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
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
Benjamin Fisher
- Fonction : Auteur
- PersonId : 782676
- ORCID : 0000-0003-4631-549X
Jacques-Eric Gottenberg
- Fonction : Auteur
- PersonId : 756827
- ORCID : 0000-0002-9469-946X
Xavier Mariette
- Fonction : Auteur
- PersonId : 756829
- ORCID : 0000-0002-4244-5417
- IdRef : 113094116
Francesca Barone
- Fonction : Auteur
- PersonId : 11410
- IdHAL : francesca-barone
- IdRef : 13162413X
Résumé
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).