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Plaque PsoriasisPhase 1NCT00382512

A Study to Evaluate the Effects of Efalizumab on Immune Responses in Subjects With Moderate Plaque Psoriasis

A Phase 1 study testing Raptiva (efalizumab) in people with Plaque Psoriasis, run by Genentech, Inc..

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

This is a Phase I, randomized, placebo-controlled, single blind, parallel group, single-center study designed to evaluate immune responses during and after administration of 12 weekly SC doses of 1.0 mg/kg efalizumab in subjects with moderate plaque psoriasis. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Plaque Psoriasis
What is being tested?
Raptiva (efalizumab)
How many people
60 participants
Where
No sites listed yet
Study dates
May 2003to not given
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 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed informed consent
  • Plaque psoriasis covering 8%-15% of the total BSA
  • Diagnosis of plaque psoriasis for at least 6 months
  • Body weight of ≤140 kg
  • 18 to 65 years old
  • For women of childbearing potential and men who may father children, 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 (the following methods of contraception are acceptable: condom; abstinence; oral, implantable or injectable contraceptives by the sexual partner; IUD, female condom, diaphragm with spermicide, cervical cap; a sterile sexual partner)
  • Willingness to hold sun exposure reasonably constant and to avoid use of tanning booths or other UV light sources during the study
  • History of tetanus vaccination

Who cannot join

  • Guttate, erythrodermic, or pustular psoriasis as sole or predominant form of psoriasis
  • History of severe allergic or anaphylactic reactions to humanized monoclonal antibodies or fusion proteins that contain an Ig Fc region
  • Clinically significant psoriasis exacerbation during screening or at the time of enrollment
  • 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)
Show all 29Show fewer
  • Pregnancy or lactation
  • White blood cell (WBC) count <4000/uL or >14,000/uL
  • Seropositivity for hepatitis B or C virus
  • Hepatic enzymes ≥3 times the upper limit of normal
  • Tetanus or pneumococcal vaccination during the 6 months prior to the start of the study (Treatment Day 0) or failure to complete a primary series of tetanus immunizations
  • Known hypersensitivity reaction to tetanus or diphtheria toxoid
  • Known hypersensitivity to any of the administered vaccinations or their components
  • History of active tuberculosis (TB) or currently undergoing treatment for TB
  • Positive purified protein derivative (PPD) (tuberculin) testing at screening (as defined by CDC Guidelines, see Appendix C for test assessment criteria and listing of high-risk groups)
  • Presence of malignancy within the past 5 years, including lymphoproliferative disorders
  • Treatment with efalizumab (anti-CD11a) within the last 12 months
  • Previous administration of <phi>X174
  • Diagnosis of hepatic cirrhosis, regardless of cause or severity
  • Serum creatinine ≥2 times the upper limit of normal
  • Hospital admission for cardiac disease, stroke, or pulmonary disease within the last year
  • History of substance abuse within the last 5 years as judged by the Principal Investigator
  • Any medical condition that, in the judgment of the investigator, would jeopardize the subject's safety following exposure to study drug
  • Systemic therapy for psoriasis (Screening Day -28 through FU Day 98)
  • Systemic immunosuppressive drugs for any indications (Screening Day -28 through FU Day 98)
  • Live virus or bacteria vaccines other than protocol specified (Screening Day -14 through Treatment Day 84)
  • Other vaccines or allergy desensitization (must be scheduled at least 14 days prior to Treatment Day 0 or after FU Day 98)
  • Other experimental drugs or treatments (within 90 days or five half-lives, whichever is longer, prior to Treatment Day 0 and through FU Day 98)
  • <beta>-Blockers, angiotensin-converting enzyme (ACE) inhibitors, quinidine, antimalarial drugs, or lithium (if clinically indicated, such medications are allowed but the dosage should be held constant between Screening Day -28 and Treatment Day 84)

About this study

Official title: A Randomized, Placebo-Controlled, Single-Blind, Parallel-Group Study to Evaluate the Effects of 12 Weekly Subcutaneous Doses of 1.0 mg/kg Efalizumab on Immune Responses in Subjects With Moderate Plaque Psoriasis

This is a Phase I, randomized, placebo-controlled, single blind, parallel group, single-center study designed to evaluate immune responses during and after administration of 12 weekly SC doses of 1.0 mg/kg efalizumab in subjects with moderate plaque psoriasis.

Being tested
Raptiva (efalizumab)
Keywords
Moderate Plaque Psoriasis

What participants receive

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

  • Raptiva (efalizumab)Drug

What is being measured

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

  1. Mean concentrations of anti-<phi>X174 antibodies in the FU period 2 weeks after the FU Day 70 vaccinations in Group A compared with mean antibody concentrations 2 weeks after the Treatment Day 63 vaccination in Group C

  2. Mean concentrations of anti-<phi>X174 antibodies in the FU period 2 weeks after the FU Day 70 vaccination in Group B compared with mean antibody concentrations 2 weeks after the Treatment Day 63 vaccination in Group C.

Secondary outcomes (6)

  1. Characterization of mean concentrations of anti-<phi>X174 antibodies 2 weeks after the FU Day 42 vaccination in Group A compared with mean antibody concentrations 2 weeks after the Treatment Day 35 vaccination in Group C

  2. Characterization of mean concentrations of anti-<phi>X174 antibodies 2 weeks after the FU Day 42 vaccination in Group B compared with mean antibody concentrations 2 weeks after the Treatment Day 35 vaccination in Group C

  3. Characterization of mean anti-<phi>X174 concentrations 2 and 4 weeks after the first and 2 and 4 weeks after the second <phi>X174 vaccinations during efalizumab treatment (Group A) compared with placebo (Group C)

  4. Characterization of mean concentrations of anti-tetanus IgG during treatment with efalizumab compared with placebo, representing a secondary humoral immune response

  5. Characterization of anti-pneumococcal antibody concentrations on FU Day 70 after pneumococcal vaccination on FU Day 42 compared with placebo

  6. Percentage of subjects with positive skin test reactions to tetanus and Candida-recall antigens on FU Day 77 after washout from efalizumab compared with baseline.

Timeline

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

  1. First posted29 Sep 2006 (estimated)
  2. Study startMay 2003

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
Randomised
Intervention model
Parallel groups
Masking
Single blind
Enrolment
60 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00382512
Sponsor's protocol ID
ACD2244g
Status last verified
Sep 2006
First submitted
27 Sep 2006
Last updated
29 Sep 2006
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Raptiva (efalizumab) in people with Plaque Psoriasis, run by Genentech, Inc..

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 8 inclusion and 29 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 29 Sep 2006. 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?

Mean concentrations of anti-<phi>X174 antibodies in the FU period 2 weeks after the FU Day 70 vaccinations in Group A compared with mean antibody concentrations 2 weeks after the Treatment Day 63 vaccination in Group C. The study lists 2 primary outcomes in all. 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 NCT00382512.

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 29 Sep 2006.

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