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Dermatitis, AtopicPhase 1NCT00226057

Efalizumab for Moderate to Severe Atopic Dermatitis

A Phase 1 study testing Raptiva in people with Dermatitis, Atopic, run by Oregon Health and Science University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Dermatitis, Atopic
What is being tested?
Raptiva
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
No sites listed yet
Study dates
Jun 2005to May 2006
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 9Show fewer
  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • Subjects known to be immunocompromised(lymphoma, HIV+, Wiskott-Aldrich syndrome)
  • Systemic corticosteroid-dependent asthma
  • Active infection of any type at the time of enrollment

About this study

Official title: Efalizumab for Moderate to Severe Atopic Dermatitis - A Phase I Pilot Study in Adults

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.

Read the detailed description

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.

Being tested
Raptiva
Keywords
Atopic dermatitis, Raptiva
Medical subject headings
Dermatitis, Atopic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RaptivaDrug

    Also called Efalizumab

    Open Label

Study groups in NCT00226057
Study groupRoleWhat they receive
Raptiva Open LabelExperimentalRaptiva administered by weekly subcutaneous injections. First dose of 0.7mg/kg. Subsequent doses will be of 1mg/kg SQ weekly.
Receives: Drug: Raptiva

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: EASI Score collected at 12 weeks following baseline

Secondary outcomes (6)

  1. Improvement in EASI score

    Total percent of patients reaching 50% improvement in EASI score

    Measured: Assessed 12 weeks after baseline

  2. Improvement in IGA score

    Numbers of patient reaching clear, almost clear or mild disease on the Investigator Global Assessment (IGA) Score

    Measured: Assessed 12 weeks after baseline

  3. Subject's assessment of overall response

    Subject's assessment of overall response

    Measured: End of study

  4. Change in serum IgE level

    Change in serum IgE Level

    Measured: Serum IgE collected at 12 weeks following baseline

  5. Pruritis (0-10 VAS Scale) change

    Pruritis (0-10 VAS Scale) change

    Measured: VAS scale collected at 12 weeks following baseline

  6. Time to first response

    Time to first response as defined by a decrease of 25% in EASI score

    Measured: Assessed on Days 28,56, and 84

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Sep 2005 (estimated)
  2. Study startJun 2005
  3. Primary completionNov 2005
  4. Study completionMay 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00226057
Sponsor's protocol ID
578
Status last verified
Dec 2019
First submitted
22 Sep 2005
Last updated
3 Jan 2020
Results posted
No

Publications

  • 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.

    PubMed 11004621

  • 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.

    PubMed 9892950

  • 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.

    PubMed 8943405

  • 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.

    PubMed 6337197

  • 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.

    PubMed 10926735

  • 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.

    PubMed 8432915

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Raptiva in people with Dermatitis, Atopic, run by Oregon Health and Science University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluate the safety and effectiveness of Raptiva in patients with moderate to severe atopic dermatitis (time frame: EASI Score collected at 12 weeks following baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00226057, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2020.

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