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

NCT05073315 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: 202004972021-000542-18
• Study Type: interventional
• Target: 425
• Locations: 6 countries
• Sites: 88

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.

Conditions

Plaque Psoriasis

Keywords

Adalimumab; Biosimilars; Tumor necrosis factor; Psoriasis Area and Severity Index

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (9)

• 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

• 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

• Number of Participants Achieving PASI 75 Response at Week 30

  Baseline (Day 1) and Week 30

• Number of Participants Achieving PASI 90 Response at Week 30

  Baseline (Day 1) and Week 30

Study Arms (2)

Continued-use Group (Adalimumab)

ACTIVE COMPARATOR

Randomized participants will receive continuous injection of adalimumab Q2W until last dose at Week 28.

Drug: Adalimumab

Switching Group (Adalimumab - ABP 501)

EXPERIMENTAL

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; Drug: ABP 501

Interventions

Adalimumab DRUG

Participants will receive subcutaneous (SC) injection of adalimumab

Also known as: Humira®

Continued-use Group (Adalimumab); Switching Group (Adalimumab - ABP 501)

ABP 501 DRUG

Participants will receive SC injection of ABP 501

Switching Group (Adalimumab - ABP 501)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Amgen: lead

Study Sites (88)

Total Skin and Beauty Dermatology Center PC

Birmingham, Alabama, 35205, United States

Location

Johnson Dermatology Clinic

Fort Smith, Arkansas, 72916, United States

Location

First OC Dermatology

Fountain Valley, California, 92708, United States

Location

Dermatology Research Associates

Los Angeles, California, 90045, United States

Location

Clinical Science Institute

Santa Monica, California, 90404, United States

Location

Unison Clinical Trials

Sherman Oaks, California, 91403, United States

Location

Revival Research

Doral, Florida, 33122, United States

Location

Altus Research, Inc.

Lake Worth, Florida, 33461, United States

Location

International Dermatology Research, Inc

Miami, Florida, 33144, United States

Location

Tory Sullivan MD PA

North Miami Beach, Florida, 33162-4708, United States

Location

Marietta dermatology skin care

Marietta, Georgia, 30060, United States

Location

Georgia Skin and Cancer Clinic - Clinic

Savannah, Georgia, 31419, United States

Location

NorthShore University HealthSystem Dermatology

Skokie, Illinois, 60077, United States

Location

Deaconess Clinic Downtown

Evansville, Indiana, 47708, United States

Location

Lawrence J Green, MD, LLC

Rockville, Maryland, 20850, United States

Location

ALLCUTIS Research, LLC.

Beverly, Massachusetts, 01915, United States

Location

Metro Boston Clinical Partners

Brighton, Massachusetts, 02135, United States

Location

David Fivenson, MD, PLC

Ann Arbor, Michigan, 48103, United States

Location

Henry Ford Health System - New Center One

Detroit, Michigan, 48202, United States

Location

Minnesota Clinical Study Center

New Brighton, Minnesota, 55112, United States

Location

Vivida Dermatology

Las Vegas, Nevada, 89119, United States

Location

Skin Search of Rochester, Inc.

Rochester, New York, 14623, United States

Location

Wilmington Dermatology Center

Wilmington, North Carolina, 28405, United States

Location

Wright State Physicians, Inc

Fairborn, Ohio, 45324, United States

Location

Dermatologists of Southwest Ohio

Mason, Ohio, 45040, United States

Location

Oregon Dermatology and Research Center

Portland, Oregon, 97210, United States

Location

University of Pittsburgh Medical Center/Falk Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Clinical Research Center of the Carolinas

Charleston, South Carolina, 29407, United States

Location

International Clinical Research - Tennessee LLC

Murfreesboro, Tennessee, 37130, United States

Location

Bellaire Dermatology Associates (BDA)

Bellaire, Texas, 77401-3505, United States

Location

Center for Clinical Studies, LTD.LLP

Houston, Texas, 77004, United States

Location

Austin Institute for Clinical Research - Dermatology

Houston, Texas, 77056, United States

Location

Cutis Wellness Dermatology & Dermapathology, PLLC

Laredo, Texas, 78041, United States

Location

Progressive Clinical Research [Texas]

San Antonio, Texas, 78213, United States

Location

Dermatology Clinical Research Center of San Antonio

San Antonio, Texas, 78229, United States

Location

Beacon Dermatology

Calgary, Alberta, T3E 0B2, Canada

Location

Dr. Chih-ho Hong Medical Inc.

Surrey, British Columbia, V3R 6A7, Canada

Location

CCA Medical Research

Ajax, Ontario, L1S 7K8, Canada

Location

SimcoDerm Medical & Surgical Dermatology Center

Barrie, Ontario, L4M 7G1, Canada

Location

Kingsway Clinical Research

Etobicoke, Ontario, M8X 1Y9, Canada

Location

Guelph Dermatology Research

Guelph, Ontario, N1L 0B7, Canada

Location

DermEffects

London, Ontario, N6H 5L5, Canada

Location

DermEdge Research Inc.

Mississauga, Ontario, L4Y 4C5, Canada

Location

North Bay Dermatology Centre Inc.

