Actively Recruiting
A Randomized Multicenter Study for Isolated Skin Vasculitis
Led by University of Pennsylvania · Updated on 2026-01-23
90
Participants Needed
16
Research Sites
626 weeks
Total Duration
On this page
Sponsors
U
University of Pennsylvania
Lead Sponsor
N
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Multi-center sequential multiple assignment randomized trial comparing the effectiveness of three different standard of care treatment options for patients with isolated skin vasculitis.
CONDITIONS
Official Title
A Randomized Multicenter Study for Isolated Skin Vasculitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with primary skin vasculitis limited to the skin without significant involvement of other organs requiring immunosuppressive therapy
- Diagnosis confirmed by skin biopsy including immunofluorescence for small vessel vasculitis
- Active skin vasculitis lasting at least 1 month continuously or 2 or more flares in the last 6 months
- Presence of active skin vasculitis lesions at enrollment (post-inflammatory lesions not considered active)
- Patients with contraindication or prior failure to one study drug may enroll directly in stage 2 with a cap of 10 patients
- Patients on prednisone must stop it within 6 weeks after enrollment following a tapering schedule
- Stable low-dose glucocorticoids (≤5 mg/day) for other conditions allowed if dose increase unlikely during study
- Age 18 years or older
You will not qualify if you...
- Significant involvement of organs outside the skin suggesting systemic vasculitis
- Known systemic or non-skin vasculitis such as granulomatosis with polyangiitis or detectable ANCA antibodies
- Secondary skin vasculitis due to autoimmune diseases, cancer, infection, or medication
- History of severe intolerance or allergy to study drugs with direct enrollment capped at 10 patients in stage 2
- Contraindications or prior failure to two or more of the study drugs
- Glucose-6-phosphate dehydrogenase deficiency or history of hemolytic anemia with restricted enrollment
- Low or absent thiopurine methyltransferase activity if known
- Significant liver or kidney dysfunction (liver tests >2x normal, creatinine clearance <60 mL/min)
- Significant or symptomatic anemia (Hb <10 g/dL)
- Comorbid condition likely requiring prednisone courses during study
- Active cancer or cancer history within 5 years except certain remissions and skin cancers
- Active uncontrolled or serious infections
- Unable to give informed consent
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 16 locations
1
University of Kansas Medical Center
Kansas City, Kansas, United States
Actively Recruiting
2
Boston University School of Medicine
Boston, Massachusetts, United States, 02118
Completed
3
Mayo Clinic
Rochester, Minnesota, United States, 55905
Completed
4
Northwell Health
Lake Success, New York, United States, 11042
Completed
5
Hospital for Special Surgery
New York, New York, United States, 10021
Completed
6
Cleveland Clinic
Cleveland, Ohio, United States
Completed
7
Penn State Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Completed
8
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
9
Vanderbilt University
Nashville, Tennessee, United States, 37232
Actively Recruiting
10
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
11
University of Utah
Salt Lake City, Utah, United States
Completed
12
University of Virginia
Charlottesville, Virginia, United States, 22903
Actively Recruiting
13
St. Joseph's Healthcare
Hamilton, Ontario, Canada
Actively Recruiting
14
University of Toronto Mount Sinai Hospital
Toronto, Ontario, Canada
Actively Recruiting
15
McGill University Health Centre
Montreal, Quebec, Canada, H4A 3J1
Actively Recruiting
16
Tohoku Medical and Pharmaceutical University Hospital
Kyoto, Japan, 602-8566
Completed
Research Team
C
Carol McAlear, MA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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