A Comparative Study Between ABP 501 and Humira® in Participants With Moderate to Severe Plaque Psoriasis
- Registration Number
- NCT05073315
- Lead Sponsor
- Amgen
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 425
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Switching Group (Adalimumab - ABP 501) 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. Continued-use Group (Adalimumab) Adalimumab Randomized participants will receive continuous injection of adalimumab Q2W until last dose at Week 28. Switching Group (Adalimumab - ABP 501) Adalimumab 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.
- Primary Outcome Measures
Name Time Method Area Under the Curve From Time 0 Over the Dosing Interval (AUCtau) of ABP 501 (Switching Group) and Adalimumab (Continued-use Group) Week 28 pre-dose and 1hour, 1 day, 3 days, 4 days, 7 days, 11 days, and 14 days post Week 28 dose Participants analyzed according to actual treatment received.
Maximum Serum Concentration (Cmax) of ABP 501 (Switching Group) and Adalimumab (Continued-use Group) 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 Participants analyzed according to treatment received.
- Secondary Outcome Measures
Name Time Method Time to Reach Maximum Serum Concentration (Tmax) of ABP 501 (Switching Group) and Adalimumab (Continued-use Group) 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 Time to reach maximum serum concentration.
Trough Concentration (Ctrough) of ABP 501 (Switching Group) and Adalimumab (Continued-use Group) Pre-dose at Week 12, Week 16, Week 20, and Week 28 PASI Percent Improvement From Baseline (Day 1) to Week 30 Baseline (Day 1) and Week 30 The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis.
Percent improvement from baseline was calculated as (value at baseline - value at post-baseline visit) × 100 / (value at baseline).Number of Participants Achieving PASI 75 Response at Week 30 Baseline (Day 1) and Week 30 A PASI 75 response is a 75% or greater improvement (reduction) from baseline in PASI score. The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis.
Number of Participants Achieving PASI 90 Response at Week 30 Baseline (Day 1) and Week 30 A PASI 90 response is a 90% or greater improvement (reduction) from baseline in PASI score. The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis.
Number of Participants Achieving PASI 100 Response at Week 30 Baseline (Day 1) and Week 30 A PASI 100 response is a 100% or greater improvement (reduction) from baseline in PASI score. The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis.
Number of Participants Experiencing Treatment-emergent Adverse Events (TEAE) Baseline up to Week 32 TEAEs are any event that occurred after the participant received study treatment. Any clinically significant changes in vital signs, electrocardiograms, and clinical laboratory tests that occurred after study treatment administration were recorded as TEAEs.
A serious TEAE is any untoward medical occurrence in a clinical study participant after first dose irrespective of a causal relationship with the study treatment(s) that resulted in death, was immediately life threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, a congenital anomaly/birth defect, or another medically important serious event.Number of Participants Experiencing Events of Interest (EOI) Baseline up to Week 32 An EOI is defined as a noteworthy event for a particular product or class of products that a sponsor may wish to monitor carefully. It could be serious or non-serious and could include events that might be potential precursors or prodromes for more serious medical conditions in susceptible individuals.
Number of Participants With Anti-drug Antibodies (ADA) Expression Post Randomization Week 16, Week 20, Week 28, Week 30, and Week 32 Anti-drug antibody samples were drawn prior to investigational product administration at dosing visits.
Trial Locations
- Locations (88)
Johnson Dermatology Clinic
🇺🇸Fort Smith, Arkansas, United States
First OC Dermatology
🇺🇸Fountain Valley, California, United States
Clinical Science Institute
🇺🇸Santa Monica, California, United States
Toronto Research Centre - Dermatology
🇨🇦Toronto, Ontario, Canada
International Dermatology Research, Inc
🇺🇸Miami, Florida, United States
Center for Clinical Studies, LTD.LLP
🇺🇸Houston, Texas, United States
Marietta dermatology skin care
🇺🇸Marietta, Georgia, United States
UKSH Campus Kiel - ZeH (Dermatologie)
🇩🇪Kiel, Schleswig-Holstein, Germany
Klinische Forschung Gruppe Nord (KFGN)
🇩🇪Schwerin, Mecklenburg-Vorpommern, Germany
North Estonia Medical Centre
🇪🇪Tallinn, Harjumaa, Estonia
Smite Aija doctor practice in dermatology, venereology
🇱🇻Talsi, Latvia
Derma-Study-Center-FN
🇩🇪Friedrichshafen, Baden-Württemberg, Germany
Health and Aesthetics Ltd
🇱🇻Riga, Latvia
Tartu University Hospital
🇪🇪Tartu, Tartumaa, Estonia
J.Kisis LtD
🇱🇻Riga, Rga, Latvia
Total Skin and Beauty Dermatology Center PC
🇺🇸Birmingham, Alabama, United States
Dermatology Clinical Research Center of San Antonio
🇺🇸San Antonio, Texas, United States
Henry Ford Health System - New Center One
🇺🇸Detroit, Michigan, United States
Progressive Clinical Research [Texas]
🇺🇸San Antonio, Texas, United States
North Bay Dermatology Centre Inc.
🇨🇦North Bay, Ontario, Canada
Minnesota Clinical Study Center
🇺🇸New Brighton, Minnesota, United States
Dermatology Research Associates
🇺🇸Los Angeles, California, United States
NorthShore University HealthSystem Dermatology
🇺🇸Skokie, Illinois, United States
Lawrence J Green, MD, LLC
🇺🇸Rockville, Maryland, United States
ALLCUTIS Research, LLC.
