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Plaque PsoriasisPhase 3NCT05073315

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

A Phase 3 study testing Adalimumab and ABP 501 in people with Plaque Psoriasis, run by Amgen at 88 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Plaque Psoriasis
What is being tested?
Adalimumab and ABP 501
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
425 participants
Where
88 sitesin 6 countries
Study dates
4 Oct 2021to 19 Dec 2022
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

88 sites in 6 countries.

88 sites in 6 countries

United States35 sites

  • David Fivenson, MD, PLC

    Ann Arbor, Michigan, 48103

  • Bellaire Dermatology Associates (BDA)

    Bellaire, Texas, 77401-3505

  • ALLCUTIS Research, LLC.

    Beverly, Massachusetts, 01915

  • Total Skin and Beauty Dermatology Center PC

    Birmingham, Alabama, 35205

  • Metro Boston Clinical Partners

    Brighton, Massachusetts, 02135

  • Clinical Research Center of the Carolinas

    Charleston, South Carolina, 29407

  • Henry Ford Health System - New Center One

    Detroit, Michigan, 48202

  • Revival Research

    Doral, Florida, 33122

  • Deaconess Clinic Downtown

    Evansville, Indiana, 47708

  • Wright State Physicians, Inc

    Fairborn, Ohio, 45324

  • Johnson Dermatology Clinic

    Fort Smith, Arkansas, 72916

  • First OC Dermatology

    Fountain Valley, California, 92708

  • Center for Clinical Studies, LTD.LLP

    Houston, Texas, 77004

  • Austin Institute for Clinical Research - Dermatology

    Houston, Texas, 77056

  • Altus Research, Inc.

    Lake Worth, Florida, 33461

  • Cutis Wellness Dermatology & Dermapathology, PLLC

    Laredo, Texas, 78041

  • Vivida Dermatology

    Las Vegas, Nevada, 89119

  • Dermatology Research Associates

    Los Angeles, California, 90045

  • Marietta dermatology skin care

    Marietta, Georgia, 30060

  • Dermatologists of Southwest Ohio

    Mason, Ohio, 45040

  • International Dermatology Research, Inc

    Miami, Florida, 33144

  • International Clinical Research - Tennessee LLC

    Murfreesboro, Tennessee, 37130

  • Minnesota Clinical Study Center

    New Brighton, Minnesota, 55112

  • Tory Sullivan MD PA

    North Miami Beach, Florida, 33162-4708

  • University of Pittsburgh Medical Center/Falk Medical Center

    Pittsburgh, Pennsylvania, 15213

  • Oregon Dermatology and Research Center

    Portland, Oregon, 97210

  • Skin Search of Rochester, Inc.

    Rochester, New York, 14623

  • Lawrence J Green, MD, LLC

    Rockville, Maryland, 20850

  • Progressive Clinical Research [Texas]

    San Antonio, Texas, 78213

  • Dermatology Clinical Research Center of San Antonio

    San Antonio, Texas, 78229

  • Clinical Science Institute

    Santa Monica, California, 90404

  • Georgia Skin and Cancer Clinic - Clinic

    Savannah, Georgia, 31419

  • Unison Clinical Trials

    Sherman Oaks, California, 91403

  • NorthShore University HealthSystem Dermatology

    Skokie, Illinois, 60077

  • Wilmington Dermatology Center

    Wilmington, North Carolina, 28405

Other trials in United States

Poland23 sites

  • ClinicMed Daniluk, Nowak Sp. J.

    Bialystok, Podlaskie Voivodeship, 15-879

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

    Gdansk, Pomeranian Voivodeship, 80-546

  • Care Clinic SP. Z O.O.

    Katowice, 40-568

  • Centrum Medyczne Angelius Provita

    Katowice, 40-611

  • Pratia MCM Krakow

    Krakow, 30-510

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

    Krakow, 31-011

  • NZOZ ALL-MED Centrum Medyczne

    Lodz, 90-048

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

    Lodz, 90-242

  • Centrum Zdrowia i Urody Maxxmed

    Lublin, 20-080

  • ETG Lublin

    Lublin, 20-412

  • Agnieszka Miasik-Pogodzinska DrDerm Centrum Medyczne

    Nowy Targ, 34-400

  • Dermedic Jacek Zdybski

    Ostrowiec Świętokrzyski, 27-400

  • Solumed Centrum Medyczne

    Poznan, 60-529

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

    Poznan, 61-731

  • Poradnia Dermatologiczno-Wenerologiczna MEDIDERM NZOZ

    Torun, 87-100

  • High-Med Przychodnia Specjalistyczna

    Warsaw, Masovian Voivodeship, 01-817

  • Royalderm Agnieszka Nawrocka

    Warsaw, Masovian Voivodeship, 02-962

  • RCMed Oddzia Warszawa

    Warsaw, 00-892

  • Carpe Diem Centrum Medycyny Estetycznej

    Warsaw, 02-661

  • Klinika Ambroziak Dermatologia

    Warsaw, 02-953

  • Ginemedica Sp. z o.o. Sp.k

    Wroclaw, 50-414

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

    Wroclaw, 51-685

  • Centrum Medyczne Oporow

    Wroclaw, 52-416

Other trials in Poland

Canada15 sites

  • CCA Medical Research

    Ajax, Ontario, L1S 7K8

  • SimcoDerm Medical & Surgical Dermatology Center

    Barrie, Ontario, L4M 7G1

  • Beacon Dermatology

    Calgary, Alberta, T3E 0B2

  • Kingsway Clinical Research

    Etobicoke, Ontario, M8X 1Y9

  • Guelph Dermatology Research

    Guelph, Ontario, N1L 0B7

  • DermEffects

    London, Ontario, N6H 5L5

  • DermEdge Research Inc.

