Clinical trial • Phase III • Dermatology|Immunology

RISANKIZUMAB for Psoriatic arthritis

Phase III trial of RISANKIZUMAB for Psoriatic arthritis.

Overview

Trial Therapeutic Area
Dermatology|Immunology
Trial Disease
Psoriatic arthritis
Trial Stage
Phase III
Drug Modality
Monoclonal antibody|Other

Key dates

Initial CTIS Submission Date
19-01-2024
First CTIS Authorization Date
29-02-2024

Trial design

Randomised, open-label, risankizumab 150 mg (subcutaneous) administered at week 0, week 4 and week 16; placebo (blinded) as comparator; 1:1 randomization in period 1. (at week 24 subjects receive a single dose of blinded placebo to maintain the blind; period 2 open-label risankizumab 150 mg every 12 weeks from week 28 to week 316.)-controlled Phase III trial across 28 sites in Poland, Denmark, Belgium and others.

Randomised
Yes
Open Label
Yes
Comparator
Risankizumab 150 mg (subcutaneous) administered at Week 0, Week 4 and Week 16; Placebo (blinded) as comparator; 1:1 randomization in Period 1. (At Week 24 subjects receive a single dose of blinded placebo to maintain the blind; Period 2 open-label risankizumab 150 mg every 12 weeks from Week 28 to Week 316.)
Target Sample Size
420
Trial Duration For Participant
2296

Eligibility

Recruits 420 adults.

Inclusion criteria

  • {"criterion_text":"- 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.\n- Subject has active disease at Baseline\n- 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.\n- Subject has demonstrated an inadequate response or intolerance to biologic therapy(ies) or csDMARD therapy(ies)."}

Exclusion criteria

  • {"criterion_text":"- Subject is considered by investigator, for any reason, to be an unsuitable candidate for the study.\n- Subject has a known hypersensitivity to risankizumab."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- The primary endpoint is the proportion of subjects achieving American College of Rheumatology (ACR)20 response at Week 24.","definition_or_measurement_approach":"Proportion of subjects achieving ACR20 response at Week 24 (American College of Rheumatology 20% improvement criteria assessed at Week 24)."}

Secondary endpoints

  • {"endpoint_text":"- Change from Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 24.\n- Proportion of subjects achieving Psoriasis Area Severity Index (PASI) 90 response at Week 24 (in the subset of subjects with a body surface area (BSA) ≥ 3% at Baseline.\n- Proportion of subjects achieving ACR20 at Week 16.\n- Proportion of subjects achieving Minimal Disease Activity (MDA) at Week 24.\n- Change from Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) at Week 24.\n- Change from Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT Fatigue) Questionnaire at Week 24.\n- Proportion of subjects achieving ACR50 response at Week 24.\n- Proportion of subjects achieving ACR70 response at Week 24.\n- Proportion of subjects with resolution of enthesitis (LEI = 0) at Week 24 in subjects with enthesitis at Baseline.\n- Proportion of subjects with resolution of dactylitis (LDI = 0) at Week 24 in subjects with dactylitis at Baseline","definition_or_measurement_approach":"HAQ-DI: change from baseline at Week 24; PASI90: proportion achieving PASI 90 at Week 24 in BSA ≥ 3% subgroup; ACR20 at Week 16: proportion meeting ACR20 criteria at Week 16; MDA: proportion meeting Minimal Disease Activity at Week 24; SF-36 PCS: change from baseline at Week 24; FACIT-Fatigue: change from baseline at Week 24; ACR50/ACR70: proportions achieving ACR50/ACR70 at Week 24; LEI/LDI resolution: proportion with LEI=0 or LDI=0 at Week 24 among those with enthesitis/dactylitis at baseline."}

Recruitment

Planned Sample Size
420
Recruitment Window Months
81
Consent Approach
Informed consent is obtained using country-specific subject information and informed consent form (ICF) documents. Country ICFs and language versions are provided (examples in documents: Poland, Denmark, Belgium, Germany, Italy, Estonia, Greece, Hungary, Portugal, Spain) with local language versions (examples include English, Danish, Dutch, French, German, Spanish, Portuguese, Greek, Hungarian, Italian, Polish, Estonian, Russian). Optional consent documents (e.g., optional sub-study consent, pregnant partner consent) are available. No explicit details on assent procedures for minors were provided in the source.

