Actively Recruiting
An Ascending Dose Study of PIT565 in Participants With Rheumatoid Arthritis
Led by Novartis Pharmaceuticals · Updated on 2026-05-01
57
Participants Needed
14
Research Sites
152 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of the study is to determine the safety, tolerability, and pharmacokinetics of PIT565, in participants with rheumatoid arthritis (RA).
CONDITIONS
Official Title
An Ascending Dose Study of PIT565 in Participants With Rheumatoid Arthritis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent obtained before participation
- Male or female aged 18 to 75 years at screening
- Diagnosed with rheumatoid arthritis using 2010 ACR/EULAR or 1987 ACR criteria at least 12 weeks before screening
- Immunized against pneumococcus, influenza, meningococcus, and COVID-19 at least 2 weeks before first dose, following local guidelines
You will not qualify if you...
- History of unstable angina, myocardial infarction, coronary artery bypass graft, or stroke within 6 months before screening
- Clinically significant or uncontrolled heart disease such as congestive heart failure requiring treatment (NYHA Grade ≥ 2) or uncontrolled hypertension
- Significant cardiac arrhythmias like sustained ventricular tachycardia or second/third degree atrioventricular block without a pacemaker
- Family history of familial long QT syndrome or Torsades-de-Pointes
- Resting QTcF ≥ 450 msec (male) or ≥ 460 msec (female) at screening
- Use of drugs known to prolong QT interval unless they can be stopped permanently during the study
- Other protocol-defined inclusion or exclusion criteria may apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 14 locations
1
Novartis Investigative Site
CABA, Argentina, C1181ACH
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2
Novartis Investigative Site
Sofia, Bulgaria, 1618
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3
Novartis Investigative Site
Beijing, China, 100191
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4
Novartis Investigative Site
Beijing, China, 100730
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5
Novartis Investigative Site
Brest, France, 29200
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6
Novartis Investigative Site
Le Kremlin-Bicêtre, France, 94275
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7
Novartis Investigative Site
Jena, Thuringia, Germany, 07740
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8
Novartis Investigative Site
Mainz, Germany, 55131
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9
Novartis Investigative Site
Szeged, Hungary, 6725
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10
Novartis Investigative Site
Leiden, South Holland, Netherlands, 2333 CL
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11
Novartis Investigative Site
Cluj-Napoca, Cluj, Romania, 400006
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12
Novartis Investigative Site
Bucharest, Romania, 011658
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13
Novartis Investigative Site
Santiago Compostela, A Coruna, Spain, 15706
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14
Novartis Investigative Site
Barcelona, Spain, 08035
Actively Recruiting
Research Team
N
Novartis Pharmaceuticals
CONTACT
N
Novartis Pharmaceuticals
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
8
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