PsoriasisPhase 1/2NCT00050648
To Study the Effects of CD25 and Low Dose Cyclosporin in the Treatment of Active Psoriasis Vulgaris
A Phase 1/2 study testing Daclizumab, Cyclosporine and cyclosporine and Daclizumab in people with Psoriasis, run by Rockefeller University at 3 sites in United States.
Trial summary
This study compares the efficacy and analyzes the cellular effects of anti-TAC (Daclizumab) and Cyclosporine in the treatment of psoriasis vulgaris. This is a three-armed study-Daclizumab alone, Cyclosporine alone, and the combination of both Daclizumab and Cyclosporine. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis
- What is being tested?
- Daclizumab, Cyclosporine and cyclosporine and Daclizumab
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 3 sitesUnited States
- Study dates
- Oct 1997to Apr 2008
- Phase
- Phase 1/2
- 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
- Male or female patients with chronic psoriasis vulgaris (disease stable or worsening for > 6 months). Patients age 16 - 21 will be considered on a case by case basis. Patients below 18 will need parental consent.
- Extensive skin involvement.
- Scale, thickness, and erythema in individual psoriasis lesions of at least intensity.
- Psoriasis treated with emollients only for 2 weeks prior to treatment
- Patients with active psoriatic arthritis, if accompanied by psoriasis vulgaris involving more than 5% of the body surface.
- History of psoriasis that cannot be treated with topical agents or with previous systemic/ photo(chemo)therapy agents.
Who cannot join
- . Positive serology for HIV, Hepatitis B, or Hepatitis C.
- . Positive β-HCG titer. For women of childbearing potential, unwillingness or inability to use a contraceptive device during this study if negative for β-HCG.
- Guttate psoriasis, pustular psoriasis, or whole body erythroderma.
- Active infection or persistent fever of unknown origin. 5.) Major concurrent illness, which could worsen following treatment with DaclizumabTM.
- 6) Any history of an un-treated neoplasm
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Rockefeller University Hospital
New York, New York, 10021
Rockefeller University
New York, New York, 10021
Rockefeller University
New York, New York, 10065
About this study
Official title: Use of Humanized CD25 (Anti-TAC) Monoclonal Antibody and Cyclosporine for the Treatment of Active Psoriasis.
This study compares the efficacy and analyzes the cellular effects of anti-TAC (Daclizumab) and Cyclosporine in the treatment of psoriasis vulgaris. This is a three-armed study-Daclizumab alone, Cyclosporine alone, and the combination of both Daclizumab and Cyclosporine.
Read the detailed description
The purpose is to study the safety and effectiveness of a new drug called "anti-TAC" (anti-CD25) Monoclonal Antibody used together with low dose Cyclosporine in the treatment of psoriasis. While the exact cause of psoriasis is unknown, it is believed to involve white blood cells called lymphocytes, which become activated in the skin. It is believed that these activated cells are responsible for the changes you see as the rash of psoriasis. Anti-TAC (anti-CD25) Monoclonal Antibody is designed to block the activation of these lymphocytes. Because the anti-TAC (anti-CD25) Monoclonal Antibody targets the specific cells involved in the symptoms of psoriasis, this new drug may be a better way to treat psoriasis. The second drug, Cyclosporine, is an FDA-approved drug in the treatment of psoriasis. There is evidence in the laboratory that Cyclosporine and anti-TAC, used together, will have an additive effect. An additional benefit of this study is that we are using a lower dose of cyclosporine than is usually given when it is used alone because it is being used together with anti-TAC. This should reduce the side effects usually seen with higher doses of Cyclosporine when it is used as a single drug for psoriasis. The purpose of this study is to test the safety and effectiveness of anti-TAC (Monoclonal Antibody and low dose cyclosporine in patients with active, moderate to severe psoriasis vulgaris. We also hope to gain more information on how anti-TAC works in the body
- Conditions
- Psoriasis
- Being tested
- Daclizumab, Cyclosporine, cyclosporine and Daclizumab
- Keywords
- psoriasis, Daclizumab, Cyclosporin, anti-TAC, dermatology, skin
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DaclizumabDrug
1mg/kg medication every other week on the odd week (week 1-13).
CyclosporineDrug
Also called Neoral
2mg/kg/day orally from Day 0 until Day 90 or a total of 13 weeks.
cyclosporine and DaclizumabDrug
1mg/kg plus low dose cyclosporine (2 mg/kg/day)
| Study group | Role | What they receive |
|---|---|---|
| cyclosporine | Active comparator | oral medication 2mg/kg/day orally from Day 0 until Day 90 Receives: Drug: Cyclosporine |
| anti-TAC | Active comparator | 1mg/kg/dose medication every other week on the odd week (week 1-13) Receives: Drug: Daclizumab |
| Cyclosporine and anti-TAC | Experimental | DaclizumabTM at 1mg/kg plus low dose cyclosporine (2 mg/kg/day) Receives: Drug: cyclosporine and Daclizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical tolerability of DaclizumabTM and the DaclizumabTM/cyclosporine combination
Measured: day 1, week 1, 2, 3, 4, 5,7,8,9,11, 12, 13, 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2002 (estimated)
- Study startOct 1997
- Primary completionSep 2004
- Study completionApr 2008
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.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rockefeller University
- Sponsor type
- University, hospital or other
- Collaborators
- Facet Biotech
- Investigators
- James Krueger, MD, PHD, Principal investigator, Rockefeller University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00050648
- Sponsor's protocol ID
- JKR-0336
- Status last verified
- Mar 2009
- First submitted
- 17 Dec 2002
- Last updated
- 13 Mar 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Humanized CD25 (Anti-TAC) Monoclonal Antibody and Cyclosporine for the Treatment of Active Psoriasis.
- ClinicalTrials.gov ID
- NCT00050648
- Acronym / sponsor ID
- JKR-0336
- Conditions
- Psoriasis
- Keywords
- psoriasis, Daclizumab, Cyclosporin, anti-TAC, dermatology, skin
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Rockefeller UniversityUniversity, hospital or other
- Collaborators
- Facet Biotech
- Study start
- Oct 1997
- Primary completion
- Sep 2004 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 18 Dec 2002 (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 study compares the efficacy and analyzes the cellular effects of anti-TAC (Daclizumab) and Cyclosporine in the treatment of psoriasis vulgaris. This is a three-armed study-Daclizumab alone, Cyclosporine alone, and the combination of both Daclizumab and Cyclosporine.
Detailed description
The purpose is to study the safety and effectiveness of a new drug called "anti-TAC" (anti-CD25) Monoclonal Antibody used together with low dose Cyclosporine in the treatment of psoriasis. While the exact cause of psoriasis is unknown, it is believed to involve white blood cells called lymphocytes, which become activated in the skin. It is believed that these activated cells are responsible for the changes you see as the rash of psoriasis. Anti-TAC (anti-CD25) Monoclonal Antibody is designed to block the activation of these lymphocytes. Because the anti-TAC (anti-CD25) Monoclonal Antibody targets the specific cells involved in the symptoms of psoriasis, this new drug may be a better way to treat psoriasis. The second drug, Cyclosporine, is an FDA-approved drug in the treatment of psoriasis. There is evidence in the laboratory that Cyclosporine and anti-TAC, used together, will have an additive effect. An additional benefit of this study is that we are using a lower dose of cyclosporine than is usually given when it is used alone because it is being used together with anti-TAC. This should reduce the side effects usually seen with higher doses of Cyclosporine when it is used as a single drug for psoriasis. The purpose of this study is to test the safety and effectiveness of anti-TAC (Monoclonal Antibody and low dose cyclosporine in patients with active, moderate to severe psoriasis vulgaris. We also hope to gain more information on how anti-TAC works in the body
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| cyclosporine | Active comparator | Drug: Cyclosporineoral medication 2mg/kg/day orally from Day 0 until Day 90 |
| anti-TAC | Active comparator | Drug: Daclizumab1mg/kg/dose medication every other week on the odd week (week 1-13) |
| Cyclosporine and anti-TAC | Experimental | Drug: cyclosporine and DaclizumabDaclizumabTM at 1mg/kg plus low dose cyclosporine (2 mg/kg/day) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female patients with chronic psoriasis vulgaris (disease stable or worsening for > 6 months). Patients age 16 - 21 will be considered on a case by case basis. Patients below 18 will need parental consent.
- Extensive skin involvement.
- Scale, thickness, and erythema in individual psoriasis lesions of at least intensity.
- Psoriasis treated with emollients only for 2 weeks prior to treatment
- Patients with active psoriatic arthritis, if accompanied by psoriasis vulgaris involving more than 5% of the body surface.
Key exclusion criteria (5 listed)
- . Positive serology for HIV, Hepatitis B, or Hepatitis C.
- . Positive β-HCG titer. For women of childbearing potential, unwillingness or inability to use a contraceptive device during this study if negative for β-HCG.
- Guttate psoriasis, pustular psoriasis, or whole body erythroderma.
- Active infection or persistent fever of unknown origin. 5.) Major concurrent illness, which could worsen following treatment with DaclizumabTM.
- 6) Any history of an un-treated neoplasm
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 |
|---|---|---|
| Daclizumab1mg/kg medication every other week on the odd week (week 1-13). | Drug | anti-TAC |
| CyclosporineAlso: Neoral2mg/kg/day orally from Day 0 until Day 90 or a total of 13 weeks. | Drug | cyclosporine |
| cyclosporine and Daclizumab1mg/kg plus low dose cyclosporine (2 mg/kg/day) | Drug | Cyclosporine and anti-TAC |
Primary outcome
clinical tolerability of DaclizumabTM and the DaclizumabTM/cyclosporine combination
Time frame: day 1, week 1, 2, 3, 4, 5,7,8,9,11, 12, 13, 14
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 13 Mar 2009.
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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, PHD principal investigator
Rockefeller University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Daclizumab, Cyclosporine and cyclosporine and Daclizumab in people with Psoriasis, run by Rockefeller University at 3 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 6 inclusion and 5 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 13 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
clinical tolerability of DaclizumabTM and the DaclizumabTM/cyclosporine combination (time frame: day 1, week 1, 2, 3, 4, 5,7,8,9,11, 12, 13, 14). 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 13 Mar 2009.