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

Study Purpose

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 Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 75 Years
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05073315
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Amgen
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

MD
Principal Investigator Affiliation Amgen
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Canada, Estonia, Germany, Latvia, Poland, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Plaque Psoriasis
Study Website: View Trial Website
Arms & Interventions

Arms

Active Comparator: Continued-use Group (Adalimumab)

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

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.

Interventions

Drug: - Adalimumab

Participants will receive subcutaneous (SC) injection of adalimumab

Drug: - ABP 501

Participants will receive SC injection of ABP 501

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Birmingham, Alabama

Status

Recruiting

Address

Total Skin and Beauty Dermatology Center PC

Birmingham, Alabama, 35205

Johnson Dermatology Clinic, Fort Smith, Arkansas

Status

Recruiting

Address

Johnson Dermatology Clinic

Fort Smith, Arkansas, 72916

First OC Dermatology, Fountain Valley, California

Status

Recruiting

Address

First OC Dermatology

Fountain Valley, California, 92708

Dermatology Research Associates, Los Angeles, California

Status

Recruiting

Address

Dermatology Research Associates

Los Angeles, California, 90045

Clinical Science Institute, Santa Monica, California

Status

Recruiting

Address

Clinical Science Institute

Santa Monica, California, 90404

Unison Clinical Trials, Sherman Oaks, California

Status

Recruiting

Address

Unison Clinical Trials

Sherman Oaks, California, 91403

Revival Research, Doral, Florida

Status

Recruiting

Address

Revival Research

Doral, Florida, 33122

Altus Research, Inc., Lake Worth, Florida

Status

Recruiting

Address

Altus Research, Inc.

Lake Worth, Florida, 33461

International Dermatology Research, Inc, Miami, Florida

Status

Recruiting

Address

International Dermatology Research, Inc

Miami, Florida, 33144

Tory Sullivan MD PA, North Miami Beach, Florida

Status

Recruiting

Address

Tory Sullivan MD PA

North Miami Beach, Florida, 33162-4708

Renstar Medical Research, Ocala, Florida

Status

Recruiting

Address

Renstar Medical Research

Ocala, Florida, 34470

Marietta dermatology skin care, Marietta, Georgia

Status

Recruiting

Address

Marietta dermatology skin care

Marietta, Georgia, 30060

Georgia Skin and Cancer Clinic - Clinic, Savannah, Georgia

Status

Recruiting

Address

Georgia Skin and Cancer Clinic - Clinic

Savannah, Georgia, 31419

Skokie, Illinois

Status

Recruiting

Address

NorthShore University HealthSystem Dermatology

Skokie, Illinois, 60077

Deaconess Clinic Downtown, Evansville, Indiana

Status

Recruiting

Address

Deaconess Clinic Downtown

Evansville, Indiana, 47708

Lawrence J Green, MD, LLC, Rockville, Maryland

Status

Recruiting

Address

Lawrence J Green, MD, LLC

Rockville, Maryland, 20850

ALLCUTIS Research, LLC., Beverly, Massachusetts

Status

Recruiting

Address

ALLCUTIS Research, LLC.

Beverly, Massachusetts, 01915

Metro Boston Clinical Partners, Brighton, Massachusetts

Status

Recruiting

Address

Metro Boston Clinical Partners

Brighton, Massachusetts, 02135

David Fivenson, MD, PLC, Ann Arbor, Michigan

Status

Recruiting

Address

David Fivenson, MD, PLC

Ann Arbor, Michigan, 48103

Detroit, Michigan

Status

Recruiting

Address

Henry Ford Health System - New Center One

Detroit, Michigan, 48202

Minnesota Clinical Study Center, New Brighton, Minnesota

Status

Recruiting

Address

Minnesota Clinical Study Center

New Brighton, Minnesota, 55112

Vivida Dermatology, Las Vegas, Nevada

Status

Recruiting

Address

Vivida Dermatology

Las Vegas, Nevada, 89119

JUVA Skin and Laser Center, New York, New York

Status

Recruiting

Address

JUVA Skin and Laser Center

New York, New York, 10022-3350

Skin Search of Rochester, Inc., Rochester, New York

Status

Recruiting

Address

Skin Search of Rochester, Inc.

