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

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

Phase

3

Condition

Skin Wounds

Warts

Scalp Disorders

Treatment

Ustekinumab

ABP 654

Clinical Study ID

NCT04761627
20200417
2020-005205-42
  • Ages 18-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 andstatic 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, orcontraindication to at least 1 conventional antipsoriatic systemic therapy
  • Female participant should have a negative serum pregnancy test during screening and anegative urine pregnancy test at baseline
  • Participant or legally acceptable representative is capable of giving signedInstitutional 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 ofBacillus Calmette-Guérin (BCG) vaccination is allowed with a negativeQuantiferon/T-spot test
  • Participant with a positive PPD test or participant with a positive or indeterminateQuantiferon/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 receivinginvestigational 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 tothe first dose of investigational product

Exclusion

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 productof psoriasis
  • Participant has an active infection or history of infections
  • Participant has uncontrolled, clinically significant systemic disease, such asuncontrolled diabetes mellitus, cardiovascular disease, renal disease, liver disease,or hypertension
  • Participant has a mean QT internal or abnormal long QT syndrome corrected usingFridericia's formula (QTcF) of > 450 msec (for male participant) or > 470 msec (forfemale participant) at baseline that, in the opinion of the Investigator, is abnormalor clinically significant
  • Participant has moderate to severe heart failure (New York Heart Associate classIII/IV)
  • Participant has known hypersensitivity to the investigational product or to any of theexcipients
  • Participant has laboratory abnormalities at screening
  • Participant has had previous treatment with any agent specifically targetinginterleukin (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 5half-lives (whichever is longer) prior to enrollment
  • Participant has received non-biologic systemic psoriasis therapy within 4 weeks priorto enrollment
  • Participant has received ultraviolet A phototherapy (with or without psoralen) orexcimer 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 toenrollment
  • Participant has received other investigational procedures within 4 weeks prior toenrollment and during the course of the study
  • Female participant is pregnant or breastfeeding or planning to become pregnant whileparticipating in the study and for at least 5 months after the last dose ofinvestigational product
  • Sexually active participants and their partners who are of childbearing potential andnot agreeing to use adequate protocol defined contraception methods whileparticipating in the study and for 5 months after the last dose of investigationalproduct

Study Design

Total Participants: 494
Treatment Group(s): 2
Primary Treatment: Ustekinumab
Phase: 3
Study Start date:
March 24, 2021
Estimated Completion Date:
February 28, 2023

Study 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.

Connect with a study center

  • Dermatology Research Institute

    Calgary, Alberta T2J 7E1
    Canada

    Site Not Available

  • Enverus Medical Research

    Surrey, British Columbia V3V 0C6
    Canada

    Site Not Available

  • Wiseman Dermatology Research Inc.

    Winnipeg, Manitoba R3M 3Z4
    Canada

    Site Not Available

  • Dr. Irina Turchin PC Inc.

    Fredericton, New Brunswick E3B 1G9
    Canada

    Site Not Available

  • CCA Medical Research

    Ajax, Ontario L1S 7K8
    Canada

    Site Not Available

  • SimcoDerm Medical and Surgical Dermatology Center

    Barrie, Ontario L4M 7G1
    Canada

    Site Not Available

  • Guelph Dermatology Research

    Guelph, Ontario N1L 0B7
    Canada

    Site Not Available

  • Dr Wei Jing Loo Medicine Professional Corporation

    London, Ontario N6H 5L5
    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

  • Dr. S. K. Siddha Medicine Professional Corporation - Doctor's Office

    Newmarket, Ontario L3Y 5G8
    Canada

    Site Not Available

  • North York Research Inc. - Dermatology

    North York, Ontario M2M 4J5
    Canada

    Site Not Available

  • Dermatology Ottawa Research Centre

    Ottawa, Ontario K2C 3N2
    Canada

    Site Not Available

  • Research Toronto

    Toronto, Ontario M4W 2N4
    Canada

    Site Not Available

  • K. Papp Clinical Research Inc.

    Waterloo, Ontario N2J 1C4
    Canada

    Site Not Available

  • Skinsense Medical Research

    Saskatoon, Saskatchewan S7K 0H6
    Canada

    Site Not Available

  • Confido Private Medical Clinic - General Practice/Medicine

    Tallinn, Harjumaa 10138
    Estonia

    Site Not Available

  • Clinical Research Center

    Tartu, Tartumaa 50106
    Estonia

    Site Not Available

  • Tartu University Hospital

    Tartu, Tartumaa 50417
    Estonia

    Site Not Available

  • Innomedica OÜ

    Tallinn, 10117
    Estonia

    Site Not Available

  • ,,Tbilisi Cancer center"LTD

    Tbilisi, T'bilisi 0159
    Georgia

    Site Not Available

  • Acad.Fridon Todua Medical Center- Research Institute of Clinical Medicine

    Tbilisi, T'bilisi 0112
    Georgia

    Site Not Available

  • LTD Aversi Clinic

    Tbilisi, T'bilisi 0160
    Georgia

    Site Not Available

  • LTD Israeli-Georgian Medical Research Clinic Helsicore

    Tbilisi, T'bilisi 0112
    Georgia

    Site Not Available

  • ,,KANVENI - Scientific/Research National Center of Dermatology and Venereology LLC

    Tbilisi, 0159
    Georgia

    Site Not Available

  • Derma-Study-Center-FN

    Friedrichshafen, Baden-Württemberg 88045
    Germany

    Site Not Available

  • Dermazentrum Augsburg

    Augsburg, Bayern 86179
    Germany

    Site Not Available

  • Dermatologische Gemeinschaftspraxis Dres.Scholz Sebastian Schilling

    Mahlow, Brandenburg 15831
    Germany

    Site Not Available

  • Universitätsklinikum Frankfurt am Main - Klinik für Dermatol

    Frankfurt/Main, Hessen 60590
    Germany

    Site Not Available

  • Fachklinik Bad Bentheim

    Bad Bentheim, Niedersachsen 48455
    Germany

    Site Not Available

  • Praxis Hoffmann

    Witten, Nordrhein-Westfalen 58453
    Germany

    Site Not Available

  • Klinische Forschung Dresden GmbH

    Dresden, Sachsen 01069
    Germany

    Site Not Available

  • Universitätsklinikum Carl Gustav Carus

    Dresden, Sachsen 01307
    Germany

    Site Not Available

  • UK-SH - Lübeck

    Lübeck, Schleswig-Holstein 23538
    Germany

    Site Not Available

  • Charite - Campus Charite Mitte (CCM) - Dermatologie & Allergologie - Dermatologie & Allergologie

    Berlin, 10117
    Germany

    Site Not Available

  • Rothhaar Studien GmbH

    Berlin, 10783
    Germany

    Site Not Available

  • Debreceni Egyetem Klinikai Központ Nagyerdei Campus

    Debrecen, Hajdú-Bihar 4032
    Hungary

    Site Not Available

  • Brgyógyászati és Allergológiai Magánrendelés

    Szolnok, Jász-Nagykun-Szolnok 5000
    Hungary

    Site Not Available

  • Qualiclinic Kft

    Budapest, Pest 1036
    Hungary

    Site Not Available

  • UNOMEDICALTRIALS Kft

    Budapest, Pest 1152
    Hungary

    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

  • Smite Aija doctor practice in dermatology, venereology

    Talsi, LV3201
    Latvia

    Site Not Available

  • Centrum Medyczne ALL-MED Badania Kliniczne

    Krakow, Maopolskie 30-033
    Poland

    Site Not Available

  • Centrum Medyczne Plejady

    Krakow, Maopolskie 30-363
    Poland

    Site Not Available

  • MICS Centrum Medyczne Warszawa

    Warszawa, Mazowieckie 00-874
    Poland

    Site Not Available

  • RENEW CLINIC Spolka Jawna

    Bialystok, 15-794
    Poland

    Site Not Available

  • Centrum Medyczne Pratia Bydgoszcz

    Bydgoszcz, 85-796
    Poland

    Site Not Available

  • MICS Centrum Medyczne Bydgoszcz

    Bydgoszcz, 85-065
    Poland

    Site Not Available

  • Centrum Medyczne Pratia Gdynia

    Gdynia, 81-338
    Poland

    Site Not Available

  • Barbara Rewerska Diamond Clinic

    Krakow, 31-559
    Poland

    Site Not Available

  • Centrum Medyczne PROMED

    Krakow, 31-513
    Poland

    Site Not Available

  • Krakowskie Centrum Medyczne Sp. z o.o.

    Krakow, 31-501
    Poland

    Site Not Available

  • Twoja Przychodnia - Centrum Medyczne Nowa Sol

    Nowa Sol, 67-100
    Poland

    Site Not Available

  • ETG Siedlce

    Siedlce, 08-110
    Poland

    Site Not Available

  • RCMed Oddzial Sochaczew

    Sochaczew, 96-500
    Poland

    Site Not Available

  • Twoja Przychodnia - Szczecinskie Centrum Medyczne

    Szczecin, 71-434
    Poland

    Site Not Available

  • Centrum Medyczne Evimed

    Warszawa, 02-625
    Poland

    Site Not Available

  • RCMed Oddzia Warszawa

    Warszawa, 00-892
    Poland

    Site Not Available

  • DermMedica Sp. z o.o.

