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

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 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.

Study Overview

• Status: Completed
• Conditions: Plaque Psoriasis
• Intervention / Treatment: Drug: Adalimumab; Drug: ABP 501

• Study Type: Interventional
• Enrollment (Actual): 425
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T3E 0B2
      • Beacon Dermatology
  • British Columbia
    • Surrey, British Columbia, Canada, V3R 6A7
      • Dr. Chih-ho Hong Medical Inc.
  • Ontario
    • Ajax, Ontario, Canada, L1S 7K8
      • CCA Medical Research
    • Barrie, Ontario, Canada, L4M 7G1
      • SimcoDerm Medical & Surgical Dermatology Center
    • Etobicoke, Ontario, Canada, M8X 1Y9
      • Kingsway Clinical Research
    • Guelph, Ontario, Canada, N1L 0B7
      • Guelph Dermatology Research
    • London, Ontario, Canada, N6H 5L5
      • DermEffects
    • Mississauga, Ontario, Canada, L4Y 4C5
      • DermEdge Research Inc.
    • North Bay, Ontario, Canada, P1B 3Z7
      • North Bay Dermatology Centre Inc.
    • Oakville, Ontario, Canada, L6J 7W5
      • The Centre for Clinical Trials Inc.
    • Peterborough, Ontario, Canada, K9J 5K2
      • Skin Centre for Dermatology
    • Richmond Hill, Ontario, Canada, L4B 1A5
      • The Centre For Dermatology
    • Toronto, Ontario, Canada, M3H 5Y8
      • Toronto Research Centre - Dermatology
    • Windsor, Ontario, Canada, N8W 1E6
      • XLR8 Medical Research Inc.
  • Quebec
    • Saint-Jerome, Quebec, Canada, J7Z 7E2
      • Dre Angélique Gagné-Henley MD inc
• Estonia
  • Harjumaa
    • Tallinn, Harjumaa, Estonia, 13419
      • North Estonia Medical Centre
  • Tartumaa
    • Tartu, Tartumaa, Estonia, 50106
      • Clinical Research Center
    • Tartu, Tartumaa, Estonia, 50417
      • Tartu University Hospital
• Germany
  • Berlin, Germany, 10783
    • Rothhaar Studien GmbH
  • Hamburg, Germany, 20537
    • TFS Trial Form Support GmbH
  • Baden-Württemberg
    • Friedrichshafen, Baden-Württemberg, Germany, 88045
      • Derma-Study-Center-FN
  • Mecklenburg-Vorpommern
    • Schwerin, Mecklenburg-Vorpommern, Germany, 19055
      • Klinische Forschung Gruppe Nord (KFGN)
  • Nordrhein-Westfalen
    • Bochum, Nordrhein-Westfalen, Germany, 44793
      • Hautzentrum im Jahrhunderthaus
  • Sachsen
    • Dresden, Sachsen, Germany, 01069
      • Klinische Forschung Dresden Gmbh
  • Schleswig-Holstein
    • Kiel, Schleswig-Holstein, Germany, 24105
      • UKSH Campus Kiel - ZeH (Dermatologie)
• Latvia
  • Riga, Latvia, LV-1009
    • Health and Aesthetics Ltd
  • Talsi, Latvia, LV3201
    • Smite Aija doctor practice in dermatology, venereology
  • Rga
    • Riga, Rga, Latvia, LV1001
      • Riga 1st Hospital, Clinic of Dermatology and STD
    • Riga, Rga, Latvia, LV1003
      • J.Kisis LtD
    • Riga, Rga, Latvia, LV-1003
      • Health Centre 4 Ltd., Diagnostics Centre
• Poland
  • Katowice, Poland, 40-611
    • Centrum Medyczne Angelius Provita
  • Katowice, Poland, 40-568
    • Care Clinic Sp. Z O.O.
  • Krakow, Poland, 30-510
    • PRATIA MCM Kraków
  • Krakow, Poland, 31-011
    • Centrum Nowoczesnych Terapii "Dobry Lekarz" Sp. z o.o.
  • Lodz, Poland, 90-048
    • NZOZ All-Med Centrum Medyczne
  • Lodz, Poland, 90-242
    • Centrum Terapii Wspolczesnej, J.M. Jasnorzewska S.K.A.
  • Lublin, Poland, 20-412
    • ETG Lublin
  • Lublin, Poland, 20-080
    • Centrum Zdrowia i Urody Maxxmed
  • Nowy Targ, Poland, 34-400
    • Agnieszka Miasik-Pogodzinska DrDerm Centrum Medyczne
  • Ostrowiec Swietokrzyski, Poland, 27-400
    • Dermedic Jacek Zdybski
  • Poznan, Poland, 60-529
    • SOLUMED Centrum Medyczne
  • Poznan, Poland, 61-731
    • Clinical Research Center Sp. z o.o., Medic-R Sp. K.
  • Torun, Poland, 87-100
    • Poradnia Dermatologiczno-Wenerologiczna MEDIDERM NZOZ
  • Warszawa, Poland, 00-892
    • RCMed Oddzia Warszawa
  • Warszawa, Poland, 02-661
    • Carpe Diem Centrum Medycyny Estetycznej
  • Warszawa, Poland, 02-953
    • Klinika Ambroziak Dermatologia
  • Wroclaw, Poland, 52-416
    • Centrum Medyczne Oporów
  • Wroclaw, Poland, 51-685
    • WroMedica I. Bielicka, A. Strzalkowska s.c.
  • Wroclaw, Poland, 50-414
    • Ginemedica Sp. z o.o. Sp.k
  • Mazowieckie
    • Warszawa, Mazowieckie, Poland, 02-962
      • Royalderm Agnieszka Nawrocka
    • Warszawa, Mazowieckie, Poland, 01-817
      • High-Med Przychodnia Specjalistyczna
  • Podlaskie
    • Bialystok, Podlaskie, Poland, 15-879
      • ClinicMed Daniluk, Nowak Sp. J.
  • Pomorskie
    • Gdansk, Pomorskie, Poland, 80-546
      • Centrum Badan Klinicznych PI-House sp. z o.o.
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35205
      • Total Skin and Beauty Dermatology Center PC
  • Arkansas
    • Fort Smith, Arkansas, United States, 72916
      • Johnson Dermatology Clinic
  • California
    • Fountain Valley, California, United States, 92708
      • First OC Dermatology
    • Los Angeles, California, United States, 90045
      • Dermatology Research Associates
    • Santa Monica, California, United States, 90404
      • Clinical Science Institute
    • Sherman Oaks, California, United States, 91403
      • Unison Clinical Trials
  • Florida
    • Doral, Florida, United States, 33122
      • Revival Research
    • Lake Worth, Florida, United States, 33461
      • Altus Research, Inc.
    • Miami, Florida, United States, 33144
      • International Dermatology Research, INC
    • North Miami Beach, Florida, United States, 33162-4708
      • Tory Sullivan MD PA
  • Georgia
    • Marietta, Georgia, United States, 30060
      • Marietta dermatology skin care
    • Savannah, Georgia, United States, 31419
      • Georgia Skin and Cancer Clinic - Clinic
  • Illinois
    • Skokie, Illinois, United States, 60077
      • NorthShore University HealthSystem Dermatology
  • Indiana
    • Evansville, Indiana, United States, 47708
      • Deaconess Clinic Downtown
  • Maryland
    • Rockville, Maryland, United States, 20850
      • Lawrence J Green, MD, LLC
  • Massachusetts
    • Beverly, Massachusetts, United States, 01915
      • ALLCUTIS Research, LLC.
    • Brighton, Massachusetts, United States, 02135
      • Metro Boston Clinical Partners
  • Michigan
    • Ann Arbor, Michigan, United States, 48103
      • David Fivenson, MD, PLC
    • Detroit, Michigan, United States, 48202
      • Henry Ford Health System - New Center One
  • Minnesota
    • New Brighton, Minnesota, United States, 55112
      • Minnesota Clinical Study Center
  • Nevada
    • Las Vegas, Nevada, United States, 89119
      • Vivida Dermatology
  • New York
    • Rochester, New York, United States, 14623
      • Skin Search of Rochester, Inc.
  • North Carolina
    • Wilmington, North Carolina, United States, 28405
      • Wilmington Dermatology Center
  • Ohio
    • Fairborn, Ohio, United States, 45324
      • Wright State Physicians, Inc
    • Mason, Ohio, United States, 45040
      • Dermatologists of Southwest Ohio
  • Oregon
    • Portland, Oregon, United States, 97210
      • Oregon Dermatology and Research Center
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh Medical Center/Falk Medical Center
  • South Carolina
    • Charleston, South Carolina, United States, 29407
      • Clinical Research Center of the Carolinas
  • Tennessee
    • Murfreesboro, Tennessee, United States, 37130
      • International Clinical Research - Tennessee LLC
  • Texas
    • Bellaire, Texas, United States, 77401-3505
      • Bellaire Dermatology Associates (BDA)
    • Houston, Texas, United States, 77056
      • Austin Institute for Clinical Research - Dermatology
    • Houston, Texas, United States, 77004
      • Center for Clinical Studies, LTD.LLP
    • Laredo, Texas, United States, 78041
      • Cutis Wellness Dermatology & Dermapathology, PLLC
    • San Antonio, Texas, United States, 78229
      • Dermatology Clinical Research Center of San Antonio
    • San Antonio, Texas, United States, 78213
      • Progressive Clinical Research [Texas]

