PsoriasisPhase 2NCT00443326
AMG 714 20060349 Multiple Dose Study in Moderate to Severe Psoriasis Subjects
A Phase 2 study testing AMG 714 in people with Psoriasis, run by Amgen.
Trial summary
Investigational drug AMG 714 will be given to 66 subjects with moderate to severe psoriasis to study safety, pharmacokinetics, and efficacy. Dose levels include 150mg and 300mg and will be given to each subject for a total of 6 doses. Each dose for each subject will be given once every 2 weeks. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis
- What is being tested?
- AMG 714
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- Mar 2007to May 2010
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Active but clinically stable, plaque psoriasis.
- Psoriasis involving greater than or equal to 10% of the body surface area
- A minimum PASI score of 10 obtained during the screening period.
- Received at least one previous phototherapy or systemic psoriasis therapy or have been a candidate to receive phototherapy or systemic psoriasis therapy in the opinion of the investigator.
- At least 18 years of age.
- Heterosexually active men and women must be willing to practice an effective method of contraception (as outlined in section 6.7) as determined by the investigator and sponsor for the duration of the study. This includes any washout period and the follow-up period.
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- ALT and AST less than or equal to 2 x the upper limit of normal; hemoglobin greater than or equal to 10 g/dL (greater than or equal to 100 g/L in SI units); platelet count greater than or equal to 125,000 mm3 (greater than or equal to 125 x109/L in SI units); white blood cell count greater than or equal to 3,500 cells/mm3 (greater than or equal to 3.5 x109/L in SI units); serum creatinine less than or equal to 2 mg/dL (less than or equal to 177 μmol/L in SI units).
- Negative for HIV antibodies, hepatitis B surface antigen, and hepatitis C antibodies.
- Capable of understanding and giving written, voluntary informed consent before study screening.
Who cannot join
- Active guttate, erythrodermic, or pustular psoriasis at the time of the screening visit.
- Evidence of skin conditions (eg, eczema) at the time of the screening visit or between the screening visit and study drug initiation that would interfere with evaluations of the effect of investigational product on psoriasis.
- Clinically significant adverse event, infection, or laboratory toxicity, at the time of the screening visit or between the screening visit and study drug initiation that in the opinion of Amgen or the Investigator would preclude participation in the study.
- Clinically significant infection less than or equal to 30 days before the screening visit that in the opinion of Amgen or the Investigator would preclude participation in the study.
- Known positive tuberculin skin test (if not treated with appropriate chemoprophylaxis) or recent (within 6 months) exposure to a patient with active tuberculosis.
- Any other known infectious process that would, in the investigator's discretion, interfere with the subject's ability to participate in the study.
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- Significant concurrent medical conditions at the time of screening, including:
- Uncontrolled hypertension (defined as screening systolic blood pressure measurement of greater than 160 mm Hg or a screening diastolic blood pressure of greater than 100 mm Hg) confirmed by 2 separate measurements during the screening visit
- Myocardial infarction less than or equal to 52 weeks before the screening visit
- Unstable angina pectoris
- Congestive heart failure
- Steroid or oxygen dependent chronic obstructive pulmonary disease
- Diagnosis of multiple sclerosis or any other demyelinating disease
- Inadequately controlled diabetes mellitus, defined by glycohemoglobin greater than 7.0 at screening
- History of cancer (other than resected and surgically cured cervical cancer, cutaneous basal cell, squamous cell carcinoma) less than or equal to 5 years before the administration of first dose of investigational product
- Open cutaneous ulcers
- Any condition that, in the judgment of the investigator, might cause this study to be detrimental to the subject.
- Any evidence during screening of cutaneous basal or squamous cell carcinoma, or melanoma.
- Current or history of psychiatric disease that would interfere with the ability to comply with the study protocol or give informed consent.
- History of alcohol or drug abuse that would interfere with the ability to comply with the study protocol.
- Previous receipt of etanercept or any other anti-TNF agent(s), alefacept, efalizumab, or other investigational biologic agent for psoriasis.
- Receipt of any investigational product(s) less than or equal to 30 days before the first dose of investigational product in this study.
- PUVA therapy less than or equal to 30 days before the first dose of investigational product.
- UVA therapy less than or equal to 14 days before the first dose of investigational product.
- UVB therapy less than or equal to 30 days before the first dose of investigational product.
- Receipt of any other systemic psoriasis therapy or oral or parenteral corticosteroids less than or equal to 14 days before the first dose of investigational product.