Geography

Total Number Of Sites
28
Total Number Of Participants
133

Poland

Earliest CTIS Part Ii Submission Date
01-02-2024
Latest Decision Or Authorization Date
02-04-2024
Processing Time Days
61
Number Of Sites
5
Number Of Participants
42

Sites

Site Name
Centrum Kliniczno-Badawcze J.Brzezicki B.Gornikiewicz-Brzezicka Lekarze sp.p.
Contact Person Name
Jan Brzezicki
Contact Person Email
kontakt@ckb.elblag.pl
Site Name
Osteo-Medic S.C.
Contact Person Name
Artur Racewicz
Contact Person Email
sekretariat@osteo-medic.pl
Site Name
Klinika Reuma Park Sp. z o.o. S.K.
Contact Person Name
Ewa Matyska-Piekarska
Contact Person Email
k.groman@reumatika.pl
Site Name
Centrum Badan Klinicznych Pi-House Sp. z o.o.
Contact Person Name
Krystyna Przybylowska
Contact Person Email
pihouse@pihouse.pl
Site Name
Malopolskie Centrum Kliniczne
Contact Person Name
Bozena Rojek-Margas
Contact Person Email
biuro@mck-krakow.pl

Denmark

Earliest CTIS Part Ii Submission Date
01-02-2024
Latest Decision Or Authorization Date
29-02-2024
Processing Time Days
28
Number Of Sites
1
Number Of Participants
2

Sites

Site Name
Frederiksberg Hospital
Contact Person Name
Bjarke Brandt Hansen

Belgium

Earliest CTIS Part Ii Submission Date
01-02-2024
Latest Decision Or Authorization Date
11-03-2024
Processing Time Days
39
Number Of Sites
2
Number Of Participants
6

Sites

Site Name
UZ Leuven
Contact Person Name
Kurt De Vlam
Contact Person Email
kurt.devlam@uzleuven.be
Site Name
Universitair Ziekenhuis Gent
Contact Person Name
Filip Van den Bosch
Contact Person Email
filip.vandenbosch@ugent.be

Italy

Earliest CTIS Part Ii Submission Date
01-02-2024
Latest Decision Or Authorization Date
22-03-2024
Processing Time Days
50
Number Of Sites
1
Number Of Participants
5

Sites

Site Name
Azienda Ospedaliero Universitaria Delle Marche
Contact Person Name
Michele Luchetti Gentiloni
Contact Person Email
m.luchetti@staff.univpm.it

Estonia

Earliest CTIS Part Ii Submission Date
01-02-2024
Latest Decision Or Authorization Date
05-03-2024
Processing Time Days
33
Number Of Sites
3
Number Of Participants
11

Sites

Site Name
North Estonia Medical Centre Foundation
Contact Person Name
Eve Kai Raussi
Site Name
East Tallinn Central Hospital
Contact Person Name
Tiina Veldi
Contact Person Email
tiina.veldi@itk.ee
Site Name
MediTrials OÜs
Contact Person Name
Raili Muller
Contact Person Email
raili.myller@meditrials.ee

Greece

Earliest CTIS Part Ii Submission Date
01-02-2024
Latest Decision Or Authorization Date
09-04-2024
Processing Time Days
68
Number Of Sites
2
Number Of Participants
7

Sites

Site Name
University General Hospital Of Heraklion
Department Name
Internal Medicine/Rheumatology
Contact Person Name
Prodromos Sidiropoulos
Contact Person Email
sidiropp@med.uoc.gr
Site Name
Athens Naval Hospital
Department Name
Rheumatology Clinic
Contact Person Name
Gkikas Katsifis
Contact Person Email
katsifisg@yahoo.gr

Germany

Earliest CTIS Part Ii Submission Date
01-02-2024
Latest Decision Or Authorization Date
29-02-2024
Processing Time Days
28
Number Of Sites
2
Number Of Participants
2

Sites

Site Name
MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH
Contact Person Name
Andrea Everding
Contact Person Email
studienzentrum@hotmail.com
Site Name
St. Elisabeth Gruppe GmbH Katholische Kliniken Rhein-Ruhr
Contact Person Name
Xenofon Baraliakos

