Pityriasis Rubra PilarisPhase 4NCT00815633
A Pilot Study of Alefacept for the Treatment of Pityriasis Rubra Pilaris
A Phase 4 study testing Alefacept in people with Pityriasis Rubra Pilaris, run by Joshua Zeichner at 1 site in United States.
Trial summary
The purpose of this study is to determine whether the biologic medication alefacept (Amevive) is effective and safe in the treatment of Pityriasis Rubra Pilaris. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Pityriasis Rubra Pilaris
- What is being tested?
- Alefacept
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2008to Mar 2010
- 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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects may be male or female, 30 years old or older at time of consent
- Have a diagnosis of pityriasis rubra pilaris at least 6 months prior to administration of the first dose of the study medication
- Be a candidate for systemic therapy
- Women of childbearing potential and all men must use adequate contraceptive measures if sexually active. Examples include abstinence, oral contraceptives or other form of hormonal contraception, intrauterine devices, surgical sterilization, or barrier forms of contraception with spermicidal jelly. Subjects must agree to continue to use these contraceptive measures and agree not to become or plan a pregnancy within 12 months of the date of the last study drug administration.
- Agree to adhere to the study visit schedule and protocol requirements, including blood draws and clinical photographs.
- Must be able to give informed consent, and this consent must be obtained prior to any study related procedures being performed.
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- Must avoid other treatment modalities during the course of the study and adhere to standard washout periods for any medications used to treat their skin prior to receiving the first dose of study medication.
- Must agree not to receive a live viral or bacterial vaccine during the course of the study or for 12 months after the date of the last study drug administration.
- Have screening blood tests that are stable as deemed by the physician investigator. AST, ALT and alkaline phosphatase levels must be within 2.0 times the upper limit of normal to participate.
Who cannot join
- Subjects are pregnant or planning a pregnancy (both men and women) while enrolled in the study.
- Have used the medication alefacept in the past.
- Have used another investigational medication within the past 4 weeks or within 5 times the half-life of that investigational medicine.
- Have received systemic medications that could affect pityriasis rubra pilaris within 4 weeks of administration of the first dose of the study medicine.
- Have used topical medications that could affect pityriasis rubra pilaris within 2 weeks of administration of the first dose of the study medicine.
- Have received a live viral or bacterial vaccine within 3 months of administration of the first dose of the study medicine.
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- Have a history of chronic or recurrent infections of the skin or internal organs.
- Have had a serious infection requiring hospitalization or intravenous antibiotics within 2 weeks of administration of the first dose of the study medicine.
- Have a history of latent untreated tuberculosis.
- Have a known history of human immunodeficiency virus (HIV), hepatitis B or hepatitis C virus.
- Have a history of a malignancy except for squamous cell or basal cell carcinoma of the skin or cervical carcinoma in situ that has been treated with no evidence of recurrence.
- Have a known hypersensitivity to any component of alefacept.
- Have a known substance abuse problem or is deemed by the investigator as unable to follow the study protocol.
- Is participating in another study for an investigational agent or procedure during the course of this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
Official title: A Pilot Study of Alefacept for the Treatment of Pityriasis Rubra Pilaris.
The purpose of this study is to determine whether the biologic medication alefacept (Amevive) is effective and safe in the treatment of Pityriasis Rubra Pilaris.
Read the detailed description
Pityriasis Rubra Pilaris (PRP) is a therapeutic challenge, and many different medication regimens exist to treat the condition. Clinical response is variable, and no single treatment has emerged as a leading therapy. Biologic agents have emerged as effective treatments for many skin diseases, including psoriasis. Given the clinical overlap between PRP and psoriasis, it is logical to attempt to use these agents for PRP. Since the majority of patients with PRP are unresponsive to current therapies, new treatment modalities must be evaluated. This study will evaluate the treatment of adult 30 years or older with a diagnosis of PRP, either subtypes 1 or 2. In this study, the safety and efficacy of alefacept will be evaluated in adult patients with PRP refractory to current treatments. Alefacept is a dimeric fusion protein containing the CD2 extracellular binding region of human leukocyte function antigen-3 (LFA-3) linked to the Fc portion of human IgG1. The drug binds to the T-lymphocyte antigen CD2 and blocks its interaction with LFA-3 on antigen presenting cells in the body. The CD2/LFA-3 interaction is a key co-stimulatory signal in the activation of T-lymphocytes central to the pathophysiology of psoriasis. It is theorized this interaction plays a role in the pathophysiology of PRP. Alefacept is currently approved for the treatment of adults with moderate to severe, chronic, plaque-type psoriasis. The medication is administered as weekly intramuscular injections for 12 week courses. In this study, a dose of 15mg alefacept will be administered intramuscularly at weekly intervals for 12 weeks. This is the dosing regimen currently approved for the treatment of psoriasis. Patients will be followed for a total of 24 weeks.
- Conditions
- Pityriasis Rubra Pilaris
- Being tested
- Alefacept
- Keywords
- PRP, Pityriasis Rubra Pilaris, Amevive, Alefacept, Biologic, Immunosuppressant, Severe skin disease
- Medical subject headings
- Pityriasis Rubra Pilaris, Skin Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlefaceptDrug
Also called Amevive
15mg intramuscular injection weekly for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Alefacept | Experimental | Treatment Group (only one group) Receives: Drug: Alefacept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evidence of Skin Change - Physician's Global Assessment (PGA)
Measured: wks 1,2,3,4,5,6,7,8,9,10,11,12, 16,20,24
Evidence of Skin Change - PRP Area and Severity Index (PASI)
Measured: wks 1,2,3,4,5,6,7,8,9,10,11,12, 16,20,24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2008 (estimated)
- Study startDec 2008
- Primary completionJun 2009
- Study completionMar 2010
Why it stopped: Failed to enroll patients. There is no data or results for this study.
