Extracorporeal Photopheresis for Systemic Sclerosis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a treatment called Extracorporeal Photopheresis (ECP) to assess its safety and effectiveness for individuals with active diffuse cutaneous systemic sclerosis (dcSSc). This condition, a form of systemic sclerosis, causes skin hardening and thickening and can affect other organs. The study aims to determine if this treatment warrants further investigation in larger trials. Candidates for this trial include those who have experienced dcSSc symptoms for less than five years and show signs of active disease, such as skin thickening or joint issues. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group of participants.
Do I need to stop my current medications for this trial?
The trial does not specify if you need to stop taking your current medications, but it does mention that patients using more than two immunosuppressants cannot participate. If you are on photosensitizing drugs, you may need to stop those as they are listed in the exclusion criteria.
What prior data suggests that Extracorporeal Photopheresis is safe for treating systemic sclerosis?
Research has shown that Extracorporeal Photopheresis (ECP) is generally a safe treatment for systemic sclerosis. Studies have found that patients receiving ECP often experience improvements, particularly in skin symptoms. Importantly, patients usually tolerate ECP well.
Few reports exist of serious side effects. Most side effects are mild and may include fatigue or low blood pressure during the procedure. ECP has also been used safely for other conditions.
While research continues on its effectiveness in improving skin symptoms, ECP's safety record makes it a promising option for those considering clinical trials.12345Why are researchers excited about this trial's treatments?
Extracorporeal photopheresis (ECP) is unique because it offers a novel approach to treating systemic sclerosis by using light therapy to modify immune cells outside the body before reinfusing them. Unlike traditional medications that might suppress the immune system more broadly, ECP targets specific immune processes, potentially reducing side effects. Additionally, when combined with Methoxsalen and the UVADEX system, it enhances the photoactivation process, potentially increasing its effectiveness against this challenging condition. Researchers are excited because this method could offer a more targeted, less invasive option for patients, with promising results that might improve quality of life.
What evidence suggests that Extracorporeal Photopheresis might be an effective treatment for systemic sclerosis?
Research has shown that Extracorporeal Photopheresis (ECP) may help treat systemic sclerosis, particularly by improving skin conditions. Studies have found that ECP can lead to better skin scores for patients with this condition. In this trial, participants will receive ECP treatment, which involves taking blood, treating it with a special drug, and then exposing it to UVA light before returning it to the body. Some studies suggest that ECP might be effective and safe, but the evidence isn't strong enough to confirm it as the best option. However, results show a positive trend for skin-related benefits.12345
Who Is on the Research Team?
Dr. Janet E Pope, MD PhD
Principal Investigator
University of Western Ontario, Division of Rheumatology, St. Joseph's Health Care, London, Ontario, Canada
Are You a Good Fit for This Trial?
This trial is for adults with early diffuse cutaneous systemic sclerosis (dcSSc) within 5 years of their first symptoms, or those showing active disease signs. Participants must not be in other trials recently, have severe anemia or low platelets, HIV, certain heart/lung conditions, uncontrolled diseases like cancer or infections, and must not be pregnant or using certain drugs.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Extracorporeal Photopheresis treatment for diffuse cutaneous systemic sclerosis
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Extracorporeal Photopheresis (ECP)
- Extracorporeal Photopheresis (ECP) with Methoxsalen
- UVADEX
Find a Clinic Near You
Who Is Running the Clinical Trial?
London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's
Lead Sponsor
London Health Sciences Centre OR Lawson Research Institute of St. Joseph's
Lead Sponsor
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Lead Sponsor
Lawson Health Research Institute
Lead Sponsor
Mallinckrodt
Industry Sponsor
Mario Saltarelli
Mallinckrodt
Chief Medical Officer
MD
Siggi Olafsson
Mallinckrodt
Chief Executive Officer
PhD in Pharmacy