CMHV370A12201 Sjogrens

• Research type

  Research Study

• Full title

  A multi-center, randomized, participant- and investigator-blinded, placebo-controlled, parallel group basket study to evaluate the safety, tolerability and efficacy of MHV370 in participants with Sjögren’s Syndrome or Mixed Connective Tissue Disease.

• IRAS ID

  300993

• Contact name

  Elizabeth Price

• Contact email

  elizabeth.price5@nhs.net

• Sponsor organisation

  Novartis Pharma Services AG

• Eudract number

  2020-004937-19

• Clinicaltrials.gov Identifier

  NCT04988087

• Duration of Study in the UK

  2 years, 2 months, 31 days

• Research summary

  Sjögren's Syndrome (SjS) is the UK’s second most common autoimmune rheumatic disease, yet the condition remains under recognised and frequently under treated. The effects of SjS can be widespread; the moisture-producing glands of the body are affected and many organ systems may be involved as well. SjS has a severe impact on quality of life and productivity, often caused by disabling fatigue associated with the disease.

  Mixed Connective Tissue Disease (MCTD) is a rare disease syndrome with overlapping features of other systemic autoimmune diseases including SjS. There is a high frequency of Raynaud’s syndrome, swollen hands, sclerodactyly, arthritis, polymyositis and interstitial lung disease in patients with MCTD. There is currently no cure for either SjS or MCTD.

  MHV370 is an orally bioavailable antagonist of human TLR7 and TLR8, and is intended for the treatment of diseases where pathology is thought to be driven by excessive activation of TLR7/8. TLR7 and TLR8 are thought to play a role in several systemic autoimmune diseases, including SjS and MCTD.

  This is a randomised placebo-controlled phase II study designed to establish safety, tolerability and efficacy of MHV370 in participants with SjS or with MCTD.

  Female and male participants aged 18 to 75 years with moderate to severe SjS or diagnosis of MCTD; a total of approximately 60 participants will be enrolled in this study, with 3 sites in the UK and a target of 4 patients recruited in the UK.

  Participants will first undergo a screening period of up to 6 weeks, followed by a treatment duration of 24 weeks and a follow-up period of 4 weeks. The total duration for each participant in the study will be up to 34 weeks.

• REC name

  North East - Tyne & Wear South Research Ethics Committee

• REC reference

  21/NE/0169

• Date of REC Opinion

  1 Nov 2021

• REC opinion

  Further Information Favourable Opinion