Not Yet RecruitingPhase 2

Extracorporeal Photopheresis in Early Diffuse Cutaneous Systemic Sclerosis

Canada15 participantsStarted 2025-07-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Patients with SSc, aged 18 years or older, and:
✓. Subjects must meet the ACR/EULAR classification criteria for SSc (2013).
✓. Early dcSSc (within 5 years of first non-Raynaud's phenomenon symptom) or any other dcSSc patients who have at least one of the signs of disease activity: mRSS of 15 or more, presence of tendon friction rubs, elevated inflammatory markers thought to be due to active dcSSc and not related to other issues such as infection or ILD with FVC% predicted \<80% or HRCT showing ILD thought to be from SSc.
✓. Able to give informed consent.

Exclusion criteria

✕. Poor pulmonary function (FVC\<40% and/or DLCO\<30%).
✕. Class IV PAH or PH.
✕. Clinically significant cardiac disease.
✕. Significant concurrent, uncontrolled medical condition including, but not limited to, renal, cardiac, hepatic, pancreatic, hematological, gastrointestinal, endocrine, pulmonary, neurological, cerebral or psychiatric disease; and cancer (i.e. co-existing melanoma, basal cell, or squamous cell skin carcinoma).
✕. Chronic or ongoing active infectious disease requiring systemic treatment, including active tuberculosis (TB) infection.
✕. Seropositivity for human immunodeficiency virus (HIV) at study entry.
✕. Active viral infection with viral replication of hepatitis B or C virus at study entry.

What they're measuring

Change in skin thickness measured by modified Rodnan Skin Score

Timeframe: 48 weeks

Trial details

NCT IDNCT04986605

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

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-07

Contact for this trial

Dr. Janet E Pope, MD PhD

519-646-6332 janet.pope@sjhc.london.on.ca

View on ClinicalTrials.gov More Diffuse Cutaneous Systemic Sclerosis trials