A Comparative Study Between ABP 501 and Humira® in Participants With Moderate to Severe Plaque Psoriasis
NCT ID: NCT05073315
Last Updated: 2024-02-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
425 participants
INTERVENTIONAL
2021-10-04
2022-12-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Continued-use Group (Adalimumab)
Randomized participants will receive continuous injection of adalimumab Q2W until last dose at Week 28.
Adalimumab
Participants will receive subcutaneous (SC) injection of adalimumab
Switching Group (Adalimumab - ABP 501)
Participants will initially receive adalimumab until Week 10 during the lead-in period. Thereafter, starting from Week 12, participants will switch between ABP 501 and adalimumab Q2W with last dose of ABP 501 at Week 28.
Adalimumab
Participants will receive subcutaneous (SC) injection of adalimumab
ABP 501
Participants will receive SC injection of ABP 501
Interventions
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Adalimumab
Participants will receive subcutaneous (SC) injection of adalimumab
ABP 501
Participants will receive SC injection of ABP 501
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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 prior to enrollment
* Participant has received ultraviolet (UV) A phototherapy (with or without psoralen) or excimer laser within 4 weeks prior to enrollment, or UV B phototherapy within 2 weeks prior to enrollment
* Participant has received topical psoriasis treatment within 2 weeks prior to enrollment
18 Years
75 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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Total Skin and Beauty Dermatology Center PC
Birmingham, Alabama, United States
Johnson Dermatology Clinic
Fort Smith, Arkansas, United States
First OC Dermatology
Fountain Valley, California, United States
Dermatology Research Associates
Los Angeles, California, United States
Clinical Science Institute
Santa Monica, California, United States
Unison Clinical Trials
Sherman Oaks, California, United States
Revival Research
Doral, Florida, United States
Altus Research, Inc.
Lake Worth, Florida, United States
International Dermatology Research, Inc
Miami, Florida, United States
Tory Sullivan MD PA
North Miami Beach, Florida, United States
Marietta dermatology skin care
Marietta, Georgia, United States
Georgia Skin and Cancer Clinic - Clinic
Savannah, Georgia, United States
NorthShore University HealthSystem Dermatology
Skokie, Illinois, United States
Deaconess Clinic Downtown
Evansville, Indiana, United States
Lawrence J Green, MD, LLC
Rockville, Maryland, United States
ALLCUTIS Research, LLC.
Beverly, Massachusetts, United States
Metro Boston Clinical Partners
Brighton, Massachusetts, United States
David Fivenson, MD, PLC
Ann Arbor, Michigan, United States
Henry Ford Health System - New Center One
Detroit, Michigan, United States
Minnesota Clinical Study Center
New Brighton, Minnesota, United States
Vivida Dermatology
Las Vegas, Nevada, United States
Skin Search of Rochester, Inc.
Rochester, New York, United States
Wilmington Dermatology Center
Wilmington, North Carolina, United States
Wright State Physicians, Inc
Fairborn, Ohio, United States
Dermatologists of Southwest Ohio
Mason, Ohio, United States
Oregon Dermatology and Research Center
Portland, Oregon, United States
University of Pittsburgh Medical Center/Falk Medical Center
Pittsburgh, Pennsylvania, United States
Clinical Research Center of the Carolinas
Charleston, South Carolina, United States
International Clinical Research - Tennessee LLC
Murfreesboro, Tennessee, United States
Bellaire Dermatology Associates (BDA)
Bellaire, Texas, United States
Center for Clinical Studies, LTD.LLP
Houston, Texas, United States
Austin Institute for Clinical Research - Dermatology
Houston, Texas, United States
Cutis Wellness Dermatology & Dermapathology, PLLC
Laredo, Texas, United States
Progressive Clinical Research [Texas]
San Antonio, Texas, United States
Dermatology Clinical Research Center of San Antonio
San Antonio, Texas, United States
Beacon Dermatology
Calgary, Alberta, Canada
Dr. Chih-ho Hong Medical Inc.
Surrey, British Columbia, Canada
CCA Medical Research
Ajax, Ontario, Canada
SimcoDerm Medical & Surgical Dermatology Center
Barrie, Ontario, Canada
Kingsway Clinical Research
Etobicoke, Ontario, Canada
Guelph Dermatology Research
Guelph, Ontario, Canada
DermEffects
London, Ontario, Canada
DermEdge Research Inc.
Mississauga, Ontario, Canada
North Bay Dermatology Centre Inc.
North Bay, Ontario, Canada
The Centre for Clinical Trials Inc.
Oakville, Ontario, Canada
SKiN Centre for Dermatology
Peterborough, Ontario, Canada
The Centre for Dermatology
Richmond Hill, Ontario, Canada
Toronto Research Centre - Dermatology
Toronto, Ontario, Canada
XLR8 Medical Research Inc.
Windsor, Ontario, Canada
Dre Angélique Gagné-Henley MD inc
Saint-Jérôme, Quebec, Canada
North Estonia Medical Centre
Tallinn, Harju, Estonia
Clinical Research Center
Tartu, Tartu, Estonia
Tartu University Hospital
Tartu, Tartu, Estonia
Derma-Study-Center-FN
Friedrichshafen, Baden-Wurttemberg, Germany
Klinische Forschung Gruppe Nord (KFGN)
Schwerin, Mecklenburg-Vorpommern, Germany
Hautzentrum im Jahrhunderthaus
Bochum, North Rhine-Westphalia, Germany
Klinische Forschung Dresden GmbH
Dresden, Saxony, Germany
UKSH Campus Kiel - ZeH (Dermatologie)
Kiel, Schleswig-Holstein, Germany
Rothhaar Studien GmbH
Berlin, , Germany
TFS Trial Form Support GmbH
Hamburg, , Germany
Health Centre 4 Ltd., Diagnostics Centre
Riga, Rga, Latvia
Riga 1st hospital, Clinic of Dermatology and STD
Riga, Rga, Latvia
J.Kisis LtD
Riga, Rga, Latvia
Health and Aesthetics Ltd
Riga, , Latvia
Smite Aija doctor practice in dermatology, venereology
Talsi, , Latvia
High-Med Przychodnia Specjalistyczna
Warsaw, Masovian Voivodeship, Poland
Royalderm Agnieszka Nawrocka
Warsaw, Masovian Voivodeship, Poland
ClinicMed Daniluk, Nowak Sp. J.
Bialystok, Podlaskie Voivodeship, Poland
Centrum Badan Klinicznych PI-House Sp. z o.o.
Gdansk, Pomeranian Voivodeship, Poland
Care Clinic SP. Z O.O.
Katowice, , Poland
Centrum Medyczne Angelius Provita
Katowice, , Poland
Pratia MCM Krakow
Krakow, , Poland
Centrum Nowoczesnych Terapii "Dobry Lekarz" Sp. z o.o.
Krakow, , Poland
NZOZ ALL-MED Centrum Medyczne
Lodz, , Poland
Centrum Terapii Wspolczesnej, J.M. Jasnorzewska S.K.A.
Lodz, , Poland
Centrum Zdrowia i Urody Maxxmed
Lublin, , Poland
ETG Lublin
Lublin, , Poland
Agnieszka Miasik-Pogodzinska DrDerm Centrum Medyczne
Nowy Targ, , Poland
Dermedic Jacek Zdybski
Ostrowiec Świętokrzyski, , Poland
Solumed Centrum Medyczne
Poznan, , Poland
Clinical Research Center Sp. z o.o., Medic-R Sp. K.
Poznan, , Poland
Poradnia Dermatologiczno-Wenerologiczna MEDIDERM NZOZ
Torun, , Poland
RCMed Oddzia Warszawa
Warsaw, , Poland
Carpe Diem Centrum Medycyny Estetycznej
Warsaw, , Poland
Klinika Ambroziak Dermatologia
Warsaw, , Poland
Ginemedica Sp. z o.o. Sp.k
Wroclaw, , Poland
WroMedica I. Bielicka, A. Strzalkowska s.c.
Wroclaw, , Poland
Centrum Medyczne Oporow
Wroclaw, , Poland
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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AmgenTrials clinical trials website
Other Identifiers
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2021-000542-18
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
20200497
Identifier Type: -
Identifier Source: org_study_id
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