A study of OM336 in Participants with Active Sjogren’s Disease or Idiopathic Inflammatory Myopathy

• Research type

  Research Study

• Full title

  An Open-Label, Phase 1b, Multiple Ascending Dose Study of OM336 in Participants with Active Sjogren’s Disease or Idiopathic Inflammatory Myopathy

• IRAS ID

  1013246

• Contact name

  Neely Mozaffarian

• Contact email

  clinical@ouromeds.com

• Sponsor organisation

  Ouro Medicines Limited

• ISRCTN Number

  ISRCTN16355728

• Research summary

  This is an early-phase study (clinical trial) that is testing the safety of OM336 in participants with Sjogren’s disease (SjD) or idiopathic inflammatory myopathy (IIM) who still have active disease after trying standard treatments. Up to 39 people will join the study, where everyone will receive active drug and each person is assigned to one of 3 dose levels.
  About 39 men and women who are at least 18 years of age can enrol in the study.
  Participants will get four weekly injections of OM336 under the skin, starting with a low dose that increases each week. To help prevent side effects and infections, participants may receive medicines such as steroids, antihistamines, fever reducers, or antibiotics. The doctor will monitor their health and antibody levels closely and may give antibody replacement if needed

• REC name

  North West - Haydock Research Ethics Committee

• REC reference

  26/NW/0016

• Date of REC Opinion

  4 Mar 2026

• REC opinion

  Further Information Unfavourable Opinion