Psoriasis Clinical Trial

A Study Comparing Risankizumab to Placebo in Participants With Active Psoriatic Arthritis Including Those Who Have a History of Inadequate Response or Intolerance to Biologic Therapy(Ies)

Summary

The purpose of this study is to evaluate the safety and efficacy of risankizumab in adults with moderately to severely active psoriatic arthritis (PsA).

View Full Description

Full Description

The study consists of a Screening Period (approximately 35 days), Period 1, Period 2, and a 20-week Follow-up Period. Period 1 is a 24-week randomized, double-blind, placebo-controlled, parallel-group period. Period 2 is the long-term period and starts at Week 24. To maintain the blind to the original treatment allocation, treatment at the Week 24 Visit is blinded: participants randomized to placebo receive blinded risankizumab 150 mg, and participants randomized to risankizumab receive blinded placebo. At Week 28 and for the remaining dosing visits (to Week 316), all participants receive open-label risankizumab 150 mg every 12 weeks. Participants remain blinded to the original randomization allocation for the duration of the study. The total study duration is 336 weeks including a telephone call 140 days (20 weeks) after last dose of study drug.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Clinical diagnosis of psoriatic arthritis (PsA) with symptom onset at least 6 months prior to the Screening Visit and fulfillment of the Classification Criteria for PsA (CASPAR) at Screening Visit.
Participant has active disease defined as ≥ 5 tender joints (based on 68 joint counts) and ≥ 5 swollen joints (based on 66 joint counts) at both the Screening Visit and Baseline.
Diagnosis of active plaque psoriasis, with at least one psoriatic plaque of ≥ 2 cm diameter or nail changes consistent with psoriasis at Screening Visit.
Participant has demonstrated an inadequate response or intolerance to biologic therapy(ies) or conventional synthetic disease modifying anti-rheumatic drugs (csDMARD) therapy(ies).

Exclusion Criteria:

Participant is considered by investigator, for any reason, to be an unsuitable candidate for the study.
Participant has a known hypersensitivity to risankizumab.

Study is for people with:

Psoriasis

Phase:

Phase 3

Estimated Enrollment:

444

Study ID:

NCT03671148

Recruitment Status:

Active, not recruiting

Sponsor:

AbbVie

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 135 Locations for this study

See Locations Near You

Pinnacle Research Group /ID# 167953
Anniston Alabama, 36207, United States
St. Jude Heritage /ID# 166842
Fullerton California, 92835, United States
Newport Huntington Medica /ID# 207423
Huntington Beach California, 92648, United States
Arthritis & Osteo Medical Ctr /ID# 166541
La Palma California, 90623, United States
East Bay Rheumatology Medical /ID# 166845
San Leandro California, 94578, United States
Inland Rheum Clin Trials Inc. /ID# 166621
Upland California, 91786, United States
Denver Arthritis Clinic /ID# 166442
Denver Colorado, 80230, United States
New England Research Associates, LLC /ID# 166525
Bridgeport Connecticut, 06606, United States
Yale University /ID# 166330
New Haven Connecticut, 06510, United States
Arthritis & Rheumatic Disease Specialties /ID# 212582
Aventura Florida, 33180, United States
SIMED Health, LLC /ID# 207457
Gainesville Florida, 32607, United States
Sweet Hope Research Specialty Inc /ID# 168163
Hialeah Florida, 33016, United States
Rheum Assoc of Central FL /ID# 201629
Orlando Florida, 32806, United States
HMD Research LLC /ID# 208428
Orlando Florida, 32819, United States
Millennium Research /ID# 201627
Ormond Beach Florida, 32174, United States
Arthritis Center, Inc. /ID# 208116
Palm Harbor Florida, 34684, United States
IRIS Research and Development, LLC /ID# 166351
Plantation Florida, 33324, United States
BayCare Medical Group /ID# 201630
Saint Petersburg Florida, 33705, United States
West Broward Rheumatology Associates /ID# 201234
Tamarac Florida, 33321, United States
University of South Florida /ID# 208467
Tampa Florida, 33612, United States
ForCare Clinical Research /ID# 166375
Tampa Florida, 33613, United States
Arthritis and Rheumatology /ID# 169438
Atlanta Georgia, 30342, United States
Clinic of Robert Hozman/Clinical Investigation Specialists /ID# 166681
Skokie Illinois, 60076, United States
Springfield Clinic /ID# 166345
Springfield Illinois, 62702, United States
Ochsner Clinic Foundation /ID# 166622
Baton Rouge Louisiana, 70836, United States
The Arthritis & Diabetes Clinic, Inc. /ID# 166707
Monroe Louisiana, 71203, United States
MMP Women's Health /ID# 169334
Portland Maine, 04102, United States
Klein and Associates MD /ID# 166549
Hagerstown Maryland, 21740, United States
Duplicate_The Center for Rheumatology & Bone Research /ID# 166448
Wheaton Maryland, 20902, United States
Clinical Pharmacology Study Gr /ID# 166455
Worcester Massachusetts, 01605, United States
St. Paul Rheumatology /ID# 166599
Eagan Minnesota, 55121, United States
Clayton Medical Associates, P.C. dba Saint Louis Rheumatology /ID# 166389
Saint Louis Missouri, 63119, United States
Clinvest Research LLC /ID# 166745
Springfield Missouri, 65810, United States
Glacier View Research Institute /ID# 169344
Kalispell Montana, 59901, United States
Dartmouth-Hitchcock Medical Center /ID# 169443
Lebanon New Hampshire, 03756, United States
Ocean Rheumatology, PA /ID# 166561
Toms River New Jersey, 08755, United States
Arthritis Rheumatic and Back Disease Associates. P.A. /ID# 166658
Voorhees New Jersey, 08043, United States
Paramount Medical Research Con /ID# 166334
Middleburg Heights Ohio, 44130, United States
Health Research of Oklahoma /ID# 166408
Oklahoma City Oklahoma, 73103, United States
Altoona Ctr Clinical Res /ID# 166691
Duncansville Pennsylvania, 16635, United States
Clinical Research Ctr Reading /ID# 166354
Wyomissing Pennsylvania, 19610, United States
West Tennessee Research Institute /ID# 166429
Jackson Tennessee, 38305, United States
Nashville Arthritis and Rheumatology /ID# 208395
Nashville Tennessee, 37203, United States
Amarillo Ctr for Clin Research /ID# 208340
Amarillo Texas, 79124, United States
Tekton Research, Inc. /ID# 166493
Austin Texas, 78745, United States
