PsoriasisPhase 4NCT00249808
A Study of Efalizumab in Participants With Moderate to Severe Chronic Psoriasis Who Have Failed, Have a Contraindication to, or Are Intolerant of Other Systemic Therapies
A Phase 4 study testing Efalizumab - anti-CD11a recombinant human monoclonal antibody in people with Psoriasis, run by Merck KGaA, Darmstadt, Germany at 1 site in United Kingdom.
Trial summary
This is a Phase IIIb/IV, open label, multicentre study of efalizumab (anti cluster of differentiation [CD] 11a recombinant human monoclonal antibody) in participants with moderate to severe plaque psoriasis who have failed to respond to, have a contraindication to, or are intolerant to other systemic therapies… 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 - anti-CD11a recombinant human monoclonal antibody
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,266 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 13 Dec 2004to 25 Jan 2007
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Moderate to severe plaque psoriasis participants who have failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including cyclosporine, methotrexate and PUVA
- Age at least 18 years
- For women of childbearing potential and for men whose partner can become pregnant, 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 up to 3 months after the last dose of efalizumab
- Have given written informed consent, prior to any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the participant at any time without prejudice to future medical care
- Discontinuation of any systemic psoriasis treatment prior to commencement of the study drug. No washout period is required for these agents prior to starting study and receiving first dose of study drug (efalizumab)
- Discontinuation of all biologic agents (other than efalizumab) 3 months prior to receiving first dose of study drug (efalizumab)
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- Discontinuation of any investigational drug or treatment 3 months prior to Study Day 0 or as per washout requirements from previous protocol
- No primary vaccinations (e.g., tetanus, booster, influenza vaccine) at least 14 days prior to first dose of study drug
- The participant must be willing and able to comply with the protocol requirements for the duration of the study
Who cannot join
- Guttate, erythrodermic, or pustular psoriasis as sole or predominant form of psoriasis
- Participants who have previously been on efalizumab treatment who withdrew due to lack of efficacy or an adverse event. If withdrawal was due to another non-drug reason (vaccination, or infection) then the patient can be included in this study
- History of severe allergic or anaphylactic reactions to humanised monoclonal antibodies
- History of or ongoing uncontrolled bacterial, viral, fungal, or atypical mycobacterial infection
- History of opportunistic infections (eg, systemic fungal infections, parasites)
- Seropositivity for human immunodeficiency virus (HIV). Participants will undergo mandatory testing at screening. Participants who are positive for HIV will be excluded
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- Pregnancy or breast feeding
- White Blood Cell (WBC) count less than (<) 4*10^9 per liter or greater than (>) 14*10^9 per liter
- Participants with a history of clinically significant thrombocytopenia, bleeding disorders or a platelet count <100*10^9 per liter
- Seropositivity for hepatitis B or C virus. Participants will undergo testing at screening. Participants who are positive for hepatitis B antigen or hepatitis C antibody will be excluded
- History of active tuberculosis (TB) or currently undergoing treatment for TB within one year prior to Study Day 0. Chest X-ray (within 3 months prior to Study Day 0) is required for high-risk participants. Participants with a positive chest X-ray will be excluded
- Presence of malignancy within the past 5 years, including lymphoproliferative disorders. Participants with a history of fully resolved basal cell or squamous cell skin cancer may be enrolled
- Hospital admission for cardiac disease, stroke, or pulmonary disease within the last year
- Any medical condition that, in the judgment of the investigator, would jeopardize the participant's safety following exposure to study drug
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicentre, Open Label Phase IIIb/IV Study of Subcutaneously Administered Efalizumab in the Treatment of Adult Patients With Moderate to Severe Chronic Plaque Psoriasis Who Have Failed to Respond to, or Who Have a Contraindication to, or Are Intolerant to Other Systemic Therapies Including Ciclosporin, Methotrexate and PUVA
This is a Phase IIIb/IV, open label, multicentre study of efalizumab (anti cluster of differentiation [CD] 11a recombinant human monoclonal antibody) in participants with moderate to severe plaque psoriasis who have failed to respond to, have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate, and psoralen and ultraviolet A phototherapy (PUVA).
- Conditions
- Psoriasis
- Being tested
- Efalizumab - anti-CD11a recombinant human monoclonal antibody
- Keywords
- Candidates for systemic therapy for psoriasis
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Efalizumab - anti-CD11a recombinant human monoclonal antibodyDrug
Participants will receive efalizumab 1.0 milligram per kilogram (mg/kg) (with an initial conditioning dose of 0.7 mg/kg) once weekly by subcutaneous injection for 12 weeks (first treatment [FT]). Depending on the response at Week 12, participants could receive additional 8 to 12 weekly injections of efalizumab 1.0 mg/kg.
| Study group | Role | What they receive |
|---|---|---|
| Efalizumab | Experimental | Not described Receives: Drug: Efalizumab - anti-CD11a recombinant human monoclonal antibody |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Physician's Global Assessment (PGA) Ratings of Good or Better (FT)
The PGA assesses the global response of all psoriatic lesions to therapy by comparing the participant's present condition to baseline. PGA response includes: Cleared (100 percent [%] improvement; remission of all clinical signs and symptoms, except for residual manifestations such as mild erythema); Excellent (75% to 99% improvement of all clinical signs and symptoms, except for residual manifestations such as mild erythema); Good (50% to 74% improvement of all clinical signs and symptoms); Fair (25% to 49% improvement of all clinical signs and symptoms); Slight (1% to 24% improvement of all clinical signs and symptoms); Unchanged (clinical signs and symptoms unchanged); Worse (clinical signs and symptoms deteriorated). Percentage of participants with PGA ratings of Good or Better (i.e, Good, Excellent or Cleared) are reported.
Measured: Week 12
Secondary outcomes (2)
Percentage of Participants With Psoriasis Rebound
Rebound was defined as worsening of disease as assessed by Psoriasis Area and Severity Index (PASI) score >125% of baseline or new pustular, erythrodermic, or more inflammatory psoriasis occurring within 2 months of stopping therapy. PASI is an instrument used to assess the extent of cutaneous psoriasis and to measure the effects of therapy. The PASI divides the body into four anatomical regions: head, trunk, upper limbs, and lower limbs. For each region, the evaluator assesses the severity of erythema, induration/thickness and scaling and determines the percentage of the region affected by disease. A numerical PASI score is derived that evaluates the severity of symptoms in terms of the total body surface area affected. Total PASI score ranges from 0 to 72, with higher scores indicating more severe disease.
Measured: Up to 8 weeks after end of FT (up to Week 20)
Percentage of Participants With Psoriasis Exacerbation
Exacerbation was defined as disease worsening either during or after treatment which was more inflammatory in nature compared to baseline and occurred either within pre-existing plaques, at previously uninvolved sites, or as new morphologies of disease.
Measured: During study (40 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2005 (estimated)
- Study start13 Dec 2004
- Primary completion25 Jan 2007
- Study completion25 Jan 2007
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 (2)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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,266 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck KGaA, Darmstadt, Germany
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Responsible, Study director, Merck KGaA, Darmstadt, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00249808
- Sponsor's protocol ID
- 25300
- Other IDs
- Control II Study
- Status last verified
- Aug 2017
- First submitted
- 4 Nov 2005
- Last updated
- 20 Mar 2018
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Katsambas A, Peris K, Vena G, Freidmann P, Wozel G, Dauden E, Licu D, Placchi M, De La Brassinne M. Assessing the Impact of Efalizumab on Nail, Scalp and Palmoplantar Psoriasis and on Quality of Life: Results from a Multicentre, Open-label, Phase IIIb/IV Trial. Arch Drug Inf. 2009 Dec;2(4):66-70. doi: 10.1111/j.1753-5174.2009.00023.x.
PubMed 20098509Lotti T, Chimenti S, Katsambas A, Ortonne JP, Dubertret L, Licu D, Simon J. Efficacy and Safety of Efalizumab in Patients with Moderate-to-Severe Plaque Psoriasis Resistant to Previous Anti-Psoriatic Treatment: Results of a Multicentre, Open-label, Phase IIIb/IV Trial. Arch Drug Inf. 2010 Mar;3(1):9-18. doi: 10.1111/j.1753-5174.2009.00026.x.
