Chronic Plaque PsoriasisPhase 2NCT01200264
Apremilast for Chronic Plaque Psoriasis (CPP) Patients Who Have Failed One Course of Biologic Therapy
A Phase 2 study testing apremilast in people with Chronic Plaque Psoriasis, run by Duke University at 1 site in United States.
Trial summary
This is a Phase II, open label, investigator-initiated study to be done at Duke University Medical Center to treat adult patients (ages 18-80) with chronic plaque psoriasis who have failed Biologic Therapy with Apremilast 30 mg BID for 24 weeks. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Plaque Psoriasis
- What is being tested?
- apremilast
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to Sep 2012
- Phase
- Phase 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects 18-80 yrs diagnosed with moderate-to-severe chronic plaque psoriasis with a PGA of 3 or greater and require systemic therapy
- Must have received a biologic therapy for CPP and did not achieve a PGA of 'almost clear' or 'clear'
- Must meet lab criteria per Pg 20-21 of protocol
- All subjects must follow contraceptive measures as described in protocol, Pg 21.
Who cannot join
- Abnormal Chest x-ray
- Significant abnormality of ECG
- Positive HIV Ab, Hepatitis B \& C
- Subjects with erythrodermic, pustular or guttate psoriasis are ineligible
- Serious local infection or systemic infection, or tuberculosis within 3 mos of first dose of apremilast
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
Official title: Open-Label Study to Assess the Safety and Efficacy of Apremilast in Patients With Chronic Plaque Psoriasis Who Have Failed One Course of Biologic Therapy.
This is a Phase II, open label, investigator-initiated study to be done at Duke University Medical Center to treat adult patients (ages 18-80) with chronic plaque psoriasis who have failed Biologic Therapy with Apremilast 30 mg BID for 24 weeks. At the time of enrollment, the patient must have received biologic therapy without achieving a response of "almost clear" or "clear" according to PGA or has not responded with a 75% reduction of PASI score. Once deemed eligible, subjects will return for a baseline visit and receive Apremilast therapy and instructions. Subjects will be treated at weeks 0,4,8,12,16,20 and 24; subjects will be evaluated 28 days after last dose of Apremilast for safety and efficacy.
Read the detailed description
Data Analysis Data will be analyzed and reported after all subjects have completed follow-up phase of study. All subsequent data collected will be analyzed and reported in a follow-up clinical report.
Data \& Safety Monitoring Dr. Murray will be following all laboratory values and adverse events during this trial. In addition, Celgene will provide a study monitor to, at regular intervals, review all data. All data will be reported to Celgene.
- Conditions
- Chronic Plaque Psoriasis
- Being tested
- apremilast
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
apremilastDrug
Also called CC-1004
apremilast 10 mg tablets with dose titration to 30 mg BID for 169 days
| Study group | Role | What they receive |
|---|---|---|
| apremilast for all subjects | Experimental | Not described Receives: Drug: apremilast |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety/efficacy of apremilast in CPP pts that have failed 1 course of biologic therapy
Measured: 6 mos. treatment and 1 month F/U post treatment
Secondary outcomes (1)
Mechanistic studies performed to assess efficacy of apremilast to inhibit inflammatory responses in non-involved, mildly traumatized skin.
Measured: Treatment course of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2010 (estimated)
- Study startSep 2010
- Primary completionDec 2011 (estimated)
- Study completionSep 2012 (estimated)
Why it stopped: Contract never executed; withdrawn by sponsor
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Plaque PsoriasisStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Investigators
- John C Murray, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01200264
- Sponsor's protocol ID
- Pro00025452
- Other IDs
- AP00039
- Status last verified
- Sep 2010
- First submitted
- 10 Sep 2010
- Last updated
- 15 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label Study to Assess the Safety and Efficacy of Apremilast in Patients With Chronic Plaque Psoriasis Who Have Failed One Course of Biologic Therapy.
- ClinicalTrials.gov ID
- NCT01200264
- Acronym / sponsor ID
- Pro00025452
- Conditions
- Chronic Plaque Psoriasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Contract never executed; withdrawn by sponsor
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Sep 2012 (estimated)
- First posted
- 13 Sep 2010 (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 is a Phase II, open label, investigator-initiated study to be done at Duke University Medical Center to treat adult patients (ages 18-80) with chronic plaque psoriasis who have failed Biologic Therapy with Apremilast 30 mg BID for 24 weeks. At the time of enrollment, the patient must have received biologic therapy without achieving a response of "almost clear" or "clear" according to PGA or has not responded with a 75% reduction of PASI score. Once deemed eligible, subjects will return for a baseline visit and receive Apremilast therapy and instructions. Subjects will be treated at weeks 0,4,8,12,16,20 and 24; subjects will be evaluated 28 days after last dose of Apremilast for safety and efficacy.
Detailed description
Data Analysis Data will be analyzed and reported after all subjects have completed follow-up phase of study. All subsequent data collected will be analyzed and reported in a follow-up clinical report.
Data \& Safety Monitoring Dr. Murray will be following all laboratory values and adverse events during this trial. In addition, Celgene will provide a study monitor to, at regular intervals, review all data. All data will be reported to Celgene.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| apremilast for all subjects | Experimental | Drug: apremilast |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects 18-80 yrs diagnosed with moderate-to-severe chronic plaque psoriasis with a PGA of 3 or greater and require systemic therapy
- Must have received a biologic therapy for CPP and did not achieve a PGA of 'almost clear' or 'clear'
- Must meet lab criteria per Pg 20-21 of protocol
- All subjects must follow contraceptive measures as described in protocol, Pg 21.
Key exclusion criteria (5 listed)
- Abnormal Chest x-ray
- Significant abnormality of ECG
- Positive HIV Ab, Hepatitis B \& C
- Subjects with erythrodermic, pustular or guttate psoriasis are ineligible
- Serious local infection or systemic infection, or tuberculosis within 3 mos of first dose of apremilast
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 |
|---|---|---|
| apremilastAlso: CC-1004apremilast 10 mg tablets with dose titration to 30 mg BID for 169 days | Drug | apremilast for all subjects |
Primary outcome
Safety/efficacy of apremilast in CPP pts that have failed 1 course of biologic therapy
Time frame: 6 mos. treatment and 1 month F/U post treatment
1 secondary outcome
Mechanistic studies performed to assess efficacy of apremilast to inhibit inflammatory responses in non-involved, mildly traumatized skin.
Time frame: Treatment course of 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2014.
Related trials for Chronic Plaque Psoriasis
RecruitingObservational study
Collection of Samples From Subjects With Various Skin Conditions and Healthy Volunteers
Acne, Atopic Dermatitis
RecruitingPhase 4
An Open Label Trial to Evaluate Efficacy and Safety of Roflumilast 0.3% Cream for Chronic Plaque and Nail Psoriasis
Chronic Plaque Psoriasis, Nail Psoriasis
RecruitingPhase 2
Early Intervention in Plaque Psoriasis: is Bimekizumab Able to Delay Chronic Inflammation?
Psoriasis
RecruitingObservational study
Serum Substance P, Neuropathic Pain, and Central Sensitization Across Treatment Groups in Chronic Plaque Psoriasis
Chronic Plaque-type Psoriasis
Active, not recruitingPhase 3
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneously Administered Guselkumab for the Treatment of Chronic Plaque Psoriasis in Pediatric Participants
Psoriasis
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.
John C Murray, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing apremilast in people with Chronic Plaque Psoriasis, run by Duke University 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 4 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: withdrawn, as of the sponsor's last update on 15 Jul 2014. 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 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 was withdrawn before enrolling participants, so there are no results.
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?
Safety/efficacy of apremilast in CPP pts that have failed 1 course of biologic therapy (time frame: 6 mos. treatment and 1 month F/U post 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 15 Jul 2014.