A Phase 1 interventional study of Raptiva in Dermatitis, Atopic, sponsored by Oregon Health and Science University. Completed. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-01-03.
Sponsored by Oregon Health and Science University · Phase 1, Interventional, and Treatment
The purpose of this study is to determine if Raptiva will have beneficial effects in the treatment of patients with moderate to severe atopic dermatitis.
Atopic dermatitis is a common, highly pruritic, inflammatory skin disease that affects up to 17% of school-aged children. Most cases of childhood atopic dermatitis improve or resolve by adulthood. However, the majority of patients retain some features of atopic dermatitis and some continue to have severe disease that continues to adulthood. Moderate to severe atopic dermatitis cannot be adeuately controlled with topical agents. Consequently many patients are treated with systemic corticosteroids, cyclosporine, azathioprine, methotrexate, and other immunosuppressants that carry the risk of severe atopic dermatitis is greatly needed. The chronic use of current immunosuppressive agents is limited by cumulative end-organ toxicities. We propose inhibition of T cell trafficking to the skin with Raptiva will have beneficial effects in the treatment of patients with moderate to severe atopic dermatitis.
1,419 studies on the registry are indexed under Dermatitis, Atopic; 258 are open to participants now.
This study's enrollment of 10 is below the median of 83 across 1,125 interventional studies indexed under Dermatitis, Atopic.
Browse Dermatitis, Atopic studies →Oregon Health and Science University is the lead sponsor of 676 studies on the registry; 136 are open to participants now.
Of its 49 completed or terminated interventional studies of FDA-regulated products, 36 (73%) have results posted.
Counted across the registry records on this site, refreshed daily.
Pre-Study and Concomitant Washout Period Restriction (Baseline Therapy Restrictions Prior to Study Thru End of Study)
Investigational Drugs 4 Weeks Disallowed Light Treatments 4 Weeks Disallowed Systemic corticosteroid used 4 Weeks Disallowed for atopic dermatitis flare Topical tacrolimus or 2 Weeks Disallowed pimecrolimus Topical corticosteroids Must be on stable Allowed at stable doses dose for 2 weeks (Triamcinolone ointment 0.1% only) Any systemic 4 Weeks Disallowed immunosuppressive medication Topical and systemic antibiotics Cannot be on Allowed if infection antibiotics at the develops start of study
Exclusion Criteria:
Raptiva administered by weekly subcutaneous injections. First dose of 0.7mg/kg. Subsequent doses will be of 1mg/kg SQ weekly.
Drug: Raptiva
Open Label
Also known as: Efalizumab
Evaluate the safety and effectiveness of Raptiva in patients with moderate to severe atopic dermatitis
The primary efficacy outcome measure will be the change in mean Eczema Area and Severity Index (EASI) score from baseline
Time frame: EASI Score collected at 12 weeks following baseline
Improvement in EASI score
Total percent of patients reaching 50% improvement in EASI score
Time frame: Assessed 12 weeks after baseline
Improvement in IGA score
Numbers of patient reaching clear, almost clear or mild disease on the Investigator Global Assessment (IGA) Score
Time frame: Assessed 12 weeks after baseline
Subject's assessment of overall response
Subject's assessment of overall response
Time frame: End of study
Change in serum IgE level
Change in serum IgE Level
Time frame: Serum IgE collected at 12 weeks following baseline
Pruritis (0-10 VAS Scale) change
Pruritis (0-10 VAS Scale) change
Time frame: VAS scale collected at 12 weeks following baseline
Time to first response
Time to first response as defined by a decrease of 25% in EASI score
Time frame: Assessed on Days 28,56, and 84
No study locations are listed for this record.
This study is completed, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Oregon Health and Science University