Moderate to severe plaque psoriasis MedDRA version: 17.0 Level: PT Classification code 10037153 Term: Psoriasis System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Interventions
Product Name: brodalumab
Product Code: AMG 827
Pharmaceutical Form: Solution for injection
INN or Proposed INN: brodalumab
Current Sponsor code: AMG 827
Concentration unit: mg/ml milligram(s)/millilit
Sponsors
Amgen Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subject has provided informed consent. Subject was randomized into Study 20090062 and completed the week 16 evaluation. For subjects with = 3 months between the week 16 visit of 20090062 and the planned first IP dose in 20090403: Negative test for hepatitis B virus (HBV) surface antigen, hepatitis C virus (HCV) antibody, and/or human immunodeficiency virus (HIV) in subjects if clinically indicated (eg, known recent exposure) in the opinion of the investigator. For female subjects with = 4 weeks between the week 16 visit of Study 20090062 and the first planned IP dose in 20090403, a negative urine pregnancy test at baseline prior to the first dose of study drug in 20090403 (except those at least 3 years post menopausal or surgically sterile). For female subjects with > 4 weeks between the week 16 visit of Study 20090062 and the first planned IP dose in 20090403, a negative serum pregnancy test within 28 days prior to initiating IP and a negative urine pregnancy test at baseline prior to the first dose of study drug in 20090403 (except those at least 3 years post menopausal or surgically sterile). For subjects with = 3 months between the week 16 visit of Study 20090062 and the first planned IP dose of 20090403: • If the subject entered Study 20090062 with a negative purified protein derivative (PPD) test: Subject must have a negative PPD test within 30 days prior to the first planned IP dose. Tuberculin skin tests should be considered positive when they have greater than or equal to 5 mm of induration at 48 to 72 hours after test is placed. • If the subject entered Study 20090062 with a positive PPD and has had a subsequent exposure to tuberculosis: Subject must have a negative Quantiferon test within 30 days prior to the first IP dose. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 168 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 15
Exclusion criteria
Exclusion criteria: Subject had any Serious Adverse Event reported during Study 20090062 that was considered possibly related to IP. Subject experienced an adverse event in Study 20090062 that, in the opinion of the investigator, could cause extension of treatment to be detrimental to the subject. Subject is currently experiencing an infection of CTCAE grade 2 (if requiring oral antibiotics) or higher. Subject is ineligible until the infection resolves. For subjects with > 4 weeks between the week 16 visit of Study 20090062 and the first planned IP dose in 20090403, subject has laboratory abnormalities at screening, including: · Elevated aspartate aminotransferase (AST) or alanine aminotransferase (ALT); > 1.5x the upper limit of normal. · Serum total bilirubin = 1.5 mg/dL. · Hemoglobin 8.5 (for type 2 diabetics only) · Any other laboratory abnormality, which, in the opinion of the investigator, will prevent the subject from completing the study or will interfere with the interpretation of the study results. For subjects with = 3 months between the week 16 visit of 20090062 and the first planned IP dose in 20090403, subject has a serious infection, defined as requiring hospitalization or intravenous antibiotics within 8 weeks before screening. For subjects with = 3 months between the week 16 visit of 20090062 and the first planned IP dose in 20090403, subject has recurrent or chronic infections, defined as = 3 infections requiring anti-microbials over the past 12 months prior to screening. Subject has a significant concurrent medical condition, including: · Type 1 diabetes · Poorly controlled type 2 diabetes · Symptomatic heart failure (New York Heart Association class II, III, or IV) · Myocardial infarction within the last year · Current or history of unstable angina pectoris within the last year · Uncontrolled hypertension as defined by resting blood pressure > 150/90 mmHg prior to first IP dose (confirmed by a repeat assessment) · Severe chronic pulmonary disease (eg, requiring oxygen therapy) · Major chronic inflammatory disease or connective tissue disease other than psoriasis with or without arthritis · Multiple sclerosis or any other demyelinating disease · Active malignancy, including evidence of cutaneous basal or squamous cell carcinoma or melanoma, or history of cancer (except successfully treated in situ cervical cancer or squamous or basal cell carcinoma of the skin) · Any condition that, in the opinion of the investigator, might cause this study to be detrimental to the subject Subject is pregnant or breast feeding, or planning to become pregnant while enrolled in the study, up to the subject’s last study visit. Female subject is not willing to abstain from sexual intercourse or use 2 highly effective forms of birth control for the duration of the study and at least 40 days after the last dose (except women at least 3 years postmenopausal or surgically sterile). Highly effective methods of birth control for women include but are not limited to birth control pills, Depo-Provera® injections, contraceptive implants, or occlusive cap (barrier method) in combination with barrier metho
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety of long-term exposure with AMG 827 in subjects with moderate to severe psoriasis. To evaluate the efficacy of AMG 827 as measured by the following: - The proportion of subjects with a static physician’s global assessment (sPGA) of clear (0) or clear/almost clear (0 or 1) - Percent improvement in Psoriasis Area and Severity Index (PASI) - The proportion of subjects with a 50% improvement in PASI (PASI 50), PASI 75, PASI 90, and PASI 100 - Body surface area (BSA) involvement;Secondary Objective: To evaluate the effect of treatment on patient-reported outcomes, including the Medical Outcomes Short Form-36 (SF-36) and dermatology life quality index (DLQI) To determine the proportion of subjects who develop anti-AMG 827 antibodies To explore lipid profiles in subjects receiving AMG 827 To evaluate the pharmacokinetics of AMG 827 with long-term administration;Primary end point(s): Safety Endpoints Adverse events Change in laboratory parameters (hematology, chemistry, and urinalysis profiles) and vital signs Efficacy Endpoints sPGA of clear or clear/almost clear at all measured timepoints Percent improvement in PASI at all measured timepoints PASI 50, 75, 90, and 100 at all measured timepoints BSA involvement at all measured timepoints ;Timepoint(s) of evaluation of this end point: Safety endpoints measured at baseline and all following assessment timepoints. Efficacy endpoints measured at all assessment timepoints. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): N/A;Timepoint(s) of evaluation of this end point: N/A | — |
Countries
Australia, Canada, Denmark, France, United States
Contacts
Public ContactIHQ Medical Info - Clinical Trials
Amgen (EUROPE) GmbH
Outcome results
None listed