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Clinical Trials

Date: 2012-06-06

Type of information: Results

phase: 2

Announcement: results

Company: Novartis (Switzerland)

Product: ACZ885 (canakinumab)

Action mechanism:

ACZ885 is a fully human monoclonal antibody that inhibits IL-1 beta, which is an important part of the body\'s immune system defenses. Excessive production of IL-1 beta plays a major role in certain inflammatory diseases, including SJIA and TRAPS. ACZ885 works by neutralizing IL-1 beta for a sustained period of time, thereby inhibiting inflammation.
Under the brand name Ilaris®, ACZ885 is approved in more than 60 countries, including the EU, US and Switzerland for the treatment of adults and children as young as four years with CAPS, a rare, lifelong, inflammatory disorder with debilitating symptoms. ACZ885 is also being studied in other diseases in which IL-1 beta plays a key role in causing inflammation, such as gouty arthritis and cardiovascular disease. ACZ885 is not approved for the treatment of SJIA or TRAPS. Not all potential patients with these diseases would be eligible for treatment with ACZ885, if approved.

Disease:

TNF Receptor-Associated Syndrome (TRAPS)

Therapeutic area: Autoimmune diseases - Rare diseases

Country:

Trial details:

The ongoing Phase II, open-label, multicenter study investigating the efficacy and safety of ACZ885 in patients with active TRAPS involves 20 patients with a median age of 39 years (range, 7-78 years), who receive ACZ885 150 mg (or 300 mg) every four weeks. The primary endpoint of the study, is complete or almost complete response at Day 15.
Complete response was defined as clinical remission and normal CRP and/or SAA levels. Almost complete response was defined as clinical remission and elevated but >=70% reduction of baseline CRP and/or SAA.

Latest news:

Novartis has announced new data from a Phase II study with ACZ885 (canakinumab) in patients with tumor necrosis factor (TNF) receptor-associated periodic syndrome (TRAPS – a rare and serious autoinflammatory disease that usually start in childhood).
The study met its primary endpoints and the results will be presented on 7 June at the annual congress of the European League Against Rheumatism (EULAR 2012), in Berlin, Germany ( Gattorno M, Obici L, Meini A, et al. Efficacy and safety of canakinumab patients with TNF Receptor-Associated Syndrome (TRAPS): Poster presentation at: The European League Against Rheumatism (EULAR) congress: June 6-9, 2012, Berlin, Germany).

In the Phase II study, 90% of TRAPS patients treated with ACZ885 experienced clinical remission after only one week of treatment. Clinical remission included a clinically significant improvement of disease symptoms, as assessed by the treating physician. After two weeks of treatment, 95% of patients with TRAPS treated with ACZ885 had achieved a complete or almost complete response (clinical remission as well as reduced levels of CRP and/or serum amyloid A [SAA], a protein associated with acute inflammation), which was maintained until the end of treatment with monthly dosing.  Clinical remission was maintained for all patients from Day 15 onwards in the four month treatment period, except for one patient with a relapse at Day 85 who subsequently responded to the scheduled ACZ885 dose.
Side effects observed in this study were similar to those already seen for ACZ885\'s approved indication in CAPS. Infections, mostly upper respiratory tract infections (URIs), were the most commonly reported category of AE.  At least one AE was reported for 95% of patients, and most AEs were mild in severity. One SAE, a URI that lasted two days, was reported.

Is general: Yes