A Study Comparing Risankizumab to Placebo in Participants With Active Psoriatic Arthritis (PsA) Who Have a History of Inadequate Response to or Intolerance to at Least One Disease Modifying Anti-Rheumatic Drug (DMARD) Therapy
Launched by ABBVIE · Sep 15, 2018
Trial Information
Current as of August 14, 2025
Active, not recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a medication called risankizumab to see how well it works for people with active psoriatic arthritis (PsA) who have not had good results from other treatments. Psoriatic arthritis is a condition that causes joint pain and swelling, and it often occurs alongside psoriasis, a skin condition that leads to red, itchy patches. In this study, researchers want to find out if risankizumab is safe and effective compared to a placebo, which is a treatment that contains no active medication.
To be eligible for the trial, participants must be diagnosed with PsA for at least six months, have active symptoms (like tender and swollen joints), and have experienced problems with at least one previous treatment. Participants should also have visible signs of psoriasis, such as skin plaques or nail changes. During the trial, participants will receive either risankizumab or a placebo and will be monitored for how they respond to the treatment. It's important to note that this trial is currently active but not recruiting new participants, and it is only for adults ages 65 to 74. If someone is considering joining a similar study in the future, they should be aware that factors like previous treatments and specific health conditions may affect eligibility.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Clinical diagnosis of PsA with symptom onset at least 6 months prior to the Screening Visit and fulfillment of the Classification Criteria for PsA (CASPAR) at the Screening Visit.
- • Participant has active disease at Baseline defined as ≥ 5 tender joints (based on 68 joint counts) and ≥ 5 swollen joints (based on 66 joint counts)
- • 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 or contraindication for conventional synthetic disease modifying anti-rheumatic drugs (csDMARD) therapy(ies).
- * Presence of either at Screening:
- • ≥ 1 erosion on radiograph as determined by central imaging review or;
- • High sensitivity C-reactive protein (hsCRP) ≥ 3.0 mg/L.
- 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.
- • Participant has previous treatment with biologic agent.
About Abbvie
AbbVie is a global biopharmaceutical company dedicated to developing innovative therapies that address complex health challenges. Founded in 2013 as a spin-off from Abbott Laboratories, AbbVie focuses on key therapeutic areas, including immunology, oncology, neuroscience, and virology. The company is committed to advancing scientific research and delivering groundbreaking treatments that enhance patient outcomes and quality of life. With a robust pipeline and a strong emphasis on collaboration, AbbVie strives to transform the future of medicine through its commitment to clinical excellence and patient-centered approaches.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Anniston, Alabama, United States
Peoria, Arizona, United States
Phoenix, Arizona, United States
Tucson, Arizona, United States
Tucson, Arizona, United States
Jonesboro, Arkansas, United States
Los Alamitos, California, United States
San Diego, California, United States
Upland, California, United States
Whittier, California, United States
Bridgeport, Connecticut, United States
Danbury, Connecticut, United States
Hamden, Connecticut, United States
Aventura, Florida, United States
Boca Raton, Florida, United States
Gainesville, Florida, United States
Hialeah, Florida, United States
Jacksonville, Florida, United States
Orlando, Florida, United States
Orlando, Florida, United States
Plantation, Florida, United States
Tampa, Florida, United States
Atlanta, Georgia, United States
Oak Brook, Illinois, United States
Rockford, Illinois, United States
Springfield, Illinois, United States
Hagerstown, Maryland, United States
Wheaton, Maryland, United States
Worcester, Massachusetts, United States
Lansing, Michigan, United States
Lansing, Michigan, United States
Eagan, Minnesota, United States
Kalispell, Montana, United States
Lincoln, Nebraska, United States
Albany, New York, United States
Brooklyn, New York, United States
Charlotte, North Carolina, United States
Greensboro, North Carolina, United States
New Bern, North Carolina, United States
Blue Ash, Ohio, United States
Marietta, Ohio, United States
Middleburg Heights, Ohio, United States
Springboro, Ohio, United States
Oklahoma City, Oklahoma, United States
Duncansville, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Wyomissing, Pennsylvania, United States
Nashville, Tennessee, United States
Amarillo, Texas, United States
Colleyville, Texas, United States
Dallas, Texas, United States
Fort Worth, Texas, United States
The Woodlands, Texas, United States
Tomball, Texas, United States
Kennewick, Washington, United States
Beckley, West Virginia, United States
Franklin, Wisconsin, United States
Manitowoc, Wisconsin, United States
Onalaska, Wisconsin, United States
La Plata, Buenos Aires, Argentina
Buenos Aires, Ciuadad Autonoma De Buenos Aires, Argentina
Ciudad Autonoma Buenos Aires, Ciuadad Autonoma De Buenos Aires, Argentina
Ciudad Autonoma De Buenos Aire, Ciuadad Autonoma De Buenos Aires, Argentina
Ciudad Autonoma De Buenos Aire, Ciuadad Autonoma De Buenos Aires, Argentina
Ciudad Autonoma De Buenos Aire, Ciuadad Autonoma De Buenos Aires, Argentina
Rosario, Santa Fe, Argentina
Rosario, Santa Fe, Argentina
San Miguel De Tucuman, Tucuman, Argentina
Buenos Aires, , Argentina
Cordoba, , Argentina
San Miguel De Tucuman, , Argentina
Garran, Australian Capital Territory, Australia
Herston, Queensland, Australia
Maroochydore, Queensland, Australia
Southport, Queensland, Australia
Bedford, Park, South Australia, Australia
Camberwell, Victoria, Australia
Clayton, Victoria, Australia
Ghent, Oost Vlaanderen, Belgium
Genk, , Belgium
Merksem, , Belgium
Banja Luka, Republika Srpska, Bosnia And Herzegovina
Banja Luka, Republika Srpska, Bosnia And Herzegovina
Banja Luka, Republika Srpska, Bosnia And Herzegovina
Sarajevo, , Bosnia And Herzegovina
Salvador, Bahia, Brazil
Juiz De Fora, Minas Gerais, Brazil
Curitiba, Parana, Brazil
Porto Alegre, Rio Grande Do Sul, Brazil
Sao Paulo, , Brazil
Pleven, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Victoria, British Columbia, Canada
Winnipeg, Manitoba, Canada
Winnipeg, Manitoba, Canada
Peterborough, Ontario, Canada
Waterloo, Ontario, Canada
Sainte Foy, Quebec, Canada
Saskatoon, Saskatchewan, Canada
Providencia, , Chile
Santiago, , Chile
Vitacura Santiago, , Chile
Zagreb, Grad Zagreb, Croatia
Zagreb, Grad Zagreb, Croatia
Osijek, Osjecko Baranjska Zupanija, Croatia
Rijeka, Primorsko Goranska Zupanija, Croatia
Split, Splitsko Dalmatinska Zupanija, Croatia
Zagreb, , Croatia
Zagreb, , Croatia
Brno, , Czechia
Praha, , Czechia
Praha, , Czechia
Praha, , Czechia
Uherske Hradiste, , Czechia
Frederiksberg, Hovedstaden, Denmark
Aarhus C, Midtjylland, Denmark
Mustamäe Linnaosa, Harjumaa, Estonia
Tallinn, Harjumaa, Estonia
Tartu, Tartumaa, Estonia
Helsinki, Uusimaa, Finland
Kuopio, , Finland
Turku, , Finland
Herne, Nordrhein Westfalen, Germany
