PsoriasisPhase 1NCT01493518
Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Clinical Effects of AMG 557 in Adults With Psoriasis
A Phase 1 study of Psoriasis, run by Amgen at 6 sites in United States.
Trial summary
The purpose of this study is to study the safety, tolerability and immunogenicity of AMG 557 following multiple subcutaneous dose administration in adults with moderate to severe psoriasis. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Psoriasis
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6 participants
- Where
- 6 sitesUnited States
- Study dates
- Nov 2011to Jun 2013
- Phase
- Phase 1
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Subjects must sign an Institutional Review Board (IRB)-approved informed consent form (ICF) before any study specific procedures.
- Diagnosis of moderate to severe plaque PsO for at least 6 months prior to screening as defined by:
- A minimum PASI score of ≥ 10 obtained at screening;
- Psoriasis involving ≥ 10% of the Body Surface Area (BSA) at screening.
- Received at least 1 previous phototherapy or systemic PsO therapy (but not within the 30 days before study drug administration), or has been a candidate to receive phototherapy or systemic PsO therapy in the opinion of the PI.
- Stable treatment without topical or systemic steroids, topical or systemic retinoids, vitamin D analogues (Dovenex), Psoralen Ultraviolet A (PUVA) therapy, Ultraviolet A (UVA) therapy or Ultraviolet B (UVB) therapy, methotrexate, or cyclosporine for at least 60 days prior to IP administration. Stable treatment of PsO involving scalp, axillae, or groin with topical corticosteroids of moderate strength will be allowed.
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- Agrees to wear clothing that protects from sun exposure for the duration of the study.
- Agrees to use sunscreen (SPF of at least 30) on sun-exposed skin for the duration of the study.
- Male or female subjects between 18 and 55 years of age, inclusive at the time of screening.
- Body mass index (BMI) between 18 and 35 kg/m2, inclusive, at screening, unless considered by the PI and the Amgen Medical Monitor to be at an appropriate value in the context of other measured safety parameters.
- Able and willing to complete entire study (including skin biopsies) according to study schedule.
- Additional criteria per protocol.
Who cannot join
- Diagnosis of guttate, pustular, or other non plaque forms of PsO.
- Evidence of skin conditions other than PsO (eg, eczema) during the screening period that would interfere with evaluations of the effect of IP on PsO.
- Previous receipt of any approved or investigational biologic agent for PsO or other medical conditions.
- Received PUVA therapy, UVA therapy or UVB therapy ≤ 30 days prior to IP administration.
- Treatment with any other systemic PsO therapy or oral or parenteral corticosteroids ≤ 30 days prior to IP administration.
- Use of high potency topical steroids, topical vitamin A or D analog preparations, or anthralin ≤ 30 days prior to IP administration (Note: stable doses > 30 days of low or moderate strength topical steroids are permitted only on the scalp, axillae, and groin according to the package insert).
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- Received topical cyclosporin or calcineurin inhibitors such as pimecrolimus (Elidel) and tacrolimus (Protopic) ≤ 30 days prior to IP administration.
- Received IV or oral calcineurin inhibitors such as tacrolimus (Prograf) ≤ 30 days prior to IP administration.
- Significant concurrent medical conditions at the time of screening or prior to randomization, including:
- Uncontrolled hypertension (defined as screening systolic blood pressure measurement of greater than 140 mm Hg or a screening diastolic blood pressure of greater than 90 mm Hg) confirmed by 2 separate measurements during 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;
- Open cutaneous ulcers;
- Uncontrolled diabetes (HbA1c > 7%).
- History of myocardial infarction.
- Subjects with two or more cardiovascular risk factors (defined as BMI > 30, BP systolic > 140 mm Hg, diagnosis of diabetes, history of cardiovascular event).
- Evidence of significant renal insufficiency during the screening period, defined by a glomerular filtration rate < 50 mL/min using the Cockcroft and Gault equation:
- 72 x Serum Creatinine (in mg/dL) / (140 - Age) x Body Weight (in kg) x [0.85 if female]
- Evidence of any bacterial, viral, parasitic, or systemic fungal infections during the 30 days prior to study drug administration (eg, common cold, viral syndrome, flu like symptoms).
- Evidence of a recent (within 6 months of randomization) infection requiring in patient hospitalization or intravenous antibiotics.
- Positive test for HIV antibodies, hepatitis B surface antigen, or hepatitis C antibodies.
- Underlying condition that predisposes the subject to infections (eg, history of splenectomy; history of immunodeficiency).
- Evidence of past or active tuberculosis on chest x-ray performed during screening (or documented evidence on a chest x-ray performed within 6 months prior to planned dosing); known tuberculosis antecedents; known exposure (without adequate treatment) to a person with active tuberculosis; or positive protein purified derivative (PPD) Mantoux skin or serum quantiferon test at screening (without documented history of treatment). A positive result is defined as either induration greater than or equal to 5 mm 48-72 hours after administration (Mantoux) or a positive serum quantiferon test result.
- History of malignancy.
- Evidence of liver disease (eg, serum ALT and AST > 1.5 x the upper limit of normal) during screening period.
- Donated blood (including blood products) or experienced loss of blood ≥ 500 mL within 2 months of screening.
- Additional criteria per protocol.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Research Site
Birmingham, Alabama, 35233
Research Site
Dallas, Texas, 75231
Study site
Dallas, Texas
Research Site
Portland, Oregon, 97239
Research Site
Reno, Nevada, 89511
Research Site
Salt Lake City, Utah, 84107
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Multiple-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Clinical Effects of AMG 557 in Subjects With Moderate to Severe Psoriasis
The purpose of this study is to study the safety, tolerability and immunogenicity of AMG 557 following multiple subcutaneous dose administration in adults with moderate to severe psoriasis.
