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b'Evidence or history of clinically significant hematological, renal, endocrine,'
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b'pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or'
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b'allergic disease (including drug allergies, but excluding untreated, asymptomatic,'
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b'easonal allergies at the time of dosing).'
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b'History of human immunodeficiency virus (HIV) infection, hepatitis C or syphilis;'
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b'positive testing for HIV, hepatitis C antibody (HCVAb) or syphilis.'
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b'Infection with hepatitis B (HBV) according to the following algorithm using the'
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b'results of positive testing for hepatitis B surface antigen (HBsAg), hepatitis B core'
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b'antibody (HBcAb) and hepatitis B surface antibody (HBsAb) at screening.'
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b'If all three tests are negative, the participant is eligible for study inclusion.'
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b'If HBsAg is positive, the participant must be excluded from participation in the'
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b'tudy.'
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b'If HBsAg is negative, HBcAb is positive, and HBsAb is negative, the participant'
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b'must be excluded from participation in the study.'
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b'If HBsAg is negative, HBcAb is negative, HBsAb is positive, and prior HBV'
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b'vaccination is unequivocally documented, the participant is eligible for the'
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b'tudy and does not require hepatitis B DNA (HBVDNA) monitoring during the study.'
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b'If HBsAg is negative, HBcAb is negative, HBsAb is positive, and no unequivocal'
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b'documentation of prior HBV vaccination is available, the participant is required'
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b'to undergo HBVDNA reflex testing:'
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b'i. If HBVDNA is detected, the participant must be excluded from participation in the'
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b'tudy; ii. If HBVDNA is undetectable, the participant is eligible for study inclusion.'
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b'If the participant is included in the study, for subsequent visits HBVDNA testing must'
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b'be performed according to the Schedule of Activities.'
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b'f. If HBsAg is negative, HBcAb is positive, and HBsAb is positive, the participant is'
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b'required to undergo HBVDNA reflex testing: i. If HBVDNA is detected, the participant'
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b'must be excluded from participation in the study; ii. If HBVDNA is undetectable, the'
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b'participant is eligible for study inclusion. If the participant is included in the'
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b'tudy, for subsequent visits HBVDNA testing must be performed according to the'
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b'Schedule of Activities.'
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b'History of allergic or anaphylactic reaction to a therapeutic drug.'
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b'History of recent active infections within 28 days prior to the screening visit.'
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b'Participants with a fever within 48 hours prior to dosing.'
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b'History of tuberculosis or active, latent or inadequately treated tuberculosis'
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b'infection as defined by the following:'
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b'Have evidence of untreated or inadequately treated active or latent Mycobacterium'
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b'tuberculosis (TB) infection as evidenced by the following:'
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b'A positive QuantiFERON TB Gold In Tube (QFT-G) test or positive or borderline'
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b'T-SPOT.TB (T Spot) test performed within the 12 weeks prior to Day 1. If the'
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b'laboratory reports the test as indeterminate, the test should be repeated. If the'
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b'result of the repeat test is indeterminate, a purified protein derivative (PPD)'
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b'test may be substituted for the QFT-G test or T-Spot test only with approval from'
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b'the Pfizer Medical Monitor on a case by case basis.'
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b'Chest radiograph with changes suggestive of active TB infection within 3 months'
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b'prior to Screening. Chest radiograph should be performed according to local'
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b'tandards of care or country specific guidelines.'
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b'History of either untreated or inadequately treated latent or active TB'
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b'infection.'
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b'If a participant has previously received an adequate course of therapy for either'
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b'latent (9 months of isoniazid in a locale where rates of primary multi drug resistant'
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b'TB infection are <5% or an acceptable alternative regimen) or active (acceptable multi'
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b'drug regimen) TB infection, neither a QFT-G test, a T-Spot test, nor a PPD test need'
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b'be obtained. Details of the previous course of therapy (eg, medication(s) used, dose,'
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b'duration of therapy) should be documented in the source documentation.'
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b'A chest radiograph should be obtained if not done within the 3 months prior to'
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b'Screening. To be considered eligible for the study, the chest radiograph must be'
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b'negative for active TB infection.'
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b'A participant who is currently being treated for active TB infection must be excluded'
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b'from the study.'
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b'A participant who is being treated for latent TB infection can only be enrolled with'
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b'confirmation of current incidence rates of multi drug resistant TB infection,'
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b'documentation of an adequate treatment regimen, and prior approval of the Sponsor.'
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b'Other acute or chronic medical or psychiatric condition including recent (within the'
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b'past year) or active suicidal ideation or behavior or laboratory abnormality that may'
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b'increase the risk associated with study participation or investigational product'
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b'administration or may interfere with the interpretation of study results and, in the'
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b'judgment of the investigator, would make the participant inappropriate for entry into'
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b'this study.'
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b'Use of prescription or nonprescription drugs and dietary and herbal supplements within'
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b'7 days or 5 half lives (whichever is longer) prior to the first dose of'
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b'investigational product.'
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b'Recent exposure to live vaccines within 28 days of the screening visit.'
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b'Known exposure to anti-TL1A (PF-06480605) or any type of anti-TL1A therapy.'
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b'Previous administration with an investigational drug within 4 months (or as determined'
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b'by the local requirement) or 5 half lives preceding the first dose of investigational'
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b'product used in this study (whichever is longer).'
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b'A positive urine drug test.'
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b'Screening supine blood pressure (BP) >=140 mm Hg (systolic) or >=90 mm Hg (diastolic),'
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b'following at least 5 minutes of supine rest. If BP is >=140 mm Hg (systolic) or >=90'
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b'mm Hg (diastolic), the BP should be repeated 2 more times and the average of the 3 BP'
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b"values should be used to determine the participant's eligibility."
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b'Baseline 12 lead electrocardiogram (ECG) that demonstrates clinically relevant'
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b'abnormalities that may affect participant safety or interpretation of study results'
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b'(eg, baseline corrected QT (QTc) interval >450 msec, complete left bundle branch block'
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b'[LBBB], signs of an acute or indeterminate age myocardial infarction, ST T interval'
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b'changes suggestive of myocardial ischemia, second or third degree atrioventricular'
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b'[AV] block, or serious bradyarrhythmias or tachyarrhythmias). If the baseline'
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b'uncorrected QT interval is >450 msec, this interval should be rate corrected using the'
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b'Fridericia method and the resulting QTcF should be used for decision making and'
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b'reporting. If QTc exceeds 450 msec, or QRS exceeds 120 msec, the ECG should be'
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b'repeated 2 more times and the average of the 3 QTc or QRS values should be used to'
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b"determine the participant's eligibility. Computer interpreted ECGs should be overread"
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b'by a physician experienced in reading ECGs before excluding participants.'
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b'History of alcohol abuse or binge drinking and/or any other illicit drug use or'
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b'dependence within 6 months of Screening. Binge drinking is defined as a pattern of 5'
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b'(male) and 4 (female) or more alcoholic drinks in about 2 hours. As a general rule,'
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b'alcohol intake should not exceed 14 units per week (1 unit = 8 ounces (240 mL) beer, 1'
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b'ounce (30 mL) of 40% spirit or 3 ounces (90 mL) of wine).'
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b'Blood donation (excluding plasma donations and platelet donations) of approximately'
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b'>=400 mL within 3 months or >=200 mL within a month prior to dosing. Additionally,'
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b'approximately >=400 mL within 4 months for female participants.'
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b'History of sensitivity to heparin or heparin induced thrombocytopenia.'
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b'History of substance abuse within 12 months of the screening visit.'
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b'Pregnant females; breastfeeding females.'
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b'Males who are unwilling or unable to use a highly effective method of contraception as'
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b'outlined in this protocol for the duration of the study and until discharge from the'
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b'tudy.'
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b'Unwilling or unable to comply with the criteria in the Lifestyle Considerations'
|
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|
b'ection of this protocol.'
|
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b'Investigator site staff members directly involved in the conduct of the study and'
|
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|
b'their family members, site staff members otherwise supervised by the investigator, or'
|
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|
|
b'Pfizer employees, including their family members, directly involved in the conduct of'
|
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b'the study.'
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