    Wroclaw, 51-318
    Poland

    Site Not Available

  • Hospital Universitario Reina Sofia

    Córdoba, Andalucía 14004
    Spain

    Site Not Available

  • Hospital Universitario 12 de Octubre

    Madrid, 28041
    Spain

    Site Not Available

  • Burke Pharmaceutical Research

    Hot Springs, Arkansas 71913
    United States

    Site Not Available

  • Zenith Research Inc.

    Beverly Hills, California 90212
    United States

    Site Not Available

  • Center for Dermatology Clinical Research, Inc.

    Fremont, California 94538
    United States

    Site Not Available

  • Quest Dermatology Research

    Northridge, California 91324-4669
    United States

    Site Not Available

  • Southern California Dermatology, Inc

    Santa Ana, California 92701
    United States

    Site Not Available

  • Clearlyderm Dermatology

    Boca Raton, Florida 33428
    United States

    Site Not Available

  • Encore Research Group-Jacksonville Center for Clinical Resea

    Jacksonville, Florida 32216
    United States

    Site Not Available

  • Altus Research, Inc.

    Lake Worth, Florida 33461
    United States

    Site Not Available

  • International Dermatology Research, Inc.

    Miami, Florida 33144
    United States

    Site Not Available

  • Leavitt Medical Associates of Florida d/b/a Ameriderm Research

    Ormond Beach, Florida 32174
    United States

    Site Not Available

  • Research Site

    Palm Beach, Florida 33461
    United States

    Site Not Available

  • Altus Research, Inc.

    Palm Springs, Florida 33461
    United States

    Site Not Available

  • Riverchase Dermatology and Cosmetic Surgery

    Pembroke Pines, Florida 33028-1013
    United States

    Site Not Available

  • Olympian Clinical Research

    Tampa, Florida 33614
    United States

    Site Not Available

  • Hamilton Research, LLC

    Alpharetta, Georgia 30022
    United States

    Site Not Available

  • Advanced Medical Research PC

    Sandy Springs, Georgia 30328
    United States

    Site Not Available

  • Dundee Dermatology

    West Dundee, Illinois 60118
    United States

    Site Not Available

  • DS Research

    Clarksville, Indiana 47129
    United States

    Site Not Available

  • DS Research

    Corydon, Indiana 47112-2174
    United States

    Site Not Available

  • Integrated Clinical Trial Services Inc.

    West Des Moines, Iowa 50265
    United States

    Site Not Available

  • Kansas Medical Clinic, PA

    Topeka, Kansas 66614
    United States

    Site Not Available

  • Clinical Pharmacology Study Group

    Worcester, Massachusetts 01605
    United States

    Site Not Available

  • Hamzavi Dermatology

    Fort Gratiot, Michigan 48059
    United States

    Site Not Available

  • Research Site

    Fridley, Minnesota 55432
    United States

    Site Not Available

  • Minnesota Clinical Study Center

    New Brighton, Minnesota 55112
    United States

    Site Not Available

  • MediSearch Clinical Trials

    Saint Joseph, Missouri 64506
    United States

    Site Not Available

  • Skin Specialists PC

    Omaha, Nebraska 68144
    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

  • The Dermatology Group, PC

    Verona, New Jersey 07044
    United States

    Site Not Available

  • Buffalo Medical Group, PC

    Buffalo, New York 14221
    United States

    Site Not Available

  • OnSite Clinical Solutions, LLC

    Charlotte, North Carolina 28209
    United States

    Site Not Available

  • Wilmington Dermatology Center

    Wilmington, North Carolina 28405
    United States

    Site Not Available

  • Oregon Medical Research Center

    Portland, Oregon 97223
    United States

    Site Not Available

  • Austin Institute for Clinical Research, Inc.

    Dripping Springs, Texas 78620
    United States

    Site Not Available

  • Austin Institute for Clinical Research, Inc - Dermatology

    Pflugerville, Texas 78660
    United States

    Site Not Available

  • Progressive Clinical Research [Texas]

    San Antonio, Texas 78213
    United States

    Site Not Available

  • Center for Clinical Studies, LTD., LLP

    Webster, Texas 77598
    United States

    Site Not Available

  • Dermatology of Seattle

    Burien, Washington 98168
    United States

    Site Not Available

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