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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05073315
Other study ID # 20200497
Secondary ID 2021-000542-18
Status Completed
Phase Phase 3
First received
Last updated
Start date October 4, 2021
Est. completion date December 19, 2022

Study information

Verified date February 2024
Source Amgen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 425
Est. completion date December 19, 2022
Est. primary completion date December 19, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Adalimumab
Participants will receive subcutaneous (SC) injection of adalimumab
ABP 501
Participants will receive SC injection of ABP 501

Locations

Country Name City State
Canada CCA Medical Research Ajax Ontario
Canada SimcoDerm Medical & Surgical Dermatology Center Barrie Ontario
Canada Beacon Dermatology Calgary Alberta
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 Dre Angélique Gagné-Henley MD inc Saint-Jerome Quebec
Canada Dr. Chih-ho Hong Medical Inc. Surrey British Columbia
Canada Toronto Research Centre - Dermatology Toronto Ontario
Canada XLR8 Medical Research Inc. Windsor Ontario
Estonia North Estonia Medical Centre Tallinn Harjumaa
Estonia Clinical Research Center Tartu Tartumaa
Estonia Tartu University Hospital Tartu Tartumaa
Germany Rothhaar Studien GmbH Berlin
Germany Hautzentrum im Jahrhunderthaus Bochum Nordrhein-Westfalen
Germany Klinische Forschung Dresden GmbH Dresden Sachsen
Germany Derma-Study-Center-FN Friedrichshafen Baden-Württemberg
Germany TFS Trial Form Support GmbH Hamburg
Germany UKSH Campus Kiel - ZeH (Dermatologie) Kiel Schleswig-Holstein
Germany Klinische Forschung Gruppe Nord (KFGN) Schwerin Mecklenburg-Vorpommern
Latvia Health and Aesthetics Ltd Riga
Latvia Health Centre 4 Ltd., Diagnostics Centre Riga Rga
Latvia J.Kisis LtD Riga Rga
Latvia Riga 1st hospital, Clinic of Dermatology and STD Riga Rga
Latvia Smite Aija doctor practice in dermatology, venereology Talsi
Poland ClinicMed Daniluk, Nowak Sp. J. Bialystok Podlaskie
Poland Centrum Badan Klinicznych PI-House Sp. z o.o. Gdansk Pomorskie
Poland Care Clinic SP. Z O.O. Katowice
Poland Centrum Medyczne Angelius Provita Katowice
Poland Centrum Nowoczesnych Terapii "Dobry Lekarz" Sp. z o.o. Krakow
Poland Pratia MCM Krakow Krakow
Poland Centrum Terapii Wspolczesnej, J.M. Jasnorzewska S.K.A. Lodz
Poland NZOZ ALL-MED Centrum Medyczne 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 Swietokrzyski
Poland Clinical Research Center Sp. z o.o., Medic-R Sp. K. Poznan
Poland Solumed Centrum Medyczne Poznan
Poland Poradnia Dermatologiczno-Wenerologiczna MEDIDERM NZOZ Torun
Poland Carpe Diem Centrum Medycyny Estetycznej Warszawa
Poland High-Med Przychodnia Specjalistyczna Warszawa Mazowieckie
Poland Klinika Ambroziak Dermatologia Warszawa
Poland RCMed Oddzia Warszawa Warszawa
Poland Royalderm Agnieszka Nawrocka Warszawa Mazowieckie
Poland Centrum Medyczne Oporow Wroclaw
Poland Ginemedica Sp. z o.o. Sp.k Wroclaw
Poland WroMedica I. Bielicka, A. Strzalkowska s.c. Wroclaw
United States David Fivenson, MD, PLC Ann Arbor Michigan
United States Bellaire Dermatology Associates (BDA) Bellaire Texas
United States ALLCUTIS Research, LLC. Beverly Massachusetts
United States Total Skin and Beauty Dermatology Center PC Birmingham Alabama
United States Metro Boston Clinical Partners Brighton Massachusetts
United States Clinical Research Center of the Carolinas Charleston South Carolina
United States Henry Ford Health System - New Center One Detroit Michigan
United States Revival Research Doral Florida
United States Deaconess Clinic Downtown Evansville Indiana
United States Wright State Physicians, Inc Fairborn Ohio
United States Johnson Dermatology Clinic Fort Smith Arkansas
United States First OC Dermatology Fountain Valley California
United States Austin Institute for Clinical Research - Dermatology Houston Texas
United States Center for Clinical Studies, LTD.LLP Houston Texas
United States Altus Research, Inc. Lake Worth Florida
United States Cutis Wellness Dermatology & Dermapathology, PLLC Laredo Texas
United States Vivida Dermatology Las Vegas Nevada
United States Dermatology Research Associates Los Angeles California
United States Marietta dermatology skin care Marietta Georgia
United States Dermatologists of Southwest Ohio Mason Ohio
United States International Dermatology Research, Inc Miami Florida
United States International Clinical Research - Tennessee LLC Murfreesboro Tennessee
United States Minnesota Clinical Study Center New Brighton Minnesota
United States Tory Sullivan MD PA North Miami Beach Florida
United States University of Pittsburgh Medical Center/Falk Medical Center Pittsburgh Pennsylvania
United States Oregon Dermatology and Research Center Portland Oregon
United States Skin Search of Rochester, Inc. Rochester New York
United States Lawrence J Green, MD, LLC Rockville Maryland
United States Dermatology Clinical Research Center of San Antonio San Antonio Texas
United States Progressive Clinical Research [Texas] San Antonio Texas
United States Clinical Science Institute Santa Monica California
United States Georgia Skin and Cancer Clinic - Clinic Savannah Georgia
United States Unison Clinical Trials Sherman Oaks California
United States NorthShore University HealthSystem Dermatology Skokie Illinois
United States Wilmington Dermatology Center Wilmington North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Amgen

Countries where clinical trial is conducted

United States,  Canada,  Estonia,  Germany,  Latvia,  Poland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Area Under the Curve From Time 0 Over the Dosing Interval (AUCtau) of ABP 501 (Switching Group) and Adalimumab (Continued-use Group) Participants analyzed according to actual treatment received. Week 28 pre-dose and 1hour, 1 day, 3 days, 4 days, 7 days, 11 days, and 14 days post Week 28 dose
Primary Maximum Serum Concentration (Cmax) of ABP 501 (Switching Group) and Adalimumab (Continued-use Group) Participants analyzed according to treatment received. 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 Time to Reach Maximum Serum Concentration (Tmax) of ABP 501 (Switching Group) and Adalimumab (Continued-use Group) Time to reach maximum serum concentration. 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 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
Secondary PASI Percent Improvement From Baseline (Day 1) to 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).
Baseline (Day 1) and Week 30
Secondary Number of Participants Achieving PASI 75 Response at 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. Baseline (Day 1) and Week 30
Secondary Number of Participants Achieving PASI 90 Response at 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. Baseline (Day 1) and Week 30
Secondary Number of Participants Achieving PASI 100 Response at 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. Baseline (Day 1) and Week 30
Secondary Number of Participants Experiencing Treatment-emergent Adverse Events (TEAE) 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.
Baseline up to Week 32
Secondary Number of Participants Experiencing Events of Interest (EOI) 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. Baseline up to Week 32
Secondary Number of Participants With Anti-drug Antibodies (ADA) Expression Post Randomization Anti-drug antibody samples were drawn prior to investigational product administration at dosing visits. Week 16, Week 20, Week 28, Week 30, and Week 32
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