Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2025-12-26 @ 4:05 AM
Study NCT ID:
NCT01493518
Status:
TERMINATED
Last Update Posted:
2013-11-19
First Post:
2011-08-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Clinical Effects of AMG 557 in Adults With Psoriasis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011565', 'term': 'Psoriasis'}, {'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000632508', 'term': 'AMG 557'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'whyStopped': 'Sponsor decision', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'completionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-11-15', 'studyFirstSubmitDate': '2011-08-18', 'studyFirstSubmitQcDate': '2011-12-14', 'lastUpdatePostDateStruct': {'date': '2013-11-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-12-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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', 'timeFrame': '28 weeks'}], 'secondaryOutcomes': [{'measure': 'Evaluate the efficacy of AMG 557 as measured by the proportion of subjects with a PASI 50, 75 and 90 at week 28', 'timeFrame': '28 weeks'}, {'measure': 'Measure the area under the serum concentration curve versus time of AMG 557 after multiple dose administration in subjects with moderate to severe psoriasis', 'timeFrame': '28 weeks'}, {'measure': 'Measure the peak serum concentration (Cmax) of AMG 557 after multiple dose administration in subjects with moderate to severe psoriasis', 'timeFrame': '28 weeks'}]}, 'conditionsModule': {'keywords': ['SAFETY', 'ADULT', 'PSORIASIS', 'INFLAMMATION'], 'conditions': ['Psoriasis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.amgentrials.com', 'label': 'AmgenTrials clinical trials website'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects must sign an Institutional Review Board (IRB)-approved informed consent form (ICF) before any study specific procedures.\n* Diagnosis of moderate to severe plaque PsO for at least 6 months prior to screening as defined by:\n\n * A minimum PASI score of ≥ 10 obtained at screening;\n * Psoriasis involving ≥ 10% of the Body Surface Area (BSA) at screening.\n* 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.\n* 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.\n* Agrees to wear clothing that protects from sun exposure for the duration of the study.\n* Agrees to use sunscreen (SPF of at least 30) on sun-exposed skin for the duration of the study.\n* Male or female subjects between 18 and 55 years of age, inclusive at the time of screening.\n* 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.\n* Able and willing to complete entire study (including skin biopsies) according to study schedule.\n* Additional criteria per protocol.\n\nExclusion Criteria:\n\n* Diagnosis of guttate, pustular, or other non plaque forms of PsO.\n* 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.\n* Previous receipt of any approved or investigational biologic agent for PsO or other medical conditions.\n* Received PUVA therapy, UVA therapy or UVB therapy ≤ 30 days prior to IP administration.\n* Treatment with any other systemic PsO therapy or oral or parenteral corticosteroids ≤ 30 days prior to IP administration.\n* 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).\n* Received topical cyclosporin or calcineurin inhibitors such as pimecrolimus (Elidel) and tacrolimus (Protopic) ≤ 30 days prior to IP administration.\n* Received IV or oral calcineurin inhibitors such as tacrolimus (Prograf) ≤ 30 days prior to IP administration.\n* Significant concurrent medical conditions at the time of screening or prior to randomization, including:\n\n * 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;\n * Unstable angina pectoris;\n * Congestive heart failure;\n * Steroid or oxygen dependent chronic obstructive pulmonary disease;\n * Diagnosis of multiple sclerosis or any other demyelinating disease;\n * Open cutaneous ulcers;\n * Uncontrolled diabetes (HbA1c \\> 7%).\n* History of myocardial infarction.\n* Subjects with two or more cardiovascular risk factors (defined as BMI \\> 30, BP systolic \\> 140 mm Hg, diagnosis of diabetes, history of cardiovascular event).\n* Evidence of significant renal insufficiency during the screening period, defined by a glomerular filtration rate \\< 50 mL/min using the Cockcroft and Gault equation:\n\n 72 x Serum Creatinine (in mg/dL) / (140 - Age) x Body Weight (in kg) x \\[0.85 if female\\]\n* 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).\n* Evidence of a recent (within 6 months of randomization) infection requiring in patient hospitalization or intravenous antibiotics.\n* Positive test for HIV antibodies, hepatitis B surface antigen, or hepatitis C antibodies.\n* Underlying condition that predisposes the subject to infections (eg, history of splenectomy; history of immunodeficiency).\n* 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.\n* History of malignancy.\n* Evidence of liver disease (eg, serum ALT and AST \\> 1.5 x the upper limit of normal) during screening period.\n* Donated blood (including blood products) or experienced loss of blood ≥ 500 mL within 2 months of screening.\n* Additional criteria per protocol.'}, 'identificationModule': {'nctId': 'NCT01493518', 'briefTitle': 'Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Clinical Effects of AMG 557 in Adults With Psoriasis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Amgen'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '20110105'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'PLACEBO', 'interventionNames': ['Drug: AMG 557 or PLACEBO']}, {'type': 'EXPERIMENTAL', 'label': 'AMG 557', 'interventionNames': ['Drug: AMG 557 or PLACEBO']}], 'interventions': [{'name': 'AMG 557 or PLACEBO', 'type': 'DRUG', 'description': 'Multiple subcutaneous doses of AMG 557 or Placebo on Days 1, 8, 15, 29, 43, 57 and 71.', 'armGroupLabels': ['AMG 557', 'PLACEBO']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '89511', 'city': 'Reno', 'state': 'Nevada', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 39.52963, 'lon': -119.8138}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '75231', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '84107', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Amgen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Amgen', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}