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.
- Other trials for Pityriasis Rubra PilarisStudies 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 participants (actual)
Sponsor and investigators
- Lead sponsor
- Joshua Zeichner
- Sponsor type
- University, hospital or other
- Collaborators
- Astellas Pharma Inc
- Responsible party
- Sponsor-investigator, Joshua Zeichner, Icahn School of Medicine at Mount Sinai
- Investigators
- Joshua Zeichner, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00815633
- Sponsor's protocol ID
- GCO 08-0514
- Other IDs
- JM-08-001
- Status last verified
- Apr 2018
- First submitted
- 29 Dec 2008
- Last updated
- 11 May 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Alefacept for the Treatment of Pityriasis Rubra Pilaris.
- ClinicalTrials.gov ID
- NCT00815633
- Acronym / sponsor ID
- GCO 08-0514
- Conditions
- Pityriasis Rubra Pilaris
- Keywords
- PRP, Pityriasis Rubra Pilaris, Amevive, Alefacept, Biologic, Immunosuppressant, Severe skin disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Failed to enroll patients. There is no data or results for this study.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Joshua ZeichnerUniversity, hospital or other
- Collaborators
- Astellas Pharma Inc
- Study start
- Dec 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 30 Dec 2008 (estimated)
- Results
- Posted 11 May 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether the biologic medication alefacept (Amevive) is effective and safe in the treatment of Pityriasis Rubra Pilaris.
Detailed description
Pityriasis Rubra Pilaris (PRP) is a therapeutic challenge, and many different medication regimens exist to treat the condition. Clinical response is variable, and no single treatment has emerged as a leading therapy. Biologic agents have emerged as effective treatments for many skin diseases, including psoriasis. Given the clinical overlap between PRP and psoriasis, it is logical to attempt to use these agents for PRP. Since the majority of patients with PRP are unresponsive to current therapies, new treatment modalities must be evaluated. This study will evaluate the treatment of adult 30 years or older with a diagnosis of PRP, either subtypes 1 or 2. In this study, the safety and efficacy of alefacept will be evaluated in adult patients with PRP refractory to current treatments. Alefacept is a dimeric fusion protein containing the CD2 extracellular binding region of human leukocyte function antigen-3 (LFA-3) linked to the Fc portion of human IgG1. The drug binds to the T-lymphocyte antigen CD2 and blocks its interaction with LFA-3 on antigen presenting cells in the body. The CD2/LFA-3 interaction is a key co-stimulatory signal in the activation of T-lymphocytes central to the pathophysiology of psoriasis. It is theorized this interaction plays a role in the pathophysiology of PRP. Alefacept is currently approved for the treatment of adults with moderate to severe, chronic, plaque-type psoriasis. The medication is administered as weekly intramuscular injections for 12 week courses. In this study, a dose of 15mg alefacept will be administered intramuscularly at weekly intervals for 12 weeks. This is the dosing regimen currently approved for the treatment of psoriasis. Patients will be followed for a total of 24 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Alefacept | Experimental | Drug: AlefaceptTreatment Group (only one group) |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subjects may be male or female, 30 years old or older at time of consent
- Have a diagnosis of pityriasis rubra pilaris at least 6 months prior to administration of the first dose of the study medication
- Be a candidate for systemic therapy
- Women of childbearing potential and all men must use adequate contraceptive measures if sexually active. Examples include abstinence, oral contraceptives or other form of hormonal contraception, intrauterine devices, surgical sterilization, or barrier forms of contraception with spermicidal jelly. Subjects must agree to continue to use these contraceptive measures and agree not to become or plan a pregnancy within 12 months of the date of the last study drug administration.
- Agree to adhere to the study visit schedule and protocol requirements, including blood draws and clinical photographs.
Key exclusion criteria (14 listed)
- Subjects are pregnant or planning a pregnancy (both men and women) while enrolled in the study.
- Have used the medication alefacept in the past.
- Have used another investigational medication within the past 4 weeks or within 5 times the half-life of that investigational medicine.
- Have received systemic medications that could affect pityriasis rubra pilaris within 4 weeks of administration of the first dose of the study medicine.
- Have used topical medications that could affect pityriasis rubra pilaris within 2 weeks of administration of the first dose of the study medicine.
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 |
|---|---|---|
| AlefaceptAlso: Amevive15mg intramuscular injection weekly for 12 weeks | Drug | Alefacept |
Primary outcome
Evidence of Skin Change - Physician's Global Assessment (PGA)
Time frame: wks 1,2,3,4,5,6,7,8,9,10,11,12, 16,20,24
Evidence of Skin Change - PRP Area and Severity Index (PASI)
Time frame: wks 1,2,3,4,5,6,7,8,9,10,11,12, 16,20,24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Pityriasis Rubra Pilaris
Not yet recruitingPhase 4
Bimzelx (Bimekizumab) For The Treatment Of Adult Onset Pityriasis Rubra Pilaris (PRP)
Pityriasis Rubra Pilaris
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.
Joshua Zeichner, MD principal investigator
Icahn School of Medicine at Mount Sinai
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 Alefacept in people with Pityriasis Rubra Pilaris, run by Joshua Zeichner at 1 site 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 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: stopped early, as of the sponsor's last update on 11 May 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 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 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 11 May 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?
Evidence of Skin Change - Physician's Global Assessment (PGA) (time frame: wks 1,2,3,4,5,6,7,8,9,10,11,12, 16,20,24). The study lists 2 primary outcomes in all. 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 11 May 2018.