Schnitzler syndrome MedDRA version: 20.0 Level: PT Classification code 10062908 Term: Schnitzler's syndrome System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Interventions
Trade Name: Ilaris
Product Name: Ilaris
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: Canakinumab
CAS Number: 914613-48-2
Current Sponsor code: ACZ885
Other descriptive n
Sponsors
Charité - University Hospital of Berlin
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Adults (18 years or older) Informed consent signed and dated Able to read, understand and willing to sign the informed consent form and abide with study procedures SchS diagnosis based on diagnostic criteria defined in Appendix Patients with symptomatic SchS (as defined by the physician’s global assessment with a minimum score of 8 and CRP >ULN) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 15 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: Concurrent/ongoing treatment with anakinra (Kineret®) or recent treatment within 48 hours prior to day 0 Concurrent/ongoing treatment with other biologics or recent treatment (less than 5 half lives) Concurrent/ongoing treatment with immunosuppressives (e.g. cyclosporine, methotrexate, dapsone or others) within 4 weeks or 5 half lives prior to day 0, whichever is longer Concurrent/ongoing treatment with high doses of systemic steroids (>20mg prednisolone equivalent) Evidence of recurrent or latent systemic infection such as tuberculosis Significant medical condition rendering the patient immunocompromised or not suitable for a clinical trial Treatment with a live (attenuated) virus vaccine during three months prior to day 0 and for 3 months after end of study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the effect of canakinumab on the clinical signs and symptoms of Schnitzler Syndrome (SchS);Secondary Objective: To assess the safety of canakinumab in subjects with SchS To assess the change in biomarkers of inflammation (C-reactive protein, serum amyloid A, erythrocyte sedimentation rate) during the treatment period with canakinumab To assess changes in patients’ quality of life during the treatment period with canakinumab ;Primary end point(s): Proportion of patients with complete response (based on physician’s global assessment on overall autoinflammatory disease activity) at day 7 in the canakinumab treated group as compared to the placebo group ;Timepoint(s) of evaluation of this end point: at the end of the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Proportion of patients with partial response (based on physician’s global assessment on overall autoinflammatory disease activity) at day 7 in the canakinumab treated group as compared to the placebo group Change in the patient based Schnitzler Activity Score (SCHAS) during the treatment period (The SCHAS combines five symptoms, i.e. urticarial rash, periodic fever, joint pain, bone/muscle pain and fatigue; daily SCHAS values will be documented using daily health assessment forms [DHAFs]) Overall efficacy (response rate) of canakinumab as determined by the physician’s global assessment of autoinflammatory disease activity for symptoms: Urticarial rash, fatigue, fever/chills, myalgia and arthralgia Time to relapse of clinical symptoms of SchS after canakinumab treatment Safety of patients treated with canakinumab: This includes physical examination, routine safety laboratory assessments, vital signs and adverse event reporting Change in inflammation markers (ESR, CRP, SAA) during the treatment period Change in the patient’s quality of life (assessed by the Dermatology Life Quality Index and SF 36) during the treatment period ;Timepoint(s) of evaluation of this end point: at the end of the study | — |
Countries
Germany
Contacts
Public ContactClinical Trials Information
Charité - University Hospital of Berlin
Outcome results
None listed