Extracorporeal Photopheresis for Early Diffuse Cutaneous Systemic Sclerosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2 pilot study will enroll 15 adults with diffuse cutaneous systemic sclerosis to receive extracorporeal photopheresis while continuing their standard treatments. The goal is to assess feasibility, safety, and preliminary efficacy by measuring changes in skin thickness (mRSS) over one year and exploring patient-reported and physician-assessed outcomes. It is an uncontrolled, unblinded trial designed to inform the potential design of a future randomized trial. Exploratory endpoints include HAQ-DI, global assessments, inflammatory markers, and CRISS score.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Patients with SSc, aged 18 years or older, and:
2. Subjects must meet the ACR/EULAR classification criteria for SSc (2013).
3. 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.
4. Able to give informed consent.

Exclusion Criteria:

1. Poor pulmonary function (FVC\<40% and/or DLCO\<30%).
2. Class IV PAH or PH.
3. Clinically significant cardiac disease.
4. 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).
5. Chronic or ongoing active infectious disease requiring systemic treatment, including active tuberculosis (TB) infection.
6. Seropositivity for human immunodeficiency virus (HIV) at study entry.
7. Active viral infection with viral replication of hepatitis B or C virus at study entry.
8. Thrombophilia.
9. Contraindications to heparin including history of heparin-induced thrombocytopenia (HIT) or heparin-induced thrombocytopenia and thrombosis (HITTS), history of thrombocytopenia with pentosan polysulfate, known hypersensitivity to heparin or pork products.
10. Low Platelet count (less than 100,000 per mm3).
11. Aphakia (absence or loss of the eye's lens and has not been replaced with an artificial lens), because of the significantly increased risk of retinal damage due to the absence of lenses.
12. Severe anemia (hemoglobin \<70g/L).
13. High white blood cell count (greater than 25000 mm3).
14. A history of surgical spleen removal.
15. A history of a light sensitive disease state, i.e. lupus erythematosus, porphyria cutanea tarda, erythropoietic protoporphyria, variegate porphyria, xeroderma pigmentosum and albinism.
16. Previous idiosyncratic reactions to psoralen compounds.
17. Patients who are using photosensitizing drugs such as anthralin, coal tar or coal tar derivatives, griseofulvin, phenothiazines, nalidixic acid, halogenated salicylanilides (bacteriostatic soaps), sulfonamides, tetracyclines, thiazides, and certain organic staining dyes such as methylene blue, toluidine blue, rose bengal and methyl orange.
18. Treatment with more than 2 immunosuppressants (including mofetil mycophenolate, methotrexate, cyclophosphamide, biologics) at study entry.
19. Pregnancy, breast feeding or child bearing potential without practicing highly effective contraception (and partners for men in the study).
20. Patients known or suspected of not being able to comply with a study protocol (e.g. due to alcoholism, drug dependency or psychological disorder).
21. Participation in another clinical trial within six weeks before randomization in this study.
22. Previous use of Extracorporeal photopheresis.

Where it's running

• Rheumatology Clinic, St. Joseph's Health Care
  London, Ontario, Canada Recruiting

Study contacts

• Principal investigator: Dr. Janet E Pope, MD PhD — University of Western Ontario, Division of Rheumatology, St. Joseph's Health Care, London, Ontario, Canada
• Study coordinator: Dr. Janet E Pope, MD PhD
• Email: janet.pope@sjhc.london.on.ca
• Phone: 519-646-6332

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Using long-lived immune cells to calm an overactive immune system

  This trial will try QEL-005, an autologous CD19-directed CAR-T regulatory cell therapy, to calm immune overactivity in adults with diffuse cutaneous systemic sclerosis or difficult-to-treat rheumatoid arthritis.

  Recruiting at 7 sites Phase 1/2 Quell Therapeutics Limited · Düsseldorf and 9 other locations · NCT07473154

• MTX-474 for diffuse cutaneous systemic sclerosis (dcSSc)

  This trial will test whether IV MTX-474 given every four weeks helps people with diffuse cutaneous systemic sclerosis compared with placebo.

  Recruiting at 20 sites Phase 2 Mediar Therapeutics · Phoenix, Arizona and 57 other locations · NCT07287670

• Evaluating Baricitinib for Skin Tightening in Systemic Sclerosis

  This study is testing if a new medication called baricitinib can help improve skin tightness in people with diffuse cutaneous systemic sclerosis compared to a standard treatment.

  Recruiting Phase 3 Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh · Dhaka · NCT06936215

• Evaluating CTX112 for treating refractory autoimmune diseases in adults

  This study is testing a new CAR T cell treatment called CTX112 to see if it can help adults with tough autoimmune diseases like lupus and scleroderma feel better.

  Recruiting at 16 sites Phase 1 CRISPR Therapeutics · La Jolla, California and 16 other locations · NCT06925542

• Zamtocabtagene Autologous CAR-T for Autoimmune Diseases

  This early-phase study tests whether a patient’s own CAR-T cells (zamto-cel) can be safely given after standard therapy to people with lupus or systemic sclerosis.

  Recruiting Phase 1 Miltenyi Biomedicine GmbH · Milwaukee, Wisconsin · NCT06708845

• Testing Telitacicept for treating systemic sclerosis

  This study is testing if Telitacicept can help adults with early diffuse cutaneous systemic sclerosis feel better when used alongside another medication called Mycophenolate Mofetil.

  Recruiting at 9 sites Phase 2 Second Affiliated Hospital, Zhejiang University, School of Medicine · Yangzhou, Jiangsu and 8 other locations · NCT06375005

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.