Rochester, New York, 14623

Dermatology Consulting Services, PLLC, High Point, North Carolina

Status

Recruiting

Address

Dermatology Consulting Services, PLLC

High Point, North Carolina, 27262

Wilmington Dermatology Center, Wilmington, North Carolina

Status

Recruiting

Address

Wilmington Dermatology Center

Wilmington, North Carolina, 28405

Wright State Physicians, Inc, Fairborn, Ohio

Status

Recruiting

Address

Wright State Physicians, Inc

Fairborn, Ohio, 45324

Dermatologists of Southwest Ohio, Mason, Ohio

Status

Recruiting

Address

Dermatologists of Southwest Ohio

Mason, Ohio, 45040

Central Sooner Research, Norman, Oklahoma

Status

Recruiting

Address

Central Sooner Research

Norman, Oklahoma, 73071

Oregon Dermatology and Research Center, Portland, Oregon

Status

Recruiting

Address

Oregon Dermatology and Research Center

Portland, Oregon, 97210

Paddington Testing Co. Inc, Philadelphia, Pennsylvania

Status

Recruiting

Address

Paddington Testing Co. Inc

Philadelphia, Pennsylvania, 19103

Pittsburgh, Pennsylvania

Status

Recruiting

Address

University of Pittsburgh Medical Center/Falk Medical Center

Pittsburgh, Pennsylvania, 15213

Charleston, South Carolina

Status

Recruiting

Address

Clinical Research Center of the Carolinas

Charleston, South Carolina, 29407

Murfreesboro, Tennessee

Status

Recruiting

Address

International Clinical Research - Tennessee LLC

Murfreesboro, Tennessee, 37130

Bellaire Dermatology Associates (BDA), Bellaire, Texas

Status

Recruiting

Address

Bellaire Dermatology Associates (BDA)

Bellaire, Texas, 77401-3505

Center for Clinical Studies, LTD.LLP, Houston, Texas

Status

Recruiting

Address

Center for Clinical Studies, LTD.LLP

Houston, Texas, 77004

Houston, Texas

Status

Recruiting

Address

Austin Institute for Clinical Research - Dermatology

Houston, Texas, 77056

Laredo, Texas

Status

Recruiting

Address

Cutis Wellness Dermatology & Dermapathology, PLLC

Laredo, Texas, 78041

Progressive Clinical Research [Texas], San Antonio, Texas

Status

Recruiting

Address

Progressive Clinical Research [Texas]

San Antonio, Texas, 78213

San Antonio, Texas

Status

Recruiting

Address

Dermatology Clinical Research Center of San Antonio

San Antonio, Texas, 78229

CCT Research at Springville Dermatology, Springville, Utah

Status

Recruiting

Address

CCT Research at Springville Dermatology

Springville, Utah, 84663

International Sites

Beacon Dermatology, Calgary, Alberta, Canada

Status

Recruiting

Address

Beacon Dermatology

Calgary, Alberta, T3E 0B2

Alberta DermaSurgery Centre, Edmonton, Alberta, Canada

Status

Recruiting

Address

Alberta DermaSurgery Centre

Edmonton, Alberta, T6G 1C3

Dr. Chih-ho Hong Medical Inc., Surrey, British Columbia, Canada

Status

Recruiting

Address

Dr. Chih-ho Hong Medical Inc.

Surrey, British Columbia, V3R 6A7

CCA Medical Research, Ajax, Ontario, Canada

Status

Recruiting

Address

CCA Medical Research

Ajax, Ontario, L1S 7K8

Barrie, Ontario, Canada

Status

Recruiting

Address

SimcoDerm Medical & Surgical Dermatology Center

Barrie, Ontario, L4M 7G1

Kingsway Clinical Research, Etobicoke, Ontario, Canada

Status

Recruiting

Address

Kingsway Clinical Research

Etobicoke, Ontario, M8X 1Y9

Guelph Dermatology Research, Guelph, Ontario, Canada

Status

Recruiting

Address

Guelph Dermatology Research

Guelph, Ontario, N1L 0B7

DermEffects, London, Ontario, Canada

Status

Recruiting

Address

DermEffects

London, Ontario, N6H 5L5

DermEdge Research Inc., Mississauga, Ontario, Canada

Status

Recruiting

Address

DermEdge Research Inc.

