Canakinumab in Patients With Active Hyper-IgD Syndrome
- Sponsor
- Novartis Pharmaceuticals
- Study ID
- NCT01303380
- Phase
- PHASE2
- Status
- Completed
Conditions
- Mevalonate Kinase Deficiency
Eligibility Criteria
- Sex
- ALL
- Age
- 24 Months - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Canakinumab — DRUG
Study Details
This pilot study is designed to evaluate the efficacy, the safety, and the pharmacokinetics (PK) / pharmacodynamics (PD) of canakinumab treatment in patients with HIDS.
Key Dates
- Start date
- Mar 31, 2011
- Status verified
- Oct 2015
- Primary completion
- Jul 31, 2014
- Completion
- Jul 31, 2014
Study Design
- Enrollment
- 9 participants (actual)
- Allocation
- NON_RANDOMIZED
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Canakinumab
Primary Outcome Measure
Number of Flares Per Participant During Historical Period and Treatment Period [ Time Frame: Historical period, Month 6 (End of treatment period) ]