An Ascending Dose Study of PIT565 in Participants With Rheumatoid Arthritis

Launched by NOVARTIS PHARMACEUTICALS · Jun 11, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called PIT565 to see if it is safe and well-tolerated in people with rheumatoid arthritis (RA), a condition that causes joint pain and inflammation. The study will also look at how the body processes the medicine. This is an early-stage (Phase 1) trial, which means it focuses mainly on safety rather than effectiveness.

Adults aged 18 to 75 who have been diagnosed with RA for at least three months may be eligible to join. Participants will need to have received recommended vaccines for pneumococcus, flu, and COVID-19 before starting the study. People with certain heart problems or irregular heart rhythms won’t be able to participate to keep everyone safe. If you take part, you can expect to receive gradually increasing doses of PIT565 while the researchers closely monitor your health and any side effects. The study is not yet recruiting, but it aims to better understand how this new treatment might help people with RA in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Signed informed consent must be obtained prior to participation in the study. Male and female patients, aged 18 to 75 years at screening, diagnosed with RA according to the 2010 ACR/EULAR or 1987 ACR classification at least 12 weeks prior to screening.
• • Immunization (primary or from vaccinations) against pneumococcus, influenza, and COVID-19 infection at least 2 weeks prior to the first dosing. Local guidelines should be followed to determine requirement for vaccination (or booster), as well as the type and schedule of vaccination.
• Exclusion Criteria:
• • • Any of the following cardiac conditions
• • 1. Unstable angina, myocardial infarction, coronary artery bypass graft (CABG), or stroke within 6 months prior to screening
• • 2. Clinically significant and/or uncontrolled heart disease such as congestive heart failure requiring treatment (NYHA Grade ≥ 2) or uncontrolled hypertension
• • 3. Concomitant clinically significant cardiac arrhythmias, e.g., sustained ventricular tachycardia, and clinically significant second or third degree atrioventricular block without a pacemaker
• • 4. History of familial long QT syndrome or known family history of Torsades-de- Pointes
• • 5. Resting QTcF ≥ 450 msec (male) or ≥ 460 msec (female) at screening
• • 6. Use of agents known to prolong the QT interval unless they can be permanently discontinued for the duration of the study.
• • Other protocol-defined inclusion/exclusion criteria may apply.