- Conditions
- Psoriasis
- Being tested
- AMG 557 or PLACEBO
- Keywords
- SAFETY, ADULT, PSORIASIS, INFLAMMATION
- Medical subject headings
- Psoriasis, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMG 557 or PLACEBODrug
Multiple subcutaneous doses of AMG 557 or Placebo on Days 1, 8, 15, 29, 43, 57 and 71.
| Study group | Role | What they receive |
|---|---|---|
| PLACEBO | Placebo comparator | Not described Receives: Drug: AMG 557 or PLACEBO |
| AMG 557 | Experimental | Not described Receives: Drug: AMG 557 or PLACEBO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the number of adverse events per subject, including clinically significant changes in physical examinations, safety lab tests, ECG, vital signs, or immunogenicity to AMG 557
Measured: 28 weeks
Secondary outcomes (3)
Evaluate the efficacy of AMG 557 as measured by the proportion of subjects with a PASI 50, 75 and 90 at week 28
Measured: 28 weeks
Measure the area under the serum concentration curve versus time of AMG 557 after multiple dose administration in subjects with moderate to severe psoriasis
Measured: 28 weeks
Measure the peak serum concentration (Cmax) of AMG 557 after multiple dose administration in subjects with moderate to severe psoriasis
Measured: 28 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2011 (estimated)
- Study startNov 2011
- Primary completionMay 2013
- Study completionJun 2013
Why it stopped: Sponsor decision
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 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 6 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
- NCT01493518
- Sponsor's protocol ID
- 20110105
- Status last verified
- Nov 2013
- First submitted
- 18 Aug 2011
- Last updated
- 19 Nov 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Multiple-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Clinical Effects of AMG 557 in Subjects With Moderate to Severe Psoriasis
- ClinicalTrials.gov ID
- NCT01493518
- Acronym / sponsor ID
- 20110105
- Conditions
- Psoriasis
- Keywords
- SAFETY, ADULT, PSORIASIS, INFLAMMATION
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision
- Enrolment
- 6 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- Nov 2011
- Primary completion
- May 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 16 Dec 2011 (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.
The purpose of this study is to study the safety, tolerability and immunogenicity of AMG 557 following multiple subcutaneous dose administration in adults with moderate to severe psoriasis.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PLACEBO | Placebo comparator | Drug: AMG 557 or PLACEBO |
| AMG 557 | Experimental | Drug: AMG 557 or PLACEBO |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Subjects must sign an Institutional Review Board (IRB)-approved informed consent form (ICF) before any study specific procedures.
- Diagnosis of moderate to severe plaque PsO for at least 6 months prior to screening as defined by:
- Received at least 1 previous phototherapy or systemic PsO therapy (but not within the 30 days before study drug administration), or has been a candidate to receive phototherapy or systemic PsO therapy in the opinion of the PI.
- Stable treatment without topical or systemic steroids, topical or systemic retinoids, vitamin D analogues (Dovenex), Psoralen Ultraviolet A (PUVA) therapy, Ultraviolet A (UVA) therapy or Ultraviolet B (UVB) therapy, methotrexate, or cyclosporine for at least 60 days prior to IP administration. Stable treatment of PsO involving scalp, axillae, or groin with topical corticosteroids of moderate strength will be allowed.
- Agrees to wear clothing that protects from sun exposure for the duration of the study.
Key exclusion criteria (29 listed)
- Diagnosis of guttate, pustular, or other non plaque forms of PsO.
- Evidence of skin conditions other than PsO (eg, eczema) during the screening period that would interfere with evaluations of the effect of IP on PsO.
- Previous receipt of any approved or investigational biologic agent for PsO or other medical conditions.
- Received PUVA therapy, UVA therapy or UVB therapy ≤ 30 days prior to IP administration.
- Treatment with any other systemic PsO therapy or oral or parenteral corticosteroids ≤ 30 days prior to IP administration.
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 557 or PLACEBOMultiple subcutaneous doses of AMG 557 or Placebo on Days 1, 8, 15, 29, 43, 57 and 71. | Drug | AMG 557, PLACEBO |
Primary outcome
Evaluate the number of adverse events per subject, including clinically significant changes in physical examinations, safety lab tests, ECG, vital signs, or immunogenicity to AMG 557
Time frame: 28 weeks
3 secondary outcomes
Evaluate the efficacy of AMG 557 as measured by the proportion of subjects with a PASI 50, 75 and 90 at week 28
Time frame: 28 weeks
Measure the area under the serum concentration curve versus time of AMG 557 after multiple dose administration in subjects with moderate to severe psoriasis
Time frame: 28 weeks
Measure the peak serum concentration (Cmax) of AMG 557 after multiple dose administration in subjects with moderate to severe psoriasis
Time frame: 28 weeks
Results and safety
The study was stopped early (reason given: Sponsor decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2013.
- 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
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study of Psoriasis, run by Amgen at 6 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 12 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: stopped early, as of the sponsor's last update on 19 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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. Some participants in this study may receive a placebo. 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 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.
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 stopped early (reason given: Sponsor decision). Results are not available in the source record.
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?
Evaluate the number of adverse events per subject, including clinically significant changes in physical examinations, safety lab tests, ECG, vital signs, or immunogenicity to AMG 557 (time frame: 28 weeks). 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 19 Nov 2013.