PsoriasisPhase 3NCT00338143
A Study to Evaluate Efalizumab in Adults With Plaque Psoriasis, Including Those Who Are Receiving Concomitant Antipsoriatic Therapies
A Phase 3 study testing efalizumab in people with Psoriasis, run by Genentech, Inc..
Trial summary
This is a Phase IIIb, open label, uncontrolled, multicenter study designed to evaluate the safety and tolerability of 12 weeks of subcutaneously administered efalizumab in subjects with moderate to severe plaque psoriasis who are candidates for systemic therapy and may also be receiving topical therapies, PUVA, or UVB… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Psoriasis
- What is being tested?
- efalizumab
- How many people
- 1,200 participants
- Where
- No sites listed yet
- Study dates
- Oct 2003to May 2004
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent
- Plaque psoriasis covering >=10% of total BSA
- Plaque psoriasis diagnosed for at least 6 months
- In the opinion of the investigator, a candidate for systemic therapy for psoriasis
- 18-75 years old
- Body weight <=125 kg
- For women of childbearing potential, 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 and for 3 months after the last dose of efalizumab
Who cannot join
- Guttate, erythrodermic, or pustular psoriasis as sole or predominant form of psoriasis
- Pregnancy or lactation
- Clinically significant psoriasis flare 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 hepatitis B or C virus
Show all 21Show fewer
- Seropositivity for human immunodeficiency virus (HIV)
- History of active tuberculosis (TB) or currently undergoing treatment for TB
- Presence or history of malignancy within the past 5 years, including lymphoproliferative disorders
- Previous treatment with efalizumab (anti-CD11a)
- Diagnosis of hepatic cirrhosis, regardless of cause or severity
- Hospital admission for cardiovascular or pulmonary disease within the last year
- History of severe allergic or anaphylactic reactions to monoclonal antibodies or fusion proteins, which contain an Ig Fc region (e.g., etanercept, alefacept)
- History of treatment with lymphocyte-depleting monoclonal antibodies or immunoadhesion molecules (e.g., anti-CD4, CTLA4-Ig, alefacept)
- White blood cell (WBC) count < 4000/uL or > 14,000/uL
- Hepatic enzymes >= 3 times the upper limit of normal
- Creatinine >= 2 times the upper limit of normal
- Use of experimental drugs or treatments within 30 days or five half-lives, whichever is longer, prior to the first dose of efalizumab
- Use of a live virus or live bacteria vaccine in the 14 days prior to the first dose of efalizumab
- Any medical condition that, in the judgment of the investigator, would jeopardize the subject's safety following exposure to study drug or would significantly interfere with the subject's ability to comply with the provisions of this protocol
- Restrictions and/or directions apply to the following treatments during specified time periods prior to and during the efalizumab treatment period: Systemic therapy for psoriasis (biologic and non-biologic); Systemic immunosuppressive drugs for conditions other than psoriasis; Live virus or bacteria vaccine (these vaccines may include, but are not limited to, measles, mumps, rubella, polio, BCG, yellow fever, and TY21a typhoid); Other vaccines or allergy desensitization injections
About this study
Official title: A Phase IIIb, Open-Label, Multicenter Study to Evaluate the Safety of 1.0 mg/kg Subcutaneously Administered Efalizumab in Adults With Moderate to Severe Plaque Psoriasis, Including Those Who Are Receiving Concomitant Antipsoriatic Therapies or Have Recently Transitioned From Systemic Therapies
This is a Phase IIIb, open label, uncontrolled, multicenter study designed to evaluate the safety and tolerability of 12 weeks of subcutaneously administered efalizumab in subjects with moderate to severe plaque psoriasis who are candidates for systemic therapy and may also be receiving topical therapies, PUVA, or UVB phototherapy during the efalizumab treatment period.
- Conditions
- Psoriasis
- Being tested
- efalizumab
- Keywords
- Plaque psoriasis, Antipsoriatic
- Medical subject headings
- Psoriasis
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.
- First posted20 Jun 2006 (estimated)
- Study startOct 2003
- Study completionMay 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by Genentech, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Enrolment
- 1,200 participants
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ivor Caro, M.D., Study director, Genentech, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00338143
- Sponsor's protocol ID
- ACD2782g
- Status last verified
- Feb 2014
- First submitted
- 15 Jun 2006
- Last updated
- 4 Mar 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIIb, Open-Label, Multicenter Study to Evaluate the Safety of 1.0 mg/kg Subcutaneously Administered Efalizumab in Adults With Moderate to Severe Plaque Psoriasis, Including Those Who Are Receiving Concomitant Antipsoriatic Therapies or Have Recently Transitioned From Systemic Therapies
- ClinicalTrials.gov ID
- NCT00338143
- Acronym / sponsor ID
- ACD2782g
- Conditions
- Psoriasis
- Keywords
- Plaque psoriasis, Antipsoriatic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,200 participants
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2003
- Study completion
- May 2004 (actual)
- First posted
- 20 Jun 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase IIIb, open label, uncontrolled, multicenter study designed to evaluate the safety and tolerability of 12 weeks of subcutaneously administered efalizumab in subjects with moderate to severe plaque psoriasis who are candidates for systemic therapy and may also be receiving topical therapies, PUVA, or UVB phototherapy during the efalizumab treatment period.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Signed informed consent
- Plaque psoriasis covering >=10% of total BSA
- Plaque psoriasis diagnosed for at least 6 months
- In the opinion of the investigator, a candidate for systemic therapy for psoriasis
- 18-75 years old
Key exclusion criteria (21 listed)
- Guttate, erythrodermic, or pustular psoriasis as sole or predominant form of psoriasis
- Pregnancy or lactation
- Clinically significant psoriasis flare 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| efalizumab | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ivor Caro, M.D. study director
Genentech, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing efalizumab in people with 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 7 inclusion and 21 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 4 Mar 2014. 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 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?
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 4 Mar 2014.