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

NCT06335979 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2026-03-23

No results posted yet for this study

Summary

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

Conditions

  • Systemic Lupus Erythematosus, SLE

Interventions

DRUG

PIT565

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

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-08
Primary Completion
2027-07-09
Completion
2027-07-09

Countries

  • Bulgaria
  • China
  • Germany
  • Hungary
  • Netherlands
  • Spain
  • Switzerland

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06335979 on ClinicalTrials.gov