Study of Risankizumab vs. Placebo for Patients with Active Psoriatic Arthritis and Inadequate Response to DMARD Therapy

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What is this study about?

This clinical trial is focused on studying the effects of a medication called Risankizumab on individuals with Psoriatic Arthritis. Psoriatic Arthritis is a type of arthritis that affects some people who have psoriasis, a condition that features red patches of skin topped with silvery scales. The study involves comparing Risankizumab to a placebo to see how well it works in treating the symptoms of Psoriatic Arthritis. Risankizumab is given as a solution for injection using a pre-filled syringe.

The purpose of the study is to evaluate the effectiveness of Risankizumab in reducing the signs and symptoms of Psoriatic Arthritis in participants who have not responded well to or cannot tolerate at least one previous treatment known as a Disease Modifying Anti-Rheumatic Drug (DMARD). Participants will receive either Risankizumab or a placebo, and the study will monitor their progress over a period of time to assess improvements in their condition.

Throughout the study, participants will receive regular injections and attend scheduled visits to track their health and any changes in their symptoms. The study aims to determine if Risankizumab can provide significant relief from the symptoms of Psoriatic Arthritis compared to the placebo. The trial is designed to ensure that all participants are closely monitored for safety and effectiveness of the treatment.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm the diagnosis of psoriatic arthritis and to ensure the presence of active disease. This includes checking for psoriatic plaques or nail changes and reviewing previous treatment responses.

2 randomization

Participants are randomly assigned to receive either risankizumab or a placebo. This process is double-blind, meaning neither the participant nor the study team knows which treatment is being administered.

3 treatment administration

The treatment involves subcutaneous injections. Participants receive risankizumab at a dose of 150 mg or a placebo, administered through a pre-filled syringe.

4 treatment period

The treatment period lasts for 24 weeks. During this time, participants continue to receive their assigned treatment and attend regular study visits for monitoring and assessment.

5 primary assessment

At week 24, the primary assessment is conducted to evaluate the proportion of participants achieving an ACR20 response, which measures improvement in arthritis symptoms.

6 secondary assessments

Secondary assessments include evaluating changes in physical function, skin symptoms, and other health indicators. These assessments occur at various points, including weeks 16 and 24.

7 end of study

The study is estimated to conclude by July 29, 2026. Participants will have a final assessment to determine the overall impact of the treatment on their condition.

Who Can Join the Study?

  • The patient must have a clinical diagnosis of Psoriatic Arthritis (PsA), which means they have been diagnosed with this condition, and symptoms must have started at least 6 months before the screening visit.
  • The patient must have active disease at the start of the study.
  • The patient must have a diagnosis of active plaque psoriasis, which is a skin condition, with at least one psoriatic plaque that is 2 centimeters or larger, or nail changes that are consistent with psoriasis at the screening visit.
  • The patient must have either at least one erosion visible on an X-ray, as determined by a central imaging review, or a high level of hs-CRP (a marker of inflammation in the blood) of 3.0 mg/L or higher at the screening visit.
  • The patient must have shown an inadequate response, meaning the treatment did not work well enough, after at least 12 weeks of therapy with at least one csDMARD (a type of medication used to treat PsA) at the highest dose they can tolerate.
  • Both male and female patients are eligible to participate in the study.

Who Cannot Join the Study?

  • Patients who have any other serious health conditions that could interfere with the study.
  • Patients who are currently participating in another clinical trial.
  • Patients who have had a recent infection that required treatment with antibiotics.
  • Patients who have a history of allergic reactions to similar medications.
  • Patients who are pregnant or breastfeeding.
  • Patients who have a history of drug or alcohol abuse.
  • Patients who have received certain treatments for Psoriatic Arthritis recently.
  • Patients who have a weakened immune system.
  • Patients who have been diagnosed with certain types of cancer.
  • Patients who have had a recent vaccination with a live vaccine.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Hospital Universitario Y Politecnico La Fe Valencia Spain
Osteo-Medic s.c. Artur Racewicz, Jerzy Supronik Bialystok Poland
Poliklinika Vlatka Cavka d.o.o. Zagreb Croatia
CENTRUM MEDYCZNE REUMA PARK Warsaw Poland
Spitalul Clinic Judetean De Urgenta Cluj Cluj Napoca Romania
Innomedica OÜ Tallin Estonia

