Study of the Efficacy and Safety of Goflikicept and Olokizumab as the Second-line Therapy in Patients With Still's Disease

ConditionStill Disease
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorR-Pharm International, LLC

About this trial

The primary objective of the study is to evaluate the efficacy and safety of goflikicept (GFC) and olokizumab (OKZ) in patients with Still's disease

Eligibility criteria

Qualifiers

Voluntarily signed and dated Informed Consent Form (ICF) of the patient agreed to take part in this Study

Confirmed diagnosis of Adult-Onset Still's Disease (AOSD) based on the Yamaguchi M. diagnostic criteria

Patient with active disease or low disease activity per DAVID criteria

In case of current corticosteroid (CS) use, doses must be stable for at least 2 weeks prior to Day 0. The maximum allowed dose of CS is 1 mg/kg/day, up to 60 mg/day (prednisolone equivalent)

Disqualifiers

Hypersensitivity to the active and/or inactive ingredients of the investigational product

Rilonacept - less than 6 weeks prior to Day 0

Canakinumab - less than 20 weeks prior to Day 0

Anakinra - less than 1 week prior to Day 0

Trial design

Treatments tested in this trial

  • Placebo
  • Goflikicept
  • Olokizumab

Treatment groups

52 Participants
are divided into 3 treatment groups

Sponsors and collaborators