Still's Disease, Adult-Onset Clinical Trial
Official title:
Open-label, Multicenter, Dose-escalating Phase II Study to Investigate the Safety, Tolerability, and Early Signs of Efficacy of Subcutaneous Administrations of Tadekinig Alfa (IL-18BP) in Patients With Adult -Onset Still's Disease (AoSD) During 12 Weeks
The objective of this study is to assess safety, tolerability and early signs of efficacy of
the investigational drug Tadekinig alfa in Adult-onset Still's disease, a rare polygenic
auto-inflammatory disorder for which treatment remains empirical.
This disease is characterized by a daily spiking fever, arthralgia / arthritis, and skin
rashes with frequent components of sore throat, lymphadenopathies and neutrophilic
leukocytosis. The etiology is unknown. In addition to the above-mentioned clinical features,
the diagnosis includes some laboratory components that reflect the systemic inflammation:
high erythro-sedimentation rate, C-reactive protein, high serum ferritin and high levels of
interleukin 18 (IL-18).
Tadekinig alfa is the drug name for recombinant human interleukin-18 binding protein
(IL-18BP). This investigational drug was tested in healthy volunteers, psoriasis and
rheumatoid arthritis patients in phase I studies. It demonstrated good safety and
tolerability profile with only mild adverse events in the injection site.
The hypothesis of this study considers high levels of IL-18 during active Adult-onset
still's disease as the therapeutic target. Treatment with IL-18BP will permit to inhibit the
pro-inflammatory cascade triggered by IL-18 and may help to manage the different components
of the disease.
This study is an open label, dose-finding study involving multiple centers in Europe. Two
dose cohorts (80mg and 160mg) were treated during twelve weeks and followed-up for four more
weeks.
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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