Other Sites

Site Name City Country Status
Pauls Stradins Clinical University Hospital Riga Latvia
Diagnostic Consulting Center XVII Sofia Ltd. Sofia Bulgaria
Centro Ricerche Cliniche Di Verona S.r.l. Verona Italy
Saint Maria Hospital Bucharest Romania
Hospital Universitario 12 De Octubre Madrid Spain
Hospital De Santa Maria E.P.E. Lisbon Portugal
Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikos Kaunas Lithuania
Fakultna Nemocnica Trnava Trnava Slovakia
CCAB Centro Clinico Academico Braga Associacao Braga Portugal
University General Hospital Of Heraklion Heraklion Greece
Clinicmed Daniluk Nowak Sp. k. Bialystok Poland
Instituto Portugues De Reumatologia Lisbon Portugal
MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH Hamburg Germany
Reumaclinic Genk Belgium
Centrum Medyczne Intercor Sp. z o.o. Bydgoszcz Poland
Mcbk s.c. Iwona Czajkowska Anna Podrazka Szczepaniak Grodzisk Mazowiecki Poland
Medicinski centar Kuna Peric d.o.o. Zagreb Croatia
Thermium s.r.o. Piestany Slovakia
Medman s.r.o. Martin Slovakia
Etyka Osrodek Badan Klinicznych Tomasz Pesta S.K.A. Olsztyn Poland
Malopolskie Centrum Kliniczne Cracow Poland
Banat Carina Med S.R.L. Timisoara Romania
Frederiksberg Hospital Frederiksberg Denmark
Orto klinika SIA Riga Latvia
424 Military General Training Hospital Thessaloniki Greece
Medical Plus s.r.o. Uherske Hradiste Czechia
Revmacentrum MUDr. Mostera s.r.o. Brno-Zidenice Czechia
Medical Center Excelsior OOD Sofia Bulgaria
Clinical Medical Center Osijek Osijek Croatia
Respublikine Siauliu ligonine VšĮ Siauliai Lithuania
Turku University Hospital Turku Finland
St. Elisabeth Gruppe GmbH Katholische Kliniken Rhein-Ruhr Herne Germany
Poliklinika Solmed d.o.o. Zagreb Croatia
Reum.hapi s.r.o. Nove Mesto Nad Vahom Slovakia
MediTrials OÜ Tartu Estonia
Satucon Oy Kuopio Finland
Klaipedos universiteto ligonine VšĮ Klaipeda Lithuania
Unidade Local De Saude Do Alto Minho E.P.E. Ponte De Lima Portugal
PV-Medical s.r.o. Zlin Czechia
North Estonia Medical Centre Foundation Tallin Estonia
Centrum fuer innovative Diagnostik und Therapie Rheumatologie/Immunologie c i r i GmbH Frankfurt Germany
Centrum Kliniczno-Badawcze J.Brzezicki B.Gornikiewicz-Brzezicka Lekarze sp.p. Elblag Poland
MUDR. Zuzana URBANOVA Prague Czechia
Rogcisfj Psupio siidll Poprad Slovakia
Vfhk Ufi Kaunas Lithuania
Mirvcidir Ijftalomvf Chqyvnxj Srzgjpbm Sna z ortz Warsaw Poland
Pwcn Tenaq Henhcsbb Uihidjyqvqmu Sabadell Spain
D Sfmzmtvz Kkfdnhqpfh Ptdpsyv Pwxbawzk Liepaja Latvia
Kjdmflqy bfkwefrk ciezma Rsdwsl (sdmcgwgn Hhsauiim Cxchsa Rivscfl Rijeka Croatia
Hgjckwgk Ugardcboku Czcvysf Hxxochhm Helsinki Finland
Alfmmg Upugfrryyc Hecfrxrg Aarhus Denmark
Roayq Amxsbqce kbntyxbb uahfcaumsahgc sarhmxgu Svk Riga Latvia
Iaxwthgadhvjabmgkrpm Gwpv Berlin Germany
Mgflewts Mawqusr Avilugz Pleven Bulgaria
Mhvclgt Cqdvja Mmnnnshzqp Pudicf Ovo Pleven Bulgaria
Hjumluio Utajdfqdeevyy do A Cfrluo A Coruna Galicia Spain
M &ucil M coczee Sly Adazi Latvia

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
30.07.2019
Bulgaria Bulgaria
Not recruiting
30.07.2019
Croatia Croatia
Not recruiting
30.07.2019
Czechia Czechia
Not recruiting
30.07.2019
Denmark Denmark
Not recruiting
30.07.2019
Estonia Estonia
Not recruiting
30.07.2019
Finland Finland
Not recruiting
30.07.2019
Germany Germany
Not recruiting
30.07.2019
Greece Greece
Not recruiting
30.07.2019
Italy Italy
Not recruiting
30.07.2019
Latvia Latvia
Not recruiting
30.07.2019
Lithuania Lithuania
Not recruiting
30.07.2019
Poland Poland
Not recruiting
30.07.2019
Portugal Portugal
Not recruiting
30.07.2019
Romania Romania
Not recruiting
30.07.2019
Slovakia Slovakia
Not recruiting
30.07.2019
Spain Spain
Not recruiting
30.07.2019

Trial locations

Investigated drugs:

Risankizumab is a medication used in this clinical trial to treat individuals with active psoriatic arthritis. It is being tested to see how effective it is in reducing the signs and symptoms of the condition. This medication is being compared to a placebo to determine its effectiveness in patients who have not responded well to or cannot tolerate at least one other type of treatment known as disease-modifying anti-rheumatic drugs (DMARDs).

Psoriatic Arthritis – Psoriatic arthritis is a chronic inflammatory condition that affects both the skin and joints. It typically occurs in individuals with psoriasis, a skin disease characterized by red, scaly patches. The disease can cause joint pain, stiffness, and swelling, often affecting fingers, toes, and the spine. Over time, psoriatic arthritis can lead to joint damage and reduced mobility if not managed properly. The severity and progression of symptoms can vary widely among individuals. Some people may experience mild symptoms, while others may have more severe joint involvement.

Trial ID:
2023-505478-14-00
Protocol code:
M16-011
NCT ID:
NCT03675308
Trial Phase:
Therapeutic confirmatory (Phase III)

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