INVESTIGATIONAL CLINICAL TRIAL FOR PULMONARY SARCOIDOSIS PATIENTS
aTyr Pharma has partnered with the Foundation for Sarcoidosis Research for this clinical trial exploring a new treatment.
The purpose of this study is to determine if the investigational drug, ATYR1923, is safe and tolerable in patients with pulmonary sarcoidosis who are undergoing a protocol-guided oral corticosteroid taper. This study will also explore whether ATYR1923 has the potential to reduce oral corticosteroid use, as well as the effects ATYR1923 may have on pulmonary sarcoidosis by FDG-PET/CT, lung function, and biomarkers.
Investigational means that this drug is not approved by the United States Food and Drug Administration (FDA) or any other regulatory agencies to treat your pulmonary sarcoidosis. This is a double-blinded and placebo-controlled study. ‘Placebo-controlled’ means that for every 3 patients enrolled in the study, 2 patients will be randomly selected to receive ATYR1923 and 1 patient will receive placebo. Placebo looks like medicine but does not have any real medicine in it. ‘Double-blinded’ means that neither patients nor researchers will know which patients are receiving placebo and which are receiving ATYR1923. Using a placebo will help researchers better understand the actual effects of ATYR1923.
Patients who are eligible for the study will receive a dose of study drug (placebo or ATYR1923) once every 4 weeks intravenously (through an IV) for approximately 5 months (a total of 6 doses). The study drug dose received will depend on which study group the participant belongs.
The study drug and the required examinations and procedures during the study are at no cost to you.
Researchers are looking for patients that meet the following characteristics:
- Adults living in the United States ages 18-65
- Biopsy-proven diagnosis of pulmonary sarcoidosis for greater than or equal to 1 year. Patients may also have skin or eye involvement.
- Patients with symptomatic or active disease based on pulmonary function tests, FDG-PET/CT scan, and an evaluation of the shortness of breath you experience
- Be on a stable dose of 10-25 mg/day oral prednisone or similar medication
- Weight between 55 kg (approximately 121 pounds) and 140 kg (approximately 308 pounds)
Criteria that may not allow for you to participate include:
- Evidence of sarcoidosis affecting your heart, liver, kidneys, cardiovascular, hepatic, renal, blood, metabolism, or gastrointestinal (GI) system.
- Pulmonary Hypertension that requires treatment
- Hospitalization within 3 months of the time you start the study
Please note that if you qualify and are selected for the study you must be able to visit the study site every 2 weeks for the first month and then at least every four weeks for a 6-month period.
Interested in learning more about participating?
The participating sites that are currently recruiting are listed below- click on a site on contact them or to let FSR know you’d like to learn more.
Additional sites that will be recruiting soon include:
- Birmingham, AL
- Dallas, TX
- Falls Church, VA
- Greenville, NC
- Iowa City, IA
- Philadelphia, PA
Study details and additional information is available on clinicaltrials.gov (NCT03824392) or contact:
aTyr Pharma Clinical Research
Choosing to participate in a study is an important decision we encourage you to discuss with your physicians, family members, and friends. Every study comes with potential risks and benefits you should discuss thoroughly with your physicians and study coordinators.