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An Ascending Dose Study of PIT565 in Participants With Rheumatoid Arthritis | Clinical Trials | Clareo Health

RECRUITINGPHASE1

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)

NCT07029555•Novartis Pharmaceuticals

View on ClinicalTrials.gov

Summary

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

Detailed Description

This is an open-label, uncontrolled study in participants with RA. PIT565 will be administered subcutaneously. The objective of the study is to assess the safety of PIT565 in participants with RA.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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.

Locations (12)

Novartis Investigative Site

CABA, Argentina

Novartis Investigative Site

Sofia, Bulgaria

Novartis Investigative Site

Beijing, China

Novartis Investigative Site

Beijing, China

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

Key Dates

Start Date

June 12, 2025

Primary Completion Date

May 15, 2028

Completion Date

May 16, 2028

Last Updated

March 5, 2026

Enrollment

ESTIMATED participants

Conditions

Rheumatoid Arthritis

Interventions

PIT565

BIOLOGICAL

Contacts

Novartis Pharmaceuticals

CONTACT

+41613241111 novartis.email@novartis.com

Novartis Pharmaceuticals

CONTACT

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 5, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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An Ascending Dose Study of PIT565 in Participants With Rheumatoid Arthritis

Inclusion Criteria

Exclusion Criteria

Clinical Cohort Construction and Therapeutic Effect Evaluation of Integrated Traditional Chinese and Western Medicine in the Treatment of Rheumatoid Arthritis

A Study to Evaluate the Safety and Activity of SAR448501/DR-0201 in Patients With Autoimmune Rheumatic Diseases

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