sarcoidosis App
- Penn Medicine developed a sarcoidosis app that allows patients and researchers to be connected in real time. Patients answer survey’s that are sent to their mobile phones and researchers can pull data from the information they receive. For example, researching can determine if there is any seasonal variability and how quickly the patients respond to treatment.
- This app can allow patients to report about their disease easily and allow researchers have access to data that they would otherwise not receive.
- The app is available on Google Play and search from Sarcoidosis App. This app is still active and looking for more participants to join!
- To find out more about this trial, please visit https://www.stopsarcoidosis.org/sarcoidosis-app/
Outcome Study of Sarcoidosis: A New Paraneoplastic Syndrome in Patient with Cancer
- Development of cancer following sarcoidosis has been studied in the past, but, little is known about the development of sarcoidosis following cancer. Investigators proposed an association between cancer and sarcoidosis previously. They have suggested that sarcoidosis could be a paraneoplastic disease, so this trial is looking at paraneoplastic (a disease caused by a cancer) sarcoidosis disease.
- The aim of the trial is to find an association between sarcoidosis and cancer and to determine the outcome of sarcoidosis in patients with cancer.
- This trial is currently recruiting. To be eligible for this trial, you must have a diagnosis of sarcoidosis following cancer.
- This trial is being conducted at the University of Miami, Florida by Dr. Mehdi Mirsaeidi.
- To find out more about this trial, including recruitment status, please visit clinicaltrials.gov
Inhaled Treprostinil in Sarcoidosis Patients with Pulmonary Hypertension (SAPPHIRE)
- This trial aims to evaluate the efficacy and safety of inhaled treprostinil in participants with sarcoidosis-associated interstitial lung disease and pulmonary hypertension.
- This trial is a collaboration of University of Florida and United Therapeutics. It is not yet recruiting.
- To be eligible for this trial, you must have a diagnosis of sarcoidosis, pulmonary hypertension, presence of interstitial lung disease, and must be on stable sarcoidosis therapy for at least 3 months prior to screening.
- To find out more about this trial, please visit clinicaltrials.gov
Vitamin D Homeostasis in Sarcoidosis
- This trial will evaluate the relationship between vitamin-D status and severity of sarcoidosis and the effects of vitamin-D repletion in the vitamin-D insufficient patients with sarcoidosis.
- This trial is being sponsored by and conducted at the University of Texas Southwestern Medical Center.
- They are not currently recruiting until July 2019.
- To find out more about this trial, please visit clinicaltrials.gov
University of Florida Cardiac Sarcoidosis Trial
- This trial is being conducted at the University of Florida and will give patients a blood test to identify if they will develop future scarring and will have specialized scans to assess whether there is any sarcoidosis-related scarring in their hearts. This trial is recruiting if you’re in the North Florida/South Georgia area.
- The goal of this research is to develop tests that determine who should be treated and whether the treatment is effective.
- To find out more about this trial, please visit stopsarcoidosis.org/clinical-trial-gainsville
Study of ACZ885 (Canakinumab) in Patients with Pulmonary Sarcoidosis
- The purpose of this study is to assess if drug ACZ885 will improve lung function in association with reduction of tissue inflammation in patients with chronic sarcoidosis. This trial, being funded by Novartis, requires patients to have had pulmonary sarcoidosis disease for over one year and have clinical active disease.
- This trial will be taking place in multiple sites including:
- Birmingham, Alabama
- Albany, New York
- Cleveland, Ohio
- Essen, Germany
- Frankfurt, Germany
- Hannover, German
- Nieuwegein, Netherlands
- Rotterdam, Netherlands
- To find out more about this trial, including recruitment status, please visit clinicaltrials.gov
Glucocorticoid Induction Therapy in Subjects with Pulmonary Sarcoidosis
- This trial is looking at the effect size of HRCT (high resolution computed tomography) endpoints in response to beginning glucocorticoid therapy in partcipants with a diagnosis of pulmonary sarcoidosis who have not received glucocorticoid as initial sarcoidosis therapy (≥ 20 mg/day prednisone or prednisolone) or other sarcoidosis therapy for at least 3 months prior to enrollment
- This is a small trial, of about 24 participants, sponsored by Celegene.
- This trial is currently recruiting in some sites.
- To find out more about this trial, including more about eligibility criteria, please visit clinicaltrials.gov
A Dose Escalation Study to Assess the Safety and Efficacy of Pulsed Inhaled Nitric Oxide in Subjects with Pulmonary Fibrosis or Sarcoidosis
- This is a phase 2b trial to trial the efficacy and safety of increased doses of inhaled nitric oxide in participants with pulmonary sarcoidosis on long term oxygen therapy followed by a long term extension trial.
- This trial is being sponsored by Bellerophon, and is not currently recruiting.
- To find out more about this trial, please visit clinicaltrials.gov
Ursodeoxycholic Acid (UDCA) for Hepatic Sarcoidosis
- This trial is looking to evaluate the efficacy of UDCA in improving liver function and quality of life in patients with hepatic sarcoidosis. This is a crossover trial which means patients will be observed both without UDCA and with UDCA. This trial is only going to be taking place at University of Pennsylvania. The sponsors of the trial are American Association for the Study of Liver Disease and Exalenz Bioscience LTD.
- This trial is currently
- To be eligible, patients must meet the following criteria:
- Systemic sarcoidosis with evidence of liver involvement
- Stable dose of immunosuppressant
- Absence of hepatocellular carcinoma
- To find out more about this trial, please visit clinicaltrials.gov
Pirfenidone for Progressive Fibrotic Sarcoidosis
- This trial was a part of the FSR-CSN in 2018, and is still currently recruiting. This trial is intended to determine the effects of Pirfenidone on sarcoidosis associated pulmonary fibrosis. This trial is being undertaken at University of Cincinnati by Dr. Robert Baughman.
- To find out more about this trial, please visit clinicaltrials.gov
CNS Sarcoidosis and Acthar Gel
- This trial being done at University of Maryland and sponsored by Mallinckrodt pharmaceuticals, looks to determine if treatment with H.P. Acthar Gel will result in the improvement and long-term stabilization of clinical and radiographic abnormalities that occur in patients with neuroscarcoidosis. It will also look at improvements in measures of quality of life.
- To find out more about this trial, please visit clinicaltrials.gov
Study in Subjects with Sarcoidosis-associated Pulmonary Hypertension (SAPH) to Assess the Efficacy and Safety of Oral Selexipag
- This trial will comprise of 150 participants with sarcoidosis-associated pulmonary hypertension and will investigate whether selexipag could be helpful to treat patients with SAPH.
- Estimated Trial Start Date is August 2, 2019. This trial is NOT YET RECRUITING.
- To find out more information, go to clinicaltrials.gov
Open-label Trial of Tofacitinib in Cutaneous Sarcoidosis and Granuloma Annulare
- This trial is looking at the ability of Tofacitinib to treat patients with cutaneous sarcoidosis and granuloma annulare during 6 months of therapy. This trial is currently not yet recruiting.
You can find more about any trial on this list by going to clinicaltrials.gov