A Study to Investigate ABP 654 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis

Last updated: December 10, 2024
Sponsor: Amgen
Overall Status: Completed

Phase

3

Condition

Rosacea

Warts

Rash

Treatment

Ustekinumab

ABP 654

Clinical Study ID

NCT04607980
20190232
2020-003184-25
  • Ages 18-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 screeningand 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 anegative urine pregnancy test at baseline

  • No known history of latent or active tuberculosis (TB), and has a negative test forTB during screening (with negative purified protein derivative (PPD), and NegativeQuantiferon®/T-spot test)

  • Participants with a positive purified protein derivative and a history of BacillusCalmette-Guérin (BCG) vaccination are allowed with a negative Quantiferon®/T-spot®

  • Participants with a positive PPD test (without history of BCG vaccination) orparticipants with a positive or indeterminate Quantiferon®/T-spot test are allowedif they have all of the following:

  • No symptoms per TB worksheet provided by the sponsor

  • Documented history of adequate prophylaxis initiation prior to receivinginvestigational 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 firstdose of IP

Exclusion

Exclusion Criteria:

Participants are excluded from the study if any of the following criteria apply:

  • Skin disease related conditions such as, Erythrodermic psoriasis (PsO), pustularPsO, guttate PsO, medication induced PsO, or other skin conditions at the time ofthe screening visit (eg, eczema) that would interfere with evaluations of the effectof IP on PsO

  • Participant has an active infection, recurrent or chronic infections, seriousinfection 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 diabetesmellitus, 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 orIL-23

  • Received biologic treatment for psoriasis within the previous month or 5 drughalf-lives prior to randomization

  • Received non-biologic systemic psoriasis therapy within 4 weeks prior torandomization

  • Received Ultra-violet A (UVA) phototherapy (with or without psoralen) or excimerlaser within 4 weeks prior to randomization, or ultra-violet B (UVB) phototherapywithin 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 steroidspermitted on the palms, soles, face, and intertriginous areas; bland emollients)

  • Received live viral or live bacterial vaccination within 2 weeks prior torandomization

  • Received BCG vaccination within 1 year prior to randomization

  • Other investigational procedures within 4 weeks prior to randomization and duringthe study

  • Participants not agreeing to follow protocol defined contraceptives procedures

  • Participants likely not to be available to complete all protocol-required studyvisits or procedures, and/or to comply with all required study procedures

Study Design

Total Participants: 563
Treatment Group(s): 2
Primary Treatment: Ustekinumab
Phase: 3
Study Start date:
November 11, 2020
Estimated Completion Date:
June 03, 2022

Study 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:

  1. 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.

  2. 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).

  3. 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.

Connect with a study center

  • Beacon Dermatology

    Calgary, Alberta T3E 0B2
    Canada

    Site Not Available

  • Research Site

    Edmonton, Alberta T5K 1X3
    Canada

    Site Not Available

  • Dr. Chih-ho Hong Medical Inc.

    Surrey, British Columbia V3R 6A7
    Canada

    Site Not Available

  • CCA Medical Research

    Ajax, Ontario L1S 7K8
    Canada

    Site Not Available

  • Kingsway Clinical Research

    Etobicoke, Ontario M8X 1Y9
    Canada

    Site Not Available

  • Dermatrials Research Inc

    Hamilton, Ontario L8N1Y2
    Canada

    Site Not Available

  • Lynderm Research Inc

    Markham, Ontario L3P 1X3
    Canada

    Site Not Available

  • DermEdge Research Inc.

    Mississauga, Ontario L4Y 4C5
    Canada

    Site Not Available

  • North Bay Dermatology Centre Inc.

    North Bay, Ontario P1B 3Z7
    Canada

    Site Not Available

  • JRB Research Inc.

    Ottawa, Ontario K1H 7X3
    Canada

    Site Not Available

  • Skin Centre for Dermatology

    Peterborough, Ontario K9J 5K2
    Canada

    Site Not Available

  • The Centre for Dermatology

    Richmond Hill, Ontario L4B 1A5
    Canada

    Site Not Available

  • Toronto Research Centre - Dermatology

    Toronto, Ontario M3H 5Y8
    Canada

    Site Not Available

  • K. Papp Clinical Research Inc.

    Waterloo, Ontario N2J 1C4
    Canada

    Site Not Available

  • XLR8 Medical Research Inc.

