NCT07029555

An Ascending Dose Study of PIT565 in Participants With Rheumatoid Arthritis

A Phase Ib, Open-label, Ascending Dose Study to Assess Safety, Tolerability and Pharmacokinetics of PIT565 in Participants With Rheumatoid Arthritis (RA)

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 57 (estimated)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to determine the safety, tolerability, and pharmacokinetics of PIT565, in participants with rheumatoid arthritis (RA).

Detailed description

This is an open-label, uncontrolled study in participants with RA. PIT565 will be administered subcutaneously. The objective of the study is to assess the safety of PIT565 in participants with RA.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
BIOLOGICAL	PIT565	Study treatment will be provided in vials as open-label participant specific supply.

Timeline

• Start date: 2025-06-12
• Primary completion: 2028-05-15
• Completion: 2028-05-16
• First posted: 2025-06-19
• Last updated: 2026-03-23

Locations

13 sites across 9 countries: Argentina, Bulgaria, China, France, Germany, Hungary, Netherlands, Romania, Spain