Psoriasis Clinical Trial
A Study to Investigate Interchangeability of ABP 654 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis
Summary
The purpose of the study is to evaluate pharmacokinetic similarity, efficacy, safety and immunogenicity of multiple switches between ustekinumab and ABP 654 compared with continued use of ustekinumab in participants with moderate to severe plaque psoriasis.
Full Description
This is a multi-center study and will enroll approximately 480 participants.
After eligibility confirmation, all participants will be randomized in a 1:1 ratio into 2 treatment arms: continued use of ustekinumab or multiple switches between ustekinumab and ABP 654 at Week 28. The randomization will be stratified by prior biologic use for psoriasis (yes versus [vs] no) at baseline (Week 0), geographic region, and baseline (Week 0) body weight.
All participants will receive an initial 3 doses of ustekinumab on Day 1 (Week 0), Week 4 and Week 16. At Week 28, participants will be randomized to continue on ustekinumab or switching between ABP 654 and ustekinumab every 12 weeks.
At Week 28, efficacy assessments will be conducted including evaluation of Psoriasis and Area Severity Index (PASI). Participants who do not achieve PASI 50 response or better improvement at Week 28 will be considered as run-in failures and will not be randomized at Week 28; these participants will complete End of Study procedures at Week 28. The run-in period will occur from Day 1 until randomization at Week 28. Those unable to complete the Week 28 visit or did not have a PASI assessment completed at Week 28 will be discontinued from the study.
The total duration of study participation for each participant will be 68 weeks, with up to 4 weeks for screening and 64 weeks after the first investigational product administration.
Eligibility Criteria
Inclusion Criteria:
Participant has stable moderate to severe plaque psoriasis for at least 6 months
Participant has a score of PASI ≥ 12, involvement of ≥ 10% body surface area and static Physician Global Assessment ≥ 3 at screening and at baseline
Participant is a candidate for phototherapy or systemic therapy
Participant has previous failure, inadequate response, intolerance, or contraindication to at least 1 conventional antipsoriatic systemic therapy
Female participant should have a negative serum pregnancy test during screening and a negative urine pregnancy test at baseline
Participant or legally acceptable representative is capable of giving signed Institutional Review Board (IRB)/Independent Ethics Committee (IEC) informed consent
Participant has no known history of latent or active tuberculosis
Participant with a positive purified protein derivative (PPD) test and a history of Bacillus Calmette-Guérin (BCG) vaccination is allowed with a negative Quantiferon/T-spot test
Participant with a positive PPD test or participant with a positive or indeterminate Quantiferon/T-spot test is allowed if he/she has all the following:
No symptoms per tuberculosis worksheet provided by the sponsor, Amgen Inc.
Documented history of adequate prophylaxis initiation prior to receiving investigational product in accordance with local recommendations
No known exposure to a case of active tuberculosis after most recent prophylaxis
No evidence of active tuberculosis on chest radiograph within 3 months prior to the first dose of investigational product
Exclusion Criteria:
Participant has erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, medication induced psoriasis, or other skin conditions at the time of screening (eg, eczema) that would interfere with evaluations of the effect of investigational product of psoriasis
Participant has an active infection or history of infections
Participant has uncontrolled, clinically significant systemic disease, such as uncontrolled diabetes mellitus, cardiovascular disease, renal disease, liver disease, or hypertension
Participant has a mean QT internal or abnormal long QT syndrome corrected using Fridericia's formula (QTcF) of > 450 msec (for male participant) or > 470 msec (for female participant) at baseline that, in the opinion of the Investigator, is abnormal or clinically significant
Participant has moderate to severe heart failure (New York Heart Associate class III/IV)
Participant has known hypersensitivity to the investigational product or to any of the excipients
Participant has laboratory abnormalities at screening
Participant has had previous treatment with any agent specifically targeting interleukin (IL)-12 or IL-23 within 1 year prior to enrollment
Participant has received biologic treatment for psoriasis within the previous month or 5 drug half-lives (whichever is longer) prior to enrollment
Participant has received any investigational agents within the previous month or 5 half-lives (whichever is longer) prior to enrollment
Participant has received non-biologic systemic psoriasis therapy within 4 weeks prior to enrollment
Participant has received ultraviolet A phototherapy (with or without psoralen) or excimer laser within 4 weeks prior to enrollment, or ultraviolet B phototherapy within 2 weeks prior to enrollment
Participant has received topical psoriasis treatment within 2 weeks prior to enrollment
Participant has received other investigational procedures within 4 weeks prior to enrollment and during the course of the study
Female participant is pregnant or breastfeeding or planning to become pregnant while participating in the study and for at least 5 months after the last dose of investigational product
Sexually active participants and their partners who are of childbearing potential and not agreeing to use adequate protocol defined contraception methods while participating in the study and for 5 months after the last dose of investigational product
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 84 Locations for this study
Hot Springs Arkansas, 71913, United States
Beverly Hills California, 90212, United States
Fremont California, 94538, United States
Northridge California, 91324, United States
Santa Ana California, 92701, United States
Jacksonville Florida, 32216, United States
Lake Worth Florida, 33461, United States
Miami Florida, 33144, United States
Ormond Beach Florida, 32174, United States
Pembroke Pines Florida, 33028, United States
Tampa Florida, 33614, United States
Alpharetta Georgia, 30022, United States
Sandy Springs Georgia, 30328, United States
West Dundee Illinois, 60118, United States
Clarksville Indiana, 47129, United States
West Des Moines Iowa, 50265, United States
Topeka Kansas, 66614, United States
Worcester Massachusetts, 01605, United States
Fort Gratiot Michigan, 48059, United States
New Brighton Minnesota, 55112, United States
Saint Joseph Missouri, 64506, United States
Omaha Nebraska, 68144, United States
Portsmouth New Hampshire, 03801, United States
East Windsor New Jersey, 08520, United States
Verona New Jersey, 07044, United States
Wilmington North Carolina, 28405, United States
Portland Oregon, 97223, United States
Dripping Springs Texas, 78620, United States
Pflugerville Texas, 78660, United States
San Antonio Texas, 78213, United States
Webster Texas, 77598, United States
Surrey British Columbia, V3V 0, Canada
Winnipeg Manitoba, R3M 3, Canada
Fredericton New Brunswick, E3B 1, Canada
Ajax Ontario, L1S 7, Canada
Barrie Ontario, L4M 7, Canada
Guelph Ontario, N1L 0, Canada
London Ontario, N6H 5, Canada
Markham Ontario, L3P 1, Canada
Mississauga Ontario, L4Y 4, Canada
Newmarket Ontario, L3Y 5, Canada
North York Ontario, M2M 4, Canada
Ottawa Ontario, K2C 3, Canada
Toronto Ontario, M4W 2, Canada
Waterloo Ontario, N2J 1, Canada
Tallinn Harjumaa, 10138, Estonia
Tartu Tartumaa, 50106, Estonia
Tartu Tartumaa, 50417, Estonia
Tallinn , 10117, Estonia
Tbilisi T'bilisi, 0112, Georgia
Tbilisi T'bilisi, 0112, Georgia
Tbilisi T'bilisi, 0159, Georgia
Tbilisi T'bilisi, 0160, Georgia
Tbilisi , 0159, Georgia
Friedrichshafen Baden-Württemberg, 88045, Germany
Augsburg Bayern, 86179, Germany
Mahlow Brandenburg, 15831, Germany
Frankfurt/Main Hessen, 60590, Germany
Bad Bentheim Niedersachsen, 48455, Germany
Witten Nordrhein-Westfalen, 58453, Germany
Dresden Sachsen, 01069, Germany
Dresden Sachsen, 01307, Germany
Lübeck Schleswig-Holstein, 23538, Germany
Berlin , 10117, Germany
Berlin , 10783, Germany
Debrecen Hajdú-Bihar, 4032, Hungary
Szolnok Jász-Nagykun-Szolnok, 5000, Hungary
Budapest Pest, 1036, Hungary
Budapest Pest, 1152, Hungary
Riga Rga, LV100, Latvia
Riga Rga, LV100, Latvia
Talsi , LV320, Latvia
Krakow Maopolskie, 30-03, Poland
Krakow Maopolskie, 30-36, Poland
Warszawa Mazowieckie, 00-87, Poland
Bialystok , 15-79, Poland
Bydgoszcz , 85-06, Poland
Bydgoszcz , 85-79, Poland
Gdynia , 81-33, Poland
Krakow , 31-50, Poland
Krakow , 31-51, Poland
Krakow , 31-55, Poland
Siedlce , 08-11, Poland
Sochaczew , 96-50, Poland
Szczecin , 71-43, Poland
Warszawa , 00-89, Poland
Warszawa , 02-62, Poland
Wroclaw , 51-31, Poland
How clear is this clinincal trial information?