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Moderate to Severe PsoriasisPhase 3NCT00442650

Efalizumab for Treatment of Patients With Moderate to Severe Psoriasis

A Phase 3 study testing Efalizumab in people with Moderate to Severe Psoriasis, run by Merck KGaA, Darmstadt, Germany at 1 site in Switzerland.

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

Multicentre, open label, phase III study. Subjects with moderate to severe psoriasis were given efalizumab subcutaneously once per week for the 12-week treatment period. Assessments involved physical examination, disease activity assessments, clinical laboratory tests (haematology, blood chemistry and standard… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Moderate to Severe Psoriasis
What is being tested?
Efalizumab
How many people
Not given
Where
1 siteSwitzerland
Study dates
Jan 2004to Dec 2005
Phase
Phase 3
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 to 75 years
  • All sexes
  • Adult, Older adult

Who may be able to join

  • Signed informed consent
  • Plaque psoriasis covering ³10% of total BSA
  • Diagnosis of plaque psoriasis for at least 6 months
  • A minimum PASI score of 12.0 at screening
  • In the opinion of the investigator, candidate for systemic therapy for psoriasis
  • Body weight of £120 kg
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  • 18 to 75 years old
  • For women of childbearing potential and for men whose partner can become pregnant, use of an acceptable method of contraception to prevent pregnancy and agreement to continue to practice an acceptable method of contraception for the duration of their participation in the study (including the FU period).
  • Willingness to hold sun exposure reasonably constant and to avoid use of tanning booths or other UV light sources during the study
  • Willingness to enter Study

Who cannot join

  • Guttate, erythrodermic, or pustular psoriasis as sole or predominant form of psoriasis
  • History of severe allergic or anaphylactic reactions to humanised monoclonal antibodies or fusion proteins that contain an Ig Fc region
  • Clinically significant psoriasis flare during screening or at the time of enrollment that would necessitate immediate relief for that patient
  • History of or ongoing uncontrolled bacterial, viral, fungal, or atypical mycobacterial infection
  • History of opportunistic infections (e.g., systemic fungal infections, parasites)
  • Seropositivity for human immunodeficiency virus (HIV)
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  • Patients will undergo mandatory testing at screening. Patients who are positive for HIV will be excluded.
  • Pregnancy or lactation
  • WBC count <4000/mL or >14,000/mL
  • Patients with an history of clinically significant thrombocytopenia, bleeding disorder or a platelet count <100,000/mL
  • Seropositivity for hepatitis B or C virus
  • Patients will undergo testing during screening. Patients who are positive for hepatitis B antigen or hepatitis C antibody will be excluded.
  • Hepatic enzymes ³3 times the upper limit of normal
  • History of active tuberculosis (TB) or currently undergoing treatment for TB
  • Chest X-ray within 3 months of Day 0 is required for all patients. Patients with a positive chest X-ray consistent with TB infection will be excluded.
  • Presence of malignancy within the past 5 years, including lymphoproliferative disorders
  • Patients with a history of fully resolved basal cell or squamous cell skin cancer may be enrolled even if it is less than 5 years.
  • Previous treatment with efalizumab (anti-CD11a)
  • Diagnosis of hepatic cirrhosis, regardless of cause or severity
  • Serum creatinine ³2 times the upper limit of normal
  • Hospital admission for cardiac disease, stroke, or pulmonary disease within the last year
  • History of substance abuse (e.g. narcotics, alcohol) within the last 5 years
  • Any medical condition that, in the judgment of the investigator, would jeopardize the patient's safety following exposure to study drug
  • Note: Restrictions and/or directions apply to the following treatments during specified time periods prior to initial study drug administration and during the study:
  • Systemic therapy for psoriasis within 28 days prior to Study Day 0
  • Systemic immunosuppressive drugs for other indications within 28 days prior to Study Day 0
  • Topical therapies for psoriasis within 14 days prior to Study Day 0
  • Live or killed virus or bacteria vaccines within 14 days prior to Study Day 0
  • Other vaccines or allergy desensitization within 14 days prior to study Day 0
  • Other experimental drugs or treatments within 28 days or five half lives, whichever is longer, prior to Day 0
  • Use of b Blockers, ACE inhibitors, interferons, quinidine, antimalarial drugs, or lithium (if clinically indicated, such medications are allowed but the dosage should be held constant from Day -28 throughout the study)

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • Merck Serono Medical Information Office

    Geneva

Other trials in Switzerland

About this study

Multicentre, open label, phase III study. Subjects with moderate to severe psoriasis were given efalizumab subcutaneously once per week for the 12-week treatment period. Assessments involved physical examination, disease activity assessments, clinical laboratory tests (haematology, blood chemistry and standard urinalysis), evaluation of the Psoriasis Area and Severity Index (PASI), the Physician's Global Assessment (PGA), the Patient's Global Psoriasis Assessment (PGPA), the SF-36 Health Survey and psoriatic body surface area (BSA). The 12-week treatment period was followed by a 12-week follow-up (FU) period, during which other antipsoriatic medications were allowed. The same assessments were also performed in the 12-week FU period.

Being tested
Efalizumab

What participants receive

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

  • EfalizumabDrug

Timeline

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

  1. First posted2 Mar 2007 (estimated)
  2. Study startJan 2004
  3. Primary completionDec 2005
  4. Study completionDec 2005

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 3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00442650
Sponsor's protocol ID
25030
Status last verified
Mar 2009
First submitted
28 Feb 2007
Last updated
21 Nov 2016
Results posted
No

Publications

  • Tsai TF, Liu MT, Liao YH, Licu D. Clinical effectiveness and safety experience with efalizumab in the treatment of patients with moderate-to-severe plaque psoriasis in Taiwan: results of an open-label, single-arm pilot study. J Eur Acad Dermatol Venereol. 2008 Mar;22(3):345-52. doi: 10.1111/j.1468-3083.2007.02430.x. Epub 2007 Nov 14.

    PubMed 18005021

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Efalizumab in people with Moderate to Severe Psoriasis, run by Merck KGaA, Darmstadt, Germany at 1 site in Switzerland.

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 10 inclusion and 31 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 21 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00442650, which also lists 1 linked publication.

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 21 Nov 2016.

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