Clinical trial NCT05073315: A Comparative Study Between ABP 501 and Humira® in Participants With Moderate to Severe Plaque Psoriasis
Official title: A Multicenter, Randomized, Double-blind Study Evaluating the Pharmacokinetics, Efficacy, Safety, and Immunogenicity of Multiple Switches Between Humira® (Adalimumab [US]) and ABP 501 Compared With Continued Use of Adalimumab in Subjects With Moderate to Severe Plaque Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Plaque Psoriasis
Keywords: Adalimumab
Biosimilars
Tumor necrosis factor
Psoriasis Area and Severity Index
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2021-10-11
Enrollment: 425
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 Criteria:

* Participants has moderate to severe plaque psoriasis (with or without psoriatic arthritis) 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 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 product of 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 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

Primary outcomes:
measure: Area Under the Curve From Time 0 Over the Dosing Interval (AUCtau) of ABP 501 (Switching Group) and Adalimumab (Continued-use Group)
timeFrame: Week 28 pre-dose and 1hour, 1 day, 3 days, 4 days, 7 days, 11 days, and 14 days post Week 28 dose
measure: Maximum Serum Concentration (Cmax) of ABP 501 (Switching Group) and Adalimumab (Continued-use Group)
timeFrame: Week 28 pre-dose, 1h post Week 28 dose, 1 day post Week 28 dose, 3 days, 4 days, 7 days, 11 days, and 14 days post Week 28 dose
Secondary outcomes:
measure: Time to Reach Maximum Serum Concentration (Tmax) of ABP 501 (Switching Group) and Adalimumab (Continued-use Group)
timeFrame: Week 28 pre-dose, 1h post Week 28 dose, 1 day post Week 28 dose, 3 days, 4 days, 7 days, 11 days, and 14 days post Week 28 dose
measure: Trough Concentration (Ctrough) of ABP 501 (Switching Group) and Adalimumab (Continued-use Group)
timeFrame: Pre-dose at Week 12, Week 16, Week 20, and Week 28
measure: PASI Percent Improvement From Baseline (Day 1) to Week 30
timeFrame: Baseline (Day 1) and Week 30
measure: Number of Participants Achieving PASI 75 Response at Week 30
timeFrame: Baseline (Day 1) and Week 30
measure: Number of Participants Achieving PASI 90 Response at Week 30
timeFrame: Baseline (Day 1) and Week 30
measure: Number of Participants Achieving PASI 100 Response at Week 30
timeFrame: Baseline (Day 1) and Week 30
measure: Number of Participants Experiencing Treatment-emergent Adverse Events (TEAE)
timeFrame: Baseline up to Week 32
measure: Number of Participants Experiencing Events of Interest (EOI)
timeFrame: Baseline up to Week 32
measure: Number of Participants With Anti-drug Antibodies (ADA) Expression Post Randomization
timeFrame: Week 16, Week 20, Week 28, Week 30, and Week 32
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Total Skin and Beauty Dermatology Center PC
state: Alabama
city: Fort Smith
country: United States
facility: Johnson Dermatology Clinic
state: Arkansas
city: Fountain Valley
country: United States
facility: First OC Dermatology
state: California
city: Los Angeles
country: United States
facility: Dermatology Research Associates
state: California
city: Santa Monica
country: United States
facility: Clinical Science Institute
state: California
city: Sherman Oaks
country: United States
facility: Unison Clinical Trials
state: California
city: Doral
country: United States
facility: Revival Research
state: Florida
city: Lake Worth
country: United States
facility: Altus Research, Inc.
state: Florida
city: Miami
country: United States
facility: International Dermatology Research, Inc
state: Florida
city: North Miami Beach
country: United States
facility: Tory Sullivan MD PA
state: Florida
city: Marietta
country: United States
facility: Marietta dermatology skin care
state: Georgia
city: Savannah
country: United States
facility: Georgia Skin and Cancer Clinic - Clinic
state: Georgia
city: Skokie
country: United States
facility: NorthShore University HealthSystem Dermatology
state: Illinois
city: Evansville
country: United States
facility: Deaconess Clinic Downtown
state: Indiana
city: Rockville
country: United States
facility: Lawrence J Green, MD, LLC
state: Maryland
city: Beverly
country: United States
facility: ALLCUTIS Research, LLC.
state: Massachusetts
city: Brighton
country: United States
facility: Metro Boston Clinical Partners
state: Massachusetts
city: Ann Arbor
country: United States
facility: David Fivenson, MD, PLC
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Health System - New Center One
state: Michigan
city: New Brighton
country: United States
facility: Minnesota Clinical Study Center
state: Minnesota
city: Las Vegas
country: United States
facility: Vivida Dermatology
state: Nevada
city: Rochester
country: United States
facility: Skin Search of Rochester, Inc.
state: New York
city: Wilmington
country: United States
facility: Wilmington Dermatology Center
state: North Carolina
city: Fairborn
country: United States
facility: Wright State Physicians, Inc
state: Ohio
city: Mason
country: United States
facility: Dermatologists of Southwest Ohio
state: Ohio
city: Portland
country: United States
facility: Oregon Dermatology and Research Center
state: Oregon
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center/Falk Medical Center
state: Pennsylvania
city: Charleston
country: United States
facility: Clinical Research Center of the Carolinas
state: South Carolina
city: Murfreesboro
country: United States
facility: International Clinical Research - Tennessee LLC
state: Tennessee
city: Bellaire
country: United States
facility: Bellaire Dermatology Associates (BDA)
state: Texas
city: Houston
country: United States
facility: Center for Clinical Studies, LTD.LLP
state: Texas
city: Houston
country: United States
facility: Austin Institute for Clinical Research - Dermatology
state: Texas
city: Laredo
country: United States
facility: Cutis Wellness Dermatology & Dermapathology, PLLC
state: Texas
city: San Antonio
country: United States
facility: Progressive Clinical Research [Texas]
state: Texas
city: San Antonio
country: United States
facility: Dermatology Clinical Research Center of San Antonio
state: Texas
city: Calgary
country: Canada
facility: Beacon Dermatology
state: Alberta
city: Surrey
country: Canada
facility: Dr. Chih-ho Hong Medical Inc.
