Scleroderma Center

Clinical Trials

Currently Enrolling Patients

ASScERT-QoL Trial

Title: A Randomized, Double-Blind Clinical Trial of the Apollo Device in Systemic Sclerosis for the Management of Fatigue, Raynaud Phenomenon, and Quality of Life (ASScERT-QoL)

This study is evaluating whether the Apollo Neuro wearable device can improve fatigue, Raynaud phenomenon, and overall quality of life in individuals with systemic sclerosis (SSc). Participants will use the device, which provides gentle vibratory stimulation through the wrist or ankle, as part of a randomized, double-blind trial. Because there are currently no approved treatments for SSc-related fatigue or Raynaud phenomenon, this non-pharmacologic approach may offer a promising alternative to help manage two of the most burdensome symptoms of the disease.

DAISY Trial

Title: A Multicenter, Randomized, Double-Blind, Phase III Study to Evaluate the Safety and Efficacy of Anifrolumab Compared with Placebo in Participants with Systemic Sclerosis

The DAISY trial is a phase III study assessing the safety and efficacy of anifrolumab, a monoclonal antibody targeting type I interferon signaling, compared with placebo in adults with systemic sclerosis of less than six years’ duration. Participants may continue stable doses of standard therapies such as mycophenolate, methotrexate, or hydroxychloroquine during the trial. The goal is to determine whether anifrolumab can meaningfully reduce disease activity and improve clinical outcomes in both limited and diffuse cutaneous forms of systemic sclerosis.

Skin Biopsy Research Repository

Enrolling:  Scleroderma Patients and Healthy Controls

The UPMC/University of Pittsburgh Scleroderma Center has established a systemic sclerosis (SSc) skin biopsy research repository to collect and store tissue specimens for ongoing and future studies. We are currently enrolling individuals diagnosed with SSc as well as healthy control participants (adults aged 18 years and older without SSc). A parallel, de-identified database of medical information is maintained to complement the tissue repository and support integrated clinical research.

The underlying causes of SSc are not fully understood, though genetic, environmental, and immune system factors are believed to contribute. The repository and database enable researchers to investigate disease mechanisms, complications, and potential therapeutic targets. Skin biopsy procedures are performed in Dr. Robert Lafyatis’s laboratory and typically take about 30 minutes.

Collected skin samples are analyzed to explore biological and genetic factors that may influence SSc onset, progression, and immune function. Future studies may compare tissue from participants with and without SSc to identify genes that increase susceptibility, alter disease severity, or regulate immune pathways. Any samples shared with outside research centers will be transferred without identifying information to ensure participant confidentiality.

If you are interested in participating in a trial or would like additional information regarding clinical studies at our center, please contact Maureen Laffoon (laffoonm@pitt.edu).