PsoriasisPhase 2PSOR-001NCT00604682
Open-Label,Single-Arm Pilot Study to Evaluate the Pharmacodynamics, Pharmacokinetics, Safety, and Preliminary Efficacy of CC1004 in Subjects With Severe Plaque Type Psoriasis
A Phase 2 study testing CC10004 in people with Psoriasis, run by Amgen at 3 sites in United States.
Trial summary
Open label study for patients with severe plaque type psoriasis. This study is looking to evaluate the pharmacodynamic effect of CC10004 when taken for 29 days in reducing the epidermal thickness in subjects with severe placque type psoriasis. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Psoriasis
- What is being tested?
- CC10004
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Jan 2005to 1 Dec 2005
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must understand and voluntarily sign an informed consent form
- Must be age > or = to 18 years to 65 years at the time of singing the informed consent form.
- Must be able to adhere to the study visit schedule and other protocol requirements
- Must have a history of severe plaque type psoriasis for at least 6 months, and at least a 15% affected total body surface area (BSA)
- Must meet the following clinical laboratory criteria:
- White Blood Cell Count > or = to 3000/cu mm and < 20,000/cu mm
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- Platelet count > or = to 100,000/microliters
- Serum creatinine < or = to 1.5 mg/dl
- Total bilirubin < or = to 2.0 mg/dl
- AST (SGOT) and ALT (SGPT) < or = to 1.5 X ULN
- Must have a psoriatic plaque > or = to 2.5 cm in diameter (for biopsy)
- Must be candidate for photo/systemic therapy (a subject is considered a candidate for photo/systemic therapy if a clinician judges that the subject requires any systemic therapy (e.g., ultraviolet light B(UVB), Psoralens and long-wave ultraviolet radiation (PUVA), cyclosporine, corticosteroids, methotrexate, oral retinoids, mycophenolate mofetil, thioguanine, hydroxyurea, sirolimus, tacrolimus, azathioprine)to control psoriasis whether or not that subject has a history of receiving systemic therapy)
- Women of child bearing potential (WCBP) must have a negative urine pregnancy test at Screening (Visit 1). In addition, sexually active WCBP must agree to use two forms of adequate forms on contraception throughout the trial.
Who cannot join
- Any serious medical condition, laboratory abnormality , or psychiatric illness that would prevent the subject from signing the informed consent form
- Pregnant or lactating females
- Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study
- Current erythrodermic, guttate, or pustular psoriasis
- Use of medication that is metabolized by the CYP3A4 or CYP2A6 pathways within the 14 days of study medication initiation and/or required use of such medication during study treatment.
- Drinking or ingesting grapefruits, grapefruit juice or grapefruit containing products within 14 days of study medication initiation
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- Use of topical therapy ( topical steroids, topical vitamin A or D analog preparations, tacrolimus, pimecrolimus, or anthralin) within 14 days of study medications initiation (Exception: Non-medicated emollients and tar shampoo will be allowed)
- Use of systemic therapy for psoriasis
- Use or phototherapy within 28 days of study medication initiation
- Use Humira or Remicade within 3 months of study medication initiation
- Use of Enbrel within 56 days of study medication initiation
- Use of Raptiva within 56 days of study medication initiation
- Use of Amevive within 6 months of study medication initiation
- Use of any investigational drug within 30 days of study medication initiation or 5 half lives if known
- History of clinically significant cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic insufficiency disease or other major diseases
- Clinically significant abnormality on 12-lead ECG at screening
- Positive HIV, Hepatitis B or Hepatitis C laboratory result at screening
- History of active tuberculosis within previous 3 years
- Clinically significant abnormality on the chest x-ray at screening or on CXR taken within 6 months of screening
- History of positive purified protein derivative (PPD) test at screening
- History of malignancy within previous five years
- Evidence of skin conditions at the time of screening visit other than psoriasis that would interfere with evaluations of the effect of study medication on psoriasis
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Medicine and Dentistry of New Jersey
New Brunswick, New Jersey, 08903
NYU School of Medicine
New York, New York, 10016
Mt Sinai School of Medicine
New York, New York, 10029
About this study
Official title: Open-Label, Single-Arm Pilot Study to Evaluate the Pharmacodynamics, Pharmacokinetics, Safety, and Preliminary Efficacy of CC10004 in Subjects With Severe Plaque Type Psoriasis
Open label study for patients with severe plaque type psoriasis. This study is looking to evaluate the pharmacodynamic effect of CC10004 when taken for 29 days in reducing the epidermal thickness in subjects with severe placque type psoriasis.
- Conditions
- Psoriasis
- Being tested
- CC10004
- Keywords
- psoriasis
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CC10004Drug
Also called Apremilast
2 X 10 mg caps taken once daily for a daily dose of 20 mg. Must be taken upon awakening and fasted
| Study group | Role | What they receive |
|---|---|---|
| Administration of CC10004 | Experimental | Not described Receives: Drug: CC10004 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the pharmacodynamic effect of orally administered CC10004 when taken for 29 days in reducing epidermal thickness in subjects with severe plaque-type psoriasis.
