CompletedPhase 2

Canakinumab in Patients With Active Hyper-IgD Syndrome

Spain9 participantsStarted 2011-03

Plain-language summary

This pilot study is designed to evaluate the efficacy, the safety, and the pharmacokinetics (PK) / pharmacodynamics (PD) of canakinumab treatment in patients with HIDS.

Who can participate

Age range24 Months

SexALL

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Inclusion criteria

✓. Patients with a diagnosis of HIDS proven by DNA analysis and/or enzymatic studies.
✓. At time of start of drug treatment: active HIDS as evidenced by a physician global assessment of HIDS flare severity ≥ 2 and CRP values \>10 mg/L (normal CRP \< or = 10 mg/L).
✓. Patients who have a history of \> or = 3 febrile acute HIDS flares in a 6-month period when not receiving prophylaxis treatment (e.g. anakinra daily treatment) with a duration of each flare lasting \> or = 4 days and limiting the normal daily activities.

Exclusion criteria

✕. Pregnant or nursing (lactating) women.
✕. History of being immunocompromised, including a positive HIV at screening (ELISA and Western blot) test result.
✕. Positive Hepatitis B or Hepatitis C.
✕. Live vaccinations within 3 months prior to the start of the trial
✕. Positive tuberculosis screening test.

What they're measuring

Number of Flares Per Participant During Historical Period and Treatment Period

Timeframe: Historical period, Month 6 (End of treatment period)

Trial details

NCT IDNCT01303380

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2014-07

Results submitted2015-07-15

View on ClinicalTrials.gov More Mevalonate Kinase Deficiency trials