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NCT03671148RecruitingPhase 3

A Study Comparing Risankizumab to Placebo in Subjects with Active Psoriatic Arthritis Including Those Who Have a History of Inadequate Response or Intolerance to Biologic Therapy(ies) (KEEPsAKE 2)

A Phase 3, Randomized, Double-Blind Study Comparing Risankizumab to Placebo in Subjects with Active Psoriatic Arthritis Including Those Who Have a History of Inadequate Response or Intolerance to Biologic Therapy(ies) (KEEPsAKE 2)

Source: EU CTIS (euclinicaltrials.eu) · Last updated 3 Nov 2026

Brief summary (registry, in English)

To compare the efficacy of risankizumab 150 mg versus placebo for the treatment of signs and symptoms of PsA in the study population

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
133 (estimated)
First submitted
19 Jan 2024
Start date
18 Jun 2019
Lead sponsor
AbbVie Deutschland GmbH & Co. KG
NCT number
NCT03671148
EU CT number
2023-505477-33-00
EudraCT number
2017-002464-40

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 133
  • 27 sites in 10 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study, not your situation.

Who cannot take part

Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Subject has a known hypersensitivity to risankizumab.

Other

  • Subject is considered by investigator, for any reason, to be an unsuitable candidate for the study.

Who the study is looking for

  • 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 Screening Visit.
  • Subject has active disease at Baseline
  • Diagnosis of active plaque psoriasis with at least one psoriatic plaque of ≥ 2 centimeter (cm) diameter or nail changes consistent with psoriasis at Screening Visit.
  • Subject has demonstrated an inadequate response or intolerance to biologic therapy(ies) or csDMARD therapy(ies).

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (27)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Universitair Ziekenhuis Gent
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GentBelgiumActive, not recruiting
UZ Leuven
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LeuvenBelgiumActive, not recruiting
MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH
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HamburgGermanyCompleted
St. Elisabeth Gruppe GmbH Katholische Kliniken Rhein-Ruhr
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HerneGermanyCompleted
Frederiksberg Hospital
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FrederiksbergDenmarkRecruiting
North Estonia Medical Centre Foundation
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TallinnEstoniaActive, not recruiting
East Tallinn Central Hospital
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TallinnEstoniaActive, not recruiting
MediTrials OÜ
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Tartu LinnEstoniaActive, not recruiting
Complexo Hospitalario Universitario A Coruña
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A CoruñaSpainActive, not recruiting
Hospital Universitario 12 de Octubre
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MadridSpainActive, not recruiting
Parc Tauli Hospital Universitari
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SabadellSpainActive, not recruiting
Hospital Universitario Y Politecnico La Fe
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ValenciaSpainActive, not recruiting
Athens Naval Hospital
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AthensGreeceCompleted
University General Hospital of Heraklion
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HeraklionGreeceCompleted
Betegapolo Irgalmasrend Budai Irgalmasrendi Korhaz
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Budapest IIHungaryActive, not recruiting
CRU Hungary Kft.
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EncsHungaryActive, not recruiting
University of Szeged
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SzegedHungaryActive, not recruiting
Vital-Medicina Kft.
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VeszpremHungaryActive, not recruiting
Azienda Ospedaliero-Universitaria delle Marche
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AnconaItalyCompleted
Osteo-Medic S.C.
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BialystokPolandActive, not recruiting
Malopolskie Centrum Kliniczne
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CracowPolandActive, not recruiting
Centrum Kliniczno-Badawcze J.Brzezicki B.Gornikiewicz-Brzezicka Lekarze sp.p.
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ElblagPolandActive, not recruiting
Centrum Badan Klinicznych PI-House sp. z o.o.
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GdanskPolandActive, not recruiting
Klinika Reuma Park Sp. z o.o. S.K.
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WarsawPolandActive, not recruiting
Centro Hospitalar Universitario De Lisboa Norte E.P.E.
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LisbonPortugalActive, not recruiting
Instituto Portugues de Reumatologia
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LisbonPortugalActive, not recruiting
Unidade Local De Saude Do Alto Minho E.P.E.
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Ponte De LimaPortugalActive, not recruiting

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.