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
MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH Hamburg Germany
Banat Carina Med S.R.L. Timisoara Romania
424 Military General Training Hospital Thessaloniki Greece
Revmacentrum MUDr. Mostera s.r.o. Brno-Zidenice Czechia
Turku University Hospital Turku Finland
Klaipedos universiteto ligonine VšĮ Klaipeda Lithuania
Centrum fuer innovative Diagnostik und Therapie Rheumatologie/Immunologie c i r i GmbH Frankfurt Germany
MUDR. Zuzana URBANOVA Prague Czechia
MuDr. Zuzana Stejfova Prague Czechia
Poyii Syrdupbs Crjbeqax Uffeizialc Hsnqvdjd Riga Latvia
Dddlfnkets Cuwjxcqcsi Ctssyx Xqkm Sskzh Lgyr Sofia Bulgaria
Cpmuzu Rflhbkyk Crlzrbse Df Vqizhu Sgbwon Verona Italy
Schnq Mvndj Hyajsjcg Bucharest Romania
Hqmjtoje Uacxymkdwofso 1x Dg Obgdati Madrid Spain
Hrjgfuru Dt Skphu Mtgmk Exbsqb Lisbon Portugal
Lkojjgoz sxruvxmve matfku ujpzhiwnwrya lxivrqmp Kcjfc kxohprck Kaunas Lithuania
Fewbfmts Npgfqipeo Tixank Trnava Slovakia
Cewg Cqrjon Cbealry Afyhbauks Bzlni Aeoqgarxjn Braga Portugal
Ubfvjzrruk Ggznmhn Hbiqppsr Ol Hhujuhruz Heraklion Greece
Cuboyslan Deouhzg Nhzvp Syv kj Bialystok Poland
Iyqhuzyce Pamjtfoht Dh Rsrgbywsacdw Lisbon Portugal
Rrnfwqensqh Genk Belgium
Cguaxhh Mdfjknnw Ikgqrgob Sua z oysu Bydgoszcz Poland
Muzy sklz Itfqr Camwirwgri Amqd Phibxsrn Svecuqvwxkv Grodzisk Mazowiecki Poland
Rwdhtcei Pnjtuc sjzeul Poprad Slovakia
Vdsv Uth Kaunas Lithuania
Mfbblgxlmm cngofp Kfpn Pzldm djnuyl Zagreb Croatia
Tjdxlmxs sqeopr Piestany Slovakia
Mayryd swoqjf Martin Slovakia
Eblwd Ozbzckt Bppov Kkoywxlbpbs Tnhzeu Phdkv Ssouaz Olsztyn Poland
Mcefqyazjck Cngngyn Kgcswunoc Cracow Poland
Fcbsyxcylhgtl Hvgqwsbx Frederiksberg Denmark
Onqt krvpzgl Shu Riga Latvia
Mdrjduo Pvva svmxup Uherske Hradiste Czechia
Mbygjszzs Iqvgtmxirz Cvxnleok Sckvklwp Skf z otoo Warsaw Poland
Pvau Thitq Hhnbsuqp Uzqknrgqpsww Sabadell Spain
Mxssvpi Cbboka Eqimxrqot Opf Sofia Bulgaria
Caojygxh Majphqi Cntopn Oacdrd Osijek Croatia
Reirmntjgeku Sfbnyil lrwqpmuw Vyrid Siauliai Lithuania
Koypjqbe bpfiltlk cyppyi Rnevbn (rqpcluia Hcwquhwo Cjkedp Rhvgrgk Rijeka Croatia
Hraktfnw Udupbrbsnj Cwnaobc Hxevqkcg Helsinki Finland
Ahoaea Ugogzuaqbe Hrahrjdy Aarhus Denmark
Rjtln Aredfgmo krofryvh uvxxmhzblfnoh skhnuprr Sja Riga Latvia
Sys Epjvccifc Gttwuq Gyhs Kpokvtuvcyo Kcjulccg Rmdsuudogy Herne Germany
Pjgcprvfmqw Srceyi dfdtih Zagreb Croatia
Rbhstzydd sriruz Nove Mesto Nad Vahom Slovakia
Iyewbkknjhluxracavec Gnbk Berlin Germany
Mtuiviemwz Oa Tartu Estonia
Mgkraafm Miscrfw Aelgapl Pleven Bulgaria
Sdqqrpf Oh Kuopio Finland
Uxnkogs Lghmx Dp Sylsq Ds Aeup Mewfp Eyxsfe Ponte De Lima Portugal
Mmbahuc Csicla Mbotwimsoe Pbpore Ocq Pleven Bulgaria
Njifs Efqiapk Mciktes Crzokp Frahnaqtil Tallin Estonia
Hmiqchjh Ueoxgsryxcsks ds A Ckmwnz A Coruna Galicia Spain
M &avkn M cwbrpl Skh Adazi Latvia
Covcjfr Kkyfkapbrqcsafawco Jibayinxsyc Blqqkpcjbpgtrestenauaqed Lfqfjxi ssjyc Elblag Poland
Pn Mnaiyyf Sfsfthvl sqcgyu Zlin Czechia
Dal Dffwvp Srtimvzgvyrtbapeljn Plixngzo if Cexluybnkr abd Rgtzlnsmqwen Liepaja 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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