Berlin Buch, , Germany
Frankfurt, , Germany
Hamburg, , Germany
Athens, Attiki, Greece
Heraklion, Kriti, Greece
Efkarpia (Thessalonikis), Thessaloniki, Greece
Athens, , Greece
Patras, , Greece
Ramat Gan, Tel Aviv, Israel
Ashkelon, , Israel
Haifa, , Israel
Kfar Saba, , Israel
Petakh Tikva, , Israel
Modena, Emilia Romagna, Italy
Ancona, , Italy
Catania, , Italy
Rome, , Italy
Verona, , Italy
Seoul, Seoul Teugbyeolsi, Korea, Republic Of
Seoul, Seoul Teugbyeolsi, Korea, Republic Of
Daegu, , Korea, Republic Of
Adazi, , Latvia
Liepaja, , Latvia
Riga, , Latvia
Riga, , Latvia
Riga, , Latvia
Kaunas, , Lithuania
Kaunas, , Lithuania
Klaipeda, , Lithuania
Siauliai, , Lithuania
Seremban, Negeri Sembilan, Malaysia
Ipoh, Perak, Malaysia
Batu Caves, Selangor, Malaysia
Kuala Lumpur, , Malaysia
Mexico City, Ciudad De Mexico, Mexico
Guadalajara, Jalisco, Mexico
Monterrey, Nuevo Leon, Mexico
Colonia Centro, Yucatan, Mexico
Ciudad De Mexico, , Mexico
Mexico City, , Mexico
Sneek, Fryslan, Netherlands
Groningen, , Netherlands
Leeuwarden, , Netherlands
Papatoetoe, Auckland, New Zealand
Hamilton, Waikato, New Zealand
Burwood, , New Zealand
Bydgoszcz, Kujawsko Pomorskie, Poland
Torun, Kujawsko Pomorskie, Poland
Krakow, Malopolskie, Poland
Grodzisk Mazowiecki, Mazowieckie, Poland
Warsaw, Mazowieckie, Poland
Bialystok, Podlaskie, Poland
Bialystok, Podlaskie, Poland
Elblag, Warminsko Mazurskie, Poland
Olsztyn, Warminsko Mazurskie, Poland
Vila Nova De Gaia, Porto, Portugal
Ponte De Lima, Viana Do Castelo, Portugal
Aveiro, , Portugal
Braga, , Portugal
Lisboa, , Portugal
Lisboa, , Portugal
San Juan, , Puerto Rico
Timisoara, Timis, Romania
Bucuresti, , Romania
Cluj Napoca, , Romania
Iasi, , Romania
Korolev, Moskva, Russian Federation
Moscow, Moskva, Russian Federation
Novosibirsk, Novosibirskaya Oblast, Russian Federation
St. Petersburg, Sankt Peterburg, Russian Federation
Kazan, Tatarstan, Respublika, Russian Federation
Moscow, , Russian Federation
Perm, , Russian Federation
Ulyanovsk, , Russian Federation
Belgrade, Beograd, Serbia
Belgrade, Beograd, Serbia
Belgrade, Beograd, Serbia
Belgrade, Beograd, Serbia
Belgrade, Beograd, Serbia
Novi Sad, Vojvodina, Serbia
Novi Sad, Vojvodina, Serbia
Singapore, , Singapore
Singapore, , Singapore
Singapore, , Singapore
Biely Kostol, , Slovakia
Martin, , Slovakia
Nove Mesto Nad Vahom, , Slovakia
Piestany, , Slovakia
Poprad, , Slovakia
Port Elizabeth, Eastern Cape, South Africa
Pretoria, Gauteng, South Africa
Pretoria, Gauteng, South Africa
Cape Town, Western Cape, South Africa
Somerset West, Western Cape, South Africa
Stellenbosch, Western Cape, South Africa
Badalona, Barcelona, Spain
Sabadell, Barcelona, Spain
A Coruna, , Spain
Almeria, , Spain
Barcelona, , Spain
Madrid, , Spain
Madrid, , Spain
Valencia, , Spain
Orebro, Orebro Lan, Sweden
Malmo, Skane Lan, Sweden
Falun, , Sweden
Solna, , Sweden
Uppsala, , Sweden
Vasteras, , Sweden
Chia Yi, , Taiwan
Taichung, , Taiwan
Taoyuan City, , Taiwan
Kharkiv, Kharkivska Oblast, Ukraine
Vinnytsia, Vinnytska Oblast, Ukraine
Cherkasy, , Ukraine
Chernihiv, , Ukraine
Kharkiv, , Ukraine
Khmelnytskyi, , Ukraine
Kryvyi Rih, , Ukraine
Kyiv, , Ukraine
Lutsk, , Ukraine
Lviv, , Ukraine
Poltava, , Ukraine
Zaporizhzhia, , Ukraine
London, London, City Of, United Kingdom
Glasgow, Scotland, United Kingdom
Stafford, Staffordshire, United Kingdom
Manchester, , United Kingdom
Portsmouth, , United Kingdom
Torquay, , United Kingdom
Wirral, , United Kingdom
Kazan, , Russian Federation
London, , United Kingdom
Patients applied
Trial Officials
ABBVIE INC.
Study Director
AbbVie
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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