A Phase Ib, Open-label, Ascending Dose Study to Assess Safety, Tolerability and Pharmacokinetics of PIT565 in Participants With Rheumatoid Arthritis (RA)

ReclutandoFase 1ClinicalTrials.gov

ID: NCT07029555RENIS: IS005151Tipo: INTERVENTIONALInicio: 12 de jun de 2025Fin estimado: 16 de may de 2028

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Resumen

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

Descripción detallada

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.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 75 YearsSexo: ALL

Criterios de inclusión

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.

Criterios de exclusión

• Any of the following cardiac conditions
Unstable angina, myocardial infarction, coronary artery bypass graft (CABG), or stroke within 6 months prior to screening
Clinically significant and/or uncontrolled heart disease such as congestive heart failure requiring treatment (NYHA Grade ≥ 2) or uncontrolled hypertension
Concomitant clinically significant cardiac arrhythmias, e.g., sustained ventricular tachycardia, and clinically significant second or third degree atrioventricular block without a pacemaker
History of familial long QT syndrome or known family history of Torsades-de- Pointes
Resting QTcF ≥ 450 msec (male) or ≥ 460 msec (female) at screening
Use of agents known to prolong the QT interval unless they can be permanently discontinued for the duration of the study.

Intervenciones

biological

PIT565

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

Ubicaciones

Novartis Investigative Site

CABA, Argentina

RECRUITING

Patrocinadores

PrincipalNovartis Pharmaceuticals

Contactos

Novartis Pharmaceuticals

CONTACT

novartis.email@novartis.com +41613241111

Novartis Pharmaceuticals

CONTACT

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