PsoriasisPhase 3NCT00109317
A Study to Evaluate Raptiva in Adults With Moderate to Severe Plaque Psoriasis Who Are Candidates for Systemic Therapy
A Phase 3 study testing Raptiva (efalizumab) in people with Psoriasis, run by Genentech, Inc..
Trial summary
This is a Phase IIIb, randomized, double-blind, parallel-group, placebo-controlled, multicenter study designed to evaluate the safety and tolerability of efalizumab administered subcutaneously at weekly doses of 1.0 mg/kg in subjects with moderate to severe plaque psoriasis who are candidates for systemic therapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Psoriasis
- What is being tested?
- Raptiva (efalizumab)
- How many people
- 686 participants
- Where
- No sites listed yet
- Study dates
- Sep 2002to Feb 2003
- 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
- Diagnosis of plaque psoriasis for at least 6 months
- Minimal PASI score of 12.0 at screening
- In the opinion of the investigator, candidate for systemic therapy for psoriasis who has not been previously treated (naive to systemic treatment) or prior treatment with systemic therapy for psoriasis (e.g., PUVA, cyclosporine, corticosteroids, methotrexate, oral retinoids, MMF, thioguanine, hydroxyurea, sirolimus, azathioprine, 6-MP, etanercept)
- Body weight of <=140 kg
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- 18 to 75 years old
- For women of childbearing potential, willingness to use an acceptable method of contraception to prevent pregnancy for the duration of the study
- 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 ACD2601g
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 flare during screening or on the day of randomization
- 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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- Pregnancy or lactation
- WBC count <4000/uL or >14,000/uL
- Seropositivity for hepatitis B or C virus
- Hepatic enzymes >=3x the upper limits of normal (ULN)
- History of active tuberculosis (TB) or currently undergoing treatment for TB
- Presence 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
- Serum creatinine >=2x the ULN
- Hospital admission for cardiac disease, stroke, or pulmonary disease within the last year
- History of substance abuse within the last 5 years
- Any medical condition that, in the judgment of the investigator, would jeopardize the subject's safety following exposure to study drug
About this study
Official title: A Phase IIIb, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Multicenter Study to Evaluate the Safety of 1.0 mg/kg Subcutaneously Administered Efalizumab in Adults With Moderate to Severe Plaque Psoriasis Who Are Candidates for Systemic Therapy
This is a Phase IIIb, randomized, double-blind, parallel-group, placebo-controlled, multicenter study designed to evaluate the safety and tolerability of efalizumab administered subcutaneously at weekly doses of 1.0 mg/kg in subjects with moderate to severe plaque psoriasis who are candidates for systemic therapy.
- Conditions
- Psoriasis
- Being tested
- Raptiva (efalizumab)
- Keywords
- Moderate Plaque Psoriasis, Severe Plaque Psoriasis, Topical
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Raptiva (efalizumab)Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2005 (estimated)
- Study startSep 2002
- Study completionFeb 2003
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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 686 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00109317
- Sponsor's protocol ID
- ACD2600g
- Status last verified
- Jun 2013
- First submitted
- 27 Apr 2005
- Last updated
- 21 Jun 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIIb, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Multicenter Study to Evaluate the Safety of 1.0 mg/kg Subcutaneously Administered Efalizumab in Adults With Moderate to Severe Plaque Psoriasis Who Are Candidates for Systemic Therapy
- ClinicalTrials.gov ID
- NCT00109317
- Acronym / sponsor ID
- ACD2600g
- Conditions
- Psoriasis
- Keywords
- Moderate Plaque Psoriasis, Severe Plaque Psoriasis, Topical
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 686 participants (actual)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2002
- Study completion
- Feb 2003 (actual)
- First posted
- 27 Apr 2005 (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, randomized, double-blind, parallel-group, placebo-controlled, multicenter study designed to evaluate the safety and tolerability of efalizumab administered subcutaneously at weekly doses of 1.0 mg/kg in subjects with moderate to severe plaque psoriasis who are candidates for systemic therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Signed informed consent
- Plaque psoriasis covering >=10% of total BSA
- Diagnosis of plaque psoriasis for at least 6 months
- Minimal PASI score of 12.0 at screening
- In the opinion of the investigator, candidate for systemic therapy for psoriasis who has not been previously treated (naive to systemic treatment) or prior treatment with systemic therapy for psoriasis (e.g., PUVA, cyclosporine, corticosteroids, methotrexate, oral retinoids, MMF, thioguanine, hydroxyurea, sirolimus, azathioprine, 6-MP, etanercept)
Key exclusion criteria (18 listed)
- 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 flare during screening or on the day of randomization
- 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 |
|---|---|---|
| Raptiva (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 21 Jun 2013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Raptiva (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 10 inclusion and 18 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 Jun 2013. 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 21 Jun 2013.