Study of Efficacy and Safety of Canakinumab in Patients With Hereditary Periodic Fevers

Summary

This study is to determine whether canakinumab is able to induce and maintain a clinically meaningful reduction of disease activity in participants with Hereditary Periodic Fevers (HPF) compared to placebo.

Timeline

Start

2014-06-27

Primary completion

2017-07-04

Completion

2017-07-04

Outcome

Met primary endpoint

registry analysis (superiority test); Epoch 2: crFMF: 150 mg vs Epoch 2: crCMF: Placebo; p <0.0001; Fisher's exact test NCT02059291 ↗

registry analysis (superiority test); Epoch 2: HIDS/MKD: 150 mg vs Epoch 2: HIDS/MKD: Placebo; p = 0.0020; Fisher's exact test NCT02059291 ↗

registry analysis (superiority test); Epoch 2: TRAPS: 150 mg vs Epoch 2: TRAPS: Placebo; p = 0.0050; Fisher's exact test NCT02059291 ↗

Publications

• Gattorno M, Obici L, Penades IC, Kallinich T, Benseler S, Dekker E, Levy J, De Benedetti F, Lachmann H. Long-Term Efficacy and Safety of Canakinumab in Patients With Tumor Necrosis Factor Receptor-Associated Periodic Syndrome: Results From a Phase III Trial. Arthritis Rheumatol. 2024 Feb;76(2):304-312. doi: 10.1002/art.42695. Epub 2023 Dec 8.
• Jeyaratnam J, Simon A, Calvo I, Constantin T, Shcherbina A, Hofer M, Gattorno M, Martini A, Bader-Meunier B, Vastert B, Levy J, Dekker E, de Benedetti F, Frenkel J. Long-term efficacy and safety of canakinumab in patients with mevalonate kinase deficiency: results from the randomised Phase 3 CLUSTER trial. Rheumatology (Oxford). 2022 May 5;61(5):2088-2094. doi: 10.1093/rheumatology/keab696.
• De Benedetti F, Gattorno M, Anton J, Ben-Chetrit E, Frenkel J, Hoffman HM, Kone-Paut I, Lachmann HJ, Ozen S, Simon A, Zeft A, Calvo Penades I, Moutschen M, Quartier P, Kasapcopur O, Shcherbina A, Hofer M, Hashkes PJ, Van der Hilst J, Hara R, Bujan-Rivas S, Constantin T, Gul A, Livneh A, Brogan P, Cattalini M, Obici L, Lheritier K, Speziale A, Junge G. Canakinumab for the Treatment of Autoinflammatory Recurrent Fever Syndromes. N Engl J Med. 2018 May 17;378(20):1908-1919. doi: 10.1056/NEJMoa1706314.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Canakinumab	Monoclonal antibody	2 mg/kg	Subcutaneous
Subject	Canakinumab	Monoclonal antibody	4 mg/kg	Subcutaneous
Subject	Canakinumab	Monoclonal antibody	150 mg	Subcutaneous
Subject	Canakinumab	Monoclonal antibody	300 mg	Subcutaneous

Indications