Clinical trial • Phase II • Immunology
Risankizumab for Psoriatic arthritis
Phase II trial of Risankizumab for Psoriatic arthritis. Randomised. 57 participants.
Overview
- Trial Therapeutic Area
- Immunology
- Trial Disease
- Psoriatic arthritis
- Trial Stage
- Phase II
- Drug Modality
- Monoclonal antibody
Key dates
- Initial CTIS Submission Date
- 12-03-2025
- First CTIS Authorization Date
- 25-06-2025
Trial design
Randomised Phase II trial in Czechia, France, Hungary and others.
- Randomised
- Yes
- Target Sample Size
- 57
Eligibility
Recruits 57 Vulnerable population not selected; trial enrols adult subjects only. Informed consent obtained from adult participants; no assent procedures described..
- Vulnerable Population
- Vulnerable population not selected; trial enrols adult subjects only. Informed consent obtained from adult participants; no assent procedures described.
Inclusion criteria
- {"criterion_text":"- Subject is willing and able to comply with procedures required in the Master Protocol and substudies."}
- {"criterion_text":"- Subject has a documented clinical diagnosis of PsA with symptom onset at least 6 months prior to the Screening Visit and fulfillment of the Classification Criteria for Psoriatic Arthritis (CASPAR) at Screening Visit."}
- {"criterion_text":"- Subject has active disease defined as ≥ 3 tender joints (based on 68 joint count) and ≥ 3 swollen joints (based on 66 joint count) at both the Screening Visit and Baseline."}
- {"criterion_text":"- Subject has active plaque PsO and/or a documented history of plaque PsO."}
Exclusion criteria
- {"criterion_text":"- Subjects who have had major surgery performed within 12 weeks prior to randomization or plan to have a major surgery during conduct of the study (e.g., aneurysm removal, stomach ligation)."}
- {"criterion_text":"- Subjects with the following chronic or active infections: Are infected with human immunodeficiency virus (HIV), active hepatitis B virus (HBV) or hepatitis C virus(HCV) infection, active tuberculosis(TB)"}
- {"criterion_text":"- Active skin disease other than PsO which could interfere with the assessment of PsO."}
- {"criterion_text":"- History of fibromyalgia, any arthritis with onset prior to age 17 years, or current diagnosis of inflammatory joint disease other than PsA (including but not limited to rheumatoid arthritis, gout, overlap connective tissue diseases, scleroderma, polymyositis, dermatomyositis, systemic lupus erythematosus)."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response at Week 16","definition_or_measurement_approach":"ACR50 response assessed at Week 16 (American College of Rheumatology 50% response criteria at Week 16)."}
Secondary endpoints
- {"endpoint_text":"- Percentage of Participants Achieving Minimal Disease Activity (MDA) Response at Week 16","definition_or_measurement_approach":"MDA response assessed at Week 16."}
- {"endpoint_text":"- Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 16","definition_or_measurement_approach":"ACR20 response assessed at Week 16."}
- {"endpoint_text":"- Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response at Week 16","definition_or_measurement_approach":"ACR70 response assessed at Week 16."}
- {"endpoint_text":"- Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 75 Response at Week 16 (in the subset of participants with a PsO BSA ≥ 3% at Baseline)","definition_or_measurement_approach":"PASI75 response at Week 16 in subset with baseline PsO BSA ≥ 3%."}
Recruitment
- Planned Sample Size
- 57
- Recruitment Window Months
- 30
- Consent Approach
- Informed consent obtained from adult participants. Country-specific main and optional ICFs are provided (document titles indicate ICFs for Poland, Hungary, France, Czechia). A pregnancy-specific ICF is available for Poland (document title). No assent procedures described for children, as the trial enrols adult subjects.
Geography
- Total Number Of Sites
- 21
- Total Number Of Participants
- 63
Czechia
- Earliest CTIS Part Ii Submission Date
- 21-05-2025
- Latest Decision Or Authorization Date
- 05-02-2026
- Processing Time Days
- 260
- Number Of Sites
- 5
- Number Of Participants
- 15
Sites
- Site Name
- Revmatologie s.r.o.
- Department Name
- Rheumatology
- Principal Investigator Name
- Petr Němec
- Principal Investigator Email
- revmatologie.nemec@seznam.cz
- Contact Person Name
- Petr Němec
- Contact Person Email
- revmatologie.nemec@seznam.cz
- Site Name
- PV Medical Services s.r.o.
