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

Plaque Psoriasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05073315
• Other study ID #: 20200497
• Secondary ID: 2021-000542-18
• Status: Completed
• Phase: Phase 3
• 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
• 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

Related Conditions & MeSH terms

• Plaque Psoriasis
• Psoriasis

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

External Links

•   AmgenTrials clinical trials website