PubMed 20428228
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Open Label Phase IIIb/IV Study of Subcutaneously Administered Efalizumab in the Treatment of Adult Patients With Moderate to Severe Chronic Plaque Psoriasis Who Have Failed to Respond to, or Who Have a Contraindication to, or Are Intolerant to Other Systemic Therapies Including Ciclosporin, Methotrexate and PUVA
- ClinicalTrials.gov ID
- NCT00249808
- Acronym / sponsor ID
- 25300
- Conditions
- Psoriasis
- Keywords
- Candidates for systemic therapy for psoriasis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,266 participants (actual)
- Lead sponsor
- Merck KGaA, Darmstadt, GermanyIndustry (pharma, biotech, devices)
- Study start
- 13 Dec 2004 (actual)
- Primary completion
- 25 Jan 2007 (actual)
- Study completion
- 25 Jan 2007 (actual)
- First posted
- 7 Nov 2005 (estimated)
- Results
- Posted 20 Mar 2018
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/IV, open label, multicentre study of efalizumab (anti cluster of differentiation [CD] 11a recombinant human monoclonal antibody) in participants with moderate to severe plaque psoriasis who have failed to respond to, have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate, and psoralen and ultraviolet A phototherapy (PUVA).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Efalizumab | Experimental | Drug: Efalizumab - anti-CD11a recombinant human monoclonal antibody |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Moderate to severe plaque psoriasis participants who have failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including cyclosporine, methotrexate and PUVA
- Age at least 18 years
- For women of childbearing potential and for men whose partner can become pregnant, 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 up to 3 months after the last dose of efalizumab
- Have given written informed consent, prior to any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the participant at any time without prejudice to future medical care
- Discontinuation of any systemic psoriasis treatment prior to commencement of the study drug. No washout period is required for these agents prior to starting study and receiving first dose of study drug (efalizumab)
Key exclusion criteria (14 listed)
- Guttate, erythrodermic, or pustular psoriasis as sole or predominant form of psoriasis
- Participants who have previously been on efalizumab treatment who withdrew due to lack of efficacy or an adverse event. If withdrawal was due to another non-drug reason (vaccination, or infection) then the patient can be included in this study
- History of severe allergic or anaphylactic reactions to humanised monoclonal antibodies
- History of or ongoing uncontrolled bacterial, viral, fungal, or atypical mycobacterial infection
- History of opportunistic infections (eg, 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 - anti-CD11a recombinant human monoclonal antibodyParticipants will receive efalizumab 1.0 milligram per kilogram (mg/kg) (with an initial conditioning dose of 0.7 mg/kg) once weekly by subcutaneous injection for 12 weeks (first treatment [FT]). Depending on the response at Week 12, participants could receive additional 8 to 12 weekly injections of efalizumab 1.0 mg/kg. | Drug | Efalizumab |
Primary outcome
Percentage of Participants With Physician's Global Assessment (PGA) Ratings of Good or Better (FT)
Time frame: Week 12
The PGA assesses the global response of all psoriatic lesions to therapy by comparing the participant's present condition to baseline. PGA response includes: Cleared (100 percent [%] improvement; remission of all clinical signs and symptoms, except for residual manifestations such as mild erythema); Excellent (75% to 99% improvement of all clinical signs and symptoms, except for residual manifestations such as mild erythema); Good (50% to 74% improvement of all clinical signs and symptoms); Fair (25% to 49% improvement of all clinical signs and symptoms); Slight (1% to 24% improvement of all clinical signs and symptoms); Unchanged (clinical signs and symptoms unchanged); Worse (clinical signs and symptoms deteriorated). Percentage of participants with PGA ratings of Good or Better (i.e, Good, Excellent or Cleared) are reported.
2 secondary outcomes
Percentage of Participants With Psoriasis Rebound
Time frame: Up to 8 weeks after end of FT (up to Week 20)
Percentage of Participants With Psoriasis Exacerbation
Time frame: During study (40 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 20098509Katsambas A, Peris K, Vena G, Freidmann P, Wozel G, Dauden E, Licu D, Placchi M, De La Brassinne M. Assessing the Impact of Efalizumab on Nail, Scalp and Palmoplantar Psoriasis and on Quality of Life: Results from a Multicentre, Open-label, Phase IIIb/IV Trial. Arch Drug Inf. 2009 Dec;2(4):66-70. doi: 10.1111/j.1753-5174.2009.00023.x.
- Results publication: PubMed 20428228Lotti T, Chimenti S, Katsambas A, Ortonne JP, Dubertret L, Licu D, Simon J. Efficacy and Safety of Efalizumab in Patients with Moderate-to-Severe Plaque Psoriasis Resistant to Previous Anti-Psoriatic Treatment: Results of a Multicentre, Open-label, Phase IIIb/IV Trial. Arch Drug Inf. 2010 Mar;3(1):9-18. doi: 10.1111/j.1753-5174.2009.00026.x.
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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.
Medical Responsible study director
Merck KGaA, Darmstadt, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Efalizumab - anti-CD11a recombinant human monoclonal antibody in people with Psoriasis, run by Merck KGaA, Darmstadt, Germany at 1 site in United Kingdom.
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 9 inclusion and 14 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 20 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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 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?
Yes. Results are posted in the registry (first posted 20 Mar 2018). 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?
Percentage of Participants With Physician's Global Assessment (PGA) Ratings of Good or Better (FT) (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 NCT00249808, which also lists 2 linked publications.
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 20 Mar 2018.