- Topical steroids, topical vitamin A or D analog preparations or anthralin less than or equal to 14 days before the first dose of investigational product (exception - topical steroids at no higher than moderate strength, according to the package insert, are permitted on the scalp, axillae, and groin).
- Topical cyclosporin or calcineurin inhibitors such as pimecrolimus (Elidel) and tacrolimus (Protopic) less than or equal to 14 days before the first dose of investigational product.
- Intravenous or oral calcineurin inhibitors such as tacrolimus (Prograf) less than or equal to 30 days before the first dose of investigational product.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Ascending Dose Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of AMG 714 After Multiple Dose Administration in Subjects With Moderate to Severe Psoriasis
Investigational drug AMG 714 will be given to 66 subjects with moderate to severe psoriasis to study safety, pharmacokinetics, and efficacy. Dose levels include 150mg and 300mg and will be given to each subject for a total of 6 doses. Each dose for each subject will be given once every 2 weeks. Subjects will followed for up to 300 days post the first dose of AMG 714.
- Conditions
- Psoriasis
- Being tested
- AMG 714
- Keywords
- Psoriasis, PASI, Skin Biopsy, Human Monoclonal Antibody
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMG 714Drug
Dosing Regimen is 6 Doses over 3 Months
| Study group | Role | What they receive |
|---|---|---|
| AMG 714 | Experimental | AMG 714 will be given as a multiple dose regimen Receives: Drug: AMG 714 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psoriatic Assessment Score Index
Measured: First 85 Days
Secondary outcomes (1)
Safety and Tolerability
Measured: Collected for 300 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2007 (estimated)
- Study startMar 2007
- Primary completionDec 2008
- Study completionMay 2010
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.
- 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
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 22 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
- NCT00443326
- Sponsor's protocol ID
- 20060349
- Status last verified
- Dec 2015
- First submitted
- 1 Mar 2007
- Last updated
- 20 Jan 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Ascending Dose Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of AMG 714 After Multiple Dose Administration in Subjects With Moderate to Severe Psoriasis
- ClinicalTrials.gov ID
- NCT00443326
- Acronym / sponsor ID
- 20060349
- Conditions
- Psoriasis
- Keywords
- Psoriasis, PASI, Skin Biopsy, Human Monoclonal Antibody
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- Mar 2007
- Primary completion
- Dec 2008 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 5 Mar 2007 (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.
Investigational drug AMG 714 will be given to 66 subjects with moderate to severe psoriasis to study safety, pharmacokinetics, and efficacy. Dose levels include 150mg and 300mg and will be given to each subject for a total of 6 doses. Each dose for each subject will be given once every 2 weeks. Subjects will followed for up to 300 days post the first dose of AMG 714.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AMG 714 | Experimental | Drug: AMG 714AMG 714 will be given as a multiple dose regimen |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Active but clinically stable, plaque psoriasis.
- Psoriasis involving greater than or equal to 10% of the body surface area
- A minimum PASI score of 10 obtained during the screening period.
- Received at least one previous phototherapy or systemic psoriasis therapy or have been a candidate to receive phototherapy or systemic psoriasis therapy in the opinion of the investigator.
- At least 18 years of age.
Key exclusion criteria (29 listed)
- Active guttate, erythrodermic, or pustular psoriasis at the time of the screening visit.
- Evidence of skin conditions (eg, eczema) at the time of the screening visit or between the screening visit and study drug initiation that would interfere with evaluations of the effect of investigational product on psoriasis.
- Clinically significant adverse event, infection, or laboratory toxicity, at the time of the screening visit or between the screening visit and study drug initiation that in the opinion of Amgen or the Investigator would preclude participation in the study.
- Clinically significant infection less than or equal to 30 days before the screening visit that in the opinion of Amgen or the Investigator would preclude participation in the study.
- Known positive tuberculin skin test (if not treated with appropriate chemoprophylaxis) or recent (within 6 months) exposure to a patient with active tuberculosis.
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 |
|---|---|---|
| AMG 714Dosing Regimen is 6 Doses over 3 Months | Drug | AMG 714 |
Primary outcome
Psoriatic Assessment Score Index
Time frame: First 85 Days
1 secondary outcome
Safety and Tolerability
Time frame: Collected for 300 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 20 Jan 2016.
- AmgenTrials clinical trials websiteLink 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.
MD study director
Amgen
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AMG 714 in people with Psoriasis, run by Amgen.
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 29 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 20 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Psoriatic Assessment Score Index (time frame: First 85 Days). 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 20 Jan 2016; AzTrials last refreshed its copy on 1 Nov 2026.