ACZ 885 (Novartis) continues positively in Phase II trial for TRAPS

An ongoing Phase II, open-label, multicenter study is investigating the efficacy and safety of ACZ 885 ,from Novartis, in patients with active Tumor Necrosis Factor (TNF) Receptor-associated Periodic Syndrome (TRAPS).

Patients received ACZ 885 150 mg (or increased to 300 mg for those without complete or almost complete response by Day 8) every four weeks for four months. This was followed by a second, treatment withdrawal, phase of up to five months where the patients restarted ACZ 885 treatment upon their first relapse. The third, ongoing, phase is a 24-month period involving open-label treatment every four weeks. The primary endpoint of the study is complete or almost complete response at Day 15.

Ninety percent of patients with TRAPS treated with ACZ 885 experienced clinical remission (absent or minimal signs and symptoms of TRAPS) after one week of treatment, and two patients had their dose increased to 300 mg. After two weeks of treatment, 100% of patients achieved clinical remission and 95% of patients had achieved a complete or almost complete response, which was maintained until the end of treatment with monthly dosing.