RecruitingPhase 1NCT07029555

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)


Sponsor

Novartis Pharmaceuticals

Enrollment

57 participants

Start Date

Jun 12, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called PIT565 in people with rheumatoid arthritis (RA), starting at low doses and increasing gradually, to evaluate safety and find the right dose. **You may be eligible if:** - You are between 18 and 75 years old - You have been diagnosed with rheumatoid arthritis for at least 12 weeks - You have been vaccinated against pneumococcus, flu, meningococcus, and COVID-19 - You have moderately active RA despite current treatment **You may NOT be eligible if:** - You have a serious heart condition such as unstable angina, recent heart attack, or significant heart rhythm problems - You have active or serious infections - You are pregnant or breastfeeding - You have severe liver or kidney disease - You have a history of certain cancers - You are currently taking biologics or certain immune-suppressing medications that would conflict with the study drug Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALPIT565

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


Locations(14)

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

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

View Full Details on ClinicalTrials.gov

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NCT07029555


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