A Comparative Study Between ABP 501 and Humira® in Participants With Moderate to Severe Plaque Psoriasis

Last updated: February 7, 2024
Sponsor: Amgen
Overall Status: Completed

Phase

3

Condition

Scalp Disorders

Psoriasis And Psoriatic Disorders

Rash

Treatment

ABP 501

Adalimumab

Clinical Study ID

NCT05073315
20200497
2021-000542-18
  • Ages 18-75
  • All Genders

Study Summary

Study to evaluate pharmacokinetics, efficacy, safety and immunogenicity of multiple switches between Humira® and ABP 501 (new high concentration formulation) compared with continued use of Humira® in participants with moderate to severe plaque psoriasis. This multi-center study is composed of two periods: A lead-in period of treatment with Humira® followed by a randomized two parallel arm period.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participants has moderate to severe plaque psoriasis (with or without psoriaticarthritis) for at least 6 months and has stable disease for at least 2 months
  • Participants has a score of PASI ≥ 12, involvement of ≥ 10% body surface area (BSA)and static Physician's Global Assessment (sPGA) ≥ 3 at screening and at baseline
  • Participant has no known history of latent or active tuberculosis

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 received biologic treatment for psoriasis within the previous month or 5 drug half-lives (whichever is longer) prior to enrollment
  • Participant has received nonbiologic systemic psoriasis therapy within 4 weeks priorto enrollment
  • Participant has received ultraviolet (UV) A phototherapy (with or without psoralen) orexcimer laser within 4 weeks prior to enrollment, or UV B phototherapy within 2 weeksprior to enrollment
  • Participant has received topical psoriasis treatment within 2 weeks prior toenrollment

Study Design

Total Participants: 425
Treatment Group(s): 2
Primary Treatment: ABP 501
Phase: 3
Study Start date:
October 04, 2021
Estimated Completion Date:
December 19, 2022

Connect with a study center

  • Beacon Dermatology

    Calgary, Alberta T3E 0B2
    Canada

    Site Not Available

  • Alberta DermaSurgery Centre

    Edmonton, Alberta T6G 1C3
    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

  • SimcoDerm Medical & Surgical Dermatology Center

    Barrie, Ontario L4M 7G1
    Canada

    Site Not Available

  • Kingsway Clinical Research

    Etobicoke, Ontario M8X 1Y9
    Canada

    Site Not Available

  • Guelph Dermatology Research

    Guelph, Ontario N1L 0B7
    Canada

    Site Not Available

  • DermEffects

    London, Ontario N6H 5L5
    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

  • The Centre for Clinical Trials Inc.

    Oakville, Ontario L6J 7W5
    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

  • XLR8 Medical Research Inc.

    Windsor, Ontario N8W 1E6
    Canada

    Site Not Available

  • Dre Angélique Gagné-Henley MD inc

    Saint-Jerome, Quebec J7Z 7E2
    Canada

    Site Not Available

  • North Estonia Medical Centre

    Tallinn, Harjumaa 13419
    Estonia

    Site Not Available

  • Clinical Research Center

    Tartu, Tartumaa 50106
    Estonia

    Site Not Available

  • Tartu University Hospital

    Tartu, Tartumaa 50417
    Estonia

    Site Not Available

  • Derma-Study-Center-FN

    Friedrichshafen, Baden-Württemberg 88045
    Germany

    Site Not Available

  • Dermatologische Gemeinschaftspraxis Dres.Scholz Sebastian Schilling

    Mahlow, Brandenburg 15831
    Germany

    Site Not Available

  • Klinische Forschung Gruppe Nord (KFGN)

    Schwerin, Mecklenburg-Vorpommern 19055
    Germany

    Site Not Available

  • Hautzentrum im Jahrhunderthaus

    Bochum, Nordrhein-Westfalen 44793
    Germany

    Site Not Available

  • Praxis Dominicus

    Duelmen, Nordrhein-Westfalen 48249
    Germany

    Site Not Available

  • Klinische Forschung Dresden GmbH

    Dresden, Sachsen 01069
    Germany

    Site Not Available

  • UKSH Campus Kiel - ZeH (Dermatologie)

    Kiel, Schleswig-Holstein 24105
    Germany

    Site Not Available

  • Rothhaar Studien GmbH

    Berlin, 10783
    Germany

    Site Not Available

  • TFS Trial Form Support GmbH

    Hamburg, 20537
    Germany

    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

  • High-Med Przychodnia Specjalistyczna

    Warszawa, Mazowieckie 01-817
    Poland

    Site Not Available

  • Royalderm Agnieszka Nawrocka

    Warszawa, Mazowieckie 02-962
    Poland

    Site Not Available

  • ClinicMed Daniluk, Nowak Sp. J.

    Bialystok, Podlaskie 15-879
    Poland

    Site Not Available

  • Centrum Badan Klinicznych PI-House Sp. z o.o.

    Gdansk, Pomorskie 80-546
    Poland

    Site Not Available

  • Care Clinic SP. Z O.O.

    Katowice, 40-568
    Poland

    Site Not Available

  • Centrum Medyczne Angelius Provita

    Katowice, 40-611
    Poland

    Site Not Available

  • Centrum Nowoczesnych Terapii "Dobry Lekarz" Sp. z o.o.