🇺🇸Beverly, Massachusetts, 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
International Clinical Research - Tennessee LLC
🇺🇸Murfreesboro, Tennessee, United States
Cutis Wellness Dermatology & Dermapathology, PLLC
🇺🇸Laredo, Texas, United States
Beacon Dermatology
🇨🇦Calgary, Alberta, Canada
Dr. Chih-ho Hong Medical Inc.
🇨🇦Surrey, British Columbia, Canada
DermEdge Research Inc.
🇨🇦Mississauga, Ontario, Canada
The Centre for Dermatology
🇨🇦Richmond Hill, Ontario, Canada
Dre Angélique Gagné-Henley MD inc
🇨🇦Saint-Jerome, Quebec, Canada
Clinical Research Center
🇪🇪Tartu, Tartumaa, Estonia
Revival Research
🇺🇸Doral, Florida, United States
Altus Research, Inc.
🇺🇸Lake Worth, Florida, United States
Hautzentrum im Jahrhunderthaus
🇩🇪Bochum, Nordrhein-Westfalen, Germany
Austin Institute for Clinical Research - Dermatology
🇺🇸Houston, Texas, United States
Deaconess Clinic Downtown
🇺🇸Evansville, Indiana, United States
Unison Clinical Trials
🇺🇸Sherman Oaks, California, United States
Skin Search of Rochester, Inc.
🇺🇸Rochester, New York, United States
Tory Sullivan MD PA
🇺🇸North Miami Beach, Florida, United States
Georgia Skin and Cancer Clinic - Clinic
🇺🇸Savannah, Georgia, United States
Bellaire Dermatology Associates (BDA)
🇺🇸Bellaire, Texas, United States
Oregon Dermatology and Research Center
🇺🇸Portland, Oregon, United States
Health Centre 4 Ltd., Diagnostics Centre
🇱🇻Riga, Rga, Latvia
Metro Boston Clinical Partners
🇺🇸Brighton, Massachusetts, United States
Vivida Dermatology
🇺🇸Las Vegas, Nevada, United States
University of Pittsburgh Medical Center/Falk Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States
Kingsway Clinical Research
🇨🇦Etobicoke, Ontario, Canada
Clinical Research Center of the Carolinas
🇺🇸Charleston, South Carolina, United States
Rothhaar Studien GmbH
🇩🇪Berlin, Germany
CCA Medical Research
🇨🇦Ajax, Ontario, Canada
SKiN Centre for Dermatology
🇨🇦Peterborough, Ontario, Canada
SimcoDerm Medical & Surgical Dermatology Center
🇨🇦Barrie, Ontario, Canada
DermEffects
🇨🇦London, Ontario, Canada
Guelph Dermatology Research
🇨🇦Guelph, Ontario, Canada
TFS Trial Form Support GmbH
🇩🇪Hamburg, Germany
The Centre for Clinical Trials Inc.
🇨🇦Oakville, Ontario, Canada
XLR8 Medical Research Inc.
🇨🇦Windsor, Ontario, Canada
Klinische Forschung Dresden GmbH
🇩🇪Dresden, Sachsen, Germany
ClinicMed Daniluk, Nowak Sp. J.
🇵🇱Bialystok, Podlaskie, Poland
Riga 1st hospital, Clinic of Dermatology and STD
🇱🇻Riga, Rga, Latvia
Royalderm Agnieszka Nawrocka
🇵🇱Warszawa, Mazowieckie, Poland
High-Med Przychodnia Specjalistyczna
🇵🇱Warszawa, Mazowieckie, Poland
Centrum Badan Klinicznych PI-House Sp. z o.o.
🇵🇱Gdansk, Pomorskie, Poland
Care Clinic SP. Z O.O.
🇵🇱Katowice, Poland
Centrum Nowoczesnych Terapii "Dobry Lekarz" Sp. z o.o.
🇵🇱Krakow, Poland
Centrum Medyczne Angelius Provita
🇵🇱Katowice, Poland
ETG Lublin
🇵🇱Lublin, Poland
Dermedic Jacek Zdybski
🇵🇱Ostrowiec Swietokrzyski, Poland
Solumed Centrum Medyczne
🇵🇱Poznan, Poland
Clinical Research Center Sp. z o.o., Medic-R Sp. K.
🇵🇱Poznan, Poland
RCMed Oddzia Warszawa
🇵🇱Warszawa, Poland
Carpe Diem Centrum Medycyny Estetycznej
🇵🇱Warszawa, Poland
Poradnia Dermatologiczno-Wenerologiczna MEDIDERM NZOZ
🇵🇱Torun, Poland
Centrum Medyczne Oporow
🇵🇱Wroclaw, Poland
WroMedica I. Bielicka, A. Strzalkowska s.c.
🇵🇱Wroclaw, Poland
Ginemedica Sp. z o.o. Sp.k
🇵🇱Wroclaw, Poland
David Fivenson, MD, PLC
🇺🇸Ann Arbor, Michigan, United States
Agnieszka Miasik-Pogodzinska DrDerm Centrum Medyczne
🇵🇱Nowy Targ, Poland
Pratia MCM Krakow
🇵🇱Krakow, Poland
NZOZ ALL-MED Centrum Medyczne
🇵🇱Lodz, Poland
Centrum Terapii Wspolczesnej, J.M. Jasnorzewska S.K.A.
🇵🇱Lodz, Poland
Klinika Ambroziak Dermatologia
🇵🇱Warszawa, Poland
Centrum Zdrowia i Urody Maxxmed
🇵🇱Lublin, Poland