Psoriasis Clinical Trial
Comparison of CHS-1420 Versus Humira in Subjects With Chronic Plaque Psoriasis
Summary
This is a 3-period study comparing CHS-1420 to Humira in patients with chronic plaque psoriasis.
Full Description
This is a 55-week, randomized, double-blind, active-control, parallel group, multicenter, global study in subjects with active, moderate to severe, chronic PsO.
The study will consist of 24 weeks of administration of blinded study drug, divided into Treatment Period 1 and Treatment Period 2, then 23 weeks of administration of open-label CHS-1420 and a Follow-up visit 8 weeks after the last dose. Subjects who meet inclusion/exclusion criteria will be stratified by body mass index (BMI), and age and randomized 1:1 to receive CHS-1420 or Humira in Treatment Period 1. Subjects assigned to CHS-1420 will continue to receive CHS-1420 in Period 2. Subjects assigned to Humira in Period 1 will be randomly assigned (1:1) to either continue with Humira in Treatment Period 2 or to switch to CHS-1420 in Treatment Period 2. All subjects will receive open label CHS-1420 in Treatment Period 3.
Eligibility Criteria
Inclusion Criteria:
Male or female adults
PsO diagnosis for 6 months
Active disease: PASI greater than or equal to 12, Physician's Static Global Assessment (PSGA) score greater than or equal to 3 (based on a scale of 0-5),
Body Surface Area (BSA) involved with PsO greater than or equal to 10%
Exclusion Criteria:
Forms of psoriasis other than PsO
Drug induced psoriasis
Positive QuantiFERON-tuberculosis (TB) Gold Test
Presence of significant comorbid conditions
Chemistry and hematology values outside protocol specified range
Major systemic infections
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There are 94 Locations for this study
Phoenix Arizona, 85032, United States
Encino California, 91436, United States
Sacramento California, 95819, United States
Santa Rosa California, 95405, United States
Torrance California, 90503, United States
Denver Colorado, 80220, United States
Trumbull Connecticut, 06611, United States
Coral Gables Florida, 33134, United States
Pinellas Park Florida, 33781, United States
West Palm Beach Florida, 33406, United States
Marietta Georgia, 30060, United States
Plainfield Indiana, 46168, United States
Warren Michigan, 48088, United States
Edina Minnesota, 55435, United States
Saint Louis Missouri, 63117, United States
Saint Louis Missouri, 63117, United States
Cary North Carolina, 27518, United States
Charlotte North Carolina, 28210, United States
Cincinnati Ohio, 45249, United States
Norman Oklahoma, 73031, United States
Oklahoma City Oklahoma, 73103, United States
Exton Pennsylvania, 19341, United States
Anderson South Carolina, 29621, United States
Bristol Tennessee, 37620, United States
Arlington Texas, 76011, United States
Houston Texas, 77004, United States
Houston Texas, 77065, United States
Webster Texas, 77598, United States
Sofia , 1415, Bulgaria
Etobicoke Ontario, M8X 1, Canada
London Ontario, N5X 2, Canada
Markham Ontario, L3P 1, Canada
North Bay Ontario, P1B 3, Canada
Oakville Ontario, L6J 7, Canada
Peterborough Ontario, K9J 5, Canada
Richmond Hill Ontario, L4B 1, Canada
Toronto Ontario, M4W 2, Canada
Toronto Ontario, M5S 3, Canada
Waterloo Ontario, N2J 1, Canada
Windsor Ontario, N8W 5, Canada
Santiago , 76408, Chile
Santiago , 84203, Chile
Viña Del Mar , 25200, Chile
Ivanić-Grad , 10310, Croatia
Osijek , 31000, Croatia
Raja Tartu, 50417, Estonia
Tallinn , 10117, Estonia
Tallinn , 13419, Estonia
Tbilisi , 0102, Georgia
Tbilisi , 0144, Georgia
Tbilisi , 0159, Georgia
Tbilisi , 0160, Georgia
Tbilisi , 0179, Georgia
Afula , 18341, Israel
Kfar Saba , 44281, Israel
Petah tikva , 49100, Israel
Ramat Gan , 52621, Israel
Ancona , , Italy
Reggio Emilia , , Italy
Rome , , Italy
Jurmala , LV-20, Latvia
Riga , LV-10, Latvia
Riga , LV-10, Latvia
Chisinau , MD202, Moldova, Republic of
Białystok , 15-35, Poland
Białystok , 15-87, Poland
Gdańsk , 80-45, Poland
Krakow , 31-02, Poland
Kraków , 31-53, Poland
Poznań , 60-70, Poland
Toruń , 87-10, Poland
Warsaw , 01-19, Poland
Wrocław , 51-12, Poland
Barnaul , 65104, Russian Federation
Moscow , 10904, Russian Federation
Moscow , 12161, Russian Federation
Saint Petersburg , 19118, Russian Federation
Saint Petersburg , 19525, Russian Federation
Saint Petersburg , 94356, Russian Federation
Saratov , 41002, Russian Federation
SvidnÃk , 089 0, Slovakia
Panorama Cape Town, 7500, South Africa
Pretoria West Pretoria, 0183, South Africa
Durban , 4091, South Africa
Pinelands , 7405, South Africa
Rondebosch , 7700, South Africa
Somerset West , 7130, South Africa
Worcester , 6850, South Africa
Dnipropetrovs'k , 49044, Ukraine
Ivano-Frankivs'k , 76018, Ukraine
Kharkiv , 61038, Ukraine
Khmel'nyts'kyy , 29009, Ukraine
Kyiv , 01601, Ukraine
Lviv , 79014, Ukraine
Odesa , 65006, Ukraine
Rivne , 33028, Ukraine
Ternopil' , 46006, Ukraine
Uzhhorod , 88000, Ukraine
Zaporizhzhya , 69063, Ukraine
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