Extracorporeal Photopheresis for Systemic Sclerosis

Recruiting in Palo Alto (17 mi)

Overseen by Dr. Janet E Pope, MD PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is testing a treatment called Extracorporeal Photopheresis for patients with a severe form of scleroderma. The treatment involves taking blood out, treating it with light and a drug, and then putting it back in. The goal is to see if this can safely reduce skin thickening and improve symptoms. Extracorporeal photopheresis (ECP) has been used for over 30 years, initially for cutaneous T-cell lymphoma and later for other diseases including scleroderma.

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

Eligibility Criteria

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

I have early or active diffuse cutaneous systemic sclerosis.

I am 18 or older with systemic sclerosis.

You must meet the specific classification criteria for systemic sclerosis set by ACR/EULAR in 2013.

Exclusion Criteria

I do not have an ongoing infection needing treatment.

I have a blood clotting disorder.

I have a serious heart condition.

Treatment Details

Interventions

• Extracorporeal Photopheresis (ECP) (Other)
• Extracorporeal Photopheresis (ECP) with Methoxsalen (Other)
• UVADEX (Other)

Trial Overview The study tests the safety and initial effectiveness of Extracorporeal Photopheresis (ECP) using UVADEX for treating dcSSc. It's a pilot study to see if more extensive research is needed. ECP involves treating blood with light after adding a drug that makes cells sensitive to light.

Participant Groups

Group I: Administration of Extracorporeal Photopheresis Treatment Experimental Treatment 2 Interventions

Duration of treatment: 48 weeks. Treatments occur on 2 consecutive days every 4 weeks. Dose of UVADEX: Treatment Volume x 0.017 = mL of UVADEX for each treatment Treatment Volume (TV) is defined as: The total volume of Buffy Coat plus prime solution that will undergo photoactivation. Route of administration: Extracorporeal

Who Is Running the Clinical Trial?

London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials

686

Recruited

427,000+

Dr. Alex Barron

London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's

Chief Medical Officer since 2023

MD from Western University

David Musyj

London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's

Chief Executive Officer

Physiotherapy degree

London Health Sciences Centre OR Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials

668

Recruited

424,000+

Roy Butler

London Health Sciences Centre OR Lawson Research Institute of St. Joseph's

Chief Executive Officer

PhD in Health Sciences

Dr. Cindy Hutnik

London Health Sciences Centre OR Lawson Research Institute of St. Joseph's

Chief Medical Officer

MD, PhD

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials

678

Recruited

421,000+

Lisa Porter

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Chief Medical Officer

PhD in Biomedical Sciences

Roy Butler

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Chief Executive Officer

PhD in Health Sciences

Lawson Health Research Institute

Lead Sponsor

Trials

684

Recruited

432,000+

Dr. Michael Strong

Lawson Health Research Institute

Chief Medical Officer

MD

Roy Butler

Lawson Health Research Institute

Chief Executive Officer

PhD in Health Sciences

Mallinckrodt

Industry Sponsor

Trials

202

Recruited

15,700+

Mario Saltarelli

Mallinckrodt

Chief Medical Officer

MD

Siggi Olafsson

Mallinckrodt

Chief Executive Officer

PhD in Pharmacy