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: 18.0Level: PTClassification code 10016207Term: Familial mediterranean feverSystem Organ Class: 10010331 - Congenital, familial and genetic disorders; MedDRA version: 18.0Level: LLTClassification code 10067783Term: Tumor necrosis factor receptor-associated periodic syndromeSystem Organ Class: 10010331 - Congenital, familial and genetic disorders; Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]; MedDRA version: 18.0Level: PTClassification code 10072010Term: Hyper IgD syndromeSystem Organ Class: 10010331 - Congenital, familial and genetic disorders

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06-25
• Last Update Posted: 21 August 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. Male and female patients >28 days but <2 years old at the time of the screening visit will be enrolled in the open label arm only.
• Confirmed diagnosis at screening
• Active flare and CRP >10mg/L at randomization

Are the trial subjects under 18? yes
Number of subjects for this age range: 105
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 alanine aminotransferase (ALT) =3x ULN
c. Elevated aspartate aminotransferase (AST) =3x 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
j. 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