PsoriasisPhase 4NCT00312026
A Study to Evaluate the Safety and Efficacy of Efalizumab in Adult Patients With Plaque Psoriasis Involving the Hands and/or Feet
A Phase 4 study testing efalizumab in people with Psoriasis, run by Genentech, Inc..
Trial summary
This is a Phase IV randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of SC efalizumab in adult patients (18 years of age and older) with chronic moderate to severe plaque psoriasis involving the hands and/or feet who have had no previous exposure to efalizumab. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis
- What is being tested?
- efalizumab
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- 30 Mar 2006to 28 Nov 2006
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provide written informed consent and Health Insurance Portability and Accountability Act of 1996 (HIPAA) documents
- Be aged 18 years or older
- Have chronic (6 months or greater) moderate to severe plaque psoriasis involving the hands and/or feet with or without pustules and with or without psoriasis at other sites
- Have a PGA rating of moderate (3) or severe (4) for hand and/or foot psoriasis
- Be a candidate for systemic therapy in the opinion of the investigator
- Be naive to efalizumab treatment
- Weigh no more than 125 kg
- For women of childbearing potential, use a method of contraception acceptable to the investigator to prevent pregnancy and agree to continue to practice an acceptable method of contraception for the duration of their participation in the study and for 6 weeks after the last dose of efalizumab
Who cannot join
- Have a history of hypersensitivity to efalizumab or any of its components
- Are using any excluded therapy
- Have a history of or ongoing alcohol or illegal drug abuse
- Have a history of or an ongoing uncontrolled serious bacterial, viral, fungal, or atypical mycobacterial infection. This includes diagnoses that required more than 2 weeks of therapy, such as endocarditis and osteomyelitis, that have been treated in the past 6 months. In addition, if the patient is currently receiving antibiotics, antivirals, or antifungals for an infection or for suppression or prophylaxis for any diagnosis, the patient will be excluded.
- Have any history of opportunistic infections (e.g., systemic fungal infections, parasites)
- Are seropositive for hepatitis B antigen, hepatitis C antibody, or human immunodeficiency virus (HIV). Patients will undergo testing during screening, and any patients who are seropositive for hepatitis B antigen, hepatitis C antibody, or HIV will be excluded.
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- Have a history of active tuberculosis or are currently undergoing treatment for tuberculosis. A purified protein derivative (PPD) test or chest x-ray will be performed at the screening visit. Patients with a positive PPD test (not due to BCG vaccination) or chest x-ray will be excluded.
- Have the presence or history of malignancy within the past 5 years, including lymphoproliferative disorders. Patients with a history of fully resolved basal or squamous cell skin cancer may be enrolled.
- Are pregnant or lactating women
- Have a diagnosis of hepatic cirrhosis, regardless of cause or severity
- Have a history of thrombocytopenia
- Have a history of hemolytic anemia
- Have a history of clinically significant anemia
- Have a WBC count <4,000 cells/uL or >14,000 cells/uL
- Have a hematocrit (HCT) <30% or a hemoglobin (Hgb) level <11 g/dL
- Have a platelet count <150,000 cells/uL
- Have hepatic enzyme levels ≥3 times the upper limit of normal
- Have a serum creatinine level ≥2 times the upper limit of normal
- Have been exposed to any experimental drugs or treatments within 30 days or 5 half-lives, whichever is longer, prior to the screening visit
- Have had any previous exposure to efalizumab
- Have been vaccinated with a live virus or live bacteria within the 14 days prior to the first dose of efalizumab
- Have any medical condition that, in the judgment of the investigator, would jeopardize the patient's safety following exposure to study drug (efalizumab or placebo equivalent) or would significantly interfere with the patient's ability to comply with the provisions of this protocol
About this study
Official title: A Phase IV Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of 1.0 mg/kg Efalizumab in Adult Patients With Moderate to Severe Plaque Psoriasis Involving the Hands and/or Feet
This is a Phase IV randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of SC efalizumab in adult patients (18 years of age and older) with chronic moderate to severe plaque psoriasis involving the hands and/or feet who have had no previous exposure to efalizumab. The study will consist of a screening period, a treatment period, and an observation period.
- Conditions
- Psoriasis
- Being tested
- efalizumab
- Keywords
- Plaque Psoriasis, Hands, Feet, Hand
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
efalizumabDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary efficacy outcome measure is the proportion of patients who achieve a PGA rating of clear (0), almost clear (1), or mild (2) at Day 84.
Secondary outcomes (4)
The proportion of patients who achieve a PGA rating of clear (0), almost clear (1), or mild (2) at Day 42
The proportion of patients who achieve a PGA rating of clear (0) or almost clear (1) at Day 84
The change from Day 0 to Day 84 in the following PRO measures: SF 36, PDS, Work Loss Questionnaire
The change from Day 0 in PGA rating (i.e., the number of categories changed) at Day 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2006 (estimated)
- Study start30 Mar 2006
- Primary completion28 Nov 2006
- Study completion28 Nov 2006
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 75 participants
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Ivor Caro, M.D., Study director, Genentech, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00312026
- Sponsor's protocol ID
- ACD3753g
- Status last verified
- Feb 2017
- First submitted
- 5 Apr 2006
- Last updated
- 15 Feb 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IV Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of 1.0 mg/kg Efalizumab in Adult Patients With Moderate to Severe Plaque Psoriasis Involving the Hands and/or Feet
- ClinicalTrials.gov ID
- NCT00312026
- Acronym / sponsor ID
- ACD3753g
- Conditions
- Psoriasis
- Keywords
- Plaque Psoriasis, Hands, Feet, Hand
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Mar 2006
- Primary completion
- 28 Nov 2006 (actual)
- Study completion
- 28 Nov 2006 (actual)
- First posted
- 7 Apr 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 IV randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of SC efalizumab in adult patients (18 years of age and older) with chronic moderate to severe plaque psoriasis involving the hands and/or feet who have had no previous exposure to efalizumab. The study will consist of a screening period, a treatment period, and an observation period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Provide written informed consent and Health Insurance Portability and Accountability Act of 1996 (HIPAA) documents
- Be aged 18 years or older
- Have chronic (6 months or greater) moderate to severe plaque psoriasis involving the hands and/or feet with or without pustules and with or without psoriasis at other sites
- Have a PGA rating of moderate (3) or severe (4) for hand and/or foot psoriasis
- Be a candidate for systemic therapy in the opinion of the investigator
Key exclusion criteria (22 listed)
- Have a history of hypersensitivity to efalizumab or any of its components
- Are using any excluded therapy
- Have a history of or ongoing alcohol or illegal drug abuse
- Have a history of or an ongoing uncontrolled serious bacterial, viral, fungal, or atypical mycobacterial infection. This includes diagnoses that required more than 2 weeks of therapy, such as endocarditis and osteomyelitis, that have been treated in the past 6 months. In addition, if the patient is currently receiving antibiotics, antivirals, or antifungals for an infection or for suppression or prophylaxis for any diagnosis, the patient will be excluded.
- Have any 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
The primary efficacy outcome measure is the proportion of patients who achieve a PGA rating of clear (0), almost clear (1), or mild (2) at Day 84.
4 secondary outcomes
The proportion of patients who achieve a PGA rating of clear (0), almost clear (1), or mild (2) at Day 42
The proportion of patients who achieve a PGA rating of clear (0) or almost clear (1) at Day 84
The change from Day 0 to Day 84 in the following PRO measures: SF 36, PDS, Work Loss Questionnaire
The change from Day 0 in PGA rating (i.e., the number of categories changed) at Day 84
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 15 Feb 2017.
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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 4 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 8 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 15 Feb 2017. 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 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?
The primary efficacy outcome measure is the proportion of patients who achieve a PGA rating of clear (0), almost clear (1), or mild (2) at Day 84.. It is what the study was designed to measure, not a finding.
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 15 Feb 2017.