EUCTR2010-024156-28-DEActive, not recruitingPhase 1
A multi-center, double-blind, placebo-controlled phase II study of the efficacy and safety of canakinumab in subjects with Schnitzler syndrome - ILESCH
Charité - University Hospital of Berlin0 sites20 target enrollmentStarted: April 7, 2011Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 20
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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
- •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
Investigators
Similar Trials
Active, not recruiting
Phase 1
A study to evaluate whether macitentan is an effective and safe treatment for patients with heart failure with preserved ejection fraction and pulmonary vascular diseaseEUCTR2016-003653-15-DKACTELION Pharmaceuticals Ltd300
Active, not recruiting
Phase 1
A study to evaluate whether macitentan is an effective and safe treatment for patients with heart failure with preserved ejection fraction and pulmonary vascular diseaseEUCTR2016-003653-15-SEACTELION Pharmaceuticals Ltd147
Active, not recruiting
Phase 1
A study to evaluate whether macitentan is an effective and safe treatment for patients with heart failure with preserved ejection fraction and pulmonary vascular diseaseHeart failure with preserved ejection fraction and pulmonary vascular diseaseMedDRA version: 20.1Level: LLTClassification code 10076396Term: Heart failure with preserved ejection fractionSystem Organ Class: 100000004849EUCTR2016-003653-15-GBACTELION Pharmaceuticals Ltd147
Active, not recruiting
Phase 1
A study to evaluate whether macitentan is an effective and safe treatment for patients with heart failure with preserved ejection fraction and pulmonary vascular diseaseHeart failure with preserved ejection fraction and pulmonary vascular diseaseMedDRA version: 20.1Level: LLTClassification code 10076396Term: Heart failure with preserved ejection fractionSystem Organ Class: 100000004849EUCTR2016-003653-15-HUACTELION Pharmaceuticals Ltd300
Active, not recruiting
Phase 1
A study to evaluate whether macitentan is an effective and safe treatment for patients with heart failure with preserved ejection fraction and pulmonary vascular diseaseHeart failure with preserved ejection fraction and pulmonary vascular diseaseMedDRA version: 20.1Level: LLTClassification code 10076396Term: Heart failure with preserved ejection fractionSystem Organ Class: 100000004849EUCTR2016-003653-15-BGACTELION Pharmaceuticals Ltd147