A phase 2 randomized, double-blind, placebo-controlled, proof-of-concept study of oral seletalisib in primary Sjögren’s syndrome

Maria Juarez (1) , Nieves Diaz (1) , Geoffrey Johnston (1) , Saba Nayar (2) , Andrew Payne (3) , Eric Helmer (4) , Dionne Cain (1) , Paulette Williams (5) , Valerie Devauchelle-Pensec (6) , Benjamin Fisher (2) , Roberto Giacomelli (7) , Jacques-Eric Gottenberg (8) , Giuliana Guggino (9) , Marika Kvarnström (10) , Xavier Mariette (11) , Wan Fai Ng (12, 13) , José Rosas (14) , Juan Sánchez Bursón (15) , Giovanni Triolo (9) , Francesca Barone (2) , Simon Bowman (13)

1 UCB Pharma [Slough]
2 University of Birmingham [Birmingham]
3 Emory Chemical Biology Discovery Center
4 Quantitative Clinical Pharmacology
5 UCB Pharma Raleigh
6 CHU - BREST - Rhumato - CHRU Brest - Service de Rhumatologie
7 UNIVAQ - Università degli Studi dell'Aquila = University of L'Aquila
8 Service de rhumatologie [Strasbourg]
9 Università degli studi di Palermo - University of Palermo
10 Karolinska Institutet [Stockholm]
11 Hôpital Bicêtre [AP-HP, Le Kremlin-Bicêtre]
12 Newcastle upon Tyne Hospitals [Newcastle, UK]
13 NIHR Biomedical Research Centre
14 Hospital Marina Baixa, Villajoyosa
15 Infantaluisa Hospital, Sevilla

This phase 2 proof-of-concept study (NCT02610543) assessed efficacy, safety and effects on salivary gland inflammation of seletalisib, a potent and selective PI3Kδ inhibitor, in patients with moderate-to-severe primary Sjögren's syndrome (PSS).

Mots clés: histology; phosphatidylinositol 3-kinase delta (PI3Kδ); primary Sjögren’s syndrome; proof-of-concept; seletalisib

Domaines: Immunologie

Maria Juarez, Nieves Diaz, Geoffrey Johnston, Saba Nayar, Andrew Payne, et al.. A phase 2 randomized, double-blind, placebo-controlled, proof-of-concept study of oral seletalisib in primary Sjögren’s syndrome. Rheumatology, 2020, ⟨10.1093/rheumatology/keaa410⟩. ⟨hal-03113993⟩