Portugal

Earliest CTIS Part Ii Submission Date
01-02-2024
Latest Decision Or Authorization Date
29-02-2024
Processing Time Days
28
Number Of Sites
3
Number Of Participants
4

Sites

Site Name
Instituto Portugues De Reumatologia
Contact Person Name
Filipe Alexander Duart Barcelos
Contact Person Email
fduartebarcelos@gmail.com
Site Name
Centro Hospitalar Universitario De Lisboa Norte E.P.E.
Contact Person Name
Elsa Sousa
Contact Person Email
elsa-sousa@hotmail.com
Site Name
Unidade Local De Saude Do Alto Minho E.P.E.
Contact Person Name
Jose Costa
Contact Person Email
josecosta99@gmail.com

Hungary

Earliest CTIS Part Ii Submission Date
01-02-2024
Latest Decision Or Authorization Date
01-03-2024
Processing Time Days
29
Number Of Sites
5
Number Of Participants
27

Sites

Site Name
Betegapolo Irgalmasrend Budai Irgalmasrendi Korhaz
Contact Person Name
Bernadette Rojkovich
Contact Person Email
rojkovich.b@gmail.com
Site Name
Betegapolo Irgalmasrend Budai Irgalmasrendi Korhaz
Contact Person Name
Bernadette Rojkovich
Contact Person Email
rojkovich.b@gmail.com
Site Name
Vital-Medicina Kft.
Contact Person Name
Edit Drescher
Contact Person Email
dr.dreschere@gmail.com
Site Name
CRU Hungary Kft.
Contact Person Name
Katalin Fazekas
Contact Person Email
dr.katalin.fazekas@gmail.com
Site Name
University Of Szeged
Contact Person Name
Attila Balog
Contact Person Email
balog.attila@med.u-szeged.hu

Spain

Earliest CTIS Part Ii Submission Date
01-02-2024
Latest Decision Or Authorization Date
01-03-2024
Processing Time Days
29
Number Of Sites
4
Number Of Participants
27

Sites

Site Name
Hospital Universitario Y Politecnico La Fe
Contact Person Name
Jose Andrés Román Ivorra
Contact Person Email
roman_jan@gva.es
Site Name
Parc Tauli Hospital Universitari
Contact Person Name
Mireia Moreno
Contact Person Email
moreno.parctauli@gmail.com
Site Name
Complexo Hospitalario Universitario A Coruna
Contact Person Name
Francisco Blanco Garcia
Contact Person Email
fblagar@sergas.es
Site Name
Hospital Universitario 12 De Octubre
Contact Person Name
Beatriz Joven Ibanez
Contact Person Email
ceic@h12o.es

Sponsor

Primary sponsor

Full Name
AbbVie Deutschland GmbH & Co. KG
Organisation Type
Pharmaceutical company
Country Of Registered Address
Germany

Third parties

  • {"country":"United States","full_name":"Endpoint Clinical Inc.","duties_or_roles":"sponsorDuties codes: [3]","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Medpoint Communications Inc.","duties_or_roles":"sponsorDuties: code 15 (Document Portal)","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services S.a.r.l.","duties_or_roles":"sponsorDuties: code 4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Signant Health Global LLC","duties_or_roles":"sponsorDuties: code 6","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"WCG Clinical Inc.","duties_or_roles":"sponsorDuties: code 15 (ACI Adjudication Committee)","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
Risankizumab (ABBV-066)
Active Substance
RISANKIZUMAB
Modality
Monoclonal antibody
Routes Of Administration
Subcutaneous
Route
Subcutaneous
Authorisation Status
Authorised (prodAuthStatus=1)
Starting Dose
150 mg
Dose Levels
150 mg
Frequency
Dosing in Period 1 at Week 0, Week 4, and Week 16; Period 2 dosing at Week 24, Week 28 and every 12 weeks thereafter until Week 316
Maximum Dose
Max total dose amount recorded: 4350 (mg, product field)
Investigational Product Name
Placebo for Risankizumab Solution for Injection 90 mg/mL
Modality
Other

Related trials

Other published trials that may interest you.