AzTrials
AzTrials

Plaque PsoriasisPhase 4NCT00302445

A Safety and Efficacy Study to Evaluate Efalizumab in Combination With UVB for Moderate to Severe Psoriasis

A Phase 4 study testing Efalizumab and Narrow Band Phototherapy in people with Plaque Psoriasis, run by Derm Research, PLLC at 2 sites in United States.

Completed

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

Official record
Search all trials

Trial summary

An open label, single arm study to evaluate the study and efficacy of efalizumab in combination with NB-UVB. Weeks 1-12 efalizumab will be administered once a week in combination with NB-UVB three times per week. Weeks 13-24 efalizumab monotherapy will continue. Weeks 25-36 subjects will be followed for safety. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Plaque Psoriasis
What is being tested?
Efalizumab and Narrow Band Phototherapy
Type of treatment
Medical device
How many people
20 participants
Where
2 sitesUnited States
Study dates
Mar 2006to Jul 2007
Phase
Phase 4
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

  • Subject has given informed consent
  • Subject is in generally good health, and an ambulatory male or female adult (18 years or older)
  • Subject has moderate to severe plaque psoriasis affecting greater than or equal to 5% body surface area
  • Subject is a candidate for efalizumab in combination with narrowband UVB phototherapy in the opinion of the assessing investigator
  • If a female of childbearing potential, a negative pregnancy test and commitment to the use of two forms of effective contraception (birth control) for the duration of the study are necessary
  • If a non-sterile male, commitment to the use of two forms of effective contraception (birth control) for the duration of the study is necessary.

Who cannot join

  • Subject is not in generally good health in the opinion of the investigator
  • Subject has a history of a phototoxic reaction
  • Subject has a history of NB-UVB failure or severe side effects from UVB that resulted in discontinuation of treatment
  • Subject has erythrodermic, pustular, inverse or guttate psoriasis
  • Subject is currently using other psoriasis treatments
  • Subject has used other psoriasis treatments, including herbal products or alternative therapies within 2 months (biologics), 1 month (systemic therapies including methotrexate, cyclosporine and acitretin, PUVA, Broadband UVB, NB-UVB, and tanning beds), or 2 weeks (topical therapies) of first dose of efalizumab or NB-UVB
Show all 22Show fewer
  • Subject is currently enrolled in any other study except non-treatment, biopsy studies
  • Subject has a history of any form of cancer, including lymphoma, with the exception of non-melanoma skin cancer
  • Subject has a genetic disorder that predisposes to cancer (e.g. xeroderma pigmentosum)
  • Subject has a history of squamous cell cancer within the past 5 years or basal cell cancer within the past 3 months in areas that will be treated with NB-UVB
  • Subject has a history of significant drug or alcohol abuse
  • Pregnant women, nursing mothers, or women planning to become pregnant during the study
  • Subject with congenital or acquired immunodeficiency
  • Subjects planning to have prolonged exposure to the sun or tanning beds during the study which, in the investigator's clinical judgement, may modify the subject's disease severity
  • Subject has a history of lupus erythematosus, bullous pemphigoid or any other photosensitive condition which may worsen with NB-UVB
  • Subject is taking a medication that causes photosensitivity at the discretion of the investigator
  • Subject has an active infection or sepsis prior history or serious infection or tendency to get infections easily
  • Subject has an untreated positive PD
  • Subject has a blood disorder, aplastic anemia, bleeding tendency
  • Subject is allergic to efalizumab or any of its components
  • Subject has any other condition that, in the opinion of the investigator, makes subject a poor candidate for entry into the study
  • Subject will be vaccinated with live vaccines (e.g. Flu-Mist) during the study period.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Derm Research, PLLC

    Louisville, Kentucky, 40217

  • Dermatology Associates, PLLC

    Seattle, Washington, 98101

Other trials in United States

About this study

Official title: An Open-Label Pilot Study to Evaluate the Efficacy and Safety of Raptiva (Efalizumab)in Combination With Narrow Band Phototherapy for the Treatment of Moderate to Severe Plaque Psoriasis.

An open label, single arm study to evaluate the study and efficacy of efalizumab in combination with NB-UVB. Weeks 1-12 efalizumab will be administered once a week in combination with NB-UVB three times per week. Weeks 13-24 efalizumab monotherapy will continue. Weeks 25-36 subjects will be followed for safety.

Subjects with moderate to severe plaque psoriasis often require more than one therapy to treat their disease. Because of the different mechanisms of action, it is thought that combined efalizumab and NB-UVB may be more effective and have a more rapid onset than either treatment alone.

Read the detailed description

This is an open label, single arm, phase IV study to evaluate the study and efficacy of efalizumab in combination with NB-UVB. After screening, review of inclusion and exclusion criteria and obtaining informed consent, 20 subjects from two sites (10 subjects per site) will enter the study. The estimated rate of accrual is two subjects per month per site for a total of five months. The estimated date of study conclusion, including follow-up is January 2007.

Weeks 1-12 efalizumab will be administered subcutaneously once a week in combination with NB-UVB three times per week. At week 12, NB-UVB will be discontinued. Weeks 13-24 efalizumab monotherapy will continue to determine whether or not relapse occurs. Relapse is defined as a 50% decrease in total improvement in PASI score from baseline. Weeks 25-36 subjects will be followed for safety. Patients will be transitioned to appropriate treatment at the discretion of the investigator and/or observed closely.

Subjects with moderate to severe plaque psoriasis often require more than one therapy to treat their disease. Because of the different mechanisms of action, it is thought that combined efalizumab and NB-UVB may be more effective (percent subjects who achieve PASI 75 at 12 weeks) and have a more rapid onset than either treatment alone. This study will examine combining efalizumab with NB-UVB phototherapy for twelve weeks. Then, NB-UVB will be discontinued and efalizumab will be continued for an additional twelve weeks to determine if the achieved effect from combination therapy can be sustained with monotherapy.

The follow-up observation period from 25-36 weeks was chosen to permit an adequate amount of time to observe for any signs of disease rebound and/or adverse events after discontinuation of efalizumab and to insure that subjects are treated for such conditions appropriately.

Being tested
Efalizumab, Narrow Band Phototherapy

What participants receive

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

  • EfalizumabDrug

  • Narrow Band PhototherapyDevice

What is being measured

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

  1. Percent subjects who reach PASI 75 at week 12.

    Measured: Week 12

Secondary outcomes (6)

  1. Percent subjects who reach PASI 90 at weeks 12 and 24

    Measured: Week 12 and 24

  2. Percent subjects who reach PASI 75 at week 24

    Measured: Week 24

  3. Percent subjects who reach PASI 50 at weeks 12 and 24

    Measured: Week 12 and 24

  4. Percent subjects who achieve improvement from baseline on

    Measured: Baseline, Week 12, Week 24

  5. the DLQI at weeks 12 and 24

    Measured: Week 12 and Week 24

  6. Percent subjects who relapse between weeks 12 and 24

    Measured: Week 12, Week 24

Timeline

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

  1. First posted14 Mar 2006 (estimated)
  2. Study startMar 2006
  3. Study completionJul 2007

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 4
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00302445
Sponsor's protocol ID
ACD3588s
Status last verified
Jul 2007
First submitted
10 Mar 2006
Last updated
13 Jul 2007
Results posted
No
Data monitoring committee
Yes

Publications

  • Berneburg M, Rocken M, Benedix F. Phototherapy with narrowband vs broadband UVB. Acta Derm Venereol. 2005;85(2):98-108. doi: 10.1080/00015550510025579.

    PubMed 15823900

  • Fredriksson T, Pettersson U. Severe psoriasis--oral therapy with a new retinoid. Dermatologica. 1978;157(4):238-44. doi: 10.1159/000250839.

    PubMed 357213

  • Gupta G, Long J, Tillman DM. The efficacy of narrowband ultraviolet B phototherapy in psoriasis using objective and subjective outcome measures. Br J Dermatol. 1999 May;140(5):887-90. doi: 10.1046/j.1365-2133.1999.02820.x.

    PubMed 10354027

  • Ibbotson SH, Bilsland D, Cox NH, Dawe RS, Diffey B, Edwards C, Farr PM, Ferguson J, Hart G, Hawk J, Lloyd J, Martin C, Moseley H, McKenna K, Rhodes LE, Taylor DK; British Association of Dermatologists. An update and guidance on narrowband ultraviolet B phototherapy: a British Photodermatology Group Workshop Report. Br J Dermatol. 2004 Aug;151(2):283-97. doi: 10.1111/j.1365-2133.2004.06128.x.

    PubMed 15327535

  • Weischer M, Blum A, Eberhard F, Rocken M, Berneburg M. No evidence for increased skin cancer risk in psoriasis patients treated with broadband or narrowband UVB phototherapy: a first retrospective study. Acta Derm Venereol. 2004;84(5):370-4. doi: 10.1080/00015550410026948.

    PubMed 15370703

  • 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

  • Fitzpatrick T and Ortonne JP in Fitzpatrick's Dermatology in General Medicine, Editors: Freedberg IM, Eisen AZ, Wolff K, Austen KF, Goldsmith LA, Katz, SI, 6th Edition 2003 McGraw-Hill; Chapter 88, Page 819

  • Sminkels OQ, Prins M, Veeniiuis RT, De Boo T, Gerritsen MJ, Van Der Wilt GJ, Van De Kerkhof PC, Van Der Valk PG. Effectiveness and side effects of UVB-phototherapy, dithranol inpatient therapy and a care instruction programme of short contact dithranol in moderate to severe psoriasis. Eur J Dermatol. 2004 May-Jun;14(3):159-65.

    PubMed 15246941

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Efalizumab and Narrow Band Phototherapy in people with Plaque Psoriasis, run by Derm Research, PLLC at 2 sites in United States.

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 6 inclusion and 22 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 13 Jul 2007. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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?

Percent subjects who reach PASI 75 at week 12. (time frame: Week 12). 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 NCT00302445, which also lists 8 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 13 Jul 2007.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in