Study of efficacy and safety of canakinumab in patients with Hereditary Periodic Fevers

Phase 1

• Conditions: Hereditary Periodic Fevers (TRAPS, HIDS, or crFMF); MedDRA version: 19.0Level: PTClassification code 10016207Term: Familial mediterranean feverSystem Organ Class: 10010331 - Congenital, familial and genetic disorders; MedDRA version: 19.0Level: LLTClassification code 10067783Term: Tumor necrosis factor receptor-associated periodic syndromeSystem Organ Class: 10010331 - Congenital, familial and genetic disorders; MedDRA version: 19.0Level: PTClassification code 10072010Term: Hyper IgD syndromeSystem Organ Class: 10010331 - Congenital, familial and genetic disorders; Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]

• Registration Number: EUCTR2013-004291-35-NL
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07-24
• Last Update Posted: 4 September 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

Patient's written informed consent (or parent's written informed consent in case of pediatric patient) at screening
- Male and female patients at least 2 years of age at the time of the screening visit.
- Confirmed diagnosis and active flare at randomization
- CRP >10mg/L at randomization
Are the trial subjects under 18? yes
Number of subjects for this age range: 100
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 80
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Use of the following therapies (within varying protocol defined timeframes): Corticosteroids, anakinra, canakinumab, rilonacept, tocilizumab, TNF inhibitors, abatacept, tofacitinib, rituximab, leflunomide, thalidomide, cyclosporine, intravenous immunoglobulin, 6-Merceptopurine, azathioprine, cyclophosphamide, or chlorambucil, any other investigational biologics
- History of malignancy of any organ system (other than localized basal cell carcinoma of the skin or in - situ cervical cancer), treated or untreated
- Significant medical diseases, including but not limited to the following:
a. History of organ transplantation
b. Elevated liver enzymes =2x ULN
d. Increase in total bilirubin
e. Serious hepatic disorder (Child-Pugh scores B or C)
f. Chronic Kidney Disease
g. Thyroid disease
h. Diagnosis of active peptic ulcer disease
i. Coagulopathy j. Significant CNS effects including vertigo and dizziness
- Any conditions or significant medical problems which immunecompromise the patient and/or places the patient at unacceptable risk for immunomodulatory therapy
- Live vaccinations within 3 months prior to the start of the trial, during the trial, and up to 3 months following the last dose

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified