New clinical endpoints in primary Sjögren’s syndrome: an interventional trial based on stratifying patients


Start Date
End Date
IMI2 - Call 12
Grant agreement number

Type of Action: 
RIA (Research and Innovation Action)

IMI Funding
8 200 000
EFPIA in kind
7 620 020
Total Cost
15 820 020


Primary Sjögren’s Syndrome (pSS) is an autoimmune disease in which the immune system attacks cells in the body that secrete fluids, such as tear ducts and salivary glands. Symptoms include itchy eyes, a dry mouth, joint and muscle pain, difficulty concentrating, and disabling fatigue. Around a third of patients also experience other health problems such as arthritis, fever, vasculitis, kidney disease, and lung disease. Finally, people with pSS are at a greater risk of developing B-cell lymphomas. Although there are treatments to alleviate some symptoms of pSS, there is no cure. The aim of NECESSITY is to identify sensitive clinical endpoints that could be used in clinical trials to determine whether a new pSS medicine works or not. In addition, the project aims to identify biological markers that could be used to identify specific subgroups of patients with different types of pSS. Finally, the project plans to run an innovative clinical trial (a multi-arm, multi-stage platform trial) to validate both the newly-defined pSS endpoints and the subgroups identified. Ultimately, the project results will contribute to the development of much-needed new treatments for pSS. In addition, many of the tools and methodologies developed by the project will also be useful for other autoimmune diseases.

Participants Show participants on map

EFPIA companies
  • Bristol-Myers Squibb Company Corp, Princeton, NJ, United States
  • Glaxosmithkline Research And Development LTD., Brentford, Middlesex, United Kingdom
  • Institut De Recherches Internationales Servier Iris, Suresnes, France
  • Novartis Pharma AG, Basel, Switzerland
Universities, research organisations, public bodies, non-profit groups
  • Academisch Ziekenhuis Groningen, Groningen, Netherlands
  • Assistance Publique Hopitaux De Paris, Paris, France
  • Ecrin European Clinical Research Infrastructure Network, Paris, France
  • Ethniko Kai Kapodistriako Panepistimio Athinon, Athens, Greece
  • Fundacio De Recerca Clinic Barcelona-Institut D Investigacions Biomediques August Pi I Sunyer, Barcelona, Spain
  • Fundacion Publica Andaluza Progreso Y Salud M.P., Seville , Spain
  • Helse Stavanger Hf, Stavanger, Norway
  • Hopitaux Universitaires De Strasbourg, Strasbourg, France
  • Institut National De La Sante Et De La Recherche Medicale, Paris, France
  • Institut Pasteur, Paris, France
  • Karolinska Institutet, Stockholm, Sweden
  • Queen Mary University Of London, London, United Kingdom
  • The University Of Birmingham, Birmingham, United Kingdom
  • Universita Degli Studi Di Udine, Udine, Italy
  • Universitair Medisch Centrum Utrecht, Utrecht, Netherlands
  • Universite De Bretagne Occidentale, Brest, France
  • Universite Paris Cite, Paris, France
  • University Of Newcastle Upon Tyne, Newcastle upon Tyne, United Kingdom
Small and medium-sized enterprises (SMEs) and mid-sized companies (<€500 m turnover)
  • Innovation Acta SRL, Roma, Italy
Patient organisations
  • Association Francaise Gougerot-Sjogren, Courbevoie, France
Third parties
  • Centre Hospitalier Regional Et Universitaire De Brest, Brest, France
  • Hospital Clinic De Barcelona, Barcelona, Spain
  • Universite Paris-Saclay, Saint Aubin, France
  • University College Cork - National University Of Ireland, Cork, Cork, Ireland
Project coordinator
Xavier Mariette
Institut National De La Sante Et De La Recherche Medicale