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Clinical Trials in China / NCT07029555
Active, not recruiting Phase 1

An Ascending Dose Study of PIT565 in Participants With Rheumatoid Arthritis

NCT07029555 · tracked via the Priya Life Science China tracker
Sponsor
Novartis Pharmaceuticals
Phase
Phase 1
Started
2025-06-12
Last updated
2026-06-30

Condition(s) studied

Rheumatoid Arthritis

Investigational drug(s) / intervention(s)

PIT565

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)

Trial sites (16)

FacilityCityRegionStatus
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.

View NCT07029555 on ClinicalTrials.gov ↗ ← All trials in China