state: British Columbia
city: Ajax
country: Canada
facility: CCA Medical Research
state: Ontario
city: Barrie
country: Canada
facility: SimcoDerm Medical & Surgical Dermatology Center
state: Ontario
city: Etobicoke
country: Canada
facility: Kingsway Clinical Research
state: Ontario
city: Guelph
country: Canada
facility: Guelph Dermatology Research
state: Ontario
city: London
country: Canada
facility: DermEffects
state: Ontario
city: Mississauga
country: Canada
facility: DermEdge Research Inc.
state: Ontario
city: North Bay
country: Canada
facility: North Bay Dermatology Centre Inc.
state: Ontario
city: Oakville
country: Canada
facility: The Centre for Clinical Trials Inc.
state: Ontario
city: Peterborough
country: Canada
facility: SKiN Centre for Dermatology
state: Ontario
city: Richmond Hill
country: Canada
facility: The Centre for Dermatology
state: Ontario
city: Toronto
country: Canada
facility: Toronto Research Centre - Dermatology
state: Ontario
city: Windsor
country: Canada
facility: XLR8 Medical Research Inc.
state: Ontario
city: Saint-Jerome
country: Canada
facility: Dre Angélique Gagné-Henley MD inc
state: Quebec
city: Tallinn
country: Estonia
facility: North Estonia Medical Centre
state: Harjumaa
city: Tartu
country: Estonia
facility: Clinical Research Center
state: Tartumaa
city: Tartu
country: Estonia
facility: Tartu University Hospital
state: Tartumaa
city: Friedrichshafen
country: Germany
facility: Derma-Study-Center-FN
state: Baden-Württemberg
city: Schwerin
country: Germany
facility: Klinische Forschung Gruppe Nord (KFGN)
state: Mecklenburg-Vorpommern
city: Bochum
country: Germany
facility: Hautzentrum im Jahrhunderthaus
state: Nordrhein-Westfalen
city: Dresden
country: Germany
facility: Klinische Forschung Dresden GmbH
state: Sachsen
city: Kiel
country: Germany
facility: UKSH Campus Kiel - ZeH (Dermatologie)
state: Schleswig-Holstein
city: Berlin
country: Germany
facility: Rothhaar Studien GmbH
city: Hamburg
country: Germany
facility: TFS Trial Form Support GmbH
city: Riga
country: Latvia
facility: Health Centre 4 Ltd., Diagnostics Centre
state: Rga
city: Riga
country: Latvia
facility: Riga 1st hospital, Clinic of Dermatology and STD
state: Rga
city: Riga
country: Latvia
facility: J.Kisis LtD
state: Rga
city: Riga
country: Latvia
facility: Health and Aesthetics Ltd
city: Talsi
country: Latvia
facility: Smite Aija doctor practice in dermatology, venereology
city: Warszawa
country: Poland
facility: High-Med Przychodnia Specjalistyczna
state: Mazowieckie
city: Warszawa
country: Poland
facility: Royalderm Agnieszka Nawrocka
state: Mazowieckie
city: Bialystok
country: Poland
facility: ClinicMed Daniluk, Nowak Sp. J.
state: Podlaskie
city: Gdansk
country: Poland
facility: Centrum Badan Klinicznych PI-House Sp. z o.o.
state: Pomorskie
city: Katowice
country: Poland
facility: Care Clinic SP. Z O.O.
city: Katowice
country: Poland
facility: Centrum Medyczne Angelius Provita
city: Krakow
country: Poland
facility: Pratia MCM Krakow
city: Krakow
country: Poland
facility: Centrum Nowoczesnych Terapii "Dobry Lekarz" Sp. z o.o.
city: Lodz
country: Poland
facility: NZOZ ALL-MED Centrum Medyczne
city: Lodz
country: Poland
facility: Centrum Terapii Wspolczesnej, J.M. Jasnorzewska S.K.A.
city: Lublin
country: Poland
facility: Centrum Zdrowia i Urody Maxxmed
city: Lublin
country: Poland
facility: ETG Lublin
city: Nowy Targ
country: Poland
facility: Agnieszka Miasik-Pogodzinska DrDerm Centrum Medyczne
city: Ostrowiec Swietokrzyski
country: Poland
facility: Dermedic Jacek Zdybski
city: Poznan
country: Poland
facility: Solumed Centrum Medyczne
city: Poznan
country: Poland
facility: Clinical Research Center Sp. z o.o., Medic-R Sp. K.
city: Torun
country: Poland
facility: Poradnia Dermatologiczno-Wenerologiczna MEDIDERM NZOZ
city: Warszawa
country: Poland
facility: RCMed Oddzia Warszawa
city: Warszawa
country: Poland
facility: Carpe Diem Centrum Medycyny Estetycznej
city: Warszawa
country: Poland
facility: Klinika Ambroziak Dermatologia
city: Wroclaw
country: Poland
facility: Ginemedica Sp. z o.o. Sp.k
city: Wroclaw
country: Poland
facility: WroMedica I. Bielicka, A. Strzalkowska s.c.
city: Wroclaw
country: Poland
facility: Centrum Medyczne Oporow
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: