Psoriasis Clinical Trial
A Study to Investigate ABP 654 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis
Summary
The purpose of the study is to evaluate the efficacy, safety, and immunogenicity of ABP 654 compared with ustekinumab in participants with moderate to severe plaque psoriasis.
Full Description
This is a multicenter study and will enroll approximately 542 participants.
The total duration of study participation for each participant will be 56 weeks, with up to 4 weeks for screening, and for 52 weeks after the first administration of either ABP 654 or ustekinumab.
After confirmation of eligibility, all participants will be randomized in a 1:1 ratio into 2 treatment groups (Group A will receive ABP 654, and Group B will receive ustekinumab) stratified by prior biologic use for psoriasis (yes versus [vs] no), geographic region, and baseline body weight (BW).
Based on the psoriasis area and severity index (PASI) score (to determine better improvement or partial improvement) at week 28, the participants in the study will proceed as follows:
Participants who do not achieve PASI 50 response or better improvement at Week 28 will be considered to have completed the study and will complete end of study procedures (ie, week 52 procedures), and those unable to complete week 28 visit, or did not have a PASI assessment completed, will be discontinued from the study.
Participants who achieve PASI 75 response or better improvement will continue on the study and will be re-randomized in a blinded fashion such that participants initially randomized to Group A (ABP 654) will continue to receive ABP 654 and those in Group B (ustekinumab) will re-randomized, to either continue on ustekinumab (Treatment Group B1) or switch to ABP 654 (Treatment Group B2).
Participants with PASI 50 response or better but less than PASI 75 response and on the Investigator's decision, participants will continue on the originally assigned treatment with dose intensification and will not be re-randomized. However, participants that do not dose intensify will be re-randomized.
Eligibility Criteria
Inclusion Criteria:
Participants are eligible to be included in the study only if all of the following criteria apply:
Stable moderate to severe plaque psoriasis for at least 6 months
Baseline score of PASI >= 12, involvement of >= 10% BSA, and sPGA >= 3 at screening and at baseline
Candidate for phototherapy or systemic therapy
Previous failure, inadequate response, intolerance, or contraindication to at least 1 conventional anti-psoriatic systemic therapy
Female participants should have negative serum pregnancy test during screening and a negative urine pregnancy test at baseline
No known history of latent or active tuberculosis (TB), and has a negative test for TB during screening (with negative purified protein derivative (PPD), and Negative Quantiferon®/T-spot test)
Participants with a positive purified protein derivative and a history of Bacillus Calmette-Guérin (BCG) vaccination are allowed with a negative Quantiferon®/T-spot®
Participants with a positive PPD test (without history of BCG vaccination) or participants with a positive or indeterminate Quantiferon®/T-spot test are allowed if they have all of the following:
No symptoms per TB worksheet provided by the sponsor
Documented history of adequate prophylaxis initiation prior to receiving investigational product (IP) in accordance with local recommendations
No known exposure to a case of active TB after most recent prophylaxis
No evidence of active TB on chest radiograph within 3 months prior to the first dose of IP
Exclusion Criteria:
Participants are excluded from the study if any of the following criteria apply:
Skin disease related conditions such as, Erythrodermic psoriasis (PsO), pustular PsO, guttate PsO, medication induced PsO, or other skin conditions at the time of the screening visit (eg, eczema) that would interfere with evaluations of the effect of IP on PsO
Participant has an active infection, recurrent or chronic infections, serious infection or history of infections
Known history of human immunodeficiency virus
Hepatitis B surface antigen or hepatitis C virus antibody positivity at screening
Uncontrolled, clinically significant systemic disease such as uncontrolled diabetes mellitus, cardiovascular disease, renal disease, liver disease, or hypertension
Moderate to severe heart failure (New York Heart Associate class III/IV)
Known hypersensitivity to the IP or to any of the excipients
Any abnormal laboratory parameters at screening, as defined in protocol
Previous treatment with any agent specifically targeting interleukin (IL)-12 or IL-23
Received biologic treatment for psoriasis within the previous month or 5 drug half-lives prior to randomization
Received non-biologic systemic psoriasis therapy within 4 weeks prior to randomization
Received Ultra-violet A (UVA) phototherapy (with or without psoralen) or excimer laser within 4 weeks prior to randomization, or ultra-violet B (UVB) phototherapy within 2 weeks prior to randomization
Received topical psoriasis treatment within 2 weeks prior to randomization (exception: upper mid-strength to least potent [class III to VII] topical steroids permitted on the palms, soles, face, and intertriginous areas; bland emollients)
Received live viral or live bacterial vaccination within 2 weeks prior to randomization
Received BCG vaccination within 1 year prior to randomization
Other investigational procedures within 4 weeks prior to randomization and during the study
Participants not agreeing to follow protocol defined contraceptives procedures
Participants likely not to be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures
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There are 82 Locations for this study
Birmingham Alabama, 35205, United States
Phoenix Arizona, 85032, United States
Fountain Valley California, 92708, United States
San Diego California, 92123, United States
San Luis Obispo California, 93405, United States
Santa Monica California, 90404, United States
Sherman Oaks California, 91403, United States
Doral Florida, 33122, United States
Miami Florida, 33144, United States
Ocala Florida, 34470, United States
Tampa Florida, 33609, United States
Skokie Illinois, 60077, United States
Springfield Illinois, 62703, United States
Indianapolis Indiana, 46250, United States
Overland Park Kansas, 66210, United States
Baton Rouge Louisiana, 70809, United States
Beverly Massachusetts, 01915, United States
Brighton Massachusetts, 02135, United States
Portsmouth New Hampshire, 03801, United States
East Windsor New Jersey, 08520, United States
High Point North Carolina, 27262, United States
Wilmington North Carolina, 28405, United States
Bexley Ohio, 43209, United States
Mason Ohio, 45040, United States
Portland Oregon, 97210, United States
Portland Oregon, 97223, United States
Exton Pennsylvania, 19341, United States
Johnston Rhode Island, 02919, United States
Knoxville Tennessee, 37922, United States
Cypress Texas, 77433, United States
Dallas Texas, 75231, United States
Houston Texas, 77056, United States
San Antonio Texas, 78213, United States
Sugar Land Texas, 77479, United States
Calgary Alberta, T3E 0, Canada
Surrey British Columbia, V3R 6, Canada
Ajax Ontario, L1S 7, Canada
Etobicoke Ontario, M8X 1, Canada
Hamilton Ontario, L8N1Y, Canada
Markham Ontario, L3P 1, Canada
Mississauga Ontario, L4Y 4, Canada
North Bay Ontario, P1B 3, Canada
Ottawa Ontario, K1H 7, Canada
Peterborough Ontario, K9J 5, Canada
Richmond Hill Ontario, L4B 1, Canada
Toronto Ontario, M3H 5, Canada
Waterloo Ontario, N2J 1, Canada
Windsor Ontario, N8W 1, Canada
Quebec city Quebec, G1V 4, Canada
Tallinn Harjumaa, 10134, Estonia
Tallinn Harjumaa, 10138, Estonia
Tartu Tartumaa, 50106, Estonia
Tartu Tartumaa, 50417, Estonia
Mahlow Brandenburg, 15831, Germany
Bramsche Niedersachsen, 49565, Germany
Bochum Nordrhein-Westfalen, 44793, Germany
Wuppertal Nordrhein-Westfalen, 42287, Germany
Szolnok Jász-Nagykun-Szolnok, 5000, Hungary
Budapest Pest, 1152, Hungary
Riga Rga, LV-10, Latvia
Riga Rga, LV100, Latvia
Riga Rga, LV100, Latvia
Riga , LV-10, Latvia
Talsi , LV320, Latvia
Kaunas Kauno Apskritis, LT-50, Lithuania
Vilnius Vilniaus Apskritis, LT-08, Lithuania
Krakow Maopolskie, 30-03, Poland
Warszawa Mazowieckie, 00-87, Poland
Warszawa Mazowieckie, 02-79, Poland
Warszawa Mazowieckie, 02-96, Poland
Iwonicz Zdroj Podkarpackie, 38-44, Poland
Bialystok Podlaskie, 15-01, Poland
Bialystok Podlaskie, 15-87, Poland
Katowice , 40-08, Poland
Katowice , 40-61, Poland
Krakow , 31-55, Poland
Lublin , 20-08, Poland
Lublin , 20-41, Poland
Poznan , 60-52, Poland
Torun , 87-10, Poland
Warszawa , 02-95, Poland
Wroclaw , 51-31, Poland
Wroclaw , 51-68, Poland
Skierniewice Ódzkie, 96-10, Poland
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