PIT565: Study treatment will be provided in vials as open-label participant specific supply.
Study summary
The purpose of the study is to determine the safety, tolerability, and pharmacokinetics of PIT565, in participants with rheumatoid arthritis (RA).
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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, meningococcus 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.
Primary outcome measure(s)
Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) — 6 months Incidence and severity of AEs and SAEs by treatment group, including changes in vital signs, electrocardiograms (ECGs) and laboratory results qualifying and reported as AEs.
Trial sites (16)
Facility
City
Region
Status
Novartis Investigative Site
Pilar
Buenos Aires
Novartis Investigative Site
CABA
Argentina
Novartis Investigative Site
Sofia
Bulgaria
Novartis Investigative Site
Beijing
China
Novartis Investigative Site
Beijing
China
Novartis Investigative Site
Brest
France
Novartis Investigative Site
Le Kremlin-Bicêtre
France
Novartis Investigative Site
Paris
France
Novartis Investigative Site
Jena
Thuringia
Novartis Investigative Site
Mainz
Germany
Novartis Investigative Site
Szeged
Hungary
Novartis Investigative Site
Leiden
South Holland
Novartis Investigative Site
Cluj-Napoca
Cluj
Novartis Investigative Site
Bucharest
Romania
Novartis Investigative Site
Santiago Compostela
A Coruna
Novartis Investigative Site
Barcelona
Spain
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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