Precision Comprehensive Clinical Research Solutions /ID# 208156
Colleyville Texas, 76034, United States
Rheumatology Clinic of Houston /ID# 166636
Houston Texas, 77065, United States
West Texas Clinical Research /ID# 208155
Lubbock Texas, 79410, United States
SW Rheumatology Res. LLC /ID# 166587
Mesquite Texas, 75150, United States
Trinity Universal Research Associates, Inc /ID# 208387
Plano Texas, 75024, United States
DM Clinical Research /ID# 208350
Tomball Texas, 77375, United States
Kadlec Clinic Rheumatology /ID# 167667
Kennewick Washington, 99336, United States
Arthritis Northwest, PLLC /ID# 169535
Spokane Washington, 99204, United States
Rheumatology and Pulmonary Clinic /ID# 169341
Beckley West Virginia, 25801, United States
Rheumatic Disease Center, LLP /ID# 166682
Glendale Wisconsin, 53217, United States
Hospital General de Agudos J. M. Ramos Mejia /ID# 169152
Buenos Aires Ciuadad Autonoma De Buenos Aires, 1221, Argentina
Hospital Italiano de Buenos Aires /ID# 208473
Ciudad Autonoma Buenos Aires Ciuadad Autonoma De Buenos Aires, 1199, Argentina
DOM Centro de Reumatologia /ID# 208478
Ciudad Autonoma de Buenos Aire Ciuadad Autonoma De Buenos Aires, 1111, Argentina
Centro de Enfermedades del Hígado y Aparato Digestivo /ID# 169151
Rosario Santa Fe, 2000, Argentina
Instituto CAICI /ID# 169156
Rosario Santa Fe, 2000, Argentina
Centro Medico Privado de Reumatologia /ID# 208342
San Miguel de Tucuman Tucuman, 4000, Argentina
Cimer /Id# 169155
San Miguel de Tucuman , 4000, Argentina
The Canberra Hospital /ID# 207591
Garran Australian Capital Territory, 2605, Australia
Rheumatology Research Unit Sunshine Coast /ID# 207191
Maroochydore Queensland, 4558, Australia
Griffith University /ID# 207504
Southport Queensland, 4222, Australia
Emeritus Research /ID# 207195
Camberwell Victoria, 3124, Australia
Monash Medical Centre /ID# 208033
Clayton Victoria, 3168, Australia
UZ Gent /ID# 210037
Gent Oost-Vlaanderen, 9000, Belgium
Universitair Ziekenhuis Leuven /ID# 208209
Leuven Vlaams-Brabant, 3000, Belgium
ReumaClinic /ID# 208211
Genk , 3600, Belgium
ZNA - Jan Palfijn /ID# 208210
Merksem , 2170, Belgium
CIP - Centro Internacional de Pesquisa /ID# 169524
Goiânia Goias, 74110, Brazil
LMK Sevicos Medicos S/S /ID# 169541
Porto Alegre Rio Grande Do Sul, 90480, Brazil
Percuro Clinical Research, Ltd /ID# 169530
Victoria British Columbia, V8V 3, Canada
CIADS Research Co Ltd /ID# 169526
Winnipeg Manitoba, R3N 0, Canada
Dermatrials Research /ID# 208303
Hamilton Ontario, L8N 1, Canada
K. Papp Clinical Research /ID# 169527
Waterloo Ontario, N2J 1, Canada
Centre Rhumatologie de l'Est /ID# 208302
Rimouski Quebec, G5L 8, Canada
Bispebjerg and Frederiksberg Hospital /ID# 168763
Frederiksberg Hovedstaden, 2000, Denmark
Aarhus University Hospital /ID# 168762
Aarhus C Midtjylland, 8000, Denmark
East Tallinn Central Hospital /ID# 208317
Tallinn Harjumaa, 10138, Estonia
MediTrials /ID# 207815
Tartu Tartumaa, 50708, Estonia
North Estonia Medical Centre /ID# 208319
Tallinn , 13419, Estonia
Ite Pihlajanlinna Kuopio /ID# 208316
Kuopio , 70100, Finland
Turku University Hospital /ID# 208199
Turku , 20520, Finland
Duplicate_CHU Bordeaux-Hopital Pellegrin /ID# 211159
Bordeaux , 33076, France
CHRU Tours - Hopital Trousseau /ID# 209343
Chambray Les Tours , 37170, France
Rheumazentrum Ruhrgebiet /ID# 207212
Herne Nordrhein-Westfalen, 44649, Germany
Immanuel Krankenhaus Berlin /ID# 207214
Berlin-buch , 13125, Germany
Center of Innovative Diagnostics and Therapeutics (CIRI GmbH) /ID# 209494
Frankfurt , 60590, Germany
MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH /ID# 209493
Hamburg , 20095, Germany
University General Hospital of Heraklion PA.G.N.I /ID# 206930
Heraklion Kriti, 71307, Greece
Naval Hospital of Athens /ID# 206928
Athens , 11521, Greece
Olympion General Clinic SA /ID# 207047
Patras , 26443, Greece
CRU Hungary Egeszsegugyi és Szolgaltato Kft. /ID# 169248
Miskolc Borsod-Abauj-Zemplen, 3529, Hungary
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont /ID# 169237
Szeged Csongrad, 6725, Hungary
Vital-Medicina Kft. /ID# 208123
Veszprém Veszprem, 8200, Hungary
Betegapolo Irgalmasrend Budai Irgalmasrendi Korhaz /ID# 209054
Budapest , 1023, Hungary
Sheba Medical Center /ID# 207468
Ramat Gan Tel-Aviv, 52394, Israel
Barzilai Medical Center /ID# 207471
Ashkelon , 78306, Israel
Rambam Health Care Campus /ID# 208169
Haifa , 31096, Israel
Meir Medical Center /ID# 207469
Kfar Saba , 44281, Israel
Rabin Medical Center /ID# 207470
Petakh Tikva , 49414, Israel
Duplicate_Azienda Ospedaliero-Universitaria Policlinico di Modena /ID# 207800
Modena Emilia-Romagna, 41124, Italy
Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona /ID# 207268
Ancona , 60126, Italy
Azienda Ospedaliera Universitaria di Verona/Ospedale Borgo Roma /ID# 207264
Verona , 37134, Italy
Antonius Ziekenhuis /ID# 208581
Sneek Fryslan, 8601 , Netherlands
Universitair Medisch Centrum Groningen /ID# 168450
Groningen , 9713 , Netherlands
Medisch Centrum Leeuwarden /ID# 168449
Leeuwarden , 8934 , Netherlands
Waikato Hospital /ID# 214276
Hamilton Waikato, 3204, New Zealand
Middlemore Clinical Trials /ID# 214293
Auckland , 2025, New Zealand
CGM Research Trust /ID# 210596
Burwood Christchurch , 8083, New Zealand
Malopolskie Centrum Kliniczne /ID# 208011
Krakow Malopolskie, 30-14, Poland
Centrum Medyczne Reuma Park w Warszawie /ID# 210956
Warsaw Mazowieckie, 02-69, Poland
Osteo-Medic S.C. /ID# 208013
Bialystok Podlaskie, 15-35, Poland
Centrum Badan Klinicznych PI-House sp. z o.o. /ID# 208012
Gdansk Pomorskie, 80-54, Poland
Centrum Kliniczno-Badawcze /ID# 208014
Elblag Warminsko-mazurskie, 82-30, Poland
Unidade Local de Saúde do Alto Minho, EPE - Hospital Conde de Bertiandos /ID# 208138
Ponte de Lima Viana Do Castelo, 4990-, Portugal
Instituto Português De Reumatologia /ID# 208140
Lisboa , 1050-, Portugal
Centro Hospitalar Universitário de Lisboa Norte, EPE - Hospital de Santa Maria /ID# 208139
Lisboa , 1649-, Portugal
GCM Medical Group PSC - Hato Rey /ID# 208461
San Juan , 00917, Puerto Rico
Changi General Hospital /ID# 208966
Singapore , 52988, Singapore
Dr Jenny Potts /ID# 167628
Port Elizabeth Eastern Cape, 6405, South Africa
Arthritis Clinical Research Trials /ID# 167611
Cape Town Western Cape, 7405, South Africa
Winelands Medical Research Centre /ID# 167630
Stellenbosch Western Cape, 7600, South Africa
Consorci Corporacio Sanitaria Parc Tauli Sabadell /ID# 207822
Sabadell Barcelona, 08208, Spain
Hospital Unversitario Marques de Valdecilla /ID# 208541
Santander Cantabria, 39008, Spain
Hospital Universitario A Coruna - CHUAC /ID# 207819
A Coruna , 15006, Spain
Hospital Universitario 12 de Octubre /ID# 207820
Madrid , 28041, Spain
Hospital Universitario y Politecnico La Fe /ID# 207823
Valencia , 46026, Spain
Orebro Universitetssjukhuset /ID# 169400
Orebro Orebro Lan, 701 8, Sweden
Duplicate_Karolinska Univ Sjukhuset /ID# 208174
Solna , 171 6, Sweden
Uppsala University Hospital /ID# 169098
Uppsala , 75185, Sweden
Duplicate_Vastmanlands Sjukhus /ID# 168620
Vasteras , 723 3, Sweden
Duplicate_Barts Health NHS Trust /ID# 210794
London London, City Of, E11 1, United Kingdom
Manchester University NHS Foundation Trust /ID# 207923
Manchester , M13 9, United Kingdom
Torbay and South Devon Nhs Foundation Trust /Id# 207926
Torquay , TQ2 7, United Kingdom
Duplicate_Wirral University Teaching Hospital NHS Foundation Trust /ID# 210536
Wirral , CH49 , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Phase:

Phase 3

Estimated Enrollment:

444

Study ID:

NCT03671148

Recruitment Status:

Active, not recruiting

Sponsor:


AbbVie

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.