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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
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
Patients with SSc, aged 18 years or older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 and 12 months
Awards & highlights

Study Summary

This trial will help researchers learn if a treatment called extracorporeal photopheresis is effective and safe for people with a disease called diffuse cutaneous systemic sclerosis.

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.Check my eligibility
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.See study design
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
Select...
I have early or active diffuse cutaneous systemic sclerosis.
Select...
I am 18 or older with systemic sclerosis.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in skin thickness measured by modified Rodnan Skin Score
Secondary outcome measures
Change in Forced Vital Capacity
Change in Scleroderma Health Assessment Questionnaire
Change in patient global assessment of health status
+8 more
Other outcome measures
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
+3 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%
Insomnia
24%
Acute kidney injury
24%
Alopecia
24%
Infections and infestations - Other, spe
24%
Dysgeusia
18%
Hypertension
18%
Weight loss
18%
Peripheral sensory neuropathy
18%
Hypotension
18%
Esophagitis
18%
Pruritus
18%
Constipation
18%
Hepatic failure
18%
Dizziness
12%
Sinus tachycardia
12%
Hyperhidrosis
12%
Injection site reaction
12%
Colitis
12%
Dehydration
12%
Dry skin
12%
Bladder infection
12%
Epistaxis
12%
Hypomagnesemia
12%
Muscle weakness lower limb
6%
Electrocardiogram QT corrected interval
6%
Sinus bradycardia
6%
Edema trunk
6%
Pneumonitis
6%
Pleural effusion
6%
Acute coronary syndrome
6%
Urinary tract infection
6%
Enterocolitis infectious
6%
Vascular disorders - Other, specify
6%
Purpura
6%
Mucositis oral
6%
Respiratory, thoracic and mediastinal di
6%
Pericardial effusion
6%
Hemorrhoids
6%
Depression
6%
Tremor
6%
Dry eye
6%
Eye disorders - Other, specify
6%
Hyperglycemia
6%
Hyperkalemia
6%
Hypokalemia
6%
Hyponatremia
6%
Confusion
6%
Hypoxia
6%
Pneumothorax
6%
Chills
6%
Erythema multiforme
6%
Abdominal distension
6%
Dry mouth
6%
Dysphagia
6%
Gastritis
6%
Thromboembolic event
6%
External ear inflammation
6%
Cushingoid
6%
Hot flashes
6%
Iron overload
6%
Heart failure
6%
Cardiac disorders - Other, specify
6%
Upper respiratory infection
6%
Hematuria
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%
Hiccups
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

Find a Location

Who is running the clinical trial?

Lawson Health Research InstituteLead Sponsor
654 Previous Clinical Trials
413,170 Total Patients Enrolled
MallinckrodtIndustry Sponsor
201 Previous Clinical Trials
16,252 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies available in this research project?

"The clinicaltrials.gov database reveals that this trial, first published on September 1st 2022 and last revised April 11th 2022, is not currently accepting participants. Despite its inactivity, there are 521 other medical trials actively enrolling patients."

Answered by AI

Are there any official certifications for the medicinal application of Extracorporeal Photopheresis (ECP) with Methoxsalen?

"Our team at Power has assessed the safety of Extracorporeal Photopheresis (ECP) with Methoxsalen to be a 2 as this is currently in Phase 2, indicating there is pre-existing data backing its security but none that validates efficacy."

Answered by AI
Recent research and studies
~10 spots leftby Dec 2026