*JASMINE

• Research type

  Research Study

• Full title

  A Multicenter, Parallel-group, Double-blind, 2-Arm, Phase III Study to Investigate the Efficacy and Safety of Anifrolumab Administered as Subcutaneous Injection and Added to Standard of Care Compared with Placebo Added to Standard of Care in Adult Participants with Polymyositis

• IRAS ID

  1008006

• Contact name

  Manika Azad

• Contact email

  manika.azad@astrazeneca.com

• Sponsor organisation

  Astra ZenecaAB

• Research summary

  In polymyositis, the immune system becomes overactive. It thinks the muscle tissue is something not recognized in the body and overreacts. This causes the muscle tissue to become inflamed. This is thought to happen because interferons are not working properly in polymyositis.
  Anifrolumab is a medicine that reduces the overactivity of the immune system by blocking the action of some interferons. In this study, we want to see if blocking these interferons with anifrolumab may help to better control polymyositis.
  This trial will look at the effects of using anifrolumab in adults with PM who are receiving standard medication to confirm anifrolumab is safe and effective (improves their disease activity). Participants are permitted to join this study only if they continue to meet eligibility criteria; the major is diagnosis of polymyositis and not having other conditions that affecting muscles. This trial will include about 162 participants who are 18 to 70 years old.
  The total trial duration for a participant is about 70 weeks and includes a 6-week screening period, a 52-week treatment period, and a 12-week safety follow-up period. About 162 participants will be randomly assigned (50/50) to anifrolumab or placebo for 24 weeks during the double-blind part of the treatment period. Neither the participant nor the physician will know which trial medication the participant is receiving during this part of the trial. All participants will receive anifrolumab for 28 weeks during the open-label part of the treatment period. There are a total of 18 trial visits (14 in-clinic and 4 remote), with most visits occurring during the treatment period every 4 weeks.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  23/NW/0247

• Date of REC Opinion

  23 Oct 2023

• REC opinion

  Further Information Favourable Opinion