    Windsor, Ontario N8W 1E6
    Canada

    Site Not Available

  • Centre de Recherche dermatolog

    Quebec city, Quebec G1V 4X7
    Canada

    Site Not Available

  • Confido Private Medical Clinic - General Practice/Medicine

    Tallinn, Harjumaa 10138
    Estonia

    Site Not Available

  • Vahlberg & Pild OÜ

    Tallinn, Harjumaa 10134
    Estonia

    Site Not Available

  • Clinical Research Center

    Tartu, Tartumaa 50106
    Estonia

    Site Not Available

  • Tartu University Hospital

    Tartu, Tartumaa 50417
    Estonia

    Site Not Available

  • Dermatologische Gemeinschaftspraxis Dres.Scholz Sebastian Schilling

    Mahlow, Brandenburg 15831
    Germany

    Site Not Available

  • Derma Zentrum Osnabrueck Nord

    Bramsche, Niedersachsen 49565
    Germany

    Site Not Available

  • Hautzentrum im Jahrhunderthaus

    Bochum, Nordrhein-Westfalen 44793
    Germany

    Site Not Available

  • CentroDerm GmbH

    Wuppertal, Nordrhein-Westfalen 42287
    Germany

    Site Not Available

  • Brgyógyászati és Allergológiai Magánrendelés

    Szolnok, Jász-Nagykun-Szolnok 5000
    Hungary

    Site Not Available

  • UNOMEDICALTRIALS Kft

    Budapest, Pest 1152
    Hungary

    Site Not Available

  • Health Centre 4 Ltd., Diagnostics Centre

    Riga, Rga LV-1003
    Latvia

    Site Not Available

  • J.Kisis LtD

    Riga, Rga LV1003
    Latvia

    Site Not Available

  • Riga 1st hospital, Clinic of Dermatology and STD

    Riga, Rga LV1001
    Latvia

    Site Not Available

  • Health and Aesthetics Ltd

    Riga, LV-1009
    Latvia

    Site Not Available

  • Smite Aija doctor practice in dermatology, venereology

    Talsi, LV3201
    Latvia

    Site Not Available

  • Lietuvos sveikatos mokslu universiteto ligonine Kauno klinik

    Kaunas, Kauno Apskritis LT-50161
    Lithuania

    Site Not Available

  • Vilniaus universiteto ligonine Santaros klinikos Dermatovenerologijos centras

    Vilnius, Vilniaus Apskritis LT-08411
    Lithuania

    Site Not Available

  • Centrum Medyczne Pratia Katowice

    Tychy, Lskie 43-100
    Poland

    Site Not Available

  • Centrum Medyczne ALL-MED

    Krakow, Maopolskie 30-033
    Poland

    Site Not Available

  • ETG Warszawa

    Warszawa, Mazowieckie 02-793
    Poland

    Site Not Available

  • Medycyna Kliniczna

    Warszawa, Mazowieckie 00-874
    Poland

    Site Not Available

  • Royalderm Agnieszka Nawrocka

    Warszawa, Mazowieckie 02-962
    Poland

    Site Not Available

  • Zespol Naukowo-Leczniczy Iwolang sp. z.o.o.

    Iwonicz Zdroj, Podkarpackie 38-440
    Poland

    Site Not Available

  • ClinicMed Daniluk, Nowak Sp. J.

    Bialystok, Podlaskie 15-879
    Poland

    Site Not Available

  • Specderm Poznanska Sp. j.

    Bialystok, Podlaskie 15-017
    Poland

    Site Not Available

  • ETG Skierniewice

    Skierniewice, Ódzkie 96-100
    Poland

    Site Not Available

  • Centrum Medyczne Angelius Provita

    Katowice, 40-611
    Poland

    Site Not Available

  • Centrum Medyczne Pratia Katowice

    Katowice, 40-081
    Poland

    Site Not Available

  • Barbara Rewerska Diamond Clinic

    Krakow, 31-559
    Poland

    Site Not Available

  • Centrum Zdrowia i Urody Maxxmed

    Lublin, 20-080
    Poland

    Site Not Available

  • ETG Lublin

    Lublin, 20-412
    Poland

    Site Not Available

  • Solumed

    Poznan, 60-529
    Poland

    Site Not Available

  • Nasz Lekarz Osrodek Badan Klinicznych

    Torun, 87-100
    Poland

    Site Not Available

  • Klinika Ambroziak Dermatologia

    Warszawa, 02-953
    Poland

    Site Not Available

  • DermMedica Sp. z o.o.