    Krakow, 31-011
    Poland

    Site Not Available

  • Pratia MCM Krakow

    Krakow, 30-510
    Poland

    Site Not Available

  • Centrum Terapii Wspolczesnej, J.M. Jasnorzewska S.K.A.

    Lodz, 90-242
    Poland

    Site Not Available

  • NZOZ ALL-MED Centrum Medyczne

    Lodz, 90-048
    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

  • Agnieszka Miasik-Pogodzinska DrDerm Centrum Medyczne

    Nowy Targ, 34-400
    Poland

    Site Not Available

  • Dermedic Jacek Zdybski

    Ostrowiec Swietokrzyski, 27-400
    Poland

    Site Not Available

  • Clinical Research Center Sp. z o.o., Medic-R Sp. K.

    Poznan, 61-731
    Poland

    Site Not Available

  • Solumed Centrum Medyczne

    Poznan, 60-529
    Poland

    Site Not Available

  • Poradnia Dermatologiczno-Wenerologiczna MEDIDERM NZOZ

    Torun, 87-100
    Poland

    Site Not Available

  • Carpe Diem Centrum Medycyny Estetycznej

    Warszawa, 02-661
    Poland

    Site Not Available

  • Klinika Ambroziak Dermatologia

    Warszawa, 02-953
    Poland

    Site Not Available

  • RCMed Oddzia Warszawa

    Warszawa, 00-892
    Poland

    Site Not Available

  • Centrum Medyczne Oporow

    Wroclaw, 52-416
    Poland

    Site Not Available

  • Ginemedica Sp. z o.o. Sp.k

    Wroclaw, 50-414
    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

  • Johnson Dermatology Clinic

    Fort Smith, Arkansas 72916
    United States

    Site Not Available

  • First OC Dermatology

    Fountain Valley, California 92708
    United States

    Site Not Available

  • Dermatology Research Associates

    Los Angeles, California 90045
    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

  • Altus Research, Inc.

    Lake Worth, Florida 33461
    United States

    Site Not Available

  • International Dermatology Research, Inc

    Miami, Florida 33144
    United States

    Site Not Available

  • Tory Sullivan MD PA

    North Miami Beach, Florida 33162-4708
    United States

    Site Not Available

  • Renstar Medical Research

    Ocala, Florida 34470
    United States

    Site Not Available

  • Altus Research, Inc.

    Palm Springs, Florida 33461
    United States

    Site Not Available

  • Marietta dermatology skin care

    Marietta, Georgia 30060
    United States

    Site Not Available

  • Georgia Skin and Cancer Clinic - Clinic

    Savannah, Georgia 31419
    United States

    Site Not Available

  • NorthShore University HealthSystem Dermatology

    Skokie, Illinois 60077
    United States

    Site Not Available

  • Deaconess Clinic Downtown

    Evansville, Indiana 47708
    United States

    Site Not Available

  • Lawrence J Green, MD, LLC

    Rockville, Maryland 20850
    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

  • David Fivenson, MD, PLC

    Ann Arbor, Michigan 48103
    United States

    Site Not Available

  • Henry Ford Health System - New Center One

    Detroit, Michigan 48202
    United States

    Site Not Available

  • Minnesota Clinical Study Center

    New Brighton, Minnesota 55112
    United States

    Site Not Available

  • Vivida Dermatology

    Las Vegas, Nevada 89119
    United States

    Site Not Available

  • JUVA Skin and Laser Center

    New York, New York 10022-3350
    United States

    Site Not Available

  • Skin Search of Rochester, Inc.

    Rochester, New York 14623
    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

  • Wright State Physicians, Inc

    Fairborn, Ohio 45324
    United States

    Site Not Available

  • Dermatologists of Southwest Ohio

    Mason, Ohio 45040
    United States

    Site Not Available

  • Central Sooner Research

    Norman, Oklahoma 73071
    United States

    Site Not Available

  • Oregon Dermatology and Research Center

    Portland, Oregon 97210
    United States

    Site Not Available

  • Paddington Testing Co. Inc

    Philadelphia, Pennsylvania 19103
    United States

    Site Not Available

  • University of Pittsburgh Medical Center/Falk Medical Center

    Pittsburgh, Pennsylvania 15213
    United States

    Site Not Available

  • Clinical Research Center of the Carolinas

    Charleston, South Carolina 29407
    United States

    Site Not Available

  • International Clinical Research - Tennessee LLC

    Murfreesboro, Tennessee 37130
    United States

    Site Not Available

  • Bellaire Dermatology Associates (BDA)

    Bellaire, Texas 77401-3505
    United States

    Site Not Available

  • Austin Institute for Clinical Research - Dermatology

    Houston, Texas 77056
    United States

    Site Not Available

  • Center for Clinical Studies, LTD.LLP

    Houston, Texas 77004
    United States

    Site Not Available

  • Cutis Wellness Dermatology & Dermapathology, PLLC

    Laredo, Texas 78041
    United States

    Site Not Available

  • Dermatology Clinical Research Center of San Antonio

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Progressive Clinical Research [Texas]

    San Antonio, Texas 78213
    United States

    Site Not Available

  • CCT Research at Springville Dermatology

    Springville, Utah 84663
    United States

    Site Not Available

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