    Mississauga, Ontario, L4Y 4C5

  • North Bay Dermatology Centre Inc.

    North Bay, Ontario, P1B 3Z7

  • The Centre for Clinical Trials Inc.

    Oakville, Ontario, L6J 7W5

  • SKiN Centre for Dermatology

    Peterborough, Ontario, K9J 5K2

  • The Centre for Dermatology

    Richmond Hill, Ontario, L4B 1A5

  • Dre Angélique Gagné-Henley MD inc

    Saint-Jérôme, Quebec, J7Z 7E2

  • Dr. Chih-ho Hong Medical Inc.

    Surrey, British Columbia, V3R 6A7

  • Toronto Research Centre - Dermatology

    Toronto, Ontario, M3H 5Y8

  • XLR8 Medical Research Inc.

    Windsor, Ontario, N8W 1E6

Other trials in Canada

Germany7 sites

  • Rothhaar Studien GmbH

    Berlin, 10783

  • Hautzentrum im Jahrhunderthaus

    Bochum, North Rhine-Westphalia, 44793

  • Klinische Forschung Dresden GmbH

    Dresden, Saxony, 01069

  • Derma-Study-Center-FN

    Friedrichshafen, Baden-Wurttemberg, 88045

  • TFS Trial Form Support GmbH

    Hamburg, 20537

  • UKSH Campus Kiel - ZeH (Dermatologie)

    Kiel, Schleswig-Holstein, 24105

  • Klinische Forschung Gruppe Nord (KFGN)

    Schwerin, Mecklenburg-Vorpommern, 19055

Other trials in Germany

Latvia5 sites

  • Health Centre 4 Ltd., Diagnostics Centre

    Riga, Rga, LV-1003

  • Riga 1st hospital, Clinic of Dermatology and STD

    Riga, Rga, LV1001

  • J.Kisis LtD

    Riga, Rga, LV1003

  • Health and Aesthetics Ltd

    Riga, LV-1009

  • Smite Aija doctor practice in dermatology, venereology

    Talsi, LV3201

Other trials in Latvia

Estonia3 sites

  • North Estonia Medical Centre

    Tallinn, Harju, 13419

  • Clinical Research Center

    Tartu, Tartu, 50106

  • Tartu University Hospital

    Tartu, Tartu, 50417

Other trials in Estonia

About this study

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

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.

Being tested
Adalimumab, ABP 501
Keywords
Adalimumab, Biosimilars, Tumor necrosis factor, Psoriasis Area and Severity Index

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AdalimumabDrug

    Also called Humira®

    Participants will receive subcutaneous (SC) injection of adalimumab

  • ABP 501Drug

    Participants will receive SC injection of ABP 501

Study groups in NCT05073315
Study groupRoleWhat they receive
Continued-use Group (Adalimumab)Active comparatorRandomized participants will receive continuous injection of adalimumab Q2W until last dose at Week 28.
Receives: Drug: Adalimumab
Switching Group (Adalimumab - ABP 501)ExperimentalParticipants 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.
Receives: Drug: Adalimumab; Drug: ABP 501

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Week 28 pre-dose and 1hour, 1 day, 3 days, 4 days, 7 days, 11 days, and 14 days post Week 28 dose

  2. Maximum Serum Concentration (Cmax) of ABP 501 (Switching Group) and Adalimumab (Continued-use Group)

    Participants analyzed according to treatment received.

    Measured: 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)

  1. Time to Reach Maximum Serum Concentration (Tmax) of ABP 501 (Switching Group) and Adalimumab (Continued-use Group)

    Time to reach maximum serum concentration.

    Measured: 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

  2. Trough Concentration (Ctrough) of ABP 501 (Switching Group) and Adalimumab (Continued-use Group)

    Measured: Pre-dose at Week 12, Week 16, Week 20, and Week 28

  3. 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).

    Measured: Baseline (Day 1) and Week 30

  4. 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.

    Measured: Baseline (Day 1) and Week 30

  5. 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.

    Measured: Baseline (Day 1) and Week 30

  6. 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.

    Measured: Baseline (Day 1) and Week 30

  7. 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.

    Measured: Baseline up to Week 32

  8. 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.

    Measured: Baseline up to Week 32

  9. 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.

    Measured: Week 16, Week 20, Week 28, Week 30, and Week 32

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Oct 2021
  2. Study start4 Oct 2021
  3. Primary completion19 Dec 2022
  4. Study completion19 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
425 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05073315
Sponsor's protocol ID
20200497
Other IDs
2021-000542-18
Status last verified
Feb 2024
First submitted
29 Sep 2021
Last updated
9 Feb 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request

Publications

  • Yamauchi PS, Chow V, Mytych DT, Zhou M, Radziszewski W. Comparative Study Assessing Multiple Switches Between Biosimilar ABP 501 (adalimumab-atto) and Adalimumab Reference Product in Patients with Plaque Psoriasis. Adv Ther. 2026 Jun;43(6):2795-2808. doi: 10.1007/s12325-026-03574-8. Epub 2026 Apr 9.

    PubMed 41954860

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Adalimumab and ABP 501 in people with Plaque Psoriasis, run by Amgen at 88 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 88 sites in United States, Poland, Canada, Germany, Latvia and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Area Under the Curve From Time 0 Over the Dosing Interval (AUCtau) of ABP 501 (Switching Group) and Adalimumab (Continued-use Group) (time frame: Week 28 pre-dose and 1hour, 1 day, 3 days, 4 days, 7 days, 11 days, and 14 days post Week 28 dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05073315, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2024.

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