A Phase 2 Multicenter, Randomized, Platform Study of Targeted Therapies for the Treatment of Adult Subjects with Active Psoriatic Arthritis
Key facts
- Where
- Budapest, Budapest II, Debrecen, Miskolc, Székesfehérvár és Veszprem, MagyarországSee the 6 sites
- Phase
- 2. fázis
Where in Magyarország
- Semmelweis UniversityBudapest, MagyarországTaking people
- Revita Kft.Budapest II, MagyarországTaking people
- University of DebrecenDebrecen, MagyarországTaking people
- Borsod-Abauj-Zemplen Varmegyei Koezponti Korhaz Es Egyetemi OktatokorhazMiskolc, MagyarországTaking people
- Complex Rendelo Med Zrt.Székesfehérvár, MagyarországTaking people
- Vital-Medicina Kft.Veszprem, MagyarországTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- AbbVie Deutschland GmbH & Co. KG
- Trial code
- EU 2024-519291-11-00
- Record updated
- 2026. február 9.
- Original description
- To evaluate the efficacy of lutikizumab and risankizumab combination therapy and the respective monotherapies for the treatment of active psoriatic arthritisRead full original descriptionShow less
- To evaluate the efficacy of lutikizumab and risankizumab combination therapy and the respective monotherapies for the treatment of active psoriatic arthritis
- To assess the safety and tolerability of lutikizumab and risankizumab combination therapy and the respective monotherapies for the treatment of active psoriatic arthritis
Inclusion: Subject is willing and able to comply with procedures required in the Master Protocol and substudies; 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; 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; Subject has active plaque PsO and/or a documented history of plaque PsO.
Exclusion: 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); 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); 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); Active skin disease other than PsO which could interfere with the assessment of PsO.