What side effects are associated with this type of intervention?

Common treatments for Systemic Sclerosis that modulate the immune system and reduce inflammation include immunosuppressive drugs like methotrexate, mycophenolate mofetil, and cyclophosphamide, as well as biologic agents such as TNF-alpha inhibitors. Known side effects of these treatments can include increased risk of infections, liver toxicity, gastrointestinal issues, and bone marrow suppression. Extracorporeal Photopheresis, specifically, is generally well-tolerated but can cause side effects such as low-grade fever, hypotension, and transient skin reactions.

What prior FDA approvals exist?

FDA-approved treatments for Systemic Sclerosis that focus on modulating the immune system and reducing inflammation include mycophenolate mofetil and cyclophosphamide. Mycophenolate mofetil has shown promise in preserving lung function and improving skin symptoms in patients with systemic sclerosis-related interstitial lung disease. Cyclophosphamide has been used to treat severe cases of systemic sclerosis with significant organ involvement, particularly lung disease. These treatments aim to reduce immune system activity and inflammation, similar to the mechanism of action being studied in Extracorporeal Photopheresis.

What other types of research exist?

Promising novel alternatives to Extracorporeal Photopheresis for Systemic Sclerosis patients include the use of biologics targeting specific immune pathways, such as IL-6 inhibitors (e.g., tocilizumab) and JAK inhibitors (e.g., tofacitinib). These therapies have shown potential in modulating the immune response and reducing inflammation in autoimmune conditions.

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Extracorporeal Photopheresis for Systemic Sclerosis

Phase 2

Waitlist Available

Led By Dr. Janet E Pope, MD PhD

Research Sponsored by Lawson Health Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with SSc, aged 18 years or older

Be older than 18 years old

Must not have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 and 12 months

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include reactions related to the infusion process such as fatigue or nausea; skin sensitivity due to UVADEX; increased risk of infection; and possible complications from heparin use if allergic.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 or older with systemic sclerosis.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any major health issues besides my current condition.

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I do not have an ongoing infection needing treatment.

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I have a blood clotting disorder.

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I have a serious heart condition.

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I have undergone extracorporeal photopheresis before.

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I have had my spleen removed surgically.

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I am allergic to heparin or pork, or have had bad reactions to certain blood thinners.

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My lung function is significantly impaired.

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My condition is classified as severe pulmonary hypertension.

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I am not pregnant, breastfeeding, and if capable of childbearing, I use effective contraception.

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I have a condition that makes my skin extremely sensitive to light.

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I am taking more than 2 immunosuppressants.

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I do not have the natural lens in my eye, and it hasn't been replaced with an artificial one.

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I am not using any drugs that increase sensitivity to light.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 and 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 and 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in skin thickness measured by modified Rodnan Skin Score

Secondary study objectives

Change in Forced Vital Capacity

Change in Scleroderma Health Assessment Questionnaire

Change in patient global assessment of health status

+8 more

Other study objectives

Change in CD3-positive cell count (T-cell marker) in skin biopsies of involved forearm skin

Change in myofibroblast count in skin biopsies of involved forearm skin

Change in peripheral levels of T-cell activation marker - sIL-2R

+2 more

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Administration of Extracorporeal Photopheresis TreatmentExperimental Treatment2 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

0 / 15Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Systemic Sclerosis (SSc) treatments often aim to modulate the immune system and reduce inflammation, which are crucial due to the autoimmune nature of the disease. Extracorporeal Photopheresis (ECP) is one such treatment that has shown promise. ECP works by collecting the patient's blood, treating it with a photosensitizing agent, and then exposing it to ultraviolet light before reinfusing it. This process helps to modulate the immune response and reduce inflammation, potentially slowing disease progression and alleviating symptoms. For SSc patients, these mechanisms are vital as they target the underlying autoimmune processes, offering a chance to manage the disease more effectively and improve quality of life.

A randomized, double-blind, placebo-controlled trial of photopheresis in systemic sclerosis.Phototherapy treatment of psoriasis today.Suggested mechanisms of action of UVA phototherapy in morphea: a molecular study.

Find a Location

Who is running the clinical trial?

Lawson Health Research InstituteLead Sponsor

681 Previous Clinical Trials

431,325 Total Patients Enrolled

1 Trials studying Scleroderma

10 Patients Enrolled for Scleroderma

MallinckrodtIndustry Sponsor

201 Previous Clinical Trials

15,851 Total Patients Enrolled

Dr. Janet E Pope, MD PhDPrincipal InvestigatorUniversity of Western Ontario, Division of Rheumatology, St. Joseph's Health Care, London, Ontario, Canada