NCT06335979

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).

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 54 (estimated)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

This is an open-label, ascending dose, uncontrolled study in participants with SLE systemic lupus erythematosus (SLE). PIT565 will be administered subcutaneously (s.c.) following premedication. Up to 8 cohorts are planned. Every cohort will have 3 sentinel participants and, depending on safety as well as observed biological activity, may have up to 3 additional optional participants (up to 6 participants per cohort). The decision to escalate the dose from one cohort to the next will be based both on safety and PD data. After the identification of a dose level that has been declared safe and has induced predefined B cell depletion in 100% of the participants (candidate dose level), the cohort from this candidate dose level can optionally be enriched with 6 additional participants (up to a total of 12 participants).

Conditions

• Systemic Lupus Erythematosus, SLE

Interventions

Type	Name	Description
DRUG	PIT565	In each cohort, there will be 3 sentinel participants. Additional participants might be added depending on safety and observed biological activity.

Timeline

• Start date: 2024-10-08
• Primary completion: 2027-07-09
• Completion: 2027-07-09
• First posted: 2024-03-28
• Last updated: 2026-03-23

Locations

13 sites across 7 countries: Bulgaria, China, Germany, Hungary, Netherlands, Spain, Switzerland