1305-0046: Phase IIIb FIBRONEER (SARD-ILD)

• Research type

  Research Study

• Full title

  A double blind, randomised, placebo-controlled trial evaluating the efficacy and safety of nerandomilast over 26 weeks in patients with Systemic Autoimmune Rheumatic Diseases associated Interstitial Lung Diseases (SARD-ILD)

• IRAS ID

  1010721

• Contact name

  Medical Information

• Contact email

  medinfo.bra@boehringer-ingelheim.com

• Sponsor organisation

  Boehringer Ingelheim Limited

• Research summary

  Lay Title
  A study to test whether nerandomilast helps people with lung fibrosis related to rheumatic
  diseases

  Brief Summary
  Adults 18 years of age and older or above legal age with lung fibrosis related to systemic autoimmune rheumatic disease can participate in this study. People can only take part if they show no improvement in lung function after standard treatment with immunosuppressant medicine. The main purpose of this study is to find out how a medicine called nerandomilast affects the lungs in people with systemic autoimmune rheumatic disease. Participants are put into 2 groups randomly, which means by chance. One group takes
  nerandomilast tablets and the other group takes placebo tablets. Placebo tablets look like nerandomilast tablets but do not contain any medicine. Participants take a tablet 2 times a day for at least 26 weeks and up to 1 year. Participants continue immunosuppressant
  treatment for their underlying rheumatic disease. Participants are in the study for about 7.5 to 13 months. depending on when they join the study. During this time, they visit the study site 8about 9 to 10 times. At study visits, participants have lung function tests. At select visits, chest imaging is performed. Participants fill in questionnaires about their symptoms and quality of life. The results between the 2 groups are compared to see whether the treatment works. The doctors also regularly check participants’ health and take note of any unwanted effects.

• REC name

  North East - Tyne & Wear South Research Ethics Committee

• REC reference

  24/NE/0212

• Date of REC Opinion

  9 Jan 2025

• REC opinion

  Further Information Favourable Opinion