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RECRUITINGPhase 1INTERVENTIONAL

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)

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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

Who May Be Eligible (Plain English)

Who May Qualify: - Signed willing to sign a consent form 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. Who Should NOT Join This Trial: • 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

BIOLOGICAL

PIT565

Study treatment will be provided in vials as open-label participant specific supply.

Locations (13)

Novartis Investigative Site
CABA, Argentina
Novartis Investigative Site
Sofia, Bulgaria
Novartis Investigative Site
Beijing, China
Novartis Investigative Site
Beijing, China
Novartis Investigative Site
Le Kremlin-Bicêtre, France
Novartis Investigative Site
Jena, Thuringia, Germany
Novartis Investigative Site
Mainz, Germany
Novartis Investigative Site
Szeged, Hungary
Novartis Investigative Site
Leiden, South Holland, Netherlands
Novartis Investigative Site
Cluj-Napoca, Cluj, Romania
Novartis Investigative Site
Bucharest, Romania
Novartis Investigative Site
Santiago Compostela, A Coruna, Spain
Novartis Investigative Site
Barcelona, Spain