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.

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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.

View Eligibility Criteria

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

Study is for people with:

Psoriasis

Phase:

Phase 3

Estimated Enrollment:

563

Study ID:

NCT04607980

Recruitment Status:

Completed

Sponsor:

Amgen

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There are 82 Locations for this study

See Locations Near You

Total Skin and Beauty Dermatology Center PC
Birmingham Alabama, 35205, United States
Alliance Dermatology and Mohs Center
Phoenix Arizona, 85032, United States
First OC Dermatology
Fountain Valley California, 92708, United States
University Clinical Trials, Inc.
San Diego California, 92123, United States
San Luis Dermatology and Laser Clinic - Dermatology
San Luis Obispo California, 93405, United States
Clinical Science Institute
Santa Monica California, 90404, United States
Unison Clinical Trials
Sherman Oaks California, 91403, United States
Revival Research
Doral Florida, 33122, United States
International Dermatology Research, Inc
Miami Florida, 33144, United States
Renstar Medical Research
Ocala Florida, 34470, United States
Moore Clinical Research Inc.
Tampa Florida, 33609, United States
NorthShore University HealthSystem
Skokie Illinois, 60077, United States
Springfield Clinic
Springfield Illinois, 62703, United States
Dawes Fretzin Clinical Research Group, LLC
Indianapolis Indiana, 46250, United States
Epiphany Dermatology of Kansas, LLC
Overland Park Kansas, 66210, United States
DelRicht Research
Baton Rouge Louisiana, 70809, United States
ALLCUTIS Research, LLC.
Beverly Massachusetts, 01915, United States
Metro Boston Clinical Partners
Brighton Massachusetts, 02135, United States
ActivMed Practices & Research, LLC.
Portsmouth New Hampshire, 03801, United States
Psoriasis Treatment Center of Central New Jersey
East Windsor New Jersey, 08520, United States
Dermatology Consulting Services, PLLC
High Point North Carolina, 27262, United States
Wilmington Dermatology Center
Wilmington North Carolina, 28405, United States
Bexley Dermatology Research
Bexley Ohio, 43209, United States
Dermatologists of Southwest Ohio
Mason Ohio, 45040, United States
Oregon Dermatology and Research Center
Portland Oregon, 97210, United States
Oregon Medical Research Center
Portland Oregon, 97223, United States
The Pennsylvania Centre for Dermatology, LLC
Exton Pennsylvania, 19341, United States
Clinical Partners, LLC
Johnston Rhode Island, 02919, United States
The Skin Wellness Center PC
Knoxville Tennessee, 37922, United States
Center for Clinical Studies
Cypress Texas, 77433, United States
Modern Research Associates
Dallas Texas, 75231, United States
Austin Institute for Clinical Research - Dermatology
Houston Texas, 77056, United States
Progressive Clinical Research [Texas]
San Antonio Texas, 78213, United States
Acclaim Dermatology
Sugar Land Texas, 77479, United States
Beacon Dermatology
Calgary Alberta, T3E 0, Canada
Dr. Chih-ho Hong Medical Inc.
Surrey British Columbia, V3R 6, Canada
CCA Medical Research
Ajax Ontario, L1S 7, Canada
Kingsway Clinical Research
Etobicoke Ontario, M8X 1, Canada
Dermatrials Research Inc
Hamilton Ontario, L8N1Y, Canada
Lynderm Research Inc
Markham Ontario, L3P 1, Canada
DermEdge Research Inc.
Mississauga Ontario, L4Y 4, Canada
North Bay Dermatology Centre Inc.
North Bay Ontario, P1B 3, Canada
JRB Research Inc.
Ottawa Ontario, K1H 7, Canada
Skin Centre for Dermatology
Peterborough Ontario, K9J 5, Canada
The Centre for Dermatology
Richmond Hill Ontario, L4B 1, Canada
Toronto Research Centre - Dermatology
Toronto Ontario, M3H 5, Canada
K. Papp Clinical Research Inc.
Waterloo Ontario, N2J 1, Canada
XLR8 Medical Research Inc.
Windsor Ontario, N8W 1, Canada
Centre de Recherche dermatolog
Quebec city Quebec, G1V 4, Canada
Vahlberg & Pild OÜ
Tallinn Harjumaa, 10134, Estonia
Confido Private Medical Clinic - General Practice/Medicine
Tallinn Harjumaa, 10138, Estonia
Clinical Research Center
Tartu Tartumaa, 50106, Estonia
Tartu University Hospital
Tartu Tartumaa, 50417, Estonia
Dermatologische Gemeinschaftspraxis Dres.Scholz Sebastian Schilling
Mahlow Brandenburg, 15831, Germany
Derma Zentrum Osnabrueck Nord
Bramsche Niedersachsen, 49565, Germany
Hautzentrum im Jahrhunderthaus
Bochum Nordrhein-Westfalen, 44793, Germany
CentroDerm GmbH
Wuppertal Nordrhein-Westfalen, 42287, Germany
Brgyógyászati és Allergológiai Magánrendelés
Szolnok Jász-Nagykun-Szolnok, 5000, Hungary
UNOMEDICALTRIALS Kft
Budapest Pest, 1152, Hungary
Health Centre 4 Ltd., Diagnostics Centre
Riga Rga, LV-10, Latvia
Riga 1st hospital, Clinic of Dermatology and STD
Riga Rga, LV100, Latvia
J.Kisis LtD
Riga Rga, LV100, Latvia
Health and Aesthetics Ltd
Riga , LV-10, Latvia
Smite Aija doctor practice in dermatology, venereology
Talsi , LV320, Latvia
Lietuvos sveikatos mokslu universiteto ligonine Kauno klinik
Kaunas Kauno Apskritis, LT-50, Lithuania
Vilniaus universiteto ligonine Santaros klinikos Dermatovenerologijos centras
Vilnius Vilniaus Apskritis, LT-08, Lithuania
Centrum Medyczne ALL-MED
Krakow Maopolskie, 30-03, Poland
Medycyna Kliniczna
Warszawa Mazowieckie, 00-87, Poland
ETG Warszawa
Warszawa Mazowieckie, 02-79, Poland
Royalderm Agnieszka Nawrocka
Warszawa Mazowieckie, 02-96, Poland
Zespol Naukowo-Leczniczy Iwolang sp. z.o.o.
Iwonicz Zdroj Podkarpackie, 38-44, Poland
Specderm Poznanska Sp. j.
Bialystok Podlaskie, 15-01, Poland
ClinicMed Daniluk, Nowak Sp. J.
Bialystok Podlaskie, 15-87, Poland
Centrum Medyczne Pratia Katowice
Katowice , 40-08, Poland
Centrum Medyczne Angelius Provita
Katowice , 40-61, Poland
Barbara Rewerska Diamond Clinic
Krakow , 31-55, Poland
Centrum Zdrowia i Urody Maxxmed
Lublin , 20-08, Poland
ETG Lublin
Lublin , 20-41, Poland
Solumed
Poznan , 60-52, Poland
Nasz Lekarz Osrodek Badan Klinicznych
Torun , 87-10, Poland
Klinika Ambroziak Dermatologia
Warszawa , 02-95, Poland
DermMedica Sp. z o.o.
Wroclaw , 51-31, Poland
WroMedica I. Bielicka, A. Strzalkowska s.c.
Wroclaw , 51-68, Poland
ETG Skierniewice
Skierniewice Ódzkie, 96-10, Poland

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Phase:

Phase 3

Estimated Enrollment:

563

Study ID:

NCT04607980

Recruitment Status:

Completed

Sponsor:


Amgen

How clear is this clinincal trial information?

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