RecruitingPhase 1NCT06335979

An Ascending Dose Study of PIT565 in Participants With Systemic Lupus Erythematosus (SLE).

A Phase Ib, Open-label, Ascending Dose Study With Step-up Doses to Assess Safety, Tolerability, and Pharmacokinetics of PIT565 in Participants With Systemic Lupus Erythematosus (SLE).

Sponsor

Novartis Pharmaceuticals

Enrollment

54 participants

Start Date

Oct 8, 2024

Study Type

INTERVENTIONAL

Conditions

Systemic Lupus Erythematosus (SLE)

Summary

The purpose of the study is to determine the safety, tolerability, and pharmacokinetics of PIT565 in participants with SLE

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called PIT565 for people with systemic lupus erythematosus (sle). The study is currently recruiting participants at 13 locations. People eligible for this study include aged 18 Years to 75 Years.

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

DRUGPIT565

In each cohort, there will be 3 sentinel participants. Additional participants might be added depending on safety and observed biological activity.

Locations(13)

Novartis Investigative Site

Sofia, Bulgaria

Novartis Investigative Site

Beijing, China

Novartis Investigative Site

Beijing, China

Novartis Investigative Site

Berlin, Germany

Novartis Investigative Site

Mainz, Germany

Novartis Investigative Site

Budapest, Hungary

Novartis Investigative Site

Szeged, Hungary

Novartis Investigative Site

Leiden, South Holland, Netherlands

Novartis Investigative Site

Santiago Compostela, A Coruna, Spain

Novartis Investigative Site

Barcelona, Spain

Novartis Investigative Site

Madrid, Spain

Novartis Investigative Site

Bern, Switzerland

Novartis Investigative Site

Sankt Gallen, Switzerland

View Full Details on ClinicalTrials.gov

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NCT06335979

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