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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

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 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

Side effects data

From 2014 Phase 2 trial • 17 Patients • NCT00045305
100%
Blood bilirubin increased
100%
Anemia
100%
White blood cell decreased
100%
Neutrophil count decreased
100%
Platelet count decreased
94%
Creatinine increased
88%
Nausea
82%
Fatigue
76%
Diarrhea
76%
Alkaline phosphatase increased
76%
Aspartate aminotransferase increased
71%
Edema limbs
71%
Rash maculo-papular
71%
Alanine aminotransferase increased
65%
Vomiting
41%
Anorexia
41%
Dyspnea
35%
Febrile neutropenia
35%
Abdominal pain
35%
Headache
29%
Fever
24%
Infections and infestations - Other, spe
24%
Insomnia
24%
Acute kidney injury
24%
Alopecia
24%
Dysgeusia
18%
Esophagitis
18%
Constipation
18%
Weight loss
18%
Pruritus
18%
Hypertension
18%
Peripheral sensory neuropathy
18%
Hypotension
18%
Hepatic failure
18%
Dizziness
12%
Epistaxis
12%
Sinus tachycardia
12%
Hyperhidrosis
12%
Injection site reaction
12%
Colitis
12%
Dehydration
12%
Dry skin
12%
Bladder infection
12%
Hypomagnesemia
12%
Muscle weakness lower limb
6%
Hematuria
6%
Hemorrhoids
6%
Gastritis
6%
Purpura
6%
Urinary tract infection
6%
Dysphagia
6%
Enterocolitis infectious
6%
Edema trunk
6%
Hot flashes
6%
Confusion
6%
Depression
6%
Dry eye
6%
Hiccups
6%
Pleural effusion
6%
Pneumonitis
6%
Respiratory, thoracic and mediastinal di
6%
Thromboembolic event
6%
Vascular disorders - Other, specify
6%
Electrocardiogram QT corrected interval
6%
Sinus bradycardia
6%
Acute coronary syndrome
6%
Mucositis oral
6%
Pericardial effusion
6%
Cushingoid
6%
Tremor
6%
Eye disorders - Other, specify
6%
Hyperglycemia
6%
Hyperkalemia
6%
Hypokalemia
6%
Hyponatremia
6%
Hypoxia
6%
Pneumothorax
6%
Chills
6%
Erythema multiforme
6%
Abdominal distension
6%
Dry mouth
6%
External ear inflammation
6%
Iron overload
6%
Heart failure
6%
Cardiac disorders - Other, specify
6%
Upper respiratory infection
6%
Hypoglycemia
6%
Fracture
6%
Generalized muscle weakness
6%
Anxiety
6%
Conjunctivitis
6%
Blurred vision
6%
Chest wall pain
6%
Pain in extremity
6%
Myalgia
6%
Sinus pain
6%
Vaginal pain
6%
Cough
6%
Urinary frequency
6%
General disorders and administration sit
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm I

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

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
675 Previous Clinical Trials
416,970 Total Patients Enrolled
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

Media Library

Extracorporeal Photopheresis (ECP) (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04986605 — Phase 2
Systemic Sclerosis Research Study Groups: Administration of Extracorporeal Photopheresis Treatment
Systemic Sclerosis Clinical Trial 2023: Extracorporeal Photopheresis (ECP) Highlights & Side Effects. Trial Name: NCT04986605 — Phase 2
Extracorporeal Photopheresis (ECP) (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04986605 — Phase 2
~10 spots leftby Dec 2026