North Bay, Ontario, P1B 3Z7, Canada

Location

The Centre for Clinical Trials Inc.

Oakville, Ontario, L6J 7W5, Canada

Location

SKiN Centre for Dermatology

Peterborough, Ontario, K9J 5K2, Canada

Location

The Centre for Dermatology

Richmond Hill, Ontario, L4B 1A5, Canada

Location

Toronto Research Centre - Dermatology

Toronto, Ontario, M3H 5Y8, Canada

Location

XLR8 Medical Research Inc.

Windsor, Ontario, N8W 1E6, Canada

Location

Dre Angélique Gagné-Henley MD inc

Saint-Jérôme, Quebec, J7Z 7E2, Canada

Location

North Estonia Medical Centre

Tallinn, Harju, 13419, Estonia

Location

Clinical Research Center

Tartu, Tartu, 50106, Estonia

Location

Tartu University Hospital

Tartu, Tartu, 50417, Estonia

Location

Derma-Study-Center-FN

Friedrichshafen, Baden-Wurttemberg, 88045, Germany

Location

Klinische Forschung Gruppe Nord (KFGN)

Schwerin, Mecklenburg-Vorpommern, 19055, Germany

Location

Hautzentrum im Jahrhunderthaus

Bochum, North Rhine-Westphalia, 44793, Germany

Location

Klinische Forschung Dresden GmbH

Dresden, Saxony, 01069, Germany

Location

UKSH Campus Kiel - ZeH (Dermatologie)

Kiel, Schleswig-Holstein, 24105, Germany

Location

Rothhaar Studien GmbH

Berlin, 10783, Germany

Location

TFS Trial Form Support GmbH

Hamburg, 20537, Germany

Location

Health Centre 4 Ltd., Diagnostics Centre

Riga, Rga, LV-1003, Latvia

Location

Riga 1st hospital, Clinic of Dermatology and STD

Riga, Rga, LV1001, Latvia

Location

J.Kisis LtD

Riga, Rga, LV1003, Latvia

Location

Health and Aesthetics Ltd

Riga, LV-1009, Latvia

Location

Smite Aija doctor practice in dermatology, venereology

Talsi, LV3201, Latvia

Location

High-Med Przychodnia Specjalistyczna

Warsaw, Masovian Voivodeship, 01-817, Poland

Location

Royalderm Agnieszka Nawrocka

Warsaw, Masovian Voivodeship, 02-962, Poland

Location

ClinicMed Daniluk, Nowak Sp. J.

Bialystok, Podlaskie Voivodeship, 15-879, Poland

Location

Centrum Badan Klinicznych PI-House Sp. z o.o.

Gdansk, Pomeranian Voivodeship, 80-546, Poland

Location

Care Clinic SP. Z O.O.

Katowice, 40-568, Poland

Location

Centrum Medyczne Angelius Provita

Katowice, 40-611, Poland

Location

Pratia MCM Krakow

Krakow, 30-510, Poland

Location

Centrum Nowoczesnych Terapii "Dobry Lekarz" Sp. z o.o.

Krakow, 31-011, Poland

Location

NZOZ ALL-MED Centrum Medyczne

Lodz, 90-048, Poland

Location

Centrum Terapii Wspolczesnej, J.M. Jasnorzewska S.K.A.

Lodz, 90-242, Poland

Location

Centrum Zdrowia i Urody Maxxmed

Lublin, 20-080, Poland

Location

ETG Lublin

Lublin, 20-412, Poland

Location

Agnieszka Miasik-Pogodzinska DrDerm Centrum Medyczne

Nowy Targ, 34-400, Poland

Location

Dermedic Jacek Zdybski

Ostrowiec Świętokrzyski, 27-400, Poland

Location

Solumed Centrum Medyczne

Poznan, 60-529, Poland

Location

Clinical Research Center Sp. z o.o., Medic-R Sp. K.

Poznan, 61-731, Poland

Location

Poradnia Dermatologiczno-Wenerologiczna MEDIDERM NZOZ

Torun, 87-100, Poland

Location

RCMed Oddzia Warszawa

Warsaw, 00-892, Poland

Location

Carpe Diem Centrum Medycyny Estetycznej

Warsaw, 02-661, Poland

Location

Klinika Ambroziak Dermatologia

Warsaw, 02-953, Poland

Location

Ginemedica Sp. z o.o. Sp.k

Wroclaw, 50-414, Poland

Location

WroMedica I. Bielicka, A. Strzalkowska s.c.

Wroclaw, 51-685, Poland

Location

Centrum Medyczne Oporow

Wroclaw, 52-416, Poland

Location

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Interventions

Adalimumab; ABP 501

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Study Director
• Organization: Amgen Inc.

medinfo@amgen.com

866-572-6436

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Study is double-blind.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2021
• First Posted: October 11, 2021
• Study Start: October 4, 2021
• Primary Completion: December 19, 2022
• Study Completion: December 19, 2022
• Last Updated: February 9, 2024
• Results First Posted: February 9, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• 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.
• 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.

Locations

LA (5); PL (23); CA (15); ES (3); DE (7); US (35)