- Department Name
- Rheumatology
- Principal Investigator Name
- Petr Vitek
- Principal Investigator Email
- pv.medical@seznam.cz
- Contact Person Name
- Petr Vitek
- Contact Person Email
- pv.medical@seznam.cz
- Site Name
- L.K.N. Arthrocentrum s.r.o.
- Department Name
- Rheumatology
- Principal Investigator Name
- Libor Novosad
- Principal Investigator Email
- libor.novosad@email.cz
- Contact Person Name
- Libor Novosad
- Contact Person Email
- libor.novosad@email.cz
- Site Name
- Fakultni Thomayerova nemocnice
- Department Name
- Rheumatology
- Principal Investigator Name
- Petr Kopsa
- Principal Investigator Email
- petr.kopsa@ftn.cz
- Contact Person Name
- Petr Kopsa
- Contact Person Email
- petr.kopsa@ftn.cz
- Site Name
- Medical Plus s.r.o.
- Department Name
- Rheumatology
- Principal Investigator Name
- Eva Dokoupilova
- Principal Investigator Email
- evadokoupil@gmail.com
- Contact Person Name
- Eva Dokoupilova
- Contact Person Email
- evadokoupil@gmail.com
France
- Earliest CTIS Part Ii Submission Date
- 21-05-2025
- Latest Decision Or Authorization Date
- 09-02-2026
- Processing Time Days
- 264
- Number Of Sites
- 5
- Number Of Participants
- 15
Sites
- Site Name
- Centre Hospitalier Regional Universitaire De Tours
- Department Name
- Service de Rhumatologie
- Principal Investigator Name
- Philippe Goupille
- Principal Investigator Email
- philippe.goupille@univ-tours.fr
- Contact Person Name
- Philippe Goupille
- Contact Person Email
- philippe.goupille@univ-tours.fr
- Site Name
- Centre Hospitalier Universitaire De Nice
- Department Name
- Service de Rhumatologie
- Principal Investigator Name
- Christian Roux
- Principal Investigator Email
- roux.c2@chu-nice.fr
- Contact Person Name
- Christian Roux
- Contact Person Email
- roux.c2@chu-nice.fr
- Site Name
- Ass Hospitaliere Protestante De Lyon
- Department Name
- Service de Rhumatologie
- Principal Investigator Name
- André Bash
- Principal Investigator Email
- andcroco@gmail.com
- Contact Person Name
- André Bash
- Contact Person Email
- andcroco@gmail.com
- Site Name
- Centre Hospitalier Universitaire D Orleans
- Department Name
- Service IPROS_ Rhumatologie
- Principal Investigator Name
- Carine Salliot
- Principal Investigator Email
- carine.salliot@chr-orleans.fr
- Contact Person Name
- Carine Salliot
- Contact Person Email
- carine.salliot@chr-orleans.fr
- Site Name
- Pellegrin Hospital
- Department Name
- Service de Rhumatologie
- Principal Investigator Name
- Nadia Mehsen-Cetre
- Principal Investigator Email
- nadia.mehsen@chu-bordeaux.fr
- Contact Person Name
- Nadia Mehsen-Cetre
- Contact Person Email
- nadia.mehsen@chu-bordeaux.fr
Hungary
- Earliest CTIS Part Ii Submission Date
- 28-05-2025
- Latest Decision Or Authorization Date
- 06-02-2026
- Processing Time Days
- 254
- Number Of Sites
- 6
- Number Of Participants
- 18
Sites
- Site Name
- Complex Rendelo Med Zrt.
- Department Name
- -
- Principal Investigator Name
- Tunde Varga
- Principal Investigator Email
- info@cmed.hu
- Contact Person Name
- Tunde Varga
- Contact Person Email
- info@cmed.hu
- Site Name
- Vital-Medicina Kft.
- Department Name
- -
- Principal Investigator Name
- Edit Drescher
- Principal Investigator Email
- study.vitalmedicalcenter@gmail.com
- Contact Person Name
- Edit Drescher
- Contact Person Email
- study.vitalmedicalcenter@gmail.com
- Site Name
- Revita Kft.