Measured: 29 days
Secondary outcomes (3)
To evaluate the safety of orally administered CC10004 in subjects with severe plaque-type psoriasis during the treatment and follow up phases.
Measured: 58 days
To explore the clinical efficacy of orally administered CC10004 when taken for 29 days in subjects with severe plaque-type psoriasis.
Measured: 29 days
To explore the clinical efficacy of CC10004 when taken for 29 days in subjects with psoriatic arthritis.
Measured: 29 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2008 (estimated)
- Study start1 Jan 2005
- Primary completion1 Oct 2005
- Study completion1 Dec 2005
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 PsoriasisStudies of the same condition, open and under way.
- More trials run by AmgenThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00604682
- Sponsor's protocol ID
- CC-10004-PSOR-001
- Acronym
- PSOR-001
- Status last verified
- Apr 2020
- First submitted
- 17 Jan 2008
- Last updated
- 24 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Gottlieb AB, Strober B, Krueger JG, Rohane P, Zeldis JB, Hu CC, Kipnis C. An open-label, single-arm pilot study in patients with severe plaque-type psoriasis treated with an oral anti-inflammatory agent, apremilast. Curr Med Res Opin. 2008 May;24(5):1529-38. doi: 10.1185/030079908x301866. Epub 2008 Apr 16.
PubMed 18419879
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label, Single-Arm Pilot Study to Evaluate the Pharmacodynamics, Pharmacokinetics, Safety, and Preliminary Efficacy of CC10004 in Subjects With Severe Plaque Type Psoriasis
- ClinicalTrials.gov ID
- NCT00604682
- Acronym / sponsor ID
- PSOR-001 / CC-10004-PSOR-001
- Conditions
- Psoriasis
- Keywords
- psoriasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 1 Jan 2005 (actual)
- Primary completion
- 1 Oct 2005 (actual)
- Study completion
- 1 Dec 2005 (actual)
- First posted
- 30 Jan 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.
Open label study for patients with severe plaque type psoriasis. This study is looking to evaluate the pharmacodynamic effect of CC10004 when taken for 29 days in reducing the epidermal thickness in subjects with severe placque type psoriasis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Administration of CC10004 | Experimental | Drug: CC10004 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Must understand and voluntarily sign an informed consent form
- Must be age > or = to 18 years to 65 years at the time of singing the informed consent form.
- Must be able to adhere to the study visit schedule and other protocol requirements
- Must have a history of severe plaque type psoriasis for at least 6 months, and at least a 15% affected total body surface area (BSA)
- Must meet the following clinical laboratory criteria:
Key exclusion criteria (22 listed)
- Any serious medical condition, laboratory abnormality , or psychiatric illness that would prevent the subject from signing the informed consent form
- Pregnant or lactating females
- Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study
- Current erythrodermic, guttate, or pustular psoriasis
- Use of medication that is metabolized by the CYP3A4 or CYP2A6 pathways within the 14 days of study medication initiation and/or required use of such medication during study treatment.
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 |
|---|---|---|
| CC10004Also: Apremilast2 X 10 mg caps taken once daily for a daily dose of 20 mg. Must be taken upon awakening and fasted | Drug | Administration of CC10004 |
Primary outcome
To evaluate the pharmacodynamic effect of orally administered CC10004 when taken for 29 days in reducing epidermal thickness in subjects with severe plaque-type psoriasis.
Time frame: 29 days
3 secondary outcomes
To evaluate the safety of orally administered CC10004 in subjects with severe plaque-type psoriasis during the treatment and follow up phases.
Time frame: 58 days
To explore the clinical efficacy of orally administered CC10004 when taken for 29 days in subjects with severe plaque-type psoriasis.
Time frame: 29 days
To explore the clinical efficacy of CC10004 when taken for 29 days in subjects with psoriatic arthritis.
Time frame: 29 days
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 24 Apr 2020.
- Background: PubMed 18419879Gottlieb AB, Strober B, Krueger JG, Rohane P, Zeldis JB, Hu CC, Kipnis C. An open-label, single-arm pilot study in patients with severe plaque-type psoriasis treated with an oral anti-inflammatory agent, apremilast. Curr Med Res Opin. 2008 May;24(5):1529-38. doi: 10.1185/030079908x301866. Epub 2008 Apr 16.
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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.
MD study director
Amgen
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CC10004 in people with Psoriasis, run by Amgen 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 13 inclusion and 22 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 24 Apr 2020. 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 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 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?
To evaluate the pharmacodynamic effect of orally administered CC10004 when taken for 29 days in reducing epidermal thickness in subjects with severe plaque-type psoriasis. (time frame: 29 days). 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 NCT00604682, 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 24 Apr 2020.