Mississauga, Ontario, L4Y 4C5

North Bay Dermatology Centre Inc., North Bay, Ontario, Canada

Status

Recruiting

Address

North Bay Dermatology Centre Inc.

North Bay, Ontario, P1B 3Z7

The Centre for Clinical Trials Inc., Oakville, Ontario, Canada

Status

Recruiting

Address

The Centre for Clinical Trials Inc.

Oakville, Ontario, L6J 7W5

SKiN Centre for Dermatology, Peterborough, Ontario, Canada

Status

Recruiting

Address

SKiN Centre for Dermatology

Peterborough, Ontario, K9J 5K2

The Centre for Dermatology, Richmond Hill, Ontario, Canada

Status

Recruiting

Address

The Centre for Dermatology

Richmond Hill, Ontario, L4B 1A5

Toronto Research Centre - Dermatology, Toronto, Ontario, Canada

Status

Recruiting

Address

Toronto Research Centre - Dermatology

Toronto, Ontario, M3H 5Y8

XLR8 Medical Research Inc., Windsor, Ontario, Canada

Status

Recruiting

Address

XLR8 Medical Research Inc.

Windsor, Ontario, N8W 1E6

Dre Angélique Gagné-Henley MD inc, Saint-Jerome, Quebec, Canada

Status

Recruiting

Address

Dre Angélique Gagné-Henley MD inc

Saint-Jerome, Quebec, J7Z 7E2

North Estonia Medical Centre, Tallinn, Harjumaa, Estonia

Status

Recruiting

Address

North Estonia Medical Centre

Tallinn, Harjumaa, 13419

Clinical Research Center, Tartu, Tartumaa, Estonia

Status

Recruiting

Address

Clinical Research Center

Tartu, Tartumaa, 50106

Tartu University Hospital, Tartu, Tartumaa, Estonia

Status

Recruiting

Address

Tartu University Hospital

Tartu, Tartumaa, 50417

Derma-Study-Center-FN, Friedrichshafen, Baden-Württemberg, Germany

Status

Recruiting

Address

Derma-Study-Center-FN

Friedrichshafen, Baden-Württemberg, 88045

Mahlow, Brandenburg, Germany

Status

Recruiting

Address

Dermatologische Gemeinschaftspraxis Dres.Scholz Sebastian Schilling

Mahlow, Brandenburg, 15831

Klinische Forschung Schwerin GmbH, Schwerin, Mecklenburg-Vorpommern, Germany

Status

Recruiting

Address

Klinische Forschung Schwerin GmbH

Schwerin, Mecklenburg-Vorpommern, 19055

Hautzentrum im Jahrhunderthaus, Bochum, Nordrhein-Westfalen, Germany

Status

Recruiting

Address

Hautzentrum im Jahrhunderthaus

Bochum, Nordrhein-Westfalen, 44793

Praxis Dominicus, Duelmen, Nordrhein-Westfalen, Germany

Status

Recruiting

Address

Praxis Dominicus

Duelmen, Nordrhein-Westfalen, 48249

Klinische Forschung Dresden GmbH, Dresden, Sachsen, Germany

Status

Recruiting

Address

Klinische Forschung Dresden GmbH

Dresden, Sachsen, 01069

UK-SH Kiel - ZeH (Dermatologie), Kiel, Schleswig-Holstein, Germany

Status

Recruiting

Address

UK-SH Kiel - ZeH (Dermatologie)

Kiel, Schleswig-Holstein, 24105

Rothhaar Studien GmbH, Berlin, Germany

Status

Recruiting

Address

Rothhaar Studien GmbH

Berlin, , 10783

TFS Trial Form Support GmbH, Hamburg, Germany

Status

Recruiting

Address

TFS Trial Form Support GmbH

Hamburg, , 20537

Health Centre 4 Ltd., Diagnostics Centre, Riga, Rga, Latvia

Status

Recruiting

Address

Health Centre 4 Ltd., Diagnostics Centre

Riga, Rga, LV-1003

Riga, Rga, Latvia

Status

Recruiting

Address

Riga 1st hospital, Clinic of Dermatology and STD

Riga, Rga, LV1001

J.Kisis LtD, Riga, Rga, Latvia

Status

Recruiting

Address

J.Kisis LtD

Riga, Rga, LV1003

Health and Aesthetics Ltd, Riga, Latvia

Status

Recruiting

Address

Health and Aesthetics Ltd

Riga, , LV-1009

Talsi, Latvia

Status

Recruiting

Address

Smite Aija doctor practice in dermatology, venereology

Talsi, , LV3201

High-Med Przychodnia Specjalistyczna, Warszawa, Mazowieckie, Poland

Status

Recruiting

Address

High-Med Przychodnia Specjalistyczna

Warszawa, Mazowieckie, 01-817

Royalderm Agnieszka Nawrocka, Warszawa, Mazowieckie, Poland

Status

Recruiting

Address

Royalderm Agnieszka Nawrocka

Warszawa, Mazowieckie, 02-962

ClinicMed Daniluk, Nowak Sp. J., Bialystok, Podlaskie, Poland

Status

Recruiting

Address

ClinicMed Daniluk, Nowak Sp. J.

Bialystok, Podlaskie, 15-879

Gdansk, Pomorskie, Poland

Status

Recruiting

Address

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

Gdansk, Pomorskie, 80-546

Care Clinic SP. Z O.O., Katowice, Poland

Status

Recruiting

Address

Care Clinic SP. Z O.O.

Katowice, , 40-568

Centrum Medyczne Angelius Provita, Katowice, Poland

Status

Recruiting

Address

Centrum Medyczne Angelius Provita

Katowice, , 40-611

Pratia MCM Krakow, Krakow, Poland

Status

Recruiting

Address

Pratia MCM Krakow

Krakow, , 30-510

Krakow, Poland

Status

Recruiting

Address

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

Krakow, , 31-011

NZOZ ALL-MED Centrum Medyczne, Lodz, Poland

Status

Recruiting

Address

NZOZ ALL-MED Centrum Medyczne

Lodz, , 90-048

Lodz, Poland

Status

Recruiting

Address

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

Lodz, , 90-242

Centrum Zdrowia i Urody Maxxmed, Lublin, Poland

Status

Recruiting

Address

Centrum Zdrowia i Urody Maxxmed

Lublin, , 20-080

ETG Lublin, Lublin, Poland

Status

Recruiting

Address

ETG Lublin

Lublin, , 20-412

Nowy Targ, Poland

Status

Recruiting

Address

Agnieszka Miasik-Pogodzinska DrDerm Centrum Medyczne

Nowy Targ, , 34-400

Dermedic Jacek Zdybski, Ostrowiec Swietokrzyski, Poland

Status

Recruiting

Address

Dermedic Jacek Zdybski

Ostrowiec Swietokrzyski, , 27-400

Solumed, Poznan, Poland

Status

Recruiting

Address

Solumed

Poznan, , 60-529

Poznan, Poland

Status

Recruiting

Address

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

Poznan, , 60-848

Torun, Poland

Status

Recruiting

Address

Poradnia Dermatologiczno-Wenerologiczna MEDIDERM NZOZ

Torun, , 87-100

RCMed Oddzia Warszawa, Warszawa, Poland

Status

Recruiting

Address

RCMed Oddzia Warszawa

Warszawa, , 00-892

Carpe Diem Centrum Medycyny Estetycznej, Warszawa, Poland

Status

Recruiting

Address

Carpe Diem Centrum Medycyny Estetycznej

Warszawa, , 02-661

Klinika Ambroziak Dermatologia, Warszawa, Poland

Status

Recruiting

Address

Klinika Ambroziak Dermatologia

Warszawa, , 02-953

Ginemedica Sp. z o.o. Sp.k, Wroclaw, Poland

Status

Recruiting

Address

Ginemedica Sp. z o.o. Sp.k

Wroclaw, , 50-414

Wroclaw, Poland

Status

Recruiting

Address

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

Wroclaw, , 51-685

Centrum Medyczne Oporow, Wroclaw, Poland

Status

Recruiting

Address

Centrum Medyczne Oporow

Wroclaw, , 52-416

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