- Department Name
- -
- Principal Investigator Name
- Marta Megyaszai
- Principal Investigator Email
- info@revitarendelo.hu
- Contact Person Name
- Marta Megyaszai
- Contact Person Email
- info@revitarendelo.hu
- Site Name
- Borsod-Abauj-Zemplen Varmegyei Koezponti Korhaz Es Egyetemi Oktatokorhaz
- Department Name
- Reumatologiai Osztaly
- Principal Investigator Name
- Zsofia Kardos
- Principal Investigator Email
- dr.kardos.zsofia@bazmkorhaz.hu
- Contact Person Name
- Zsofia Kardos
- Contact Person Email
- dr.kardos.zsofia@bazmkorhaz.hu
- Site Name
- University Of Debrecen
- Department Name
- Reumatologiai es Immunologiai Klinika
- Principal Investigator Name
- Janos Gaal
- Principal Investigator Email
- gaalja65@gmail.com
- Contact Person Name
- Janos Gaal
- Contact Person Email
- gaalja65@gmail.com
- Site Name
- Semmelweis University
- Department Name
- III. Reumatologiai Osztaly
- Principal Investigator Name
- Peter Balint
- Principal Investigator Email
- balint.peter.vince@semmelweis.hu
- Contact Person Name
- Peter Balint
- Contact Person Email
- balint.peter.vince@semmelweis.hu
Poland
- Earliest CTIS Part Ii Submission Date
- 29-05-2025
- Latest Decision Or Authorization Date
- 08-02-2026
- Processing Time Days
- 255
- Number Of Sites
- 5
- Number Of Participants
- 15
Sites
- Site Name
- Medicover Integrated Clinical Services Sp. z o.o.
- Principal Investigator Name
- Katarzyna Kolossa
- Principal Investigator Email
- k.kolossa@naszlekarz.pl
- Contact Person Name
- Katarzyna Kolossa
- Contact Person Email
- k.kolossa@naszlekarz.pl
- Site Name
- Osteo-Medic s.c. Artur Racewicz, Jerzy Supronik
- Principal Investigator Name
- Artur Racewicz
- Principal Investigator Email
- osteo_medic_bial@op.pl
- Contact Person Name
- Artur Racewicz
- Contact Person Email
- osteo_medic_bial@op.pl
- Site Name
- Mcbk s.c. Iwona Czajkowska Anna Podrazka Szczepaniak
- Principal Investigator Name
- Anna Małys-Bryłka
- Principal Investigator Email
- abrylka@mcbk.pl
- Contact Person Name
- Anna Małys-Bryłka
- Contact Person Email
- abrylka@mcbk.pl
- Site Name
- Klinika Reuma Park Sp. z o.o. S.K.
- Principal Investigator Name
- Paula Śliwińska-Stańczyk
- Principal Investigator Email
- stanczyki@post.pl
- Contact Person Name
- Paula Śliwińska-Stańczyk
- Contact Person Email
- stanczyki@post.pl
- Site Name
- Centrum Kliniczno-Badawcze J.Brzezicki B.Gornikiewicz-Brzezicka Lekarze sp.p.
- Principal Investigator Name
- Jan Brzezicki
- Principal Investigator Email
- jan.brzezicki@ckb.elblag.pl
- Contact Person Name
- Jan Brzezicki
- Contact Person Email
- jan.brzezicki@ckb.elblag.pl
Sponsor
Primary sponsor
- Full Name
- AbbVie Deutschland GmbH & Co. KG
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Germany
Contract research organisations
- Name
- Iqvia Biotech LLC
- Responsibilities
- 3
- Name
- Medidata Solutions Inc.
- Responsibilities
- Electronic Patient-Reported Outcome Services
- Name
- WCG Clinical Inc.
- Responsibilities
- CAC Adjudication & Rater Training
- Name
- Labcorp Central Laboratory Services LP
- Responsibilities
- 4
Third parties
- {"country":"United States","full_name":"Iqvia Biotech LLC","duties_or_roles":"3","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"Electronic Patient-Reported Outcome Services","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"WCG Clinical Inc.","duties_or_roles":"CAC Adjudication & Rater Training","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"4","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- ABBV-066
- Active Substance
- Risankizumab
- Modality
- Monoclonal antibody
- Routes Of Administration
- Subcutaneous injection
- Route
- Subcutaneous injection
- Authorisation Status
- Authorised
- Investigational Product Name
- Lutikizumab
- Active Substance
- Lutikizumab
- Modality
- Monoclonal antibody
- Routes Of Administration
- Subcutaneous injection
- Route
- Subcutaneous injection
- Authorisation Status
- Authorised
- Combination Treatment
- Yes
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