Efficacy and Safety of S95011 in Primary Sjögren's Syndrome Patients

PHASE2CompletedINTERVENTIONAL
Enrollment

48

Participants

Timeline

Start Date

August 3, 2021

Primary Completion Date

January 16, 2023

Study Completion Date

May 9, 2023

Conditions
Primary Sjögren's Syndrome
Interventions
DRUG

S95011 concentrate for solution for infusion

IV administration every 2 weeks until week 4 and then every 3 weeks until week 10.

DRUG

Placebo concentrate for solution for infusion

IV administration every 2 weeks until week 4 and then every 3 weeks until week 10.

Trial Locations (19)

4032

Debreceni Egyetem Orvos és Egészségtudományi Centrum Belgyógyászat C épület - Klinikai Immunológiai Tanszék, Debrecen

5011

The Queen Elizabeth Hospital Rheumatology Unit, Woodville

5700

Békés Megyei Központi Kórház, Pándy Kálmán Tagkórház, Infektológia-Hepatológia, Gyula

8000

Vita Verum Medical Bt. Berényi u. 72-100. 95. számú épület 16. Rendelő, Székesfehérvár

15702

CLINICAL GAIAS SANTIAGO Servicio de Reumatología, Santiago de Compostela

16635

Altoona Center for Clinical Research, Duncansville

33000

Hôpital Saint-André, Bordeaux

41010

Hospital Infanta Luisa Quirón Salud Servicio de Reumatología, Seville

75010

Hôpital Laribiosière, Paris

75013

Hôpital Pitié-Salpêtrière, Paris

75571

Hôpital Saint Antoine, Paris

79106

Universitätsklinikum Freiburg Department Innere Medizin Klinik für Rheumatologie und Klinische Immunologie, Freiburg im Breisgau

80228

Colorado Arthritis Associates, Lakewood

91054

Universitätsklinikum Erlangen Medizinische Klinik 3 Rheumatologie und Immunologie, Erlangen

94275

CHU de Bicêtre, Le Kremlin-Bicêtre

08022

CLINICA SAGRADA FAMILIA Servicio de Reumatología y Unidad de Ensayos Clínicos, Barcelona

B15 2TH

Queen Elizabeth Hospital, University Hospitals Birmingham NHS Foundation Trust, Birmingham

NE7 7DN

Freeman Hospital, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne

SO16 6YD

Southampton General Hospital, University Hospital Southampton NHS Trust, Southampton

All Listed Sponsors
collaborator

ADIR, a Servier Group company

INDUSTRY

lead

Institut de Recherches Internationales Servier

OTHER

NCT04605978 - Efficacy and Safety of S95011 in Primary Sjögren's Syndrome Patients | Biotech Hunter | Biotech Hunter