    Wroclaw, 51-318
    Poland

    Site Not Available

  • WroMedica I. Bielicka, A. Strzalkowska s.c.

    Wroclaw, 51-685
    Poland

    Site Not Available

  • Total Skin and Beauty Dermatology Center PC

    Birmingham, Alabama 35205
    United States

    Site Not Available

  • Alliance Dermatology and Mohs Center

    Phoenix, Arizona 85032
    United States

    Site Not Available

  • First OC Dermatology

    Fountain Valley, California 92708
    United States

    Site Not Available

  • University Clinical Trials, Inc.

    San Diego, California 92123
    United States

    Site Not Available

  • San Luis Dermatology and Laser Clinic - Dermatology

    San Luis Obispo, California 93405
    United States

    Site Not Available

  • Clinical Science Institute

    Santa Monica, California 90404
    United States

    Site Not Available

  • Unison Clinical Trials

    Sherman Oaks, California 91403
    United States

    Site Not Available

  • Revival Research

    Doral, Florida 33122
    United States

    Site Not Available

  • International Dermatology Research, Inc

    Miami, Florida 33144
    United States

    Site Not Available

  • Renstar Medical Research

    Ocala, Florida 34470
    United States

    Site Not Available

  • Moore Clinical Research Inc.

    Tampa, Florida 33609-2230
    United States

    Site Not Available

  • NorthShore University HealthSystem

    Skokie, Illinois 60077
    United States

    Site Not Available

  • Springfield Clinic

    Springfield, Illinois 62703-2403
    United States

    Site Not Available

  • Dawes Fretzin Clinical Research Group, LLC

    Indianapolis, Indiana 46250-2041
    United States

    Site Not Available

  • Research Site

    West Des Moines, Iowa 50265
    United States

    Site Not Available

  • Epiphany Dermatology of Kansas, LLC

    Overland Park, Kansas 66210
    United States

    Site Not Available

  • DelRicht Research

    Baton Rouge, Louisiana 70809
    United States

    Site Not Available

  • ALLCUTIS Research, LLC.

    Beverly, Massachusetts 01915
    United States

    Site Not Available

  • Metro Boston Clinical Partners

    Brighton, Massachusetts 02135
    United States

    Site Not Available

  • Research Site

    Warren, Michigan 48088
    United States

    Site Not Available

  • ActivMed Practices & Research, LLC.

    Portsmouth, New Hampshire 03801
    United States

    Site Not Available

  • Psoriasis Treatment Center of Central New Jersey

    East Windsor, New Jersey 08520
    United States

    Site Not Available

  • Dermatology Consulting Services, PLLC

    High Point, North Carolina 27262
    United States

    Site Not Available

  • Wilmington Dermatology Center

    Wilmington, North Carolina 28405
    United States

    Site Not Available

  • Bexley Dermatology Research

    Bexley, Ohio 43209-2421
    United States

    Site Not Available

  • Dermatologists of Southwest Ohio

    Mason, Ohio 45040
    United States

    Site Not Available

  • Oregon Dermatology and Research Center

    Portland, Oregon 97210
    United States

    Site Not Available

  • Oregon Medical Research Center

    Portland, Oregon 97223
    United States

    Site Not Available

  • The Pennsylvania Centre for Dermatology, LLC

    Exton, Pennsylvania 19341
    United States

    Site Not Available

  • Clinical Partners, LLC

    Johnston, Rhode Island 02919
    United States

    Site Not Available

  • The Skin Wellness Center PC

    Knoxville, Tennessee 37922
    United States

    Site Not Available

  • Center for Clinical Studies

    Cypress, Texas 77433
    United States

    Site Not Available

  • Modern Research Associates

    Dallas, Texas 75231
    United States

    Site Not Available

  • Austin Institute for Clinical Research - Dermatology

    Houston, Texas 77056
    United States

    Site Not Available

  • Progressive Clinical Research [Texas]

    San Antonio, Texas 78213
    United States

    Site Not Available

  • Acclaim Dermatology

    Sugar Land, Texas 77479-2645
    United States

    Site Not Available

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