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Continued-use Group (Adalimumab); Randomized participants will receive continuous injection of adalimumab Q2W until last dose at Week 28.	Drug: Adalimumab; Participants will receive subcutaneous (SC) injection of adalimumab; Other Names: Humira®
Experimental: 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.	Drug: Adalimumab; Participants will receive subcutaneous (SC) injection of adalimumab; Other Names: Humira®; Drug: ABP 501; Participants will receive SC injection of ABP 501

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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	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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Amgen
• Investigators: Study Director: MD, Amgen

Publications and helpful links

Helpful Links

• AmgenTrials clinical trials website

Study record dates

Study Major Dates

• Study Start (Actual): October 4, 2021
• Primary Completion (Actual): December 19, 2022
• Study Completion (Actual): December 19, 2022

Study Registration Dates

• First Submitted: September 29, 2021
• First Submitted That Met QC Criteria: September 29, 2021
• First Posted (Actual): October 11, 2021

Study Record Updates

• Last Update Posted (Estimated): February 9, 2024
• Last Update Submitted That Met QC Criteria: February 7, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Adalimumab; Biosimilars; Psoriasis Area and Severity Index; Tumor necrosis factor
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Anti-Inflammatory Agents; Antirheumatic Agents; Tumor Necrosis Factor Inhibitors; Adalimumab
• Other Study ID Numbers: 20200497; 2021-000542-18 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
• IPD Sharing Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
• IPD Sharing Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No