Chronic Plaque PsoriasisPhase 4CobAcENCT00707070
Combining Acitretin and Efalizumab in the Therapy of Chronic Plaque Psoriasis
A Phase 4 study testing efalizumab plus acitretin in people with Chronic Plaque Psoriasis, run by Universita di Verona at 1 site in Italy.
Trial summary
It is a phase IV multicentric, placebo-controlled, clinical trial investigating the efficacy and safety of acitretin combined to efalizumab in the therapy of chronic plaque psoriasis. PASI 75 at week 24 will be the primary end point. PASI 75 at week 12, and PASI 50 at week 24 will be the secondary end points. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Plaque Psoriasis
- What is being tested?
- efalizumab plus acitretin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- Sep 2008to Oct 2009
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men aged 18-70
- Women in postmenopausal
- Moderate to severe chronic plaque psoriasis in patients with contraindication, intolerance or non responsive to cyclosporine, methotrexate or PUVA
- PASI > 10 e/o BSA (Body Surface Area) > 10
Who cannot join
- Drug induced psoriasis
- Pustular or erythrodermic psoriasis
- Fertile women
- Pregnancy or lactation
- cholesterol > 230mg/dL e triglyceride > 200 mg/dL
- Known intolerance to efalizumab and acitretin
- Serious infection at enrollement
- History of previous neoplasia
Trial locations and contacts
1 site in 1 country.
Italy1 site
Univeristy Hospital
Verona, 37126
Paolo Gisondi, MD, 45-812-2547 ext. 0039, paolo.gisondi@univr.it
Micol Del Giglio, MD
About this study
Official title: Phase IV Study on Efficacy and Safety of the Combination Treatment Acitretin and Efalizumab in Moderate to Severe Chronic Plaque Psoriasis
It is a phase IV multicentric, placebo-controlled, clinical trial investigating the efficacy and safety of acitretin combined to efalizumab in the therapy of chronic plaque psoriasis. PASI 75 at week 24 will be the primary end point. PASI 75 at week 12, and PASI 50 at week 24 will be the secondary end points. Safety measures will be the monitoring of serum parameters including AST; ALT; gammaGT; creatinine; cholesterol and triglycerides.
- Conditions
- Chronic Plaque Psoriasis
- Being tested
- efalizumab plus placebo, efalizumab plus acitretin
- Keywords
- psoriasis, acitretin, efalizumab
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
efalizumab plus placeboDrug
1 mg/kg/week subcutaneous for 24 weeks
efalizumab plus acitretinDrug
1 mg/Kg/week for 24 weeks plus oral acitretin 0.4 mg/kg/day
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | efalizumab 1 mg/kg/week subcutaneous plus acitretin 0.4 mg/kg/day oral Receives: Drug: efalizumab plus acitretin |
| 2 | Placebo comparator | efalizumab 1 mg/Kg/week subcutaneous plus oral placebo Receives: Drug: efalizumab plus placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
PASI 75 and PASI 50 at week 24 Physician Global Assessment
Measured: week 12 and 24
Secondary outcomes (1)
SKINDEX 29 at week 24 and AST, ALT, cholesterol, triglycerides at week 12 and week 24
Measured: week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2008 (estimated)
- Study startSep 2008
- Primary completionOct 2009 (estimated)
- Study completionOct 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Plaque 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universita di Verona
- Sponsor type
- University, hospital or other
- Investigators
- Giampiero Girolomoni, Principal investigator, Universita di Verona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00707070
- Sponsor's protocol ID
- Gisondi 2
- Other IDs
- No grants were received
- Acronym
- CobAcE
- Status last verified
- Jun 2008
- First submitted
- 26 Jun 2008
- Last updated
- 30 Jun 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Gisondi P, Girolomoni G. Combination of efalizumab and acitretin in chronic plaque psoriasis. J Eur Acad Dermatol Venereol. 2008 Feb;22(2):247-8. doi: 10.1111/j.1468-3083.2007.02303.x. No abstract available.
PubMed 18211428
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IV Study on Efficacy and Safety of the Combination Treatment Acitretin and Efalizumab in Moderate to Severe Chronic Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT00707070
- Acronym / sponsor ID
- CobAcE / Gisondi 2
- Conditions
- Chronic Plaque Psoriasis
- Keywords
- psoriasis, acitretin, efalizumab
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Universita di VeronaUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Oct 2009 (estimated)
- Study completion
- Oct 2009 (estimated)
- First posted
- 30 Jun 2008 (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.
It is a phase IV multicentric, placebo-controlled, clinical trial investigating the efficacy and safety of acitretin combined to efalizumab in the therapy of chronic plaque psoriasis. PASI 75 at week 24 will be the primary end point. PASI 75 at week 12, and PASI 50 at week 24 will be the secondary end points. Safety measures will be the monitoring of serum parameters including AST; ALT; gammaGT; creatinine; cholesterol and triglycerides.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: efalizumab plus acitretinefalizumab 1 mg/kg/week subcutaneous plus acitretin 0.4 mg/kg/day oral |
| 2 | Placebo comparator | Drug: efalizumab plus placeboefalizumab 1 mg/Kg/week subcutaneous plus oral placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men aged 18-70
- Women in postmenopausal
- Moderate to severe chronic plaque psoriasis in patients with contraindication, intolerance or non responsive to cyclosporine, methotrexate or PUVA
- PASI > 10 e/o BSA (Body Surface Area) > 10
Key exclusion criteria (8 listed)
- Drug induced psoriasis
- Pustular or erythrodermic psoriasis
- Fertile women
- Pregnancy or lactation
- cholesterol > 230mg/dL e triglyceride > 200 mg/dL
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 plus placebo1 mg/kg/week subcutaneous for 24 weeks | Drug | 2 |
| efalizumab plus acitretin1 mg/Kg/week for 24 weeks plus oral acitretin 0.4 mg/kg/day | Drug | 1 |
Primary outcome
PASI 75 and PASI 50 at week 24 Physician Global Assessment
Time frame: week 12 and 24
1 secondary outcome
SKINDEX 29 at week 24 and AST, ALT, cholesterol, triglycerides at week 12 and week 24
Time frame: week 24
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2008.
- Background: PubMed 18211428Gisondi P, Girolomoni G. Combination of efalizumab and acitretin in chronic plaque psoriasis. J Eur Acad Dermatol Venereol. 2008 Feb;22(2):247-8. doi: 10.1111/j.1468-3083.2007.02303.x. No abstract available.
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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.
Giampiero Girolomoni principal investigator
Universita di Verona
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 plus acitretin in people with Chronic Plaque Psoriasis, run by Universita di Verona at 1 site in Italy.
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 4 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 30 Jun 2008. 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 Italy. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Giampiero Girolomoni, Prof (39-045-812-2547 ext. 0039, giampiero.girolomoni@univr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PASI 75 and PASI 50 at week 24 Physician Global Assessment (time frame: week 12 and 24). 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 NCT00707070, 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 30 Jun 2008.