Efalizumab for Moderate to Severe Atopic Dermatitis

NCT00226057 | Completed Phase 1

• 1 other identifier: 578
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Dermatitis, Atopic

Keywords

Atopic dermatitis; Raptiva

Outcome Measures

Primary Outcomes (1)

• 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

  EASI Score collected at 12 weeks following baseline

Secondary Outcomes (6)

• Improvement in EASI score

  Assessed 12 weeks after baseline

• Improvement in IGA score

  Assessed 12 weeks after baseline

• Subject's assessment of overall response

  End of study

• Change in serum IgE level

  Serum IgE collected at 12 weeks following baseline

• Pruritis (0-10 VAS Scale) change

  VAS scale collected at 12 weeks following baseline

Study Arms (1)

Raptiva Open Label

EXPERIMENTAL

Raptiva administered by weekly subcutaneous injections. First dose of 0.7mg/kg. Subsequent doses will be of 1mg/kg SQ weekly.

Drug: Raptiva

Interventions

Raptiva DRUG

Open Label

Also known as: Efalizumab

Raptiva Open Label

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability to provide written informed consent and comply with study assessments for the full duration of the study
• Age \>= 18 years
• If a female of child bearing potential, a negative pregnancy test and commitment to birth control for the duration of the study are necessary.
• Diagnosis of atopic dermatitis using the Hanifin-Rajka criteria
• Disease severity of Moderate or Severe on the Rajka-Langeland Severity Score
• Candidate for, or previously on systemic therapy, including cyclosporine, methotrexate, ultraviolet light or other immunosuppressant. Specifically, patients are considered candidates for systemic therapy when their disease is not adequately controlled using topical therapies or side-effects prevent the further safe use of topical therapies.
• Patients must meet the following washout requirements:
• 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

You may not qualify if:

• Patient's with known hypersensitivity to Raptiva (efalizumab) or any of its components
• Pregnant or lactating women
• Patients receiving immunosuppressive agents
• Prior enrollment in the study
• Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated.
• Participation in another simultaneous medical investigation or trial
• Subjects known to be immunocompromised(lymphoma, HIV+, Wiskott-Aldrich syndrome)
• Systemic corticosteroid-dependent asthma
• Active infection of any type at the time of enrollment

Sponsors & Collaborators

• Oregon Health and Science University: lead

Related Publications (6)

• Laughter D, Istvan JA, Tofte SJ, Hanifin JM. The prevalence of atopic dermatitis in Oregon schoolchildren. J Am Acad Dermatol. 2000 Oct;43(4):649-55. doi: 10.1067/mjd.2000.107773.

  PMID: 11004621 BACKGROUND

• Williams HC, Strachan DP. The natural history of childhood eczema: observations from the British 1958 birth cohort study. Br J Dermatol. 1998 Nov;139(5):834-9. doi: 10.1046/j.1365-2133.1998.02509.x.

  PMID: 9892950 BACKGROUND

• Werther WA, Gonzalez TN, O'Connor SJ, McCabe S, Chan B, Hotaling T, Champe M, Fox JA, Jardieu PM, Berman PW, Presta LG. Humanization of an anti-lymphocyte function-associated antigen (LFA)-1 monoclonal antibody and reengineering of the humanized antibody for binding to rhesus LFA-1. J Immunol. 1996 Dec 1;157(11):4986-95.

  PMID: 8943405 BACKGROUND

• Leung DY, Bhan AK, Schneeberger EE, Geha RS. Characterization of the mononuclear cell infiltrate in atopic dermatitis using monoclonal antibodies. J Allergy Clin Immunol. 1983 Jan;71(1 Pt 1):47-56. doi: 10.1016/0091-6749(83)90546-8.

  PMID: 6337197 BACKGROUND

• Reitamo S, Wollenberg A, Schopf E, Perrot JL, Marks R, Ruzicka T, Christophers E, Kapp A, Lahfa M, Rubins A, Jablonska S, Rustin M. Safety and efficacy of 1 year of tacrolimus ointment monotherapy in adults with atopic dermatitis. The European Tacrolimus Ointment Study Group. Arch Dermatol. 2000 Aug;136(8):999-1006. doi: 10.1001/archderm.136.8.999.

  PMID: 10926735 BACKGROUND

• Hanifin JM, Schneider LC, Leung DY, Ellis CN, Jaffe HS, Izu AE, Bucalo LR, Hirabayashi SE, Tofte SJ, Cantu-Gonzales G, et al. Recombinant interferon gamma therapy for atopic dermatitis. J Am Acad Dermatol. 1993 Feb;28(2 Pt 1):189-97. doi: 10.1016/0190-9622(93)70026-p.

  PMID: 8432915 BACKGROUND

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

efalizumab

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Eric L Simpson, MD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., M.C.R.

Study Record Dates

• First Submitted: September 22, 2005
• First Posted: September 26, 2005
• Study Start: June 1, 2005
• Primary Completion: November 1, 2005
• Study Completion: May 1, 2006
• Last Updated: January 3, 2020

Record last verified: 2019-12