PsoriasisPhase 3NCT00115076
Study of the Drug Efalizumab (Raptiva), for Adult Patients With Moderate to Severe Plaque Psoriasis
A Phase 3 study testing Efalizumab in people with Psoriasis, run by Rockefeller University at 2 sites in United States.
Trial summary
Our laboratory is studying a skin disease known as psoriasis. The purpose of this protocol is to study the action and the effects of Efalizumab, on psoriasis. This medication has been studied extensively and has been found to be effective and safe in the treatment of psoriasis. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Psoriasis
- What is being tested?
- Efalizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 2 sitesUnited States
- Study dates
- 4 Aug 2003to 6 Apr 2011
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 70 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
- PASI score >=12 (see Appendix A) or Linear PASI score of >= 8.0 at screening (see Appendix B)
- In the opinion of the investigator, candidate for systemic therapy for psoriasis:
- Who has not been previously treated (naive to systemic treatment) OR
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- Who has had prior treatment with systemic therapy for psoriasis (e.g., PUVA, cyclosporine, corticosteroids, methotrexate, oral retinoids, mycophenolate mofetil (MMF), thioguanine, hydroxyurea, sirolimus, azathioprine, 6-MP, etanercept)
- Body weight of <140 kg
- 18 to 75 years old. As the risk of Efalizumab in childhood is unknown, those < 18years will be excluded from the study
- For women of childbearing potential or in men whose partners may become pregnant, willingness to use an acceptable method of contraception to prevent pregnancy for the duration of the study (while receiving study medication and 3 months following). Acceptable methods of contraception include use of a condom; abstinence; use by sexual partner of oral implantable or injectable contraceptives, IUD, female condom, diaphragm with spermicide, cervical cap; or 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
Who cannot join
- Subjects who meet any of the following exclusion criteria are ineligible for study entry:
- 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 first treatment day
- Treatment with efalizumab (anti-CD11a) within the last 12 months before enrollment
- Pregnancy or lactation. As the risk of Efalizumab in pregnancy is unknown, pregnant women will be excluded from the study
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- History of or ongoing uncontrolled bacterial, viral, fungal, or atypical mycobacterial infection
- History of active tuberculosis (TB) or currently undergoing treatment for TB. PPD testing or chest X-ray is required for high-risk subjects (see Appendix D).
- Subjects with a positive PPD (not due to BCG vaccination) or chest X-ray will be excluded
- History of opportunistic infections (e.g., systemic fungal infections, parasites)
- Seropositivity for human immunodeficiency virus (HIV)
- Seropositivity for hepatitis B or C virus
- Hepatic enzymes >3 times the upper limits of normal (ULN)
- Diagnosis of hepatic cirrhosis, regardless of cause or severity
- WBC count <4000μL or >14,000/μL
- Serum creatinine >2 times the ULN
- Hospital admission for cardiac disease, stroke, or pulmonary disease within the last year
- Presence of malignancy within the past 5 years, including lymphoproliferative disorders. Subjects with a history of fully resolved basal cell or squamous cell skin cancer may be enrolled
- 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 Note: Certain medications and vaccines may not be used for specified periods of time prior to enrollment or at any time during the treatment period.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Rockefeller University
New York, New York, 10065
The Rockefeller University
New York, New York, 10065
About this study
Official title: A Phase IIIB Study to Evaluate the Mechanism of Action of 1.0 mg/kg Subcutaneously Administered Efalizumab in Adults With Moderate to Severe Plaque Psoriasis Who Are Candidates for Systemic Therapy
Our laboratory is studying a skin disease known as psoriasis. The purpose of this protocol is to study the action and the effects of Efalizumab, on psoriasis. This medication has been studied extensively and has been found to be effective and safe in the treatment of psoriasis. The eligible patient will have 10% of his/her body surface area involved with psoriasis vulgaris.
Read the detailed description
The eligible patient will receive the drug Efalizumab, weekly for 12 weeks, by injection. The patient will be seen weekly for 12 weeks and every other week for the 12 weeks of follow up. At those visits, the patient can expect that a physical and skin exam will be done. At specific weeks, blood work will be drawn, clinical photography taken and a skin biopsy done. Two types of skin biopsies will be done after local anesthesia has been administered. One is a punch biopsy where a small piece of skin will be taken, the approximate size of a pencil eraser. The second type of skin biopsy is shave biopsy, where a postage sized piece of skin will be taken.
- Conditions
- Psoriasis
- Being tested
- Efalizumab
- Keywords
- skin, psoriasis
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EfalizumabDrug
Also called Raptiva
24 weekly doses of 1.0 mg/kg Efalizumab. Study drug will be administered by SC injection
| Study group | Role | What they receive |
|---|---|---|
| psoriasis | Experimental | moderate to severe plaque psoriasis Receives: Drug: Efalizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Clinical Improvement of Target Lesions
a single composite score based on quantitative measurement of epidermal acanthosis, qualitative expression of Keratin16 (histochemistry assessment) and quantitative measurement of K16 mRNA.
