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Active (not recruiting) Phase 3 NCT03671148

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)

Phase 3 – large-scale trial before approval
Conditions: Psoriatic Arthritis (PsA)

Sponsor: AbbVie

trial.available_in: БГ
Overview
The purpose of this study is to evaluate the safety and efficacy of risankizumab in adults with moderately to severely active psoriatic arthritis (PsA).
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.
Who can participate
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.
Locations 23
Argentina (1)
Hospital General de Agudos J. M. Ramos Mejia /ID# 169152
Buenos Aires , Ciuadad Autonoma de Buenos Aires
Australia (1)
The Canberra Hospital /ID# 207591
Garran , Australian Capital Territory
Belgium (1)
UZ Gent /ID# 210037
Ghent , Oost-Vlaanderen
Brazil (1)
CIP - Centro Internacional de Pesquisa /ID# 169524
Goiânia , Goiás
Canada (1)
Percuro Clinical Research, Ltd /ID# 169530
Victoria , British Columbia
Denmark (1)
Bispebjerg and Frederiksberg Hospital /ID# 168763
Frederiksberg , Capital Region
Estonia (1)
East Tallinn Central Hospital /ID# 208317
Tallinn , Harju
Finland (1)
Ite Pihlajanlinna Kuopio /ID# 208316
Kuopio
France (1)
Duplicate_CHU Bordeaux-Hopital Pellegrin /ID# 211159
Bordeaux
Greece (1)
University General Hospital of Heraklion PA.G.N.I /ID# 206930
Heraklion , Crete
Hungary (1)
CRU Hungary Egeszsegugyi és Szolgaltato Kft. /ID# 169248
Miskolc , Borsod-Abauj Zemplen county
Israel (1)
Sheba Medical Center /ID# 207468
Ramat Gan , Tel Aviv
Italy (1)
Duplicate_Azienda Ospedaliero-Universitaria Policlinico di Modena /ID# 207800
Modena , Emilia-Romagna
Netherlands (1)
Antonius Ziekenhuis /ID# 208581
Sneek , Provincie Friesland
New Zealand (1)
Waikato Hospital /ID# 214276
Hamilton , Waikato Region
Poland (1)
Malopolskie Centrum Kliniczne /ID# 208011
Krakow , Lesser Poland Voivodeship
Puerto Rico (1)
GCM Medical Group PSC - Hato Rey /ID# 208461
San Juan
Singapore (1)
Changi General Hospital /ID# 208966
Singapore
South Africa (1)
Dr Jenny Potts /ID# 167628
Port Elizabeth , Eastern Cape
Spain (1)
Consorci Corporacio Sanitaria Parc Tauli Sabadell /ID# 207822
Sabadell , Barcelona
Sweden (1)
Duplicate_Karolinska Univ Sjukhuset /ID# 208174
Solna
United Kingdom (1)
Duplicate_Barts Health NHS Trust /ID# 210794
London , London, City of
United States (1)
Pinnacle Research Group /ID# 167953
Anniston , Alabama
Technical details
Status
Active (not recruiting)
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
07.03.2019
Completion date
01.06.2026
Registry ID
NCT03671148
Source
anzctr
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