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NOT YET RECRUITING
NCT04986605
PHASE2

Extracorporeal Photopheresis in Early Diffuse Cutaneous Systemic Sclerosis

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

View on ClinicalTrials.gov

Summary

The purpose of this study is to assess feasibility, safety and preliminary efficacy of Extracorporeal Photopheresis in the treatment of active diffuse cutaneous systemic sclerosis (dcSSc). This pilot study will help to determine if further study (a RCT) is justified.

Official title: The Effectiveness of ECP in Diffuse Cutaneous Systemic Sclerosis

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

15

Start Date

2025-07-01

Completion Date

2027-07

Last Updated

2025-03-13

Healthy Volunteers

No

Interventions

DEVICE

Extracorporeal Photopheresis (ECP)

Drug Intervention using a medical device. The ECP device is already licensed in Canada. License No.7703. ECP treatment, using the drug UVADEX, will be given on 2 consecutive days every 4 weeks for a total of 26 treatment days (48 weeks).

DRUG

UVADEX

The phase II aspect of the study refers to the drug, methoxsalen. Methoxsalen is being used off label from the currently approved indications in the monograph. The study is proposing to use methoxsalen in combination with with extracorporeal photopheresis for the treatment of diffuse cutaneous systemic sclerosis. Treatment will be given in addition to standard of care medications for SSc.

Locations (1)

Rheumatology Clinic, St. Joseph's Health Care

London, Ontario, Canada