An Ascending Dose Study of PIT565 in Participants With Rheumatoid Arthritis

Inclusion Criteria:

• Signed informed consent must be obtained prior to participation in the study. Maleand female patients, aged 18 to 75 years at screening, diagnosed with RA accordingto the 2010 ACR/EULAR or 1987 ACR classification at least 12 weeks prior toscreening.

• Immunization (primary or from vaccinations) against pneumococcus, influenza,meningococcus and COVID-19 infection at least 2 weeks prior to the first dosing.Local guidelines should be followed to determine requirement for vaccination (orbooster), 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), orstroke within 6 months prior to screening

2. Clinically significant and/or uncontrolled heart disease such as congestive heartfailure requiring treatment (NYHA Grade ≥ 2) or uncontrolled hypertension

3. Concomitant clinically significant cardiac arrhythmias, e.g., sustained ventriculartachycardia, and clinically significant second or third degree atrioventricularblock 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 permanentlydiscontinued for the duration of the study.

Other protocol-defined inclusion/exclusion criteria may apply.