CPIT565C12101: A phase Ib of PIT565 in rheumatoid arthritis

• Research type

  Research Study

• Full title

  A Phase Ib, open-label, ascending dose study to assess safety, tolerability and pharmacokinetics of PIT565 in participants with rheumatoid arthritis (RA)

• IRAS ID

  1010992

• Contact name

  Fiona Morris

• Contact email

  Fiona.morris@novartis.com

• Sponsor organisation

  Novartis Pharmaceuticals UK Ltd

• Clinicaltrials.gov Identifier

  NCT07029555

• Research summary

  The purpose of the study is to investigate whether PIT565 is safe and well tolerated, and if it can help people with Rheumatoid arthritis (RA). RA is a long-term (chronic) auto-immune disease affecting joints and causing inflammation and pain. This study will also find out how the body processes PIT565 and how PIT565 interacts with the body. This is an open-label and ascending dose study in participants with RA. This means everyone will receive PIT565 treatment and the doses will increase as the study progresses.

• REC name

  Wales REC 3

• REC reference

  26/WA/0006

• Date of REC Opinion

  18 Feb 2026

• REC opinion

  Further Information Favourable Opinion