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Monoclonal Antibodies

NB-UVB phototherapy for Psoriasis (VIP Trial)

Phase 4
Waitlist Available
Led By Joel Gelfand, MD MSCE
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline week 4, 8 and 12
Awards & highlights
All Individual Drugs Already Approved
Drug Has Already Been Approved
Pivotal Trial

Summary

The purpose of this study is to assess the effect of adalimumab (Humira), when compared to NB-UVB (narrow-band ultraviolet B) phototherapy or placebo (an inactive substance that may resemble an active substance but has no medical value) injection. The study will compare the effects of each on systemic inflammation and cardiovascular disease risk factors in subjects diagnosed with moderate to severe psoriasis. This study will look for systemic vascular inflammation in subjects with a test called FDG-PET/CT (Fluorodeoxyglucose-positron emission tomography/computed tomography). The study will also look for cardio metabolic (heart disease and metabolic factors such as diabetes) identifiers in the blood. A blood sample will be taken that will look for these markers identifying high cholesterol, cholesterol efflux function (the ability of cholesterol to move in the body), metabolic factors, and inflammation. This study will also assess the effect of adalimumab (Humira), when compared to NB-UVB phototherapy or placebo injection on psoriasis activity and severity. The study will also compare the safety of adalimumab (Humira) to NB-UVB phototherapy or placebo injection. This study will also evaluate subjects' reported outcomes through a questionnaire that will assess quality-of-life in subjects living with psoriasis.

Eligible Conditions
  • Psoriasis
  • Cardiovascular Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline week 4, 8 and 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline week 4, 8 and 12 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 Cardiometabolic Biomarkers: Cholesterol Efflux
Change in Cardiometabolic Biomarkers: GlycA
Change in Cardiometabolic Biomarkers: High Density Lipoprotein Particle Total
+9 more
Secondary study objectives
Change in Patient-reported Outcomes-Dermatology Life Quality Index (DLQI)
Change in Patient-reported Outcomes-EuroQol EQ-5D
Change in Patient-reported Outcomes-International Physical Activity Questionnaire (IPAQ)
+3 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.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups
Active Control
Placebo Group
Group I: NB-UVB phototherapyActive Control1 Intervention
NB-UVB Phototherapy 3 times per week, no other intervention.
Group II: Adalimumab (Humira)Active Control1 Intervention
Injection of the active drug Humira.
Group III: Placebo InjectionPlacebo Group1 Intervention
Injection of placebo in place of active Humira injection.

Find a Location

Who is running the clinical trial?

University of PennsylvaniaLead Sponsor
2,082 Previous Clinical Trials
42,727,206 Total Patients Enrolled
11 Trials studying Psoriasis
2,701 Patients Enrolled for Psoriasis
Joel Gelfand, MD MSCEPrincipal InvestigatorUniversity of Pennsylvania
~7 spots leftby Dec 2025