Measured: week 12
Secondary outcomes (1)
Assessment of Overall Clinical Response as Measured by Psoriasis Area and Severity Index (PASI)
Psoriasis Area and Severity Index (PASI) combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no disease) to 72 (maximal disease). Clinical response defined as PASI improvement over 75% at week 12.
Measured: Day 0, day 14, day 42, day 84, Days 112, 140, and 168. PASI has been measured at those timepoints but outcome is related to Baseline and Day 84.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2005 (estimated)
- Study start4 Aug 2003
- Primary completion18 May 2009
- Study completion6 Apr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rockefeller University
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Sponsor
- Investigators
- James Krueger, MD, Principal investigator, Rockefeller University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00115076
- Sponsor's protocol ID
- JKR-0511
- Status last verified
- Feb 2021
- First submitted
- 20 Jun 2005
- Last updated
- 8 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Johnson-Huang LM, Pensabene CA, Shah KR, Pierson KC, Kikuchi T, Lentini T, Gilleaudeau P, Sullivan-Whalen M, Cueto I, Khatcherian A, Hyder LA, Suarez-Farinas M, Krueger JG, Lowes MA. Post-therapeutic relapse of psoriasis after CD11a blockade is associated with T cells and inflammatory myeloid DCs. PLoS One. 2012;7(2):e30308. doi: 10.1371/journal.pone.0030308. Epub 2012 Feb 10.
PubMed 22348003
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIIB Study to Evaluate the Mechanism of Action 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
- NCT00115076
- Acronym / sponsor ID
- JKR-0511
- Conditions
- Psoriasis
- Keywords
- skin, psoriasis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Rockefeller UniversityUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- 4 Aug 2003 (actual)
- Primary completion
- 18 May 2009 (actual)
- Study completion
- 6 Apr 2011 (actual)
- First posted
- 21 Jun 2005 (estimated)
- Results
- Posted 8 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Our laboratory is studying a skin disease known as psoriasis. The purpose of this protocol is to study the action and the effects of Efalizumab, on psoriasis. This medication has been studied extensively and has been found to be effective and safe in the treatment of psoriasis. The eligible patient will have 10% of his/her body surface area involved with psoriasis vulgaris.
Detailed description
The eligible patient will receive the drug Efalizumab, weekly for 12 weeks, by injection. The patient will be seen weekly for 12 weeks and every other week for the 12 weeks of follow up. At those visits, the patient can expect that a physical and skin exam will be done. At specific weeks, blood work will be drawn, clinical photography taken and a skin biopsy done. Two types of skin biopsies will be done after local anesthesia has been administered. One is a punch biopsy where a small piece of skin will be taken, the approximate size of a pencil eraser. The second type of skin biopsy is shave biopsy, where a postage sized piece of skin will be taken.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| psoriasis | Experimental | Drug: Efalizumabmoderate to severe plaque psoriasis |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Signed informed consent
- Plaque psoriasis covering >10% of total BSA
- Diagnosis of plaque psoriasis for at least 6 months
- PASI score >=12 (see Appendix A) or Linear PASI score of >= 8.0 at screening (see Appendix B)
- In the opinion of the investigator, candidate for systemic therapy for psoriasis:
Key exclusion criteria (20 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 first treatment day
- Treatment with efalizumab (anti-CD11a) within the last 12 months before enrollment
- Pregnancy or lactation. As the risk of Efalizumab in pregnancy is unknown, pregnant women will be excluded from the study
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 |
|---|---|---|
| EfalizumabAlso: Raptiva24 weekly doses of 1.0 mg/kg Efalizumab. Study drug will be administered by SC injection | Drug | psoriasis |
Primary outcome
Number of Participants With Clinical Improvement of Target Lesions
Time frame: week 12
a single composite score based on quantitative measurement of epidermal acanthosis, qualitative expression of Keratin16 (histochemistry assessment) and quantitative measurement of K16 mRNA.
1 secondary outcome
Assessment of Overall Clinical Response as Measured by Psoriasis Area and Severity Index (PASI)
Time frame: Day 0, day 14, day 42, day 84, Days 112, 140, and 168. PASI has been measured at those timepoints but outcome is related to Baseline and Day 84.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22348003Johnson-Huang LM, Pensabene CA, Shah KR, Pierson KC, Kikuchi T, Lentini T, Gilleaudeau P, Sullivan-Whalen M, Cueto I, Khatcherian A, Hyder LA, Suarez-Farinas M, Krueger JG, Lowes MA. Post-therapeutic relapse of psoriasis after CD11a blockade is associated with T cells and inflammatory myeloid DCs. PLoS One. 2012;7(2):e30308. doi: 10.1371/journal.pone.0030308. Epub 2012 Feb 10.
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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.
James Krueger, MD principal investigator
Rockefeller University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Efalizumab in people with Psoriasis, run by Rockefeller University at 2 sites in United States.
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 11 inclusion and 20 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 8 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
Yes. Results are posted in the registry (first posted 8 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Clinical Improvement of Target Lesions (time frame: week 12). 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 NCT00115076, 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 8 Feb 2021.