Canakinumab in Patients With Active Hyper-IgD Syndrome

• Status: Completed
• Trial end date: 2014-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Antibodies, Monoclonal

Criteria

Inclusion Criteria:

1. Patients with a diagnosis of HIDS proven by DNA analysis and/or enzymatic studies.

2. 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).

3. 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:

1. Pregnant or nursing (lactating) women.

2. History of being immunocompromised, including a positive HIV at screening (ELISA and Western blot) test result.

3. Positive Hepatitis B or Hepatitis C.

4. Live vaccinations within 3 months prior to the start of the trial

5. Positive tuberculosis screening test.

Other protocol-defined inclusion/exclusion criteria may apply