PsoriasisPhase 1/2NCT00050661
To Study the Use of Humanized CD25 in Preventing the Relapse of Psoriasis Vulgaris
A Phase 1/2 study testing Daclizumab and NB-UVB in people with Psoriasis, run by Rockefeller University at 3 sites in United States.
Trial summary
This study is designed to study disease relapse after NBUVB and how the administration of Daclizumab/placebo alters disease relapse. 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 and NB-UVB
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 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 to case basis.
- For those patients under the age of 18, parental consent will be obtained.
- Extensive skin involvement.
- Scale, thickness, and erythema in individual psoriasis lesions of at least moderate 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.
- Patients that are appropriate for treatment with UVB.
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.
- Major concurrent illness, which could worsen following treatment with anti-TAC.
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/ Placebo to Prevent Relapse of Psoriasis Vulgaris Following NBUVB Therapy
This study is designed to study disease relapse after NBUVB and how the administration of Daclizumab/placebo alters disease relapse.
Read the detailed description
The first part of the study involves NB-UVB light treatment, a well-established treatment to treat psoriasis. In the second part, we are testing a drug known as Humanized CD25 Monoclonal Antibody (anti-TAC) or placebo to prevent disease relapse. Anti-TAC is an injectable medicine that is also designed to treat psoriasis by blocking a part of the immune system that we believe contributes to the disease.
- Conditions
- Psoriasis
- Being tested
- Daclizumab, NB-UVB
- Keywords
- psoriasis, Cyclosporine, Daclizamub, anti-TAC, dermatology, skin, lesions
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DaclizumabDrug
Also called anti-TAC
Humanized anti-CD25 antibodies (anti-TAC), or placebo (saline solution), will be given as intravenous infusions on the following schedule: 2 mg/kg initially (maximum dose 200 mg) infusion given over 60 minutes, followed by a 1 mg/kg (maximum of 100 mg) infusion given over 30 minutes every two weeks thereafter for a total of 8 doses.
NB-UVBDevice
total body NB-UVB at a dose that is 50% of the MED. Patients are treated 3-7 times per week, with increasing doses at every treatment if no burning occurs. This is continued until for a total of 20 ± 2 treatments total.
| Study group | Role | What they receive |
|---|---|---|
| Narrow Band Ultraviolet B | Active comparator | 312nm Receives: Device: NB-UVB |
| anti-TAC or placebo | Experimental | Not described Receives: Drug: Daclizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
time to disease relapse
Measured: After a course of NB-UVB treatment
Secondary outcomes (1)
Histologic assessment of disease activity at relapse for measures of epidermal hyperplasia, leukocyte infiltration, and expression of cytokine-induced inflammatory proteins.
Measured: before and after NB-UVB treatment
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 completionApr 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
- 6 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
- NCT00050661
- Sponsor's protocol ID
- JKR-0337
- Status last verified
- Mar 2009
- First submitted
- 17 Dec 2002
- Last updated
- 25 Mar 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 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/ Placebo to Prevent Relapse of Psoriasis Vulgaris Following NBUVB Therapy
- ClinicalTrials.gov ID
- NCT00050661
- Acronym / sponsor ID
- JKR-0337
- Conditions
- Psoriasis
- Keywords
- psoriasis, Cyclosporine, Daclizamub, anti-TAC, dermatology, skin, lesions
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Rockefeller UniversityUniversity, hospital or other
- Collaborators
- Facet Biotech
- Study start
- Oct 1997
- Primary completion
- Apr 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 is designed to study disease relapse after NBUVB and how the administration of Daclizumab/placebo alters disease relapse.
Detailed description
The first part of the study involves NB-UVB light treatment, a well-established treatment to treat psoriasis. In the second part, we are testing a drug known as Humanized CD25 Monoclonal Antibody (anti-TAC) or placebo to prevent disease relapse. Anti-TAC is an injectable medicine that is also designed to treat psoriasis by blocking a part of the immune system that we believe contributes to the disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Narrow Band Ultraviolet B | Active comparator | Device: NB-UVB312nm |
| anti-TAC or placebo | Experimental | Drug: Daclizumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 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 to case basis.
- For those patients under the age of 18, parental consent will be obtained.
- Extensive skin involvement.
- Scale, thickness, and erythema in individual psoriasis lesions of at least moderate intensity.
- Psoriasis treated with emollients only for 2 weeks prior to treatment
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.
- Major concurrent illness, which could worsen following treatment with anti-TAC.
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 |
|---|---|---|
| DaclizumabAlso: anti-TACHumanized anti-CD25 antibodies (anti-TAC), or placebo (saline solution), will be given as intravenous infusions on the following schedule: 2 mg/kg initially (maximum dose 200 mg) infusion given over 60 minutes, followed by a 1 mg/kg (maximum of 100 mg) infusion given over 30 minutes every two weeks thereafter for a total of 8 doses. | Drug | anti-TAC or placebo |
| NB-UVBtotal body NB-UVB at a dose that is 50% of the MED. Patients are treated 3-7 times per week, with increasing doses at every treatment if no burning occurs. This is continued until for a total of 20 ± 2 treatments total. | Device | Narrow Band Ultraviolet B |
Primary outcome
time to disease relapse
Time frame: After a course of NB-UVB treatment
1 secondary outcome
Histologic assessment of disease activity at relapse for measures of epidermal hyperplasia, leukocyte infiltration, and expression of cytokine-induced inflammatory proteins.
Time frame: before and after NB-UVB treatment
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 25 Mar 2009.
- Rockefeller University Hospital Clinical StudiesLink provided by the sponsor.
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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 and NB-UVB 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 7 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 25 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?
time to disease relapse (time frame: After a course of NB-UVB treatment). 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 25 Mar 2009.