A Phase 1b Randomized, Double-Blind, Placebo-Controlled, Multiple-Ascending Dose Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of ACE-1334 Plus Standard of Care in Participants with Systemic Sclerosis
We are asking you to take part in this voluntary research study because you have been diagnosed with systemic sclerosis. The study drug, ACE-1334, is being studied as a potential treatment for reducing lung function loss, skin thickness, and other symptoms in patients with systemic sclerosis.
You will be required to attend study visits in-person at the Hershey Medical Center. You will be asked to come in every two weeks for six months. During your visits, various tests and examinations will be performed such as: discussing your medical history, having a physical exam, having stool samples collected, having an electrocardiogram (ECG) done, having vital signs (heart rate, blood pressure, temperature, respiratory rate, weight) taken, having blood drawn and providing a urine sample for safety laboratory tests and check for Hepatitis B/C, HIV and tuberculosis, having blood drawn to check for antibodies to the study drug (ACE-1334), performing Spirometry and diffusion capacity of the lung for carbon monoxide (DLCO), having blood drawn to check for biomarkers (substances in your body that can be used to indicate health, disease, or potential activity of the study drug [ACE-1334]), and having skin biopsies taken.
Male or female 18 years of age or older
Prior exposure to ACE-1334
Previous hematopoietic stem cell transplantation (or one planned within the next year)
On oral prednisone > 10 mg per day
On anti-coagulation therapy (including aspirin)