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 |
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.
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
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.
Status
Recruiting
Address
Total Skin and Beauty Dermatology Center PC
Birmingham, Alabama, 35205
Status
Recruiting
Address
Johnson Dermatology Clinic
Fort Smith, Arkansas, 72916
Status
Recruiting
Address
First OC Dermatology
Fountain Valley, California, 92708
Status
Recruiting
Address
Dermatology Research Associates
Los Angeles, California, 90045
Status
Recruiting
Address
Clinical Science Institute
Santa Monica, California, 90404
Status
Recruiting
Address
Unison Clinical Trials
Sherman Oaks, California, 91403
Status
Recruiting
Address
Revival Research
Doral, Florida, 33122
Status
Recruiting
Address
Altus Research, Inc.
Lake Worth, Florida, 33461
Status
Recruiting
Address
International Dermatology Research, Inc
Miami, Florida, 33144
Status
Recruiting
Address
Tory Sullivan MD PA
North Miami Beach, Florida, 33162-4708
Status
Recruiting
Address
Renstar Medical Research
Ocala, Florida, 34470
Status
Recruiting
Address
Marietta dermatology skin care
Marietta, Georgia, 30060
Status
Recruiting
Address
Georgia Skin and Cancer Clinic - Clinic
Savannah, Georgia, 31419
Status
Recruiting
Address
NorthShore University HealthSystem Dermatology
Skokie, Illinois, 60077
Status
Recruiting
Address
Deaconess Clinic Downtown
Evansville, Indiana, 47708
Status
Recruiting
Address
Lawrence J Green, MD, LLC
Rockville, Maryland, 20850
Status
Recruiting
Address
ALLCUTIS Research, LLC.
Beverly, Massachusetts, 01915
Status
Recruiting
Address
Metro Boston Clinical Partners
Brighton, Massachusetts, 02135
Status
Recruiting
Address
David Fivenson, MD, PLC
Ann Arbor, Michigan, 48103
Status
Recruiting
Address
Henry Ford Health System - New Center One
Detroit, Michigan, 48202
Status
Recruiting
Address
Minnesota Clinical Study Center
New Brighton, Minnesota, 55112
Status
Recruiting
Address
Vivida Dermatology
Las Vegas, Nevada, 89119
Status
Recruiting
Address
JUVA Skin and Laser Center
New York, New York, 10022-3350
Status
Recruiting
Address
Skin Search of Rochester, Inc.
Rochester, New York, 14623
Status
Recruiting
Address
Dermatology Consulting Services, PLLC
High Point, North Carolina, 27262
Status
Recruiting
Address
Wilmington Dermatology Center
Wilmington, North Carolina, 28405
Status
Recruiting
Address
Wright State Physicians, Inc
Fairborn, Ohio, 45324
Status
Recruiting
Address
Dermatologists of Southwest Ohio
Mason, Ohio, 45040
Status
Recruiting
Address
Central Sooner Research
Norman, Oklahoma, 73071
Status
Recruiting
Address
Oregon Dermatology and Research Center
Portland, Oregon, 97210
Status
Recruiting
Address
Paddington Testing Co. Inc
Philadelphia, Pennsylvania, 19103
Status
Recruiting
Address
University of Pittsburgh Medical Center/Falk Medical Center
Pittsburgh, Pennsylvania, 15213
Status
Recruiting
Address
Clinical Research Center of the Carolinas
Charleston, South Carolina, 29407
Status
Recruiting
Address
International Clinical Research - Tennessee LLC
Murfreesboro, Tennessee, 37130
Status
Recruiting
Address
Bellaire Dermatology Associates (BDA)
Bellaire, Texas, 77401-3505
Status
Recruiting
Address
Center for Clinical Studies, LTD.LLP
Houston, Texas, 77004
Status
Recruiting
Address
Austin Institute for Clinical Research - Dermatology
Houston, Texas, 77056
Status
Recruiting
Address
Cutis Wellness Dermatology & Dermapathology, PLLC
Laredo, Texas, 78041
Status
Recruiting
Address
Progressive Clinical Research [Texas]
San Antonio, Texas, 78213
Status
Recruiting
Address
Dermatology Clinical Research Center of San Antonio
San Antonio, Texas, 78229
Status
Recruiting
Address
CCT Research at Springville Dermatology
Springville, Utah, 84663
International Sites
Status
Recruiting
Address
Beacon Dermatology
Calgary, Alberta, T3E 0B2
Status
Recruiting
Address
Alberta DermaSurgery Centre
Edmonton, Alberta, T6G 1C3
Status
Recruiting
Address
Dr. Chih-ho Hong Medical Inc.
Surrey, British Columbia, V3R 6A7
Status
Recruiting
Address
CCA Medical Research
Ajax, Ontario, L1S 7K8
Status
Recruiting
Address
SimcoDerm Medical & Surgical Dermatology Center
Barrie, Ontario, L4M 7G1
Status
Recruiting
Address
Kingsway Clinical Research
Etobicoke, Ontario, M8X 1Y9
Status
Recruiting
Address
Guelph Dermatology Research
Guelph, Ontario, N1L 0B7
Status
Recruiting
Address
DermEffects
London, Ontario, N6H 5L5
Status
Recruiting
Address
DermEdge Research Inc.
Mississauga, Ontario, L4Y 4C5
Status
Recruiting
Address
North Bay Dermatology Centre Inc.
North Bay, Ontario, P1B 3Z7
Status
Recruiting
Address
The Centre for Clinical Trials Inc.
Oakville, Ontario, L6J 7W5
Status
Recruiting
Address
SKiN Centre for Dermatology
Peterborough, Ontario, K9J 5K2
Status
Recruiting
Address
The Centre for Dermatology
Richmond Hill, Ontario, L4B 1A5
Status
Recruiting
Address
Toronto Research Centre - Dermatology
Toronto, Ontario, M3H 5Y8
Status
Recruiting
Address
XLR8 Medical Research Inc.
Windsor, Ontario, N8W 1E6
Status
Recruiting
Address
Dre Angélique Gagné-Henley MD inc
Saint-Jerome, Quebec, J7Z 7E2
Status
Recruiting
Address
North Estonia Medical Centre
Tallinn, Harjumaa, 13419
Status
Recruiting
Address
Clinical Research Center
Tartu, Tartumaa, 50106
Status
Recruiting
Address
Tartu University Hospital
Tartu, Tartumaa, 50417
Status
Recruiting
Address
Derma-Study-Center-FN
Friedrichshafen, Baden-Württemberg, 88045
Status
Recruiting
Address
Dermatologische Gemeinschaftspraxis Dres.Scholz Sebastian Schilling
Mahlow, Brandenburg, 15831
Status
Recruiting
Address
Klinische Forschung Schwerin GmbH
Schwerin, Mecklenburg-Vorpommern, 19055
Status
Recruiting
Address
Hautzentrum im Jahrhunderthaus
Bochum, Nordrhein-Westfalen, 44793
Status
Recruiting
Address
Praxis Dominicus
Duelmen, Nordrhein-Westfalen, 48249
Status
Recruiting
Address
Klinische Forschung Dresden GmbH
Dresden, Sachsen, 01069
Status
Recruiting
Address
UK-SH Kiel - ZeH (Dermatologie)
Kiel, Schleswig-Holstein, 24105
Status
Recruiting
Address
Rothhaar Studien GmbH
Berlin, , 10783
Status
Recruiting
Address
TFS Trial Form Support GmbH
Hamburg, , 20537
Status
Recruiting
Address
Health Centre 4 Ltd., Diagnostics Centre
Riga, Rga, LV-1003
Status
Recruiting
Address
Riga 1st hospital, Clinic of Dermatology and STD
Riga, Rga, LV1001
Status
Recruiting
Address
Health and Aesthetics Ltd
Riga, , LV-1009
Status
Recruiting
Address
Smite Aija doctor practice in dermatology, venereology
Talsi, , LV3201
Status
Recruiting
Address
High-Med Przychodnia Specjalistyczna
Warszawa, Mazowieckie, 01-817
Status
Recruiting
Address
Royalderm Agnieszka Nawrocka
Warszawa, Mazowieckie, 02-962
Status
Recruiting
Address
ClinicMed Daniluk, Nowak Sp. J.
Bialystok, Podlaskie, 15-879
Status
Recruiting
Address
Centrum Badan Klinicznych PI-House Sp. z o.o.
Gdansk, Pomorskie, 80-546
Status
Recruiting
Address
Care Clinic SP. Z O.O.
Katowice, , 40-568
Status
Recruiting
Address
Centrum Medyczne Angelius Provita
Katowice, , 40-611
Status
Recruiting
Address
Pratia MCM Krakow
Krakow, , 30-510
Status
Recruiting
Address
Centrum Nowoczesnych Terapii "Dobry Lekarz" Sp. z o.o.
Krakow, , 31-011
Status
Recruiting
Address
NZOZ ALL-MED Centrum Medyczne
Lodz, , 90-048
Status
Recruiting
Address
Centrum Terapii Wspolczesnej, J.M. Jasnorzewska S.K.A.
Lodz, , 90-242
Status
Recruiting
Address
Centrum Zdrowia i Urody Maxxmed
Lublin, , 20-080
Status
Recruiting
Address
Agnieszka Miasik-Pogodzinska DrDerm Centrum Medyczne
Nowy Targ, , 34-400
Status
Recruiting
Address
Dermedic Jacek Zdybski
Ostrowiec Swietokrzyski, , 27-400
Status
Recruiting
Address
Clinical Research Center Sp. z o.o., Medic-R Sp. K.
Poznan, , 60-848
Status
Recruiting
Address
Poradnia Dermatologiczno-Wenerologiczna MEDIDERM NZOZ
Torun, , 87-100
Status
Recruiting
Address
RCMed Oddzia Warszawa
Warszawa, , 00-892
Status
Recruiting
Address
Carpe Diem Centrum Medycyny Estetycznej
Warszawa, , 02-661
Status
Recruiting
Address
Klinika Ambroziak Dermatologia
Warszawa, , 02-953
Status
Recruiting
Address
Ginemedica Sp. z o.o. Sp.k
Wroclaw, , 50-414
Status
Recruiting
Address
WroMedica I. Bielicka, A. Strzalkowska s.c.
Wroclaw, , 51-685
Status
Recruiting
Address
Centrum Medyczne Oporow
Wroclaw, , 52-416