Mode
Text Size
Log in / Sign up
Phase 3 N=203 Randomized Quadruple-blind Treatment

Study of Efficacy and Safety of Canakinumab in Patients With Hereditary Periodic Fevers

Hereditary Periodic Fevers

Enrolled (actual)
203
Serious AEs
9.4%
Results posted
Mar 2017
Primary outcome: Primary: Percentage of Participants With Resolution of Initial Flare and Absence of New Flares up to the End of the Randomized Treatment Epoch (16 Weeks) — 61.29; 6.25; 35.14; 5.71 Percentage of participants — p=<0.0001

Study Design & Population

Study type
Interventional
Phase
Phase 3
Interventions
Canakinumab (Drug); Placebo (Drug)
Age
Pediatric, Adult, Older Adult · 0+ yrs
Sex
All
Sponsor
Novartis Pharmaceuticals
Primary completion
Jul 2017

Outcome Measures

OutcomeResultp-value
PRIMARY
Percentage of Participants With Resolution of Initial Flare and Absence of New Flares up to the End of the Randomized Treatment Epoch (16 Weeks)
61.29; 6.25; 35.14; 5.71; 45.45; 8.33 <0.0001 sig
SECONDARY
Percentage of Participants Who Achieve Physician's Global Assessment (PGA) < 2
64.52; 9.38; 45.95; 5.71; 45.45; 4.17 <0.0001 sig
SECONDARY
Percentage of Participants With the Serologic Remission
67.74; 6.25; 40.54; 5.71; 36.36; 8.33 <0.0001 sig
SECONDARY
Percentage of Participants With Normalized Serum Amyloid A (SAA) Level
25.81; 0.00; 13.51; 2.86; 27.27; 0.00 0.0286 sig
SECONDARY
Percentage of Participants of Canakinumab Responders From Epoch 2 Who Maintained a Clinically Meaningful Response (Absence of New Flares) (40 Weeks)
77.8; 30.0; 50.0; 14.3; 75.0; 40.0 0.0513

Summary

This study is to determine whether canakinumab is able to induce and maintain a clinically meaningful reduction of disease activity in participants with Hereditary Periodic Fevers (HPF) compared to placebo.

Eligibility Criteria

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 10mg/L at randomization 